UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
| For the quarter ended: March 31, 2005 | Commission File Number: 0-19871 |
STEMCELLS, INC.
(Exact name of registrant as specified in its charter)
| DELAWARE | 94-3078125 | |
| (State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer identification No) |
3155 PORTER DRIVE
PALO ALTO, CA 94304
(650) 475-3100
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 twelve months (or for such shorter periods 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 Exchange Act
Rule 12b-2.
Yes þ No o
At April 26, 2005, there were 62,508,062 shares of Common Stock, $.01 par value, issued and outstanding.
STEMCELLS, INC.
INDEX
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| EXHIBIT 31.1 | ||||||||
| EXHIBIT 31.2 | ||||||||
| EXHIBIT 32.1 | ||||||||
| EXHIBIT 32.2 | ||||||||
2
PART I ITEM 1 FINANCIAL STATEMENTS
STEMCELLS, INC.
| March 31, 2005 | December 31, 2004 | |||||||
| (unaudited) | ||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 37,404,809 | $ | 41,059,532 | ||||
Receivables |
173,572 | 180,963 | ||||||
Other current assets |
629,600 | 209,074 | ||||||
Total current assets |
38,207,981 | 41,449,569 | ||||||
Property, plant and equipment, net |
3,243,279 | 3,424,294 | ||||||
Other assets, net |
2,716,761 | 2,753,419 | ||||||
Total assets |
$ | 44,168,021 | $ | 47,627,282 | ||||
Liabilities and stockholders equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 797,535 | $ | 524,917 | ||||
Accrued expenses |
656,080 | 1,547,370 | ||||||
Accrued wind-down expenses, current portion |
1,033,566 | 1,013,460 | ||||||
Capital lease obligations, current portion |
53,916 | 52,843 | ||||||
Bonds payable, current portion |
246,667 | 244,167 | ||||||
Total current liabilities |
2,787,764 | 3,382,757 | ||||||
Capital lease obligations less current maturities |
27,180 | 41,065 | ||||||
Bonds payable, less current maturities |
1,543,252 | 1,605,417 | ||||||
Deposits & other long-term liabilities |
610,126 | 610,126 | ||||||
Accrued wind-down expenses, non-current portion |
4,718,890 | 4,514,569 | ||||||
Deferred rent |
403,707 | 523,801 | ||||||
Total liabilities |
10,090,919 | 10,677,735 | ||||||
Stockholders equity: |
||||||||
Common stock, $.01 par value; 125,000,000
shares authorized; 62,507,561 and 62,129,407
shares issued and outstanding at March 31, 2005
and December 31, 2004, respectively |
624,276 | 621,293 | ||||||
Additional paid in capital |
211,890,138 | 211,419,300 | ||||||
Accumulated deficit |
(177,654,047 | ) | (174,205,214 | ) | ||||
Deferred compensation |
(783,265 | ) | (885,832 | ) | ||||
Total stockholders equity |
34,077,102 | 36,949,547 | ||||||
Total liabilities and stockholders equity |
$ | 44,168,021 | $ | 47,627,282 | ||||
See accompanying notes to condensed consolidated financial statements.
3
PART I ITEM 1 FINANCIAL STATEMENTS
STEMCELLS, INC.
| Three months ended | ||||||||
| March 31, | ||||||||
| 2005 | 2004 | |||||||
Revenue: |
||||||||
Revenue from grants |
$ | 26,092 | $ | 92,593 | ||||
Revenue from licensing agreements |
9,229 | 500 | ||||||
Total revenue |
35,321 | 93,093 | ||||||
Operating expenses: |
||||||||
Research and development |
1,824,930 | 1,867,927 | ||||||
General and administrative |
1,299,205 | 863,830 | ||||||
Wind-down expenses |
520,974 | 130,569 | ||||||
Total operating expenses |
3,645,109 | 2,862,326 | ||||||
Loss from operations |
(3,609,788 | ) | (2,769,233 | ) | ||||
Other income (expense): |
||||||||
Interest income |
227,763 | 49,127 | ||||||
Interest expense |
(46,411 | ) | (49,495 | ) | ||||
Other income (expense) |
(20,397 | ) | (1,011 | ) | ||||
Total other income (expense) |
160,955 | (1,379 | ) | |||||
Net loss applicable to common stockholders |
(3,448,833 | ) | (2,770,612 | ) | ||||
Net loss per share applicable to common
stockholders; basic and diluted |
($ | 0.06 | ) | ($ | 0.07 | ) | ||
Weighted average shares used to compute
net loss per share applicable to common
stockholders; basic and diluted |
62,406,725 | 41,010,068 | ||||||
See accompanying notes to condensed consolidated financial statements.
