In October 2001, the Company sold its ophthalmic product line to Bausch & Lomb. Future payments were subject to certain milestones related to product approvals by the FDA and the royalties on the sales of these products.
At the time of the sale in 2001, Pharmos received gross proceeds of approximately $25 million in cash. In January 2005, Pharmos received additional gross proceeds of approximately $12.275 million from Bausch & Lomb in connection with their successful commercial launch of the Zylet™ product. The net proceeds to Pharmos from this payment were approximately $9.2 million, after making the payments to Bausch & Lomb, Dr. Nicholas Bodor and the Israel-U.S. Binational Industrial Research and Development Foundation as described below. In addition, Pharmos may receive a royalty payment of up to $10 million if actual Zylet™ sales during the first two years after commercialization exceed agreed-upon amounts.
As part of the original agreement with Bausch & Lomb, Pharmos agreed to pay up to $3.75 million of the costs of developing Zylet™. In January 2005, Pharmos paid approximately $1.56 million (included in accounts payable on December 31, 2004) which was the remaining balance owed to Bausch & Lomb for the Zylet™ project development under the terms of the agreement.
Dr. Nicholas Bodor, a former director of and consultant to Pharmos, is the patent owner and licensor of the technology underlying the ophthalmic product line sold to Bausch & Lomb. In January 2005, Pharmos paid Dr. Bodor approximately $1.338 million in connection with the commercialization of Zylet™, per the license agreement with Dr. Bodor. Pharmos owes Dr. Bodor an additional 14.3% of any payments the Company may receive from Bausch & Lomb in the event that certain sales levels are exceeded in the first two years following commencement of Zylet™ sales in the U.S.
In February 2005, the Company paid the Israel-U.S. Binational Industrial Research and Development Foundation (BIRDF) $.212 million, which represented the maximum amount the Company owed the foundation for Zylet™.
Pharmos’ subsidiary, Pharmos Ltd., licensed its patents related to the oral delivery of lipophilic substances in the limited field of use of nutraceuticals to Herbamed, Ltd., a company in Israel controlled by the Chairman and Chief Executive Officer of Pharmos. In the three months ending March 31, 2006 and March 31, 2005, the Company recorded in other income royalties of $991 and $12,202, respectively, per the licensing agreement with Herbamed.
6. Private Placement of Convertible Debt
On September 26, 2003, the Company completed a private placement of convertible debentures and warrants to six institutional investors, generating total gross proceeds of $21.0 million. Five million dollars of the proceeds was to be used for working capital purposes, and $16.0 million was to be available to fund acquisitions upon the approval of the investors. The convertible debentures were convertible into common stock of the Company at a fixed price of $20.20, or 205% above the closing bid price of the stock for the five days preceding the closing date. The debentures, which bore an interest rate of 4%, were redeemed in 13 substantially equal monthly increments which began March 31, 2004. Amounts converted into shares of Pharmos common stock reduced the monthly redemption amount in inverse order of maturity. The $16.0 million earmarked for acquisition activity was to be held in escrow until used or repaid. In connection with the financing, the Company also issued 1,102,941 three-year warrants (including 102,941 placement agent warrants) to purchase 1,102,941 shares of common stock at an exercise price of $10.20 per share. The issuance costs related to the convertible debentures of approximately $1,229,000 in cash and $434,000 for the value of the placement agent warrants were capitalized and amortized over the life of the debt. The Company calculated the value of the warrants at the date of the transaction, including the placement agent warrants, as being approximately $4,652,877 under the Black-Scholes option-pricing method (assumption: volatility 75%, risk free rate 1.59% and zero dividend yield). The Company allocated the $21.0 million in gross proceeds between the convertible debentures and the warrants based on their relative fair values. The Company has reported the debt discount as a direct reduction to the face amount of the debt in accordance with APB 21. The discount had accreted over the life of the outstanding debentures. The issuance costs allocated to the convertible debentures were deferred and amortized to interest expense over the life of the debt. APB 21 also requires the Company to allocate the warrant costs between the convertible debentures and the transaction warrants. The issuance costs allocated to the warrants were recorded as a debit to additional paid in capital. During the first quarter of 2004, one of the investors from the September 2003 Convertible Debentures private placement converted a total of $2 million plus interest. The Company issued 99,532 shares of common stock. As of March 31, 2005, the Convertible Debentures were repaid.
