e10qsb
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-QSB
|
|
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2007
Commission file number 001-31608
XCORPOREAL, INC.
(Exact name of small business issuer as specified in its charter)
|
|
|
Delaware
|
|
98-0349685 |
(State or other jurisdiction of incorporation or organization)
|
|
(IRS Employer Identification Number) |
11150 Santa Monica Blvd., Suite 340, Los Angeles, California 90025
(Address of principal executive offices)
(310) 424-5668
(Issuers telephone number)
(Former name, former address and former fiscal year, if changed since last report)
Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the
Exchange Act during the past 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 shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
State the number of shares outstanding of each of the issuers classes of common equity, as of the
latest practicable date.
|
|
|
Class
|
|
Outstanding as of May 9, 2007 |
Common Stock, $0.0001 par value
|
|
14,200,050 shares |
Transitional Small Business Disclosure Format (Check one): Yes o No þ
PART I FINANCIAL INFORMATION
ITEM 1. Financial Statements
XCORPOREAL, INC.
(a Development Stage Company)
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(Unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
444,075 |
|
|
$ |
27,440,987 |
|
Marketable securities, at fair value |
|
|
24,623,290 |
|
|
|
|
|
Restricted cash |
|
|
75,000 |
|
|
|
|
|
Prepaids |
|
|
133,202 |
|
|
|
70,850 |
|
Other current assets |
|
|
1,265 |
|
|
|
19,378 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
25,276,832 |
|
|
|
27,531,215 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
37,869 |
|
|
|
3,328 |
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
13,031 |
|
|
|
1,000 |
|
|
|
|
|
|
|
|
Total Assets |
|
|
25,327,732 |
|
|
|
27,535,543 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
|
|
Current |
|
|
|
|
|
|
|
|
Accounts payable |
|
|
492,940 |
|
|
|
143,606 |
|
Accrued placement agent fees |
|
|
|
|
|
|
1,348,470 |
|
Accrued professional fees |
|
|
312,208 |
|
|
|
312,208 |
|
Accrued other liabilities |
|
|
583,276 |
|
|
|
204,522 |
|
Other current liabilities |
|
|
115,400 |
|
|
|
124,676 |
|
|
|
|
|
|
|
|
Total Current Liabilities |
|
|
1,503,824 |
|
|
|
2,133,482 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
|
Preferred Stock, $0.001 par value, 10,000,000
shares authorized, none outstanding |
|
|
|
|
|
|
|
|
Common Stock, $0.0001 par value, 40,000,000
shares authorized, 14,200,050 outstanding on
March 31, 2007 and December 31, 2006 |
|
|
1,420 |
|
|
|
1,420 |
|
Additional paid-in capital |
|
|
33,221,109 |
|
|
|
29,924,410 |
|
Deficit accumulated during the development stage |
|
|
(9,398,621 |
) |
|
|
(4,523,769 |
) |
|
|
|
|
|
|
|
Total Stockholders Equity |
|
|
23,823,908 |
|
|
|
25,402,061 |
|
|
|
|
|
|
|
|
Total Liabilities & Stockholders Equity |
|
$ |
25,327,732 |
|
|
$ |
27,535,543 |
|
|
|
|
|
|
|
|
See accompanying notes to the interim financial statements
3
XCORPOREAL, INC.
(a Development Stage Company)
STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 4, 2001 (Date |
|
|
|
Three Months Ended |
|
|
of Inception) to |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
$ |
4,041,634 |
|
|
$ |
6,203 |
|
|
$ |
7,360,286 |
|
Research and development |
|
|
1,143,563 |
|
|
|
|
|
|
|
2,430,885 |
|
Depreciation and amortization |
|
|
1,521 |
|
|
|
|
|
|
|
1,616 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before Other Income and Income Tax |
|
|
(5,186,718 |
) |
|
|
(6,203 |
) |
|
|
(9,792,787 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest Income |
|
|
311,866 |
|
|
|
|
|
|
|
394,166 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(4,874,852 |
) |
|
|
(6,203 |
) |
|
|
(9,398,621 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(4,874,852 |
) |
|
$ |
(6,203 |
) |
|
$ |
(9,398,621 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share |
|
$ |
(0.34 |
) |
|
$ |
(0.00 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares
outstanding |
|
|
14,200,050 |
|
|
|
3,820,000 |
|
|
|
|
|
See accompanying notes to the interim financial statements
4
XCORPOREAL, INC.
