Oncotelic Therapeutics, Inc. - Quarter Report: 2006 March (Form 10-Q)
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2006
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 0-21990
OXiGENE, INC.
(Exact name of registrant as specified in its charter)
Delaware | 13-3679168 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
230 THIRD AVENUE
WALTHAM, MA 02451
(Address of principal executive offices, including zip code)
WALTHAM, MA 02451
(Address of principal executive offices, including zip code)
(781) 547-5900
(Registrants telephone number, including area code)
(Registrants telephone number, including area code)
Not applicable
(Former name, former address and former fiscal year, if changed since last report)
(Former name, former address and former fiscal year, if changed since last report)
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 a large accelerated filer, an accelerated
filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated
filer in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
As of April 15, 2006, there were 28,037,498 shares of the Registrants Common Stock issued and
outstanding.
Table of Contents
OXiGENE, INC.
Cautionary Factors that may Affect Future Results
The disclosure and analysis by OXiGENE, Inc. (the Company) in this report contain
forward-looking statements. Forward-looking statements give managements current expectations or
forecasts of future events. You can identify these statements by the fact that they do not relate
strictly to historic or current facts. They use words such as anticipate, estimate, expect,
project, intend, plan, believe, and other words and terms of similar meaning. These include
statements, among others, relating to our planned future actions, our clinical trial plans, our
research and development plans, our prospective products or product approvals, our beliefs with
respect to the sufficiency of our cash resources, our plans with respect to funding operations,
projected expense levels, and the outcome of contingencies.
Any or all of our forward-looking statements in this report may turn out to be wrong. They can
be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties.
Consequently, no forward-looking statement can be guaranteed. Actual results may vary materially
from those set forth in forward-looking statements. The uncertainties that may cause differences
include, but are not limited to: the Companys history of losses, anticipated continuing losses and
uncertainty of future revenues or profitability; the early stage of product development;
uncertainties as to the future success of ongoing and planned clinical trials; the unproven safety
and efficacy of products under development; the sufficiency of the Companys existing capital
resources; the possible need for additional funds; uncertainty of future funding; the Companys
dependence on others for much of the clinical development of its product candidates under
development, as well as for obtaining regulatory approvals and conducting manufacturing and
marketing of any product candidates that might successfully reach the end of the development
process; the impact of government regulations, health care reform and managed care; competition
from other companies and other institutions pursuing the same, alternative or superior
technologies; the risk of technological obsolescence; uncertainties related to the Companys
ability to obtain adequate patent and other intellectual property protection for its proprietary
technology and product candidates; dependence on officers, directors and other individuals; and
risks related to product liability exposure.
We will not update forward-looking statements, whether as a result of new information, future
events or otherwise, unless required by law. You are advised to consult any further disclosures we
make in our reports to the Securities and Exchange Commission, including our Form10-Q, 8-K and 10-K
reports. Our filings list various important factors that could cause actual results to differ
materially from expected results. We note these factors for investors as permitted by the Private
Securities Litigation Reform Act of 1995. You should understand that it is not possible to predict
or identify all such factors. Consequently, you should not consider any such list to be a complete
set of all potential risks or uncertainties.
2
INDEX
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15 | ||||||||
15 | ||||||||
15 | ||||||||
16 | ||||||||
Ex-10.35 Lease Modification Agreement No. 2 | ||||||||
Ex-31.1 Section 302 Certification of CEO | ||||||||
Ex-31.2 Section 302 Certification of CFO | ||||||||
Ex-32.1 Section 906 Certification of CEO & CFO |
3
Table of Contents
PART IFINANCIAL INFORMATION
Item 1. Financial StatementsUnaudited
OXiGENE, Inc.
Condensed Balance Sheets
(All amounts in
thousands, except per share data)
(Unaudited)
(Unaudited)
March 31, 2006 | December 31, 2005 | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 26,663 | $ | 32,344 | ||||
Available-for-sale securities |
27,271 | 23,355 | ||||||
Prepaid
expenses and other current assets |
447 | 256 | ||||||
Total current assets |
54,381 | 55,955 | ||||||
Furniture and fixtures, equipment and leasehold improvements |
1,114 | 1,054 | ||||||
Accumulated depreciation |
(934 | ) | (919 | ) | ||||
180 | 135 | |||||||
Available-for-sale securities long term |
1,457 | 3,156 | ||||||
License agreements, net of accumulated amortization of $650
and $626 at March 31, 2006 and December 31, 2005,
respectively |
849 | 873 | ||||||
Deposits |
144 | 149 | ||||||
Total assets |
$ | 57,011 | $ | 60,268 | ||||
Liabilities and stockholders equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable |
$ | 392 | $ | 693 | ||||
Accrued research and development |
1,916 | 1,719 | ||||||
Accrued other |
1,038 | 1,322 | ||||||
Total current liabilities |
3,346 | 3,734 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
||||||||
Common Stock, $.01 par value, 100,000 shares
authorized; 28,037 shares at March 31, 2006 and
December 31, 2005, issued and
outstanding |
280 | 280 | ||||||
Additional paid-in capital |
158,961 | 160,885 | ||||||
Accumulated deficit |
(105,291 | ) | (101,955 | ) | ||||
Accumulated other comprehensive loss |
(96 | ) | (85 | ) | ||||
Notes receivable |
(189 | ) | (187 | ) | ||||
Deferred compensation |
| (2,404 | ) | |||||
Total stockholders equity |
53,665 | 56,534 | ||||||
Total liabilities and stockholders equity |
$ | 57,011 | $ | 60,268 | ||||
See accompanying notes.
4
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OXiGENE, Inc.