7. Common Stock Transactions
In the three months ended March 31, 2006, there were no shares of common stock issued pursuant to the Pharmos Corporation 2001 Employee Stock Purchase Plan or options exercised under the Company’s Stock Option Plans.
On May 26, 2005, Pharmos Corporation filed a Certificate of Change with the Nevada Secretary of State which served to effect, as of May 31, 2005, a 1-for-5 reverse split of Pharmos’ common stock. As a result of the reverse stock split, every five shares of Pharmos common stock were combined into one share of common stock; any fractional shares created by the reverse stock split were rounded up to whole shares. The reverse stock split affected all of Pharmos’ common stock, stock options, restricted shares and warrants outstanding immediately prior to the effective date of the reverse stock split. The reverse split reduced the number of shares of Pharmos’ common stock outstanding from 95,137,076 shares to 19,027,809 shares, and the number of authorized shares of common stock was reduced from 150,000,000 shares to 30,000,000 shares. The authorized shares of common stock were increased to 60,000,000 shares at the Annual Meeting held in September 2005.
On September 6, 2004, the Board of Directors approved the Retention Award Agreements and Pharmos entered into Retention Award Agreements with each of Dr. Haim Aviv, Chairman and Chief Executive Officer, and Dr. Gad Riesenfeld, its then President and Chief Operating Officer. The Company granted retention awards of $300,000 cash and 75,950 restricted stock units to Dr. Aviv and $200,000 cash and 50,633 shares of restricted stock to Dr. Riesenfeld (the “Awards”). Under the agreement, one-half of the Awards vested on December 31, 2005 and the balance of Dr. Aviv’s Awards shall vest and become non-forfeitable on June 30, 2007, subject to certain accelerated vesting provisions. Under the terms of Dr. Riesenfeld’s severance agreement, the balance of his Awards vested on his departure from the Company on April 2, 2006 and the expense of those awards was accelerated through April 2, 2006. The fair value of the restricted shares was based on the fair value of the stock on the issuance date. The aggregate fair value of the restricted stock awards totaled $2 million. For financial reporting purposes, the cash awards and the fair value of the restricted stock awards, which totaled $2,500,000, are being expensed pro rata over the vesting periods. During the quarter ended March 31, 2006, the Company recorded an expense of approximately $265,000 in connection with the Awards including the accelerated vesting of Dr. Riesenfeld’s awards.
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On March 4, 2003, the Company raised $4.3 million from the placement of common stock and warrants. The private placement offering was completed by issuing 1,011,765 shares of common stock at a price of $4.25 per share and approximately 200 thousand warrants at an exercise price of $6.25 per share. Additionally, the remaining balance of the September 2000 Convertible Debenture offering was redeemed for cash. The original face amount of $3.5 million was redeemed for approximately $4.0 million, which included accrued and unpaid interest. According to EITF 00-19, the issued warrants meet the requirements of and are being accounted for as a liability since registered shares must be delivered upon settlement. The Company calculated the initial value of the warrants, including the placement agent warrants, as being approximately $394,000 under the Black-Scholes option-pricing method (assumption: volatility 75%, risk free rate 2.88% and zero dividend yield). The value of the warrants is being marked to market each reporting period as a gain/loss until exercised or expiration and amounted to $24,776 at March 31, 2006. Upon exercise of each of the warrants, the related liability is reduced by recording an adjustment to additional paid-in-capital.
The fair value of the warrants is being marked to market using the Black-Scholes option-pricing model with the following assumptions:
| Three months ended March 31, | |
| 2006 | 2005 |
Risk-free interest rate | 4.77% | 3.73% |
Expected lives (in years) | 1 | 2 |
Dividend yield | 0% | 0% |
Expected volatility | 103% | 93% |
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8. Segment and Geographic Information
The Company is active in one business segment: designing, developing, selling and marketing pharmaceutical products. The Company maintains development operations in the United States and Israel. The Company’s selling operations are maintained in the United States.