(a Development Stage Company)
STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 4, 2001 (Date |
|
|
|
Three Months Ended |
|
|
of Inception) to |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
Cash flows used in operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss for the Period |
|
$ |
(4,874,852 |
) |
|
$ |
(6,203 |
) |
|
$ |
(9,398,621 |
) |
Adjustments to reconcile net loss to net cash used in
operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Non-employee Stock Based Compensation |
|
|
2,657,635 |
|
|
|
|
|
|
|
4,820,246 |
|
Stock Based Compensation |
|
|
639,064 |
|
|
|
|
|
|
|
903,315 |
|
Depreciation and amortization |
|
|
1,521 |
|
|
|
|
|
|
|
1,616 |
|
Net Change in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid Expenses |
|
|
(62,352 |
) |
|
|
|
|
|
|
(133,202 |
) |
Other Current Assets |
|
|
18,113 |
|
|
|
|
|
|
|
(1,265 |
) |
Other Assets |
|
|
(12,031 |
) |
|
|
|
|
|
|
(13,031 |
) |
Accounts Payable and Accrued Liabilities |
|
|
(620,382 |
) |
|
|
2,702 |
|
|
|
1,388,424 |
|
Other Current Liabilities |
|
|
(9,276 |
) |
|
|
|
|
|
|
115,400 |
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used in Operating Activities |
|
|
(2,262,560 |
) |
|
|
(3,501 |
) |
|
|
(2,317,118 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Investing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Capital Expenditures |
|
|
(36,062 |
) |
|
|
|
|
|
|
(39,485 |
) |
Restricted Cash |
|
|
(75,000 |
) |
|
|
|
|
|
|
(75,000 |
) |
Purchase of marketable securities |
|
|
(24,623,290 |
) |
|
|
|
|
|
|
(24,623,290 |
) |
|
|
|
|
|
|
|
|
|
|
Net Cash Used in Investing Activities |
|
|
(24,734,352 |
) |
|
|
|
|
|
|
(24,737,775 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Capital Stock issued in Private Placement for
$29,400,351 in
cash; fees of $2,058,024 |
|
|
|
|
|
|
|
|
|
|
27,434,348 |
|
Advances from related party |
|
|
|
|
|
|
3,540 |
|
|
|
64,620 |
|
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by Financing Activities |
|
|
|
|
|
|
3,540 |
|
|
|
27,498,968 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/(decrease) in cash during the period |
|
|
(26,996,912 |
) |
|
|
39 |
|
|
|
444,075 |
|
Cash, beginning of the period |
|
|
27,440,987 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, end of the period |
|
$ |
444,075 |
|
|
$ |
39 |
|
|
$ |
444,075 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information;
cash paid
for: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the interim financial statements
5
XCORPOREAL, INC.