Condensed Statements of Operations
(All amounts in thousands, except per share data)
(Unaudited)
(Unaudited)
Three months ended | ||||||||
March 31, | ||||||||
2006 | 2005 | |||||||
Costs and expenses: |
||||||||
Research and development (1) |
$ | 2,321 | $ | 1,217 | ||||
General and administrative (1) |
1,621 | 997 | ||||||
Total costs and expenses |
3,942 | 2,214 | ||||||
Operating loss |
(3,942 | ) | (2,214 | ) | ||||
Investment income |
612 | 181 | ||||||
Other income
(expense), net |
(6 | ) | 5 | |||||
Net loss |
$ | (3,336 | ) | $ | (2,028 | ) | ||
Basic and diluted net loss per common share |
$ | (0.12 | ) | $ | (0.12 | ) | ||
Weighted average number of common shares outstanding |
27,517 | 17,604 | ||||||
(1) Includes share-based compensation expense as follows: |
||||||||
Research and development |
$ | 131 | $ | (7 | ) | |||
General and administrative |
349 | | ||||||
Total share-based compensation expense |
$ | 480 | $ | (7 | ) | |||
See accompanying notes.
5
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OXiGENE, Inc.
Condensed Statements of Cash Flows
(All amounts in thousands)
(Unaudited)
(Unaudited)
Three months ended | ||||||||
March 31, | ||||||||
2006 | 2005 | |||||||
Operating activities: |
||||||||
Net loss |
$ | (3,336 | ) | $ | (2,028 | ) | ||
Adjustment to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation |
15 | 8 | ||||||
Share-based compensation |
480 | (7 | ) | |||||
Amortization of licensing agreement |
24 | 24 | ||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other current assets |
(191 | ) | (131 | ) | ||||
Accounts payable and accrued expenses |
(388 | ) | 162 | |||||
Net cash used in operating activities |
(3,396 | ) | (1,972 | ) | ||||
Investing activities: |
||||||||
Purchase of available-for-sale securities |
(12,876 | ) | | |||||
Proceeds from sale of available-for-sale securities |
10,646 | 5,949 | ||||||
Purchase of furniture, fixtures and equipment |
(60 | ) | (5 | ) | ||||
Deposits |
5 | | ||||||
Net cash provided by (used in) investing activities |
(2,285 | ) | 5,944 | |||||
Financing activities: |
||||||||
Proceeds from the issuance of common stock |
| 13,745 | ||||||
Payment of notes receivable and related interest |
| 58 | ||||||
Net cash provided by financing activities |
| 13,803 | ||||||
Net
increase/(decrease) in cash and cash equivalents |
(5,681 | ) | 17,775 | |||||
Cash and cash equivalents at beginning of period |
32,344 | 15,988 | ||||||
Cash and cash equivalents at end of period |
$ | 26,663 | $ | 33,763 | ||||
See accompanying notes.
6
Table of Contents
OXiGENE, Inc.
Notes to Condensed Financial Statements
March 31, 2006
(Unaudited)
(Unaudited)
1. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in accordance
with accounting principles generally accepted in the United States 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 accounting principles
generally accepted in the United States 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. Operating results for the three months ended March 31, 2006
are not necessarily indicative of the results that may be expected for the year ending December 31,
2006.
The condensed balance sheet at December 31, 2005 has been derived from the audited
consolidated financial statements at that date but does not include all of the information and
footnotes required by generally accepted accounting principles for complete financial statements.
For further information, refer to the financial statements and footnotes thereto included in the
Annual Report on Form 10-K for OXiGENE, Inc. (the Company) for the year ended December 31, 2005,
which can be found at www.oxigene.com.
Revenue Recognition
Revenue is deemed earned when all of the following have occurred: all obligations of the
Company relating to the revenue have been met and the earnings process is complete; the amounts
received or receivable are not refundable irrespective of the research results; and there are
neither future obligations nor future milestones to be met by the Company with respect to such
revenue.
Collaboration revenues are earned based upon research expenses incurred and milestones
achieved. Revenue from non-refundable payments received upon initiation of contracts are deferred
and amortized over the period in which the Company is obligated to participate on a continuing and
substantial basis in the research and development activities outlined in each contract. Amounts
received in advance of reimbursable expenses are recorded as deferred revenue until the related
expenses are incurred. Milestone payments are recognized as revenue in the period in which the
parties agree that the milestone has been achieved and no further obligation is deemed to exist.
Available-for-Sale Securities
In accordance with the Companys investment policy, surplus cash is invested primarily in
investment-grade corporate bonds, commercial paper, U.S. government agency and debt securities,
asset backed securities and certificates of deposit. In accordance with Statement of Financial
Accounting Standards No. 115 (SFAS 115), Accounting for Certain Investments in Debt and Equity
Securities, the Company separately discloses cash and cash equivalents from investments in
marketable securities. The Company designates its marketable securities as available-for-sale
securities. Available-for-sale securities are carried at fair value with the unrealized gains and
losses, net of tax, if any, reported as accumulated other comprehensive income (loss) in
stockholders equity. The Company reviews the status of the unrealized gains and losses of its
available-for-sale marketable securities on a regular basis. Realized gains and losses and
declines in value judged to be other-than-temporary on available-for-sale securities are included
in investment income. Interest and dividends on securities classified as available-for-sale are
included in investment income. Securities in an unrealized loss position deemed not to be
other-than-temporarily impaired, due to the Companys positive intent and ability to hold the
securities until anticipated recovery, with maturation greater than twelve months are classified as
long term assets.
The Companys investment objectives are to preserve principal, maintain a high degree of
liquidity to meet operating needs and obtain competitive returns subject to prevailing market
conditions. The Company assesses the market risk of its investments on an ongoing basis so as to
avert risk of loss. The Company assesses the market risk of its investments by continuously
monitoring the market prices of its investments and related rates of return, continuously looking
for the safest, most risk-averse investments that will yield the highest rates of return in their
category.