Geographic information for the three months ending March 31, 2006 and 2005 are as follows:
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| | Three months ended March 31, | |
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| | 2006 | | 2005 | |
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Net (loss) income | | | | | | | |
United States | | $ | (2,928,140 | ) | $ | 6,752,687 | |
Israel | | | (74,546 | ) | | (75,160 | ) |
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| | $ | (3,002,686 | ) | $ | 6,677,527 | |
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Capital Expenditures | | | | | | | |
United States | | $ | — | | $ | 3,945 | |
Israel | | | 96,097 | | | 18,558 | |
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| | $ | 96,097 | | $ | 22,503 | |
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| | | | | | | |
| | 2006 | | 2005 | |
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Total Assets | | | | | | | |
United States | | $ | 42,613,531 | | $ | 54,222,038 | |
Israel | | | 3,908,732 | | | 3,613,137 | |
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| |
|
| |
| | $ | 46,522,263 | | $ | 57,835,175 | |
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|
| |
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| |
| | | | | | | |
Long Lived Assets, net | | | | | | | |
United States | | $ | 73,947 | | $ | 122,724 | |
Israel | | | 686,525 | | | 772,305 | |
| |
|
| |
|
| |
| | $ | 760,472 | | $ | 895,029 | |
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|
| |
|
| |
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9. Subsequent Events
The Company and James A. Meer, Chief Financial Officer, have agreed that when his current employment agreement expires in July 2006, it will not be renewed. Mr. Meer will remain in his current role until the engagement of his successor.
10. Commitments and Contingencies
The Company and certain current officers have been named as defendants in several purported shareholder class action lawsuits alleging violations of federal securities laws. These lawsuits were filed beginning in January 2005 and are pending in the U.S. District Court for the District of New Jersey. These lawsuits assert claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder. The complaints allege generally that the defendants knowingly or recklessly made false or misleading statements regarding the effectiveness of dexanabinol in treating TBI (Traumatic Brain Injury) which had the effect of artificially inflating the price of the Company’s common stock. The complaints seek unspecified damages. These class actions have been consolidated by order of the court and lead plaintiffs and lead plaintiffs’ counsel have been appointed. An amended complaint was filed in September 2005. In November 2005, the Company moved to dismiss the litigation, and the motion was fully briefed on February 10, 2006. Decision on the motion is pending.
In addition, two purported shareholders of the Company’s common stock have commenced derivative actions against the Company’s directors and against certain current and former officers. The first derivative lawsuit was commenced in February 2005 in the U.S. District Court for the District of New Jersey, and has been consolidated for pretrial purposes with the class actions. An amended complaint in the federal derivative lawsuit was filed in September 2005. The Company also moved to dismiss this litigation, and briefing on the motion was completed on February 10, 2006. Decision on the motion is pending. The second lawsuit was filed in April 2005 in the Superior Court of New Jersey, County of Middlesex. An amended complaint in the state court case was filed in November 2005. This action has been stayed pending decisions on the motions to dismiss in the Federal actions. Both lawsuits allege generally, on behalf of the Company (which has been named as a nominal defendant), breaches of fiduciary duty and other state law violations arising from the same set of underlying facts as the class actions. The complaints seek unspecified damages.
Management intends to defend these lawsuits vigorously. However, we cannot assure you that we will prevail in these actions, and, if the outcome is unfavorable to Pharmos, our reputation, profitability and share price could be adversely affected.
16
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
This discussion and analysis of our financial condition and results of operations contains forward-looking statements that involve risks and uncertainties. The Company has based these forward-looking statements on our current expectations and projections of future events. Such statements reflect our current views with respect to future events and are subject to unknown risks, uncertainty and other factors that may cause results to differ materially from those contemplated in such forward looking statements. Statements made in this document related to the development, commercialization and market expectations of the Company’s drug candidates, to the establishment of corporate collaborations, and to the Company’s operational projections are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Among the factors that could result in a materially different outcome are the inherent uncertainties accompanying new product development, action of regulatory authorities and the results of further trials. Additional economic, competitive, governmental, technological, marketing and other factors identified in Pharmos’ filings with the Securities and Exchange Commission could affect such results. In addition, the following discussion should be read in conjunction with the consolidated financial statements and the related notes thereto included elsewhere in this report.