4
PART I ITEM 1 FINANCIAL STATEMENTS
STEMCELLS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
| Three months ended | ||||||||
| March 31, | ||||||||
| 2005 | 2004 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
($ | 3,448,833 | ) | ($ | 2,770,612 | ) | ||
Adjustments to reconcile net loss to net cash used in
operating activities: |
||||||||
Depreciation and amortization |
273,155 | 254,835 | ||||||
Amortization of deferred compensation |
(76,382 | ) | 15,095 | |||||
Stock-based compensation expense |
36,011 | 106,130 | ||||||
Changes in operating assets and liabilities: |
||||||||
Accrued interest receivable |
(11,660 | ) | (235 | ) | ||||
Receivables |
19,051 | (30,006 | ) | |||||
Other current assets |
(420,526 | ) | 91,000 | |||||
Other assets, net |
52,947 | | ||||||
Accounts payable and accrued expenses |
(618,672 | ) | (56,158 | ) | ||||
Accrued wind-down expenses |
224,427 | (158,247 | ) | |||||
Deferred rent |
(120,094 | ) | (93,100 | ) | ||||
Net cash used in operating activities |
(4,090,576 | ) | (2,641,298 | ) | ||||
Cash flows from investing activities: |
||||||||
Purchase of property, plant and equipment |
(58,429 | ) | (26,885 | ) | ||||
Acquisition of other assets |
(50,000 | ) | | |||||
Net cash used in investing activities |
(108,429 | ) | (26,885 | ) | ||||
Cash flows from financing activities: |
||||||||
Proceeds from the exercise of stock options |
269,432 | | ||||||
Proceeds from the exercise of warrants |
347,327 | | ||||||
Proceeds (expense) from issuance of common stock, net |
| (8,641 | ) | |||||
Repayments of capital lease obligations |
(12,812 | ) | | |||||
Repayment of debt obligations |
(59,665 | ) | (58,750 | ) | ||||
Net cash provided (used) by financing activities |
544,282 | (67,391 | ) | |||||
Decrease in cash and cash equivalents |
(3,654,723 | ) | (2,735,574 | ) | ||||
Cash and cash equivalents, beginning of period |
41,059,532 | 13,081,703 | ||||||
Cash and cash equivalents, end of period |
$ | 37,404,809 | $ | 10,346,129 | ||||
Supplemental disclosure of cash flow information: |
||||||||
Interest paid |
$ | 46,411 | $ | 49,495 | ||||
See accompanying notes to condensed consolidated financial statements
5
PART I ITEM 1. FINANCIAL STATEMENTS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The terms StemCells, the Company, our, we and us as used in this report refer to StemCells Inc. The accompanying unaudited, condensed consolidated financial statements have been prepared by the Company in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, the accompanying financial statements include all adjustments, consisting of normal recurring accruals, considered necessary for a fair presentation of the financial position, results of operations and cash flows for the periods presented. Results of operations for the three months ended March 31, 2005, are not necessarily indicative of the results that may be expected for the entire fiscal year ending December 31, 2005.
The balance sheet at December 31, 2004 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required for complete financial statements in accordance with accounting principles generally accepted in the United States of America. For the complete financial statements, refer to the audited financial statements and footnotes thereto as of December 31, 2004, included on Form 10-K.