(a Development Stage Company)
STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIENCY)
For the Period May 4, 2001 (Inception) to March 31, 2007
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
During |
|
|
|
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Development |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Stage |
|
|
Total |
|
Common stock issued for cash at $0.01 per share |
|
|
2,500,000 |
|
|
$ |
250 |
|
|
$ |
24,750 |
|
|
|
|
|
|
$ |
25,000 |
|
Net Loss for the year ended December 31, 2001 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(40,255 |
) |
|
|
(40,255 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2001 |
|
|
2,500,000 |
|
|
|
250 |
|
|
|
24,750 |
|
|
|
(40,255 |
) |
|
|
(15,255 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for cash at $0.05 per share |
|
|
1,320,000 |
|
|
|
132 |
|
|
|
65,868 |
|
|
|
|
|
|
|
66,000 |
|
Net Loss for the year ended December 31, 2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(31,249 |
) |
|
|
(31,249 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2002 |
|
|
3,820,000 |
|
|
|
382 |
|
|
|
90,618 |
|
|
|
(71,504 |
) |
|
|
19,496 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss for the year ended December 31, 2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,962 |
) |
|
|
(12,962 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2003 |
|
|
3,820,000 |
|
|
|
382 |
|
|
|
90,618 |
|
|
|
(84,466 |
) |
|
|
6,534 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss for the year ended December 31, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(23,338 |
) |
|
|
(23,338 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2004 |
|
|
3,820,000 |
|
|
|
382 |
|
|
|
90,618 |
|
|
|
(107,804 |
) |
|
|
(16,804 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss for the year ended December 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(35,753 |
) |
|
|
(35,753 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2005 |
|
|
3,820,000 |
|
|
|
382 |
|
|
|
90,618 |
|
|
|
(143,557 |
) |
|
|
(52,557 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for a licence rights |
|
|
9,600,000 |
|
|
|
960 |
|
|
|
40 |
|
|
|
|
|
|
|
1,000 |
|
Capital stock cancelled |
|
|
(3,420,000 |
) |
|
|
(342 |
) |
|
|
342 |
|
|
|
|
|
|
|
|
|
Warrants granted for consulting fees |
|
|
|
|
|
|
|
|
|
|
2,162,611 |
|
|
|
|
|
|
|
2,162,611 |
|
Forgiveness of debt |
|
|
|
|
|
|
|
|
|
|
64,620 |
|
|
|
|
|
|
|
64,620 |
|
Common stock issued for cash at $7.00, net of
placement fees of $2,058,024 |
|
|
4,200,050 |
|
|
|
420 |
|
|
|
27,341,928 |
|
|
|
|
|
|
|
27,342,348 |
|
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
264,251 |
|
|
|
|
|
|
|
264,251 |
|
Net loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,380,212 |
) |
|
|
(4,380,212 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2006 |
|
|
14,200,050 |
|
|
|
1,420 |
|
|
|
29,924,410 |
|
|
|
(4,523,769 |
) |
|
|
25,402,061 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants granted for consulting services |
|
|
|
|
|
|
|
|
|
|
2,657,635 |
|
|
|
|
|
|
|
2,657,635 |
|
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
639,064 |
|
|
|
|
|
|
|
639,064 |
|
Net loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,874,852 |
) |
|
|
(4,874,852 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2007 |
|
|
14,200,050 |
|
|
$ |
1,420 |
|
|
$ |
33,221,109 |
|
|
$ |
(9,398,621 |
) |
|
$ |
23,823,908 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the interim financial statements
6
XCORPOREAL, INC.
(a Development Stage Company)
NOTES TO THE INTERIM FINANCIAL STATEMENTS
March 31, 2007
(Unaudited)
Note 1 Interim Reporting
While information presented in the accompanying interim financial statements is unaudited, it
includes all adjustments, which are, in the opinion of management, necessary to present fairly the
financial position, results of operations and cash flows for the interim period presented. All
adjustments are of a normal recurring nature. It is suggested that these interim financial
statements be read in conjunction with our December 31, 2006 financial statements.
The results of operations for the period ended March 31, 2007, are not necessarily indicative
of the results that can be expected for the year ended December 31, 2007.
Note 2 Nature and Continuance of Operations
We were incorporated in the State of Nevada as Pacific Spirit Inc. on May 4, 2001 to engage in
the acquisition, exploration and development of natural resource properties. On August 31, 2006, we
changed our name to Xcorporeal, Inc. and thereafter acquired the rights to our Wearable Artificial
Kidney, congestive heart failure treatment products, and other medical devices. As a result, we
transitioned to a development stage company focused on researching, developing and commercializing
technology and products related to the treatment of kidney failure and congestive heart failure.
On October 13, 2006, Xcorporeal, Inc., a Nevada corporation (Xcorporeal Nevada), consummated a
merger with and into its newly-formed, wholly-owned subsidiary, Xcorporeal Merger Corporation, a
Delaware corporation (Xcorporeal Delaware) for the purpose of changing our domicile from Nevada to
Delaware. Each outstanding share of Xcorporeal Nevada common stock, par value $0.001 per share, was
automatically converted into one share of Xcorporeal Delaware common stock, par value $0.0001 per
share. The change in par value has been applied retroactively. As a result of the reincorporation,
the total number of common stock authorized changed from 100,000,000 shares to 40,000,000 common
shares; the total number of preferred stock authorized remained at 10,000,000 shares, resulting in
a total number of capital stock authorized of 50,000,000 shares.