Executive Summary
Pharmos Corporation is a specialty pharmaceutical company that discovers and develops novel therapeutics to treat a range of indications including pain, inflammation, autoimmunity and select central nervous system (CNS) disorders. We have a portfolio of drug candidates and compounds in various development stages, including clinical, preclinical and discovery. The Company’s core proprietary technology platform focuses on the discovery and development of synthetic cannabinoid compounds. Collaborative research as well as in-house research at Pharmos over the last decade has served as a cornerstone of our scientific foundation, and through such efforts we have extensively characterized many of the key variables involved in cannabinoid receptor activation and modulation. In order to identify and optimize promising drug candidates quickly and efficiently, we combine:
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• | Our extensive knowledge of the cannabinoid pathways we believe are responsible for therapeutic effects and strategies for minimizing potential adverse effects |
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• | Our comprehensive library of well-annotated cannabinoid potential drug candidates |
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• | Our interdisciplinary drug discovery and development approach |
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• | Manufacturing capability of clinical material, including a cGMP-compliant pilot plant |
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• | Pharmaceutical formulation expertise, which has provided additional opportunities for developing novel drug delivery systems which can be employed both for internal programs in pain and inflammation and which also provide partnering opportunities for areas outside of our therapeutic focus |
The Company’s discovery efforts are focused primarily on CB2-selective compounds which are small molecule cannabinoid receptor agonists that bind preferentially to CB2 receptors found primarily in peripheral immune cells. Cannabinor, the lead CB2-selective receptor agonist candidate, has completed Phase I testing and is scheduled for preliminary proof-of-principle Phase IIa testing in various pain indications during the first half of 2006. Other compounds from Pharmos’ proprietary synthetic cannabinoid library are in pre-clinical studies targeting nociceptive, neuropathic and visceral pain, as well as autoimmune diseases, including multiple sclerosis, rheumatoid arthritis and inflammatory bowel disease.
The Company also has a family of synthetic cannabinoid compounds that do not bind to cannabinoid receptors. Unlike the CB2-selective agonists such as cannabinor, the pharmacologic activity of these compounds is mediated by processes other than CB receptor signaling. The Company is seeking to partner dexanabinol, its lead compound from this family, as a preventive agent against cognitive impairment following cardiac surgery.
The Company’s NanoEmulsion drug delivery system, a proprietary asset derived from our formulation expertise, is in clinical development for topical application of analgesic and anti-inflammatory agents. In 2006, the Company expects to complete a second Phase I trial of this delivery technology to confirm the excellent local tolerability as well as pharmacokinetic parameters of a more optimized formulation. The NanoEmulsion technology has demonstrated additional potential applications, including vaccine formulation as well as targeted delivery of such molecules as antibiotics. The Company is interested in partnering this technology in these areas.
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The Company intends to acquire later stage product candidates for treating diseases in line with its research and development expertise and targeted areas of interest, including pain, gastrointestinal inflammation, autoimmunity and select CNS disorders.
On March 15, 2006, the Company announced an agreement to acquire Vela Pharmaceuticals, Inc., which has a Phase II product candidate, dextofisopam, in development to treat irritable bowel syndrome. The acquisition will require shareholder approval. The Company intends to dedicate substantial resources to complete clinical development of this product candidate. The Vela acquisition also includes additional compounds in preclinical and/or clinical development for neuropathic pain, inflammation and sexual dysfunction.
The Company continues to refine its commercialization and business development strategy with the intention of capitalizing on internal resources through strategic alliances and scientific and academic collaborations, out-licensing and co-development opportunities, as well as balancing the portfolio with strategic acquisitions and in-licensing opportunities.