The Company has incurred significant operating losses and negative cash flows since inception. It has not achieved profitability and may not be able to realize sufficient revenues to achieve or sustain profitability in the future. The Company has limited capital resources and it will need to raise additional capital from time to time to sustain its product development efforts, acquisition of technologies and intellectual property rights, preclinical and clinical testing of anticipated products, pursuit of regulatory approvals, acquisition of capital equipment, laboratory and office facilities, establishment of production capabilities, general and administrative expenses and other working capital requirements. To fund its operations, the Company relies on cash balances, proceeds from equity and debt offerings, proceeds from the transfer or sale of intellectual property rights, equipment, facilities or investments, and on government grants and collaborative arrangements. The Company cannot be certain that such funding will be available when needed. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements. Actual results could differ from these estimates. Significant estimates include the accrued wind-down expenses.
Net Loss Per Share
The Company has computed net loss per common share according to the Financial Accounting Standards Board Statement (SFAS) No. 128, Earnings Per Share, which requires disclosure of basic and diluted earnings per share. Basic earnings per share excludes any dilutive effects of options, warrants and convertible securities, and is computed using the weighted average number of common shares outstanding during the period. Diluted earnings
6
per share includes the impact of potentially dilutive securities and is computed using the weighted average of common and diluted equivalent stock options, warrants and convertible securities outstanding during the period. Stock options, warrants and convertible securities that are antidilutive are excluded from the calculation of diluted loss per common share.
| Three months ended | ||||||||
| March 31, | ||||||||
| 2005 | 2004 | |||||||
Net loss applicable to common stockholders |
$ | (3,448,833 | ) | $ | (2,770,612 | ) | ||
Weighted average shares used in computing net loss per share applicable
to common stockholders, basic and diluted. |
62,406,725 | 41,010,068 | ||||||
Net loss per share applicable to common stockholders, basic and diluted. |
$ | (0.06 | ) | $ | (0.07 | ) | ||
The Company has excluded outstanding stock options, warrants and convertible securities from the calculation of diluted loss per common share because all such securities are anti-dilutive for all applicable periods presented. These outstanding securities consist of the following potential common shares:
| Outstanding at March 31, | ||||||||||||
| 2005 | 2004 | |||||||||||
Outstanding options |
6,728,787 | 5,072,389 | ||||||||||
Outstanding warrants |
5,165,283 | 2,101,074 | ||||||||||
Total |
11,894,070 | 7,173,463 | ||||||||||
Stock-Based Compensation
The Companys employee stock option plan is accounted for under Accounting Principles Board Opinion No. 25 (APB 25), Accounting for Stock Issued to Employees. The Company grants qualified stock options for a fixed number of shares to employees with an exercise price equal to the fair market value of the shares at the date of grant. In these circumstances in accordance with APB 25, the Company recognizes no compensation expense for qualified stock option grants. The Company also issues non-qualified stock options for a fixed number of shares to employees with an exercise price less than the fair market value of the shares at the date of grant. When such options vest, the Company recognizes the difference between the exercise price and fair market value as compensation expense in accordance with APB 25.
For purposes of disclosures pursuant to Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation, (SFAS 123) as amended by Statement of Financial Accounting Standards No. 148, Accounting for Stock-Based Compensation Transition and Disclosure, (SFAS 148), the estimated fair value of options is amortized to expense over the options vesting period. The following table illustrates the effect on net loss and net loss per share if the Company had applied the fair value recognition provisions of FAS 123 to stock-based employee compensation:
| Three months ended | ||||||||||||
| March 31, | ||||||||||||
| 2005 | 2004 | |||||||||||
Net loss applicable to common stockholders as reported |
$ | (3,448,833 | ) | $ | (2,770,612 | ) | ||||||
Add: Stock-based employee/director compensation expense
included in reported net loss |
| 38,728 | ||||||||||
Deduct: Total stock-based employee/director
compensation expense under the fair value based method
for all awards |
(137,461 | ) | (241,661 | ) | ||||||||
Net loss applicable to common stockholders proforma |
$ | (3,586,294 | ) | $ | (2,973,545 | ) | ||||||
Basic and diluted net loss per share applicable to
common stockholders as reported |
$ | (0.06 | ) | $ | (0.08 | ) | ||||||
Basic and diluted net loss per share applicable to
common stockholders pro forma |
$ | (0.06 | ) | $ | (0.08 | ) | ||||||
Shares used in basic and diluted loss per share
applicable to common stockholder amounts |
62,406,725 | 41,010,068 | ||||||||||
7
The effects on pro forma net loss and net loss per share of expensing the estimated fair value of stock options are not necessarily representative of the effects on reporting the results of operations for future years. As required by SFAS 123, the Company has used the Black-Scholes model for option valuation, which method may not accurately value the options described.