The following is a summary of the fair values of available-for-sale securities: (Amounts in
thousands)
March 31, | December 31, | |||||||
2006 | 2005 | |||||||
Current |
||||||||
Government bonds and notes |
||||||||
Maturing in less than 2 years |
$ | 4,448 | $ | 3,781 | ||||
Corporate bonds |
||||||||
Maturing in less than 2 years |
5,434 | 4,778 | ||||||
Maturing in 2 to 4 years |
1,199 | 1,203 | ||||||
Subtotal corporate bonds |
6,633 | 5,981 | ||||||
Commercial Paper |
12,939 | 9,333 | ||||||
Asset backed securities |
2,253 | 3,260 | ||||||
Certificates of deposit |
998 | 1,000 | ||||||
Subtotal current available-for-sale securities |
27,271 | 23,355 | ||||||
Long Term |
||||||||
Government bonds and notes |
||||||||
Maturing in less than 2 years |
974 | 1,472 | ||||||
Corporate bonds |
||||||||
Maturing in less than 2 years |
483 | 1,684 | ||||||
Subtotal long term available-for-sale securities |
1,457 | 3,156 | ||||||
Total available-for-sale securities |
$ | 28,728 | $ | 26,511 | ||||
7
Table of Contents
As
of March 31, 2006, a majority of the Companys remaining available-for-sale securities
are in an unrealized loss position of approximately $96,000, primarily attributable to increases in short to medium term
interest rates. The Company has determined that these unrealized losses are temporary, after taking
into consideration its current cash and cash equivalent balances and its expected cash requirements
over the next two years.
Accrued Research and Development
The Company charges all research and development expenses, both internal and external
costs, to operations as incurred. The Companys research and development costs represent expenses
incurred from the engagement of outside professional service organizations, product manufacturers
and consultants associated with the development of our potential product candidates. The Company
recognizes expense associated with these arrangements based on the completion of activities as
specified in the applicable contracts. Costs incurred under fixed fee contracts are accrued
ratably over the contract period absent any knowledge that the services will be performed other
than ratably. Costs incurred under contracts with clinical trial sites and principal investigators
are generally accrued on a patient-treated basis consistent with the terms outlined in the
contract. In determining costs incurred on some of these programs, the Company takes into
consideration a number of factors, including estimates and input provided by internal program
managers. Upon termination of such contracts, the Company is normally only liable for costs
incurred or committed to date. As a result, accrued research and development expenses represent
the Companys estimated contractual liability to outside service providers at any relevant times.
Net Loss Per Share
Basic and diluted net loss per share were calculated in accordance with the provisions of
Statement of Financial Accounting Standards No. 128, Earnings Per Share, by dividing the net loss
per share by the weighted-average number of common shares outstanding. Diluted net loss per share
includes the effect of all dilutive, potentially issuable common equivalent shares as defined using
the treasury stock method. All of the Companys common stock equivalents are antidilutive due to
the Companys net loss position for all periods presented. Common stock equivalents of 2,341,000
and 2,108,000 at March 31, 2006, and 2005, respectively, were excluded from the calculation of
weighted average shares for diluted loss per share.
Share-based Compensation
Effective January 1, 2006, we adopted SFAS 123R, Share-Based Payment, which requires the
expense recognition of the estimated fair value of all share-based payments issued to employees.
For the periods prior to the adoption of SFAS 123R, the Company had elected to follow Accounting
Principles Board Opinion No. 25 Accounting for Stock Issued to Employees, (APB 25) and related
interpretations in accounting for share-based payments. The Company had elected the disclosure-only
alternative under SFAS 123, Accounting for Stock-Based Compensation. Accordingly, when options
granted to employees had an exercise price equal to the market value of the stock on the date of
grant, no compensation expense was recognized. For the three months ended March 31, 2006, we
recorded approximately $315,000 of expense associated with share-based payments, which would not
have been recorded prior to the adoption of SFAS 123R. As a result of the adoption of 123R, net
loss for the three months ended March 31, 2006 was $315,000
higher, than if the Company had
continued to account for the share-based compensation under APB 25. Basic and diluted net loss
per share for the three months ended March 31, 2006 was $.01
lower as a result of the adoption of SFAS 123R.
The Company adopted SFAS 123R under the modified prospective method. Under this method,
beginning January 1, 2006, the Company recognizes compensation
cost for all share-based payments to employees (1) granted prior to
but not yet vested as of January 1, 2006 and (2) granted subsequent
to January 1, 2006 based on the grant date estimate of fair value for
those awards. Prior period
financial information has not been restated.
The following table illustrates the effect on net loss and loss per share as if the Company
had applied the fair value recognition provisions of SFAS 123 to its stock-based employee
compensation for the three months ended March 31, 2005.
Three Months Ended | ||||
March 31, 2005 | ||||
(in thousands, except per share data) | ||||
Net loss, as reported |
$ | (2,028 | ) | |
Add: stock-based employee compensation included in reported net loss |
| |||
Deduct: Total stock-based employee compensation expense determined
under fair value based method for all awards, net of related tax
effects |
(443 | ) | ||
Pro forma net loss |
$ | (2,471 | ) | |
Earnings per share |
||||
Reported basic and diluted loss per share |
$ | (0.12 | ) | |
Pro forma basic and diluted loss per share |
$ | (0.14 | ) | |
Stock Incentive Plans
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In 1996, the Company established the 1996 Stock Incentive Plan (the 1996 Plan). Under the
1996 Plan, certain directors, officers and employees of the Company and its subsidiary and
consultants and advisors thereto were granted options to purchase shares of Common Stock of the
Company. Under the terms of the 1996 Plan, incentive stock options (ISOs) within the meaning of
Section 422 of the Internal Revenue Code, nonqualified stock options (NQSOs) and stock
appreciation rights (SARs) could be granted. A maximum of 2,500,000 shares was authorized to be
issued under the 1996 Plan. Vesting for awards granted under the 1996 Plan ranges from one to
four years from the date of grant. No further grants are permitted under this plan.