2006 Business Objectives
During late 2005, the Company commenced a Phase I trial for its lead candidate for treating pain, a CB-2 selective agonist, cannabinor, which was completed in January 2006. The Company expects to enter Phase II testing in pain indications in the first half of 2006. The Company’s NanoEmulsion drug delivery system is in development for the topical application of analgesic and anti-inflammatory agents. The Company expects to commence a clinical program in the second quarter of 2006. From the dextrocannabinoid family, the neuroprotective drug candidate dexanabinol completed a Phase IIa trial as a preventive agent against post-surgical cognitive impairment in the fourth quarter of 2004. Results of the exploratory Phase II trial of dexanabinol as a preventive agent for cognitive impairment (CI) in coronary artery bypass graft (CABG) patients have been reviewed internally and with the FDA. The Company announced in March 2006 that it will seek a partner to further develop this product. The Company intends to complete the acquisition of Vela Pharmaceuticals, Inc., subject to shareholder’s approval, during the third quarter of 2006.
The results for the three months ended March 31, 2006 and 2005 were a net loss of $3.0 million and a net profit of $6.7 million or a (loss) income per share of $(0.16) and $0.35, respectively.
Except for 2001, the Company has experienced operating losses every year since inception in funding the research, development and clinical testing of our drug candidates. As of March 31, 2006, the Company’s accumulated deficit was approximately $148.9 million. The Company expects to incur additional losses over the next several years as the Company’s research and development and clinical trial programs continue. The Company’s ability to achieve profitability, if ever, is dependent on its ability to develop and obtain regulatory approvals for its product candidates, to enter into agreements for product development and commercialization with strategic corporate partners and contract to develop or acquire the capacity to manufacture and sell its products. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources.”
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Results of Operations
Quarters ended March 31, 2006 and 2005
Total operating expenses for the first quarter of 2006 decreased by $936,515 or 21%, from $4,394,699 in 2005 to $3,458,184 in 2006. The Company will enter Phase II testing in pain indications with cannabinor in the second quarter of 2006. The Company’s NanoEmulsion drug delivery system is in clinical stage development for the topical application of analgesic and anti-inflammatory agents. The Company expects to commence a clinical program in the first half of 2006 for its NanoEmulsion drug delivery system. During the first quarter of 2006, the Company incurred higher compensation costs related to severance costs for the departure of two executives and the implementation of the equity based compensation of SFAS 123(R) which were offset by lower costs for clinical studies, lower legal fees, and lower salaries related to a reduction in workforce, as compared with the first quarter of 2005.
Research efforts in the first quarter of 2006 have been focused on the completion of cannabinor toxicology, scale-up manufacturing, technology transfer to the active ingredient supplier, and clinical trial finished material at Pharmos’ facility in Rehovot, Israel, as well as continuing to identify new, potentially more potent, CB2 agonists.
The Company considers major research & development projects to be those projects that have reached at least Phase II level of clinical development. At this time, there are no projects that are in Phase II. We expect that Cannabinor will be in Phase II by the end of the second quarter.
Gross expenses for other research and development projects in early stages of development for the first quarters of 2006 and 2005 were $1,130,495 and $1,469,985, respectively. Over 65% of the spending in both 2006 and 2005 was related to cannabinor and other CB2 compounds. Research & development (R&D) gross expenses decreased by $637,525 or 26% from $2,504,639 in 2005 to $1,867,114 in 2006, related to a reduction in clinical activities which are expected to pick up in the second quarter of 2006. The Company recorded research and development grant receivables from the Office of the Chief Scientist of Israel’s Ministry of Industry and Trade of $300,635 and $19,576 during the first quarter of 2006 and 2005, respectively, which reduced the research and development expenses. Total research and development expenses, net of grants, decreased by $918,584 or 37% from $2,485,063 in 2005 to $1,566,479 in 2006.
General and administrative expenses increased by $18,510 or 1% to $1,813,221 in 2006 from $1,794,711 in 2005 in total; however, there were offsetting variances within the major expense categories. The increase in general and administrative expenses is due to higher compensation costs of $252,959 made up of an accrual of severance costs for the departure of two executives and the implementation of the equity based compensation related to implementation of SFAS 123(R) in the first quarter of 2006 compared to the first quarter of 2005 offset by lower salaries related to a reduction in workforce and by reduced amortization related to the 50% share of the Retention Awards which vested on December 31, 2005. Other decreases in general and administrative expenses are due to lower professional fees by $181,737, related to reduced costs for legal fees in 2006 related to the class action suits.