Note 3 Development Stage Company
We were previously a pre-exploration stage company as defined in the Statement of Financial
Accounting Standards (SFAS) No. 7 and the Securities and Exchange Act Guide No. 7. Effective with
the execution of the license agreement on August 31, 2006, we are a development stage company,
devoting substantially all of our efforts to the research, development and commercialization of
kidney and congestive heart failure treatment technologies.
Risks and Uncertainties We operate in an industry that is subject to intense competition,
government regulation and rapid technological change. Our operations are subject to significant
risk and uncertainties including financial, operational, technological, regulatory and other risks
associated with a development stage company, including the potential risk of business failure.
Note 4 Cash Equivalents and Marketable Securities
We invest available cash in short-term commercial paper, certificates of deposit and high
grade variable rate securities. Liquid investments with an original maturity of three months or
less when purchased are considered to be cash equivalents.
Investments, including auction rate securities and certificates of deposit, with maturity
dates greater than three months when purchased, which have readily determined fair values, are
classified as available-for-sale investments and reflected in current assets as marketable
securities at fair market value. Auction rate securities are recorded at par value, which equals
fair market value, as the rate on such securities resets generally every 7, 28 or 35 days.
Restricted cash represents deposits secured as collateral for a bank credit card program.
7
Note 5 Property and Equipment
Property and equipment consist of the following at March 31, 2007:
|
|
|
|
|
Property and equipment |
|
$ |
39,450 |
|
Accumulated depreciation |
|
|
(1,581 |
) |
|
|
|
|
Property and equipment, net |
|
$ |
37,869 |
|
|
|
|
|
Depreciation expense for the three months ended March 31, 2007 and 2006 was $1,486 and $0,
respectively.
Note 6 Interest Income
Interest income of $311,866 reported for the three months ended March 31, 2007 is a result of
the interest earned on our cash raised from our private placement during the fourth quarter of
2006.
Note 7 Mineral Property
By a lease agreement effective June 1, 2001 and amended June 25, 2002, November 25, 2002,
January 9, 2004 and April 11, 2005, we were granted the exclusive right to explore and mine the Del
Oro and NP Claims located in Pershing County of the State of Nevada. The term of this lease was for
30 years, renewable for an additional 30 years so long as the conditions of the lease are met. We
were required to pay minimum advanced royalties payments on each January 9 of $50,000. We did not
make the payment which triggered an event of default under the lease. On March 10, 2006, we
received a termination notice and the lease was subsequently terminated.
Note 8 Related Party Transaction
We were charged the following by a former director:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 2, 2001 |
|
|
|
|
|
|
|
|
|
|
(Date of |
|
|
Three months ended |
|
Inception) to |
|
|
March 31, |
|
March 31, |
|
|
2007 |
|
2006 |
|
2007 |
Administrative services |
|
$ |
|
|
|
$ |
1,500 |
|
|
$ |
12,000 |
|
Note 9 License Agreement
On August 31, 2006, we entered into a Contribution Agreement with a company whose sole
managing member is our current Chairman. We issued 9,600,000 shares of common stock in exchange for
(a) the right, title, and interest to the name Xcorporeal and related trademarks and domain
names, and (b) the right to enter into the Merger Agreement and License Agreement with National
Quality Care, Inc. (NQCI) dated September 1, 2006 pursuant to which we obtained the exclusive
rights to the technology relating to our congestive heart failure treatment, kidney failure
treatment, and other medical devices. We were a shell corporation prior to the transaction. We
valued the License Agreement at the carry-over basis of $1,000. As consideration for being granted
the License, we agreed to pay a minimum annual royalty of $250,000, or 7% of net sales. We recorded
$145,833 in royalty expenses covering the minimum royalties from commencement of the License
Agreement through March 31, 2007. The first minimum royalty payment is due by December 1, 2007. The
License Agreement expires in 2105.