In July 2005, the stockholders approved the 2005 Stock Plan at the Companys Annual Meeting of
stockholders. Under the 2005 Stock Plan, eligible employees, directors and consultants of the
Company may be granted shares of common stock of the Company, stock-based awards and/or incentive
or non-qualified stock options. Stock options granted under this plan have a 10-year contractual
term. The 2005 Plan is administered by the Compensation Committee of the Board of Directors, which
has the authority to determine to whom options may be granted, the period of exercise and what
other restrictions, if any, should apply. Vesting for the awards granted under the 2005 Plan is
principally over four years from the date of grant, with 25% of the awards vesting each year. The
Company initially reserved 2,500,000 shares of its common stock for issuance under the 2005 Plan, plus the amount of shares of Common Stock subject to awards under the Companys 1996 Plan which became unissued after adoption of the 2005 Plan upon the cancellation, surrender or
termination of such award.
Compensation
cost associated with options issued from the 1996 and 2005 Plans was
approximately $315,000 and $0
for the periods ended March 31, 2006 and March 31, 2005, respectively. The stock options were
valued using the Black-Scholes method of valuation, and the resulting fair value is recorded as
compensation cost on a straight-line basis over the option vesting period. During the three month
period ended March 31, 2006 no options were granted, and as such, no assumptions were used to
calculate a fair value.
Three | ||||
Months | ||||
Ended | ||||
March 31, | ||||
2005 | ||||
Risk free interest rate |
3.72 | % | ||
Expected life |
4 years | |||
Expected volatility |
131 | % | ||
Dividend yield |
0.00 | % |
A summary of the stock option activity under the 1996 and 2005 Plans for the three months
ended March 31, 2006 is as follows:
Weighted Average | ||||||||||||||||
Weighted Average | Remaining Contractual | Aggregate | ||||||||||||||
Shares | Exercise Price | Life | Intrinsic Value | |||||||||||||
(in thousands) | (years) | (in thousands) | ||||||||||||||
Options outstanding at December 31, 2005 |
1,672 | $ | 6.31 | |||||||||||||
Granted |
| | ||||||||||||||
Exercised |
| | ||||||||||||||
Forfeited or expired |
(1 | ) | 6.39 | |||||||||||||
Options outstanding at March 31, 2006 |
1,671 | 6.31 | 7.29 | $ | 870 | |||||||||||
Options exercisable at March 31, 2006 |
1,125 | 6.19 | 6.84 | 822 |
The weighted average grant date fair value of options granted during the three
months ended March 31, 2005 was $4.25. The total intrinsic value
of options exercised during the three months ended March 31, 2005 was approximately $4,000. As of March 31, 2006, there was approximately $1,930,000 of unrecognized
compensation cost related to stock option awards that is expected to be recognized as expense over
a weighted average period of 2.1 years. The total fair value of stock options that vested during
the three months ended March 31, 2006 and 2005 was approximately $18,000 and $579,000,
respectively.
In the third quarter of 2005, the Company awarded a total of 520,000 shares of restricted
common stock pursuant to the Companys 2005 Stock Plan. These shares have full voting rights and
are eligible to receive dividends should they be declared. The restricted stock agreements contain
lapsing repurchase rights under which a portion of the shares granted would be forfeited to the
Company should the director or officer no longer serve in his capacity as a director or officer
prior to the end of the four year vesting term. In October 2005, the Company canceled 480,000 of
these awards and immediately granted those directors and officers of the Company 480,000 shares
of replacement restricted stock under the provisions of the Companys 2005 Stock Plan, in order to
avail the participants of the ability to make a tax election under
Section
83(b) of the Internal Revenue Code of 1986, as amended. The terms of the replacement awards are similar to those of the original awards. The replacement grant resulted in a new measurement date for those awards.
83(b) of the Internal Revenue Code of 1986, as amended. The terms of the replacement awards are similar to those of the original awards. The replacement grant resulted in a new measurement date for those awards.
The restricted stock awards were valued based on the closing price of the
Companys common stock on the date of grant, and compensation expense is recorded on a
straight-line basis over the restricted share vesting period. As of March 31, 2006, the Company
had 520,000 restricted shares outstanding. The Company recorded expense of
approximately $160,000 related to restricted stock awards in the three months ended March 31, 2006.
As of March 31, 2006, there was approximately $2,233,000 of unrecognized compensation expense
related to restricted stock awards that will be recognized as expense over a weighted average
period of 3.5 years. None of the restricted stock awards were vested at March 31, 2006. The
weighted average fair value of the restricted shares was $5.18 on the
date of grant.
In June 2003, the Company issued five-year warrants in connection with a private placement
with three large institutional investors. As of March 31, 2006, there were 150,000 warrants
outstanding and exercisable, which expire in 2.2 years. The weighted average exercise price of the
outstanding and exercisable warrants was $12.00 at March 31, 2006.
9
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Comprehensive Income (Loss)
Statement of Financial Accounting Standards No. 130, Reporting Comprehensive Income (SFAS
130), establishes rules for the reporting and display of comprehensive income (loss) and its
components and requires unrealized gains or losses on the Companys available-for-sale securities
and the foreign currency translation adjustments to be included in other comprehensive income
(loss).
Accumulated other comprehensive loss consisted of an unrealized loss on available-for-sale
securities of $96,000 at March 31, 2006 and $85,000 at December 31, 2005.