Depreciation and amortization expenses decreased by $36,441, or 32%, from $114,925 in 2005 to $78,484 in 2006. The decrease is due to fixed assets which have become fully depreciated.
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Other income (expense), net, decreased by $10,616,728 from income of $11,072,226 in 2005 to income of $455,498 in 2006. The majority of the decrease is from the non-recurring receipt of the Bausch & Lomb milestone payment received in the first quarter of 2005. Interest expense decreased by $160,546 to $0 in 2006 from $160,546 in 2005 related to the retirement of the September 2003 Convertible Debentures during the first quarter of 2005. Interest income increased by $196,208, or 73%, to $465,704 in 2006 from $269,496 in 2005 as a result of higher interest rates. The gain related to the valuation of warrants decreased by $216,827 to $14,104 in 2006 from $230,931 in 2005. During the quarter, the Company recorded in other income royalties of $991 compared with $12,202 in the first quarter of 2005 per the licensing agreement with Herbamed Ltd, a company controlled by Dr. Haim Aviv, the Company’s CEO.
No tax provision is required at this time since the company expects to be in a tax loss position at year-end December 31, 2006 and has net operating losses from previous years. The Company has established a 100% valuation allowance against the deferred tax asset.
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Liquidity and Capital Resources
The Company incurred cumulative operating losses since 2002 and had an accumulated deficit of $148.9 million at March 31, 2006. The Company has financed its operations with public and private offerings of securities, advances and other funding pursuant to a marketing and asset agreement with Bausch & Lomb, grants from the Office of the Chief Scientist of Israel, research contracts, the sale of a portion of its New Jersey State Net Operating Loss carryforwards, and interest income. Should the Company be unable to raise adequate financing or generate revenue in the future, operations will need to be scaled back or discontinued.
The following table describes the Company’s liquidity and financial position on March 31, 2006, and on December 31, 2005:
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| | March 31, 2006 | | December 31, 2005 | |
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Working capital | | | $ | 41,555,607 | | | | $ | 44,763,056 | | |
Cash and cash equivalents | | | $ | 5,139,887 | | | | $ | 10,289,127 | | |
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Short term investments | | | $ | 36,477,828 | | | | $ | 35,748,343 | | |
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Total cash, cash equivalents and short term investments | | | $ | 41,617,715 | | | | $ | 46,037,470 | | |
Current working capital position
As of March 31, 2006, the Company had working capital of $41.6 million consisting of current assets of $44.1 million and current liabilities of $2.6 million. This represents a decrease of $3.2 million from its working capital of $44.8 million on current assets of $47.4 million and current liabilities of $2.6 million as of December 31, 2005. This decrease in working capital of $3.2 million was principally associated with the funding of R&D and G&A activities.
Current and future liquidity position
Management believes that the current cash, cash equivalents and short term investments, totaling $41.6 million as of March 31, 2006, will be sufficient to support the Company’s continuing operations beyond March 31, 2007. The Company is continuing to actively pursue various funding options, including additional equity offerings, strategic corporate alliances, business combinations and the establishment of product related research and development limited partnerships, to obtain additional financing to continue the development of its products and bring them to commercial markets. Should the Company be unable to raise adequate financing or generate revenue in the future, long-term operations will need to be scaled back or discontinued.
In regard to the Vela acquisition, Management believes that the current cash, cash equivalents and short term investments, totaling $41.6 million as of March 31, 2006, will be sufficient to support the Company’s continuing operations for the combined company of Pharmos and Vela beyond March 31, 2007.
Cash
At March 31, 2006, cash and cash equivalents totaled $5.1 million. At December 31, 2005 cash and cash equivalents totaled $10.3 million. This net decrease in cash of $5.2 million was due to the net investment of cash in short term investments in the amount of $.7 million, $3.8 million for normal operating requirements and capital expenditures, and $.7 million for merger related expenses. The cash, cash equivalents short term investments will be used to finance future growth.