The Company accounts for stock options granted to non-employees in accordance with SFAS 123 and Emerging Issues Task Force (EITF) 96-18 Accounting For Equity Instruments That Are Issued To Other Than Employees For Acquiring, Or In Conjunction With Selling, Goods Or Services, and accordingly, recognizes as expense the estimated fair value of such options as calculated using the Black-Scholes valuation model. The fair value is remeasured during the service period and is amortized over the vesting period of each option or the recipients contractual arrangement, if shorter.
In December 2004, FASB issued SFAS No. 123R (revised 2004), Share-Based Payment (SFAS 123R). This Statement is a revision of SFAS 123 and amends SFAS No. 95, Statement of Cash Flows. This Statement supersedes APB Opinion No. 25, Accounting for Stock Issued to Employees, and its related implementation guidance. SFAS 123R covers a wide range of share-based compensation arrangements including stock options, restricted share plans, performance-based awards, share appreciation rights, and employee share purchase plans. The new standard is effective as of the beginning of the first interim or annual reporting period that begins after December 15, 2005. Based on the aforementioned effective date, the Company will begin expensing stock options granted to its employees in its Statement of Operations using a fair-value based method effective the period beginning January 1, 2006. Adoption of the expensing requirements will increase the Companys operating expenses.
Revenue Recognition
Revenues from collaborative agreements and grants are recognized as earned upon either the incurring of reimbursable expenses directly related to the particular research plan or the completion of certain development milestones as defined within the terms of the collaborative agreement. Payments received in advance of research performed are designated as deferred revenue. Fees associated with substantive at risk, performance-based milestones are recognized as revenue upon their completion, as defined in the respective agreements. Incidental assignment of technology rights is recognized as revenue at the time of receipt.
Recent Accounting Pronouncements
In December 2004, FASB issued SFAS No. 123R (revised 2004), Share-Based Payment (SFAS 123R). This Statement is a revision of SFAS No. 123, Accounting for Stock-Based Compensation and amends SFAS No. 95, Statement of Cash Flows. This Statement supersedes APB Opinion No. 25, Accounting for Stock Issued to Employees, and its related implementation guidance. SFAS 123R covers a wide range of share-based compensation arrangements including stock options, restricted share plans, performance-based awards, share appreciation rights, and employee share purchase plans. The new standard is effective as of the beginning of the first interim or annual reporting period that begins after December 15, 2005. Based on the aforementioned effective date, the Company will begin expensing stock options granted to its employees in its Statement of Operations using a fair-value based method effective the period beginning January 1, 2006. Adoption of the expensing requirements will reduce the Companys reported earnings. See Stock-based Compensation above in this Note 1 for disclosures regarding the effect on net earnings and earnings per share if we had applied the fair value recognition provisions of the exposure draft and SFAS No. 123. Depending on the model used to calculate stock-based compensation expense in the future, that disclosure may not prove indicative of the stock-based compensation expense to be recognized in future financial statements.
8
NOTE 2. LEASES
The Company had undertaken direct financing transactions with the State of Rhode Island and received proceeds from the issuance of industrial revenue bonds totaling $5,000,000 to finance the construction of a pilot manufacturing facility related to its former encapsulated cell technology. The related leases are structured such that lease payments will fully fund all semiannual interest payments and annual principal payments through maturity in August 2014. Interest rates vary with the respective bonds maturities, ranging currently from 8.1% to 9.5%. The outstanding principal at March 31, 2005 was approximately $1,790,000. The bonds contain certain restrictive covenants, which limit among other things, the payment of cash dividends and the sale of the related assets.
The Company entered into a fifteen-year lease for a laboratory facility in connection with a sale and leaseback arrangement in 1997. The lease has escalating rent payments and accordingly, the Company is recognizing rent expense on a straight-line basis. At December 31, 2004 and March 31, 2005, the Company had deferred rent liability for this facility of $1,177,000 and $1,185,000 respectively; the deferred rent liability is presented as part of the wind-down accrual.