A reconciliation of comprehensive loss is as follows:
Three Months Ended March 31, | ||||||||
2006 | 2005 | |||||||
Net loss as reported |
$ | (3,336 | ) | $ | (2,028 | ) | ||
Unrealized gain (loss) |
(11 | ) | (28 | ) | ||||
Comprehensive loss |
$ | (3,347 | ) | $ | (2,056 | ) | ||
2. Stockholders Equity
In March 2005, the Company received gross proceeds of approximately $15,000,000
from the sale of 3,336,117 shares of its Common Stock and net proceeds of approximately $13,719,000
after the deduction of fees and expenses, pursuant to a shelf
registration statement on Form S-3 filed with the Securities and
Exchange Commission in October 2003, allowing it to sell up to
$50,000,000 of its Common Stock, debt securities and/or warrants to
purchase its securities (the 2003 Shelf Registration).
In December 2005, the Company received gross proceeds of approximately $27,284,000 from the
sale of 7,475,000 shares of its Common Stock and net proceeds of approximately $25,205,000 after
the deduction of fees and expenses, pursuant to a shelf registration statement on Form S-3 filed
with the Securities and Exchange Commission in September 2005, allowing it to sell up to
$75,000,000 of its Common Stock, debt securities and/or warrants to purchase its securities. This
registration statement, which became effective on October 6, 2005, replaced the 2003 Shelf
Registration.
3. License agreement
In August 1999, we entered into an exclusive license for the commercial development, use and sale
of products or services covered by certain patent rights owned by Arizona State University. This
agreement was subsequently amended in June 2002. From the inception of the agreement through March
31, 2006, we have paid a total of $2,200,000 in connection with the license. The agreement
provides for additional payments in connection with the license arrangement upon the initiation of
certain clinic trials or the completion of certain regulatory approvals, which payments could be
accelerated upon the achievement of certain financial milestones, as defined in the agreement. In
the three months ended March 31, 2006 we recognized a research and development charge of $100,000
payable to ASU in the second quarter of 2006 in accordance with the terms of the agreement. The
license agreement also provides for additional payments upon our election to develop certain
additional compounds, as defined in the agreement. Future milestone payments under the agreement
could total an additional $400,000. We are also required to pay royalties on future net sales of
products associated with these patent rights.
10
Table of Contents
Item 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations
Our Managements Discussion and Analysis of Financial Condition and Results of Operations
as of March 31, 2006 and 2005 should be read in conjunction with the sections of our audited
consolidated financial statements and notes thereto, as well as our Managements Discussion and
Analysis of Financial Condition and Results of Operations that is included in our Annual Report on
Form 10-K for the year ended December 31, 2005.
Overview
We were incorporated in 1988 in the state of New York and reincorporated in 1992 in the
state of Delaware, and are a biopharmaceutical company developing novel small-molecule therapeutics
to treat cancer and certain eye diseases. Our focus is the development and commercialization of
drug candidates that selectively disrupt abnormal blood vessels associated with solid tumor
progression and visual impairment. Currently, we have two lead therapeutic product candidates in
various stages of clinical development, as well as additional compounds that we are evaluating in
preclinical studies.
Our primary drug development programs are based on a series of natural products called
Combretastatins, which were originally isolated from the African bush willow tree (Combretum
caffrum) by researchers at Arizona State University, or ASU. ASU has granted us an exclusive,
worldwide, royalty-bearing license with respect to the commercial rights to particular
Combretastatins. Through in vitro and in vivo testing, it has been established that certain
Combretastatins selectively disrupt the function of newly formed abnormal blood vessels associated
with solid cancers and have a similar effect on abnormal blood vessels associated with certain
diseases of the eye. We have developed two distinct technologies that are based on Combretastatins.
We refer to the first technology as vascular disrupting agents, or VDAs. We are currently
developing VDAs for indications in both oncology and ophthalmology. We refer to the second
technology as ortho-quinone prodrugs, or OQPs. We are currently developing OQPs for indications in
oncology.
Currently, we do not have any products available for sale. The only source of potential
revenue at this time is from a license to a third party of our formerly owned Nicoplex and Thiol
test technology. Revenue in connection with this license arrangement is earned based on sales of
products or services utilizing this technology. Revenue from this license agreement is recognized
when payments are received due to the uncertainty of the timing of sales of products or services.
Future revenues, if any, from this license agreement are expected to be minimal. We do not expect
to generate material revenue or fee income in the foreseeable future unless we enter into a major
licensing arrangement.
We are committed to a disciplined financial strategy and as such maintain a limited employee
and facilities base, with development, scientific, finance and administrative functions, which
include, among other things, product development, regulatory oversight and clinical testing,
managed from our Waltham, Massachusetts headquarters. Our research and development team members
typically work on a number of development projects concurrently. Accordingly, we do not separately
track the costs for each of these research and development projects to enable separate disclosure
of these costs on a project-by-project basis. We conduct substantial scientific activities pursuant
to collaborative arrangements with universities. Regulatory and clinical testing functions are
generally contracted out to third-party, specialty organizations.
Our failure to successfully complete human clinical trials, develop and market products over
the next several years, or to realize product revenues, would materially adversely affect our
business, financial condition and results of operations. Royalties or other revenue generated by us
from commercial sales of our potential products are not expected for several years, if at all.
We
have generated a cumulative net loss of approximately $105,291,000 for the period from our
inception through March 31, 2006. We expect to incur significant additional operating losses over
at least the next several years, principally as a result of our continuing clinical trials and
anticipated research and development expenditures. The principal source of our working capital has
been the proceeds of private and public equity financing and the exercise of warrants and stock
options; we currently have no material amount of licensing or other fee income. As of March 31,
2006, we had no long-term debt or loans payable.
Results of Operations
Revenues
Three Months Ended March 31, 2006 and 2005
No license revenues were reported for the three months ended March 31, 2006 and March 31,
2005.