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Operating activities
Net cash used in operating activities through the first quarter of 2006 was $3.6 million compared to net cash used of $3.9 million through the first quarter of 2005. The decrease in cash used of $0.3 million is primarily due to lower R&D spending related to the clinical trials and the timing of the of grants.
Investing activities
The Company invested cash of approximately $.7 million in merger related costs during the three months ended March 31, 2006 and an increased net investment in short term investments of $.7 million.
Capital expenditures for property, plant and equipment for the three months ended March 31, 2006 and 2005 totaled approximately $96,000 and $23,000, respectively for normal replacements and improvements.
Financing activities
There were no financing activities in the first quarter of 2006. In the first quarter of 2005, the repayment of the remainder of the September 2003 Convertible Debentures was made.
Other Proceeds
In October 2001, the Company sold its ophthalmic product line to Bausch & Lomb. Future payments were subject to certain milestones related to product approvals by the FDA and the royalties on the sales of these products.
At the time of the sale in 2001, Pharmos received gross proceeds of approximately $25 million in cash. In January 2005, Pharmos received additional gross proceeds of approximately $12.275 million from Bausch & Lomb in connection with their successful commercial launch of the Zylet™ product and income from the Office of the Chief Scientist of Israel. The net proceeds to Pharmos from this payment were approximately $9.2 million, after making the payments to Bausch & Lomb, Dr. Nicholas Bodor and the Israel-U.S. Binational Industrial Research and Development Foundation as described below. In addition, Pharmos may receive a royalty payment of up to $10 million if actual Zylet™ sales during the first two years after commercialization exceed agreed-upon amounts.
As part of the original agreement with Bausch & Lomb, Pharmos agreed to pay up to $3.75 million of the costs of developing Zylet™. In January 2005, Pharmos paid approximately $1.56 million (included in accounts payable on December 31, 2004) which was the remaining balance owed to Bausch & Lomb for the Zylet™ project development under the terms of the agreement.
Dr. Nicholas Bodor, a former director of and consultant to Pharmos, is the patent owner and licensor of the technology underlying the ophthalmic product line sold to Bausch & Lomb. In January 2005, Pharmos paid Dr. Bodor approximately $1.338 million in connection with the commercialization of Zylet™, per the license agreement with Dr. Bodor. Pharmos owes Dr. Bodor an additional 14.3% of any payments the Company may receive from Bausch & Lomb in the event that certain sales levels are exceeded in the first two years following commencement of Zylet™ sales in the U.S.
In February 2005, the Company paid the Israel-U.S. Binational Industrial Research and Development Foundation (BIRDF) $.212 million, which represented the maximum amount the Company owed the foundation for Zylet™.
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Commitment and Contingencies
As of March 31, 2006, the Company had the following contractual commitments and long-term obligations:
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| | Total | | Less than 1 Year | | 1 – 3 Years | | 3 – 5 Years | | More than 5 Years | | Undetermined | |
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Operating Leases | | $ | 1,190,058 | | $ | 537,604 | | $ | 479,124 | | $ | 173,330 | | $ | — | | $ | — | |
Other long-term liabilities reflected on our balance sheet* | | | 1,104,749 | | | — | | | — | | | — | | | — | | | 1,104,749 | |
Other Commitment** | | | 250,000 | | | 100,000 | | | 150,000 | | | — | | | — | | | — | |
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Total | | $ | 2,544,807 | | $ | 637,604 | | $ | 629,124 | | $ | 173,330 | | $ | — | | $ | 1,104,749 | |
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* | Consists of severance benefits payable under Israeli law. Because these benefits are paid only upon termination of employment, it is not possible to allocate the liability across future years. The Company has funded $803,754. |
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** | Represents cash portion of the September 2004 Retention Award Agreement given to the CEO and former President. The Company has accrued $183,824 through March 31, 2006. |
Subsequent Events
The Company and James A. Meer, Chief Financial Officer, have agreed that when his current employment agreement expires in July 2006, it will not be renewed. Mr. Meer will remain in his current role until the engagement of his successor.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk
We assessed our vulnerability to certain market risks, including interest rate risk associated with financial instruments included in cash, cash equivalents, short term investments and the currency impact in Israel. Due to the relatively short-term nature of these investments the Company has determined that the risks associated with interest rate fluctuations related to these financial instruments do not pose a material risk to us. The value of the warrant liability is generally based upon the Company’s stock price.