Although the Company previously discontinued activities relating to encapsulated cell technology, the Company remains obligated under the leases for the pilot manufacturing facility and the laboratory facility. The Company has succeeded in subleasing the pilot manufacturing facility and part of the laboratory facility. The aggregate income received by the Company is significantly less than the Companys aggregate obligations under the leases, and the Companys continued receipt of rental income is dependent on the financial ability of the occupants to comply with their obligations under the subleases. The Company continues to seek to sublet the vacant portions of the Rhode Island facilities, to assign or sell its interests in all of these properties, or to otherwise arrange for the termination of its obligations under the lease obligations on these facilities. There can be no assurance, however, that the Company will be able to dispose of these properties in a reasonable time, if at all, or to terminate its lease obligations without the payment of substantial consideration
As of February 1, 2001, the Company entered into a 5-year lease for a 40,000 square foot facility located in the Stanford Research Park in Palo Alto, CA. The facility includes space for animals, laboratories, offices, and a GMP (Good Manufacturing Practices) suite. GMP facilities can be used to manufacture materials for clinical trials. On December 19, 2002 the Company negotiated an amendment to the lease, which resulted in reducing the average annual rent over the remaining term of the lease from approximately $3.7 million to $2.0 million. As part of the amendment the Company issued a letter of credit on January 2, 2003 for $503,079, which was an addition to the letter of credit in the amount of $275,000 issued at commencement of the lease, to serve as a deposit for the duration of the lease. As the lease involved an upfront payment as well as escalating rent payments, the Company is recognizing rent expense on a straight-line basis. At March 31, 2005, the Company had $404,000 in deferred rent liability for this facility. In 2001 and 2002, the Company entered into space-sharing agreements currently covering in total approximately 13,000 square feet of the 40,000 square foot facility. The Company receives the amount of base rent plus the proportionate share of the operating expenses that it pays for such space over the term of these agreements. See Note 6. Subsequent Events.
NOTE 3. WIND-DOWN OF ENCAPSULATED CELL TECHNOLOGY RESEARCH AND DEVELOPMENT PROGRAM
Until mid-1999, the Company engaged in research and development in encapsulated cell therapy technology, including a pain control program funded by AstraZeneca Group plc. In June 1999 AstraZeneca terminated the collaboration, as allowed under the terms of the original collaborative agreement signed in 1995. As a result of termination, management determined in July 1999 to restructure its research operations to abandon all further encapsulated cell technology research and concentrate its resources on the research and development of its proprietary platform of stem cell technologies. The Company wound down its research and manufacturing operations in Lincoln, Rhode Island, and relocated its remaining research and development activities, and its corporate headquarters, to California, in October 1999.
In 1999 the Company established a reserve for the estimated lease payments and operating costs of the Rhode Island facilities through an expected disposal date of June 30, 2000. The Company did not fully sublet the Rhode Island facilities in 2000. Even though it is the intent of the Company to dispose the facility at the earliest possible time, it cannot determine with certainty a fixed date by which such disposal will occur. In light of this
9
uncertainty, based on estimates, the Company periodically re-evaluates and adjusts the reserve. The Company considers various factors such as the Companys lease payments through to the end of the lease, operating expenses, the current real estate market in Rhode Island, and estimated subtenant income based on occupancy both actual and projected. At December 31, 2004 the reserve was $4,350,000. For the three month period ending March 31, 2005 the Company incurred $303,000 in operating expenses which was recorded against the reserve. After evaluating the afore mentioned factors the Company re-evaluated its estimate and adjusted the reserve to $4,568,000 at March 31, 2005 by recording an additional $521,000 as wind-down expenses. The Company will continue to periodically re-evaluate and adjust the reserve.