Costs and expenses
Three Months Ended March 31, 2006 and 2005
Total costs and expenses for the three months ended March 31, 2006 and 2005 amounted to
approximately $3,942,000 and $2,214,000, respectively.
Research and development expenses were approximately $2,321,000 during the three months ended
March 31, 2006, compared to approximately $1,217,000 for the comparable 2005 period, an
increase of $1,104,000, or 91%. The increase is primarily attributable to an increase in the direct
program spending with third-party service providers and consultants of $777,000 and expenditure on
additional headcount to support our ongoing and anticipated clinical trials in oncology and
ophthalmology of approximately $325,000, which includes approximately $131,000 related to stock
option and restricted stock compensation expense. In addition, included in research and
development expense is a charge in accordance with the terms of our license agreement with Arizona
State University of $100,000 and $200,000 for the three months ended March 31, 2006 and 2005,
respectively. The terms of our agreement with ASU provide for the payment of amounts in connection
with certain patent rights upon the achievement of certain milestones and events as described in
the agreement. The agreement provides for additional payments, totaling $400,000, in future
periods based upon the achievement of certain milestones and events as described in the agreement.
We anticipate research and development expenses to continue to increase as compared to the previous
year as we enter into additional and later-stage trials during 2006.
General and administrative expenses for the three months ended March 31, 2006 increased to
approximately $1,621,000 from $997,000 for the comparable 2005 period. The increase of
approximately $624,000, or 63%, was primarily attributable to additional headcount, compensation
and other employee related expenses of approximately $469,000, which includes approximately
$349,000 relating to stock option and restricted stock compensation expense, increased general
corporate costs of approximately $95,000 and an increase in
administrative expenses of
approximately $60,000. We have added additional space, management and staffing in the support and
management of our increased activities for both our current and
anticipated development programs. As such, we anticipate general and
administrative expenses to trend higher than the comparable periods
in 2005.
Other income and expenses
Investment income increased to approximately $612,000 in the three-month period ended March
31, 2006, compared to approximately $181,000 in the three-month period ended March 31, 2005, an
increase of approximately $431,000, or 238%. The increase was due primarily to higher average cash,
cash equivalents and
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marketable securities balances and higher average yields on our cash and cash equivalents and
available-for-sale securities balances in the 2006 period.
Liquidity and Capital Resources
We have experienced net losses and negative cash flow from operations each year since our
inception, except in fiscal 2000. As of March 31, 2006, we had an accumulated deficit of
approximately $105,291,000. We expect to incur expenses, resulting in operating losses, over the
next several years due to, among other factors, our continuing clinical trials, planned future
clinical trials, and other anticipated research and development activities. Our cash, cash
equivalents and available-for-sale securities balance was approximately $55,391,000 at March 31,
2006, compared to approximately $58,855,000 at December 31, 2005.
In the three-month period ended March 31, 2006, we experienced a decrease in cash and cash
equivalents of $5,681,000. The decrease in cash and cash equivalents
is due to cash used in
investing activities of $2,285,000 and cash used in operating activities of $3,396,000.
The net cash used in investing activities of $2,285,000 is primarily attributable to purchases
of available-for-sale securities of $12,876,000 and, to a lesser extent, the purchase of furniture
and equipment of $60,000, offset by the proceeds from the sale of available-for-sale securities of
$10,646,000 and a decrease in deposits of $5,000.
Cash used in operating activities of $3,396,000 is primarily attributable to the net loss of
$3,336,000, an increase in prepaid expense of $191,000 and a decrease in accounts payable, accrued
expense and other payables of $388,000, offset by non-cash charges totaling $519,000 of which
share-based compensation totaled $480,000.
We anticipate that our cash, cash equivalents and available-for-sale marketable securities,
will be sufficient to satisfy the Companys projected cash requirements at least through the end of
fiscal 2007. Our cash requirements may vary materially from those now planned for or anticipated by
management due to numerous risks and uncertainties. These risks and uncertainties include, but are
not limited to: the progress of and results of our pre-clinical testing and clinical trials of our
VDAs and OQPs under development, including CA4P, our lead compound, and OXi4503; the progress of
our research and development programs; the time and costs expended and required to obtain any
necessary or desired regulatory approvals; the resources, if any, that we devote to developing
manufacturing methods and advanced technologies; our ability to enter into licensing arrangements,
including any unanticipated licensing arrangements that may be necessary to enable us to continue
our development and clinical trial programs; the costs and expenses of filing, prosecuting and, if
necessary, enforcing our patent claims, or defending ourselves against possible claims of
infringement by us of third party patent or other technology rights; the costs of commercialization
activities and arrangements, if any, undertaken by us; and, if and when approved, the demand for
our products, which demand is dependent in turn on circumstances and uncertainties that cannot be
fully known, understood or quantified unless and until the time of approval, for example the range
of indications for which any product is granted approval.
If our existing funds are not sufficient to continue operations, we would be required to seek
additional funding and/or take other measures. If additional financing is needed, there can be no
assurance that additional financing will be available on acceptable terms when needed, if at all.
We have no material commitments for capital expenditures as of March 31, 2006.
The following table presents our contractual obligations and commercial commitments as of
March 31, 2006:
Payments due by period | ||||||||||||||||||||
(All amounts in thousands) | ||||||||||||||||||||
Total | Less than 1 year | 1-3 years | 4-5 years | After 5 years | ||||||||||||||||
Pre-clinical, chemistry and
manufacturing and clinical
development commitments |
$ | 5,220 | $ | 4,692 | $ | 518 | $ | 10 | $ | | ||||||||||
Operating leases |
2,608 | 675 | 1,195 | 738 | | |||||||||||||||
Total contractual cash obligations |
$ | 7,828 | $ | 5,367 | $ | 1,713 | $ | 748 | $ | |
Payments under the pre-clinical, chemistry and manufacturing and clinical development
contracts are based on the completion of activities as specified in the contract. The amounts in
the table above assume the successful completion, by third-party contractors, of all of the
activities contemplated in the agreements with such parties. In addition, not included in the
operating leases above, is sublease income which is expected to total approximately $210,000,
$212,000 and $89,000 for the 12 month periods ending March 31, 2007, 2008 and 2009, respectively.