Item 4. Controls And Procedures
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| (a) Evaluation of Disclosure Controls and Procedures: An evaluation of Pharmos’ disclosure controls and procedures (as defined in Section13a - 15(e) of the Securities Exchange Act of 1934 (the “Act”)) was carried out under the supervision and with the participation of Pharmos’ Chief Executive Officer and Chief Financial Officer and several other members of Pharmos’ senior management at March 31, 2006. Based on this evaluation, Pharmos’ Chief Executive Officer and Chief Financial Officer concluded that as of March 31, 2006, Pharmos’ disclosure controls and procedures were effective, at a reasonable level of assurance, in ensuring that the information required to be disclosed by Pharmos in the reports it files or submits under the Act is (i) accumulated and communicated to Pharmos’ management (including the Chief Executive Officer and Chief Financial Officer) in a timely manner, and (ii) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. |
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| (b) Changes in Internal Control Over Financial Reporting: There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Securities Exchange Act of 1934, as amended) during our last fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. |
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Part II
Other Information
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| The Company and certain current officers have been named as defendants in several purported shareholder class action lawsuits alleging violations of federal securities laws. These lawsuits were filed beginning in January 2005 and are pending in the U.S. District Court for the District of New Jersey. These lawsuits assert claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder. The complaints allege generally that the defendants knowingly or recklessly made false or misleading statements regarding the effectiveness of dexanabinol in treating TBI (Traumatic Brain Injury) which had the effect of artificially inflating the price of the Company’s common stock. The complaints seek unspecified damages. These class actions have been consolidated by order of the court and lead plaintiffs and lead plaintiffs’ counsel have been appointed. An amended complaint was filed in September 2005. In November 2005, the Company moved to dismiss the litigation, and the motion was fully briefed on February 10, 2006. Decision on the motion is pending. |
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| In addition, two purported shareholders of the Company’s common stock have commenced derivative actions against the Company’s directors and against certain current and former officers. The first derivative lawsuit was commenced in February 2005 in the U.S. District Court for the District of New Jersey, and has been consolidated for pretrial purposes with the class actions. An amended complaint in the federal derivative lawsuit was filed in September 2005. The Company also moved to dismiss this litigation, and briefing on the motion was completed on February 10, 2006. Decision on the motion is pending. The second lawsuit was filed in April 2005 in the Superior Court of New Jersey, County of Middlesex. An amended complaint in the state court case was filed in November 2005. This action has been stayed pending decisions on the motions to dismiss in the Federal actions. Both lawsuits allege generally, on behalf of the Company (which has been named as a nominal defendant), breaches of fiduciary duty and other state law violations arising from the same set of underlying facts as the class actions. The complaints seek unspecified damages. |
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| Management intends to defend these lawsuits vigorously. However, we cannot assure you that we will prevail in these actions, and, if the outcome is unfavorable to Pharmos, our reputation, profitability and share price could be adversely affected. |
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| There are no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2005. |
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Item 2 Unregistered Sales of Equity Securities and Use of Proceeds | NONE | |
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Item 3 Defaults upon Senior Securities | NONE | |
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Item 4 Submission of Matters to Vote of Security Holders | NONE | |
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| (a) The Company and James A. Meer, Chief Financial Officer, have agreed that when his current employment agreement expires in July 2006, it will not be renewed. Mr. Meer will remain in his current role until the engagement of his successor. |
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| (b) NONE |
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SIGNATURE PAGE
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.
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| PHARMOS CORPORATION |
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Dated: May 12, 2006 | |
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| by: /s/ James A. Meer | |
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| James A. Meer |
| Senior Vice President and Chief |
| Financial Officer |
| (Principal Accounting and |
| Financial Officer) |
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