Wind-down reserve
| January to March | January to December | |||||||
| 31, 2005 | 31, 2004 | |||||||
Accrued wind-down reserve at beginning of period |
$ | 4,350,000 | $ | 2,676,000 | ||||
Less actual expenses recorded against estimated
reserve during the period |
(303,000 | ) | (1,152,000 | ) | ||||
Additional expense recorded to revise estimated
reserve at period-end |
521,000 | 2,826,000 | ||||||
Revised reserve at period-end |
4,568,000 | 4,350,000 | ||||||
Add deferred rent at period end (Note 2) |
1,185,000 | 1,178,000 | ||||||
Total accrued wind-down expenses at period-end
(current and non current portion) |
$ | 5,753,000 | $ | 5,528,000 | ||||
Accrued wind-down expenses
|
||||||||
Current portion |
$ | 1,034,000 | $ | 1,013,000 | ||||
Non current portion |
4,719,000 | 4,515,000 | ||||||
Total Accrued wind-down expenses |
$ | 5,753,000 | $ | 5,528,000 | ||||
NOTE 4. GRANTS
In September 2003 the Company was awarded a one year, $342,000, Small Business Innovation Research grant from the National Institute of Neurological Disease and Stroke (NINDS), to further its work in the treatment of spinal cord injuries. For this award, the Company has recognized revenue of $143,000 in 2003, and $93,000 in 2004. No revenue from this grant was recognized in 2005 as the remaining $107,000 was paid to a subcontractor. In September 2004, the National Institutes of Health (NIH) awarded the Company a Small Business Technology Transfer grant of $464,000 for studies in Alzheimers disease, consisting of $308,000 for the first year and $156,000 for the remainder of the grant term, September 30, 2004 through March 31, 2006. The studies will be conducted by Dr. George A. Carlson of the McLaughlin Research Institute (MRI) in Great Falls, Montana, which will receive approximately $222,000 of the total award. The Company recognized $26,000 in 2004 and $26,000 for the three month period ended March 31, 2005.
NOTE 5. STOCKHOLDERS EQUITY
In January 2005 and March 2005, warrants issued as part of the June 16, 2004 financing arrangement, were exercised to purchase an aggregate of 50,250 and 2,500 shares respectively of the Companys common stock at $1.90 per share. The Company issued 52,750 shares of its common stock and received proceeds of $100,000. Also in January 2005, 79,899 shares of unregistered stock were issued upon the cashless exercise by the holder of a warrant acquired as partial compensation for services to the Company. On April 13, 2000 the Company issued 1,500 shares of 6% cumulative convertible preferred stock plus adjustable warrants to two members of its Board of Directors. The preferred shares were converted into common shares in 2002. In March 2005, one of the members exercised his adjustable warrant in full for 72,252 shares at $3.42 per share. The Company issued 72,252 shares and received proceeds of $247,000. For the three month period ended March 31, 2005, the Company issued 173,252
10
shares from activity related to its stock option plans. The following table presents the activity of the Companys stock option plans for the three month period ended March 31, 2005
| 2005 | ||||||||
| Weighted | ||||||||
| Average Exercise | ||||||||
| Options | Price | |||||||
Outstanding at January 1 |
6,682,201 | $ | 2.91 | |||||
Granted |
329,838 | $ | 4.33 | |||||
Exercised |
(173,252 | ) | $ | 1.76 | ||||
Canceled |
(110,000 | ) | $ | 1.95 | ||||
Outstanding at March 31 |
6,728,787 | $ | 2.79 | |||||
Options exercisable at March 31 |
3,623,637 | $ | 3.00 | |||||
NOTE 6. SUBSEQUENT EVENTS
The Company has negotiated an amendment to the lease for its facility located in Palo Alto, California effective as of April 1, 2005, which extends the term through March 31, 2010, includes an immediate reduction in the rent per square foot, and provides for an expansion of the leased premises by approximately 28,000 additional square feet effective July 1, 2006. In addition, the Company has sublet some of the additional space for the period from April 1, 2005 through June 30, 2006. The average annual rent for the period commencing April 1, 2005 to March 31, 2010 will be approximately $2 million before sub tenant income. See Note 2, Leases.
11
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of our financial condition and the results of our operations for the three month periods ended March 31, 2005 and 2004 should be read in conjunction with the accompanying unaudited condensed consolidated financial statements and the related footnotes thereto.