Note 10 Terminated Merger Agreement
On September 1, 2006, we entered into a Merger Agreement with our licensor, NQCI, which
contemplated that we would either (i) acquire it as a wholly owned subsidiary pursuant to a
triangular merger, or (ii) issue shares of our common stock in consideration of the assignment of
the licensed technology. The Merger Agreement expired by its own terms on December 31, 2006. In
addition, on December 29, 2006, NQCI served written notice that it was terminating the Merger
Agreement, and on January 2, 2007, we consented to the termination. Accordingly, the Merger
Agreement is now terminated. We will not be proceeding with any merger with NQCI. The termination
of the Merger Agreement had no effect on the License Agreement, the Contribution Agreement, or the
shares we issued to CNL.
8
Note 11 Stock Options and Warrants
Incentive Compensation Plan
On October 13, 2006, after the effectiveness of the Nevada reincorporation, we adopted the
Xcorporeal, Inc. 2006 Incentive Compensation Plan and the related form of option agreement. The
plan authorizes the grant of stock options, restricted stock, restricted stock units and stock
appreciation rights. Effective February 28, 2007, there are 3,900,000 shares of common stock
reserved for issuance pursuant to the plan (subject to adjustment in accordance with the provisions
of the plan). The plan will continue in effect for a term of up to ten years
Stock Options to Employees, Officer and Directors
The Compensation Committee of our Board of Directors determines the terms of the options
granted, including the exercise price, the number of shares subject to option, and the vesting
period. Options generally vest over five years and have a maximum life of ten years. On February
27, 2007, we granted options to purchase an aggregate of 650,000 shares of our common stock under
the 2006 Incentive Compensation Plan to employees. The options vest ratably over 5 years, are
exercisable at $7.00 per share, the fair market value of our common stock on the grant date, and
expire in 2017.
We reported $639,064 in stock-based compensation expense for the three month period ended
March 31, 2007. No stock-based compensation expense was reported for the three month period ended
March 31, 2006.
All compensation expense for stock options granted have been determined under the fair value
method using the Black-Scholes option-pricing model with the following assumptions:
|
|
|
|
|
|
|
Three months ended |
|
|
March 31, 2007 |
Expected dividend yield |
|
|
0.00 |
% |
Expected volatility |
|
|
110 |
% |
Risk-free interest rate |
|
|
4.46 |
% |
Expected terms in years |
|
6.5 years |
Warrants and Stock Options to Non-Employees
On February 27, 2007, we issued stock options and warrants to purchase an aggregate of 835,000
shares of common stock whereby 435,000 vested immediately on the grant date and 400,000 vest
ratably over 5 years to consultants in exchange for consulting services. These stock options and
warrants are exercisable at $7.00 per share, the fair market value of our common stock on the grant
date, and expire between 2012 and 2017. The resulting fair value of such stock options and warrants
was $5.3 million, of which $2.7 million was expensed in the accompanying unaudited interim
financial statements for the first quarter ended March 31, 2007. No such expense was reported for
the three month period ended March 31, 2006.
Compensation for options granted to non-employees has been determined in accordance with SFAS
No. 123 and EITF 96-18, Accounting for Equity Instruments that are Issued to Other Than Employees
for Acquiring, or in Conjunction with Selling, Goods or Services. Accordingly, compensation is
determined using the fair value of the consideration received or the fair value of the equity
instruments issued, whichever is more reliably measured.
For options and warrants issued as compensation to non-employees for services that are fully
vested and non-forfeitable at the time of issuance, the estimated value is recorded in equity and
expensed when the services are performed and benefit is received as provided by Financial
Accounting and Standards Board (FASB) Emerging Issues Task Force No. 96-18 Accounting For Equity
Instruments That Are Issued To Other Than Employees For Acquiring Or In Conjunction With Selling
Goods Or Services.
9
All charges for warrants granted have been determined under the fair value method using the
Black-Scholes option-pricing model with the following assumptions:
|
|
|
|
|
|
|
Three months ended |
|
|
March 31, 2007 |
Expected dividend yield |
|
|
0.00 |
% |
Expected volatility |
|
|
135 |
% |
Risk-free interest rate |
|
|
4.50 - 4.65 |
% |
Expected terms in years |
|
5.0-10.0 years |
The following table shows the change in unamortized compensation expense for stock options and
warrants issued to employees, officers, directors and non-employees during the quarter ended March
31, 2007:
|
|
|
|
|
|
|
|
|
|
|
Stock Options |
|
|
Unamortized |