Our primary drug development programs are based on a series of natural products called
Combretastatins. In August 1999, we entered into an exclusive license for the commercial
development, use and sale of products or services covered by certain patent rights owned by Arizona
State University. This agreement was subsequently amended in June 2002. From the inception of the
agreement through March 31, 2006, we have paid a total of $2,200,000 in connection with this
license. The agreement provides for additional payments in connection with the license arrangement
upon the initiation of certain clinical trials or the completion of certain regulatory approvals,
which payments could be accelerated upon the achievement of certain financial milestones, as
defined in the agreement. In the three months ended March 31, 2006, we recognized a research and
development charge of $100,000 payable to ASU in the second quarter of 2006 in accordance with the
terms of the agreement. The license agreement also provides for additional payments upon our
election to develop certain additional compounds, as defined in the agreement. Future milestone
payments under this agreement could total up to an additional $400,000. We are also required to pay
royalties on future net sales of products associated with these patent rights.
Critical Accounting Policies and Significant Judgments and Estimates
Our managements discussion and analysis of our financial condition and results of operations
is based on our financial statements, which have been prepared in accordance with accounting
principles generally accepted in the United States. The preparation of these financial statements
requires us to make estimates and assumptions that affect the reported amounts of assets and
liabilities and the disclosure of contingent assets and liabilities at the date of the financial
statements, as well as the reported revenues and expenses during the reporting periods. On an
ongoing basis, we evaluate our estimates and judgments, including those related to intangible
assets. We base our estimates on historical experience and on various other factors that are
believed to be appropriate under the circumstances, the results of which form the basis for making
the judgments about the carrying value of assets and liabilities that are not readily apparent from
other sources. Actual results may differ from these estimates.
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While our significant accounting policies are more fully described in Note 1 to our
consolidated financial statements included in our Annual Report on Form 10-K for the year ended
December 31, 2005 and in our financial statements set forth in Item 1 of this Quarterly Report on
Form 10-Q, we believe the following accounting policies are most critical to aid in fully
understanding and evaluating our reported financial results.
Available-for-Sale Securities
We designate our marketable securities as available-for-sale securities. Available-for-sale
securities are carried at fair value with the unrealized gains and losses, net of tax, if any,
reported as accumulated other comprehensive income (loss) in stockholders equity. Realized gains
and losses and declines in value judged to be other-than-temporary on available-for-sale securities
are included in investment income. Interest and dividends on securities classified as
available-for-sale are included in investment income.
Accrued Research and Development
We charge all research and development expenses, both internal and external costs, to
operations as incurred. External costs consist of fees paid to consultants and other outside
providers under service contracts. Costs incurred under fixed fee contracts are accrued ratably
over the contract period absent any knowledge that the services will be performed other than
ratably. Costs incurred under contracts to perform clinical trials are accrued on a
patients-treated basis consistent with the typical terms of reimbursement. Upon termination of such
contracts, we are normally only liable for costs incurred to date. As a result, accrued research
and development expenses represent our estimated contractual liability to outside service providers
at any of the relevant times.
Impairment of Long-lived Assets
On August 2, 1999, we entered into an exclusive license for the commercial development, use
and sale of products or services covered by certain patent rights owned by Arizona State
University. The present value of the amount payable under the license agreement has been
capitalized based on a discounted cash flow model and is being amortized over the term of the
agreement (approximately 15.5 years). We review this asset for impairment whenever there are
indications of impairment based on an undiscounted net cash flow approach, in accordance with the
Statement of Financial Accounting Standards No. 144, Accounting for the Impairment or Disposal of
Long-lived Assets (SFAS 144). If the undiscounted cash flows of an intangible asset are less
than the carrying value of an intangible asset, the intangible asset is written down to the
discounted cash flow value.
Share-Based Compensation
Effective January 1, 2006, we adopted SFAS 123R, Share-Based Payment, which requires the
expense recognition of the estimated fair value of all share-based payments issued to employees.
Prior to the adoption of SFAS 123R, we had elected to follow Accounting Principles Board Opinion No. 25 Accounting for Stock Issued to
Employees, (APB 25) and related interpretations in accounting for share-based payments. We had
elected the disclosure-only alternative under SFAS 123, Accounting for Stock-Based Compensation.
Accordingly, when options granted to employees had an exercise price equal to the market value of
the stock on the date of grant, no compensation expense was recognized. For
the three month period ended March 31, 2006, we recorded approximately $315,000 of expense
associated with share-based payments, which would not have been recorded prior to the adoption of
SFAS 123R.
The valuation of employee stock options is an inherently subjective process, since market
values are generally not available for long-term, non-transferable employee stock options.