This report contains forward looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act that involve substantial risks and uncertainties. Such statements include, without limitation, all statements as to expectation or belief and statements as to our future results of operations, the progress of our research, product development and clinical programs, the need for, and timing of, additional capital and capital expenditures, partnering prospects, costs of manufacture of products, the protection of and the need for additional intellectual property rights, effects of regulations, the need for additional facilities and potential market opportunities. Our actual results may vary materially from those contained in such forward-looking statements because of risks to which we are subject, including uncertainty as to whether the U.S. Food and Drug Administration will remove the clinical hold on our proposed initial clinical trial and permit us to proceed to clinical testing despite the novel and unproven nature of the Companys technology; the risk that, even if approved, our initial clinical trial could be substantially delayed beyond its expected dates or cause us to incur substantial unanticipated costs; uncertainties regarding the our ability to obtain the capital resources needed to continue our current research and development operations and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals; the risk of failure to obtain a corporate partner or partners to support the development of our stem cell programs, the uncertainty regarding the outcome of the Phase I clinical trial and any other trials the Company may conduct in the future; the uncertainty regarding the validity and enforceability of issued patents; the uncertainty whether any products that may be generated in the Companys stem cell programs will prove clinically effective and not cause tumors or other side effects; the uncertainty whether the Company will achieve revenues from product sales or become profitable; uncertainties regarding the Companys obligations in regard to its former encapsulated cell therapy facilities in Rhode Island; obsolescence of our technology; competition from third parties; intellectual property rights of third parties; litigation and other risks to which we are subject. Before you invest in our common stock, you should be aware that the occurrence of the events described in the Cautionary Factors Relevant to Forward Looking Information and Business sections included in our Form 10-K report as of December 31, 2004 could harm our business, operating results and financial condition. All forward-looking statements attributable to us or to persons acting on our behalf are expressly qualified in their entirety by the cautionary statements and risk factors contained or referred to herein.
OVERVIEW
Since our inception in 1988, we have been primarily engaged in research and development of human therapeutic products. Since the second half of 1999, our sole focus has been on our stem cell technology. In the last quarter of 2004 we filed the first in a planned series of INDs (Investigational New Drug Applications) for CNS (Central Nervous System) diseases or conditions with the FDA (U.S. Food and Drug Administration). This IND, which is for a Phase I clinical trial of our human neural stem cells in Batten disease, is currently on clinical hold until questions and issues raised by the FDA have been resolved. Batten disease is included among the neuronal ceroid lipofuscinoses (NCLs), a set of several closely related genetic lysosomal storage disorders caused by a deficiency of specific enzymes required for normal cell metabolism. The deficiency results in storage of toxic waste materials and the death of certain neurons. The NCLs primarily affect infants and young children, and are always fatal. There can be no assurance that the FDA will lift the clinical hold and permit the trial to go forward.
We have not derived any revenues from the sale of any products apart from license revenue for the research use of our human neural stem cells and other patented cells and media, and we do not expect to receive revenues from product sales for at least several years. We have not commercialized any product and in order to do so we must, among other things, substantially increase our research and development expenditures as research and product development efforts accelerate and clinical trials are initiated. We had expenditures for toxicology and other studies in preparation for submitting the Batten disease IND to the FDA, and will incur more such expenditures for any future INDs. We have incurred annual operating losses since inception and expect to incur substantial operating
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losses in the future. As a result, we are dependent upon external financing from equity and debt offerings and revenues from collaborative research arrangements with corporate sponsors to finance our operations. There are no such collaborative research arrangements at this time and there can be no assurance that such financing or partnering revenues will be available when needed or on terms acceptable to us.
Since 2001, we have entered into a number of financing arrangements including an equity line (which has now expired) from which we drew $4.6 million; sale of 1 million shares of common stock for $1.1 million; sale of 4 million shares of common stock for $6.5 million; issuance of convertible preferred stock for $5 million (all of which has now been converted); sale of 5 million shares of common stock for a total of $9.5 million, and in 2004, two financing arrangements for gross proceeds of $20 million and $22.5 million in June and October respectively. (See Liquidity and Capital Resources below for further detail on each of these transactions.