Accordingly, an option pricing model is utilized to derive an estimated fair value. In calculating
the estimated fair value of our stock options, we used the Black-Scholes pricing model which
requires the consideration of the following six variables for purposes of estimating fair value:
| the stock option exercise price | ||
| the expected term of the option | ||
| the grant date price of our common stock, which is issuable upon exercise of the option, | ||
| the expected volatility of our common stock | ||
| the expected dividends on our common stock (we do not anticipate paying dividends for the foreseeable future), and | ||
| the risk free interest rate for the expected option term |
Of the variables above, the selection of an expected term and expected stock price volatility are
the most subjective. The specific valuation assumptions noted above would have been applied to
stock options that were granted subsequent to our adoption of SFAS 123R, however, for the three
month period ended March 31, 2006, we did not grant any options. The majority of the stock option
expense recorded in the three month period ended March 31, 2006 relates to continued vesting of
stock options that were granted prior to January 1, 2006. In accordance with the transition
provisions of SFAS 123R, the grant date estimates of fair value associated with prior awards, which
were also calculated using the Black-Scholes option pricing model, have not been changed. The specific
valuation assumptions that were utilized for purposes of deriving an estimate of fair value at the
time that prior awards were issued are as disclosed in our prior annual reports on Form 10-K, as
filed with the SEC.
Upon adoption of SFAS 123R, we were also required to estimate the level of award forfeitures
expected to occur, and record compensation expense only for those awards that are ultimately
expected to vest. This requirement applies to all awards that are not yet vested, including awards
granted prior to January 1, 2006. Accordingly, we performed a historical analysis of option awards
that were forfeited prior to vesting, and ultimately recorded total stock option expense that
reflected this estimated forfeiture rate. In our calculation we segregated participants into two
distinct groups, (1) directors and officers and
(2) employees and, as such, our estimated annual forfeiture rates were
calculated at 0% and 5%, respectively. This analysis will be re-evaluated quarterly and the
forfeiture rate will be adjusted as necessary. Ultimately, the actual expense recognized over the
vesting period will only be for those shares that vest. From a sensitivity perspective, had we
estimated our forfeiture rate at 0% for employees the expense for the three months ended March 31,
2006 would have increased by approximately $8,000.
Tax Matters
As of December 31, 2005, the Company had net operating loss carry-forwards of
approximately $98,000,000 for U.S. income tax purposes, which will be expiring through 2025. Due
to the degree of uncertainty related to the ultimate use of these loss carry-forwards, the Company
has fully reserved this tax benefit. Additionally, the future utilization of the net operating
loss carry-forwards is subject to limitations under the change in stock ownership rules of the
Internal Revenue Service.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
At March 31, 2006, the Company did not hold any derivative financial instruments,
commodity-based instruments or other long-term debt obligations. The
Company has adopted an Investment Policy and maintains its investment portfolio in accordance
with the Investment Policy. The primary objectives of the Investment
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Policy are to preserve
principal, maintain proper liquidity to meet operating needs and maximize yields while preserving
principal. Although the Companys investments are subject to credit risk, OXiGENE follows
procedures to limit the amount of credit exposure in any single issue, issuer or type of
investment. The Companys investments are also subject to interest rate risk and will decrease in
value if market interest rates increase. However, due to the conservative nature of the Companys
investments and their relatively short duration, OXiGENE believes interest rate risk is mitigated.
The Companys cash and cash equivalents are maintained in U.S. dollar accounts. Although we
conduct a number of our trials and studies outside of the United States, we believe our exposure to
foreign currency risk to be limited as the arrangements are in jurisdictions with relatively stable
currencies.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures.
The Securities and Exchange Commission requires that as of the end of the period covered by
this quarterly report on Form 10-Q, the Chief Executive Officer (CEO) and the Chief Financial
Officer (CFO) evaluate the effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Rule 13a-15(e)) under the Securities Exchange Act of 1934, as amended, or
the Exchange Act, and report on the effectiveness of the design and operation of our disclosure
controls and procedures. Based upon that evaluation, our CEO and CFO concluded that our disclosure
controls and procedures were effective to provide reasonable assurance that we record, process,
summarize and report the information we must disclose in reports that we file or submit under the
Exchange Act within the time periods specified in the SECs rules and forms.
Changes in Internal Control.
There were no changes in the Companys internal control over financial reporting, identified
in connection with the evaluation of such control that occurred during the last fiscal quarter,
that have materially affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
Important Considerations.
The effectiveness of our disclosure controls and procedures and our internal control over
financial reporting is subject to various inherent limitations, including cost limitations,
judgments used in decision making, assumptions about the likelihood of future events, the soundness
of our systems, the possibility of human error, and the risk of fraud. Moreover, projections of any
evaluation of effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions and the risk that the degree of compliance with
policies or procedures may deteriorate over time. Because of these limitations, there can be no
assurance that any system of disclosure controls and procedures or internal control over financial
reporting will be successful in preventing all errors or fraud or in making all material
information known in a timely manner to the appropriate levels of management.
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PART IIOTHER INFORMATION
Item 1. Legal Proceedings
None.
Item 1A. Risk Factors
There have been no material changes to the risk factors as described in our Annual Report Form
10-K for the year ended December 31, 2005 filed with the SEC.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
Item 6. Exhibits
10.35 | Second Amendment to Lease by and between BP Prospect Place LLC and the Registrant, dated as of March 28, 2006. | |
31.1 | Certification of Principal Executive Officer required by Section 302 of the Sarbanes-Oxley Act of 2002. |
31.2 | Certification of Principal Financial Officer required by Section 302 of the Sarbanes-Oxley Act of 2002. |
32.1 | Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
OXiGENE, INC. | ||||||
(Registrant) | ||||||
Date:
May 3, 2006
|
By: | /s/ Frederick W. Driscoll | ||||
Frederick W. Driscoll | ||||||
President and Chief Executive Officer | ||||||
Date:
May 3, 2006
|
By: | /s/ James B. Murphy | ||||
James B. Murphy | ||||||
Vice President and Chief Financial Officer |
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EXHIBIT INDEX
Exhibit | ||
Number | Description | |
10.35
|
Second Amendment to Lease by and between BP Prospect Place LLC and the Registrant, dated as of March 28, 2006. | |
31.1
|
Certification of Principal Executive Officer required by Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2
|
Certification of Principal Financial Officer required by Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
17