Our results of operations have varied significantly from year to year and quarter to quarter and may vary significantly in the future due to the occurrence of material recurring and nonrecurring events including, without limitation, the receipt and payment of licensing payments, the initiation or termination of research collaborations, the changes in the sublease income and rental and other expenses to lease and maintain our facilities in Rhode Island and changes in the costs associated with our move to a larger facility in California. To expand and provide high quality systems and support to our research and development programs, we would need to hire more personnel, which would lead to higher operating expenses.
CRITICAL ACCOUNTING POLICIES
We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our consolidated financial statements:
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements. Actual results could differ from these estimates. The significant estimates include the accrued wind-down expenses related to our Rhode Island facilities.
Stock-Based Compensation
As permitted by the provisions of Statement of Financial Accounting Standards (SFAS) No. 148, Accounting for Stock-Based Compensation Transition and Disclosure, and Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation, our employee stock option plan is accounted for under Accounting Principles Board Opinion No. 25 (APB 25), Accounting for Stock Issued to Employees. We grant qualified stock options for a fixed number of shares to employees with an exercise price equal to the fair market value of the shares at the date of grant. In these circumstances in accordance with APB 25, we recognize no compensation expense for qualified stock option grants. We also issue non-qualified stock options for a fixed number of shares to employees with an exercise price less than the fair market value of the shares at the date of grant. When such options vest, we recognize the difference between the exercise price and fair market value as compensation expense in accordance with APB 25. Note 9 of the Notes to the Consolidated Financial Statements, included in our 2004 Annual Report on Form 10-K, describes our equity compensation plans, and Note 1 of the Notes to the Condensed Consolidated Financial Statements elsewhere in this report contains a summary of the pro forma effects to reported net loss and loss per share for the three months ended March 31, 2005 and 2004 as if we had elected to recognize compensation cost based on the fair value of the options granted at grant date, as prescribed by SFAS 123. We account for certain stock options granted to non-employees in accordance with SFAS No. 123 and Emerging Issues Task Force (EITF) 96-18 accounting for equity instruments that are issued to other than employees for acquiring, or in conjunction with selling, goods or services, and accordingly, we recognize as expense the estimated fair value of such options as calculated using the Black-Scholes valuation model, and as re-measured during the service period. Fair value is determined using methodologies allowable by SFAS No. 123. The cost is amortized over the vesting period of each option or the recipients contractual arrangement, if shorter.
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In December 2004, FASB issued SFAS 123R (revised 2004), Share-Based Payment (SFAS 123R). This Statement is a revision of SFAS 123, Accounting for Stock-Based Compensation and amends SFAS No. 95, Statement of Cash Flows. This Statement supersedes APB Opinion No. 25, Accounting for Stock Issued to Employees, and its related implementation guidance. SFAS 123R covers a wide range of share-based compensation arrangements including stock options, restricted share plans, performance-based awards, share appreciation rights, and employee share purchase plans. The new standard is effective as of the beginning of the first interim or annual reporting period that begins after December 15, 2005. Based on the afore mentioned effective date, we will begin expensing stock options granted to our employees in our Statement of Operations using a fair-value based method effective the period beginning January 1, 2006. Adoption of the expensing requirements will reduce the Companys reported earnings.
Research and Development Costs
We expense all research and development costs as incurred. Research and Development costs include costs of personnel, external services, supplies, facilities and miscellaneous other costs.
Wind-down and Exit Costs
In connection with the wind-down of our former encapsulated cell technology operations, our research and manufacturing operations in Lincoln, Rhode Island, and the relocation of our remaining research and development activities and corporate headquarters to California, in October 1999, we provided a reserve for our estimate of the exit cost obligation in accordance with EITF 94-3, Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity. As the lease for our former research facility in Rhode Island terminates in 2013, we will adjust our reserve on an ongoing basis by reevaluating our estimated costs to exit this facility. The estimates are based on assumptions and experience relevant to the real estate market conditions for the facility. Such re-evaluation will include lease payments over the lease term, occupancy and sublease rental rates, and facility operating expenses. We are seeking to sublease, assign, sell or otherwise divest itself of our interest in the facility at the earliest possible time, but we cannot determine with certainty a fixed date by which such events will occur.
RESULTS OF OPERATIONS
Three months ended March 31, 2005 and 2004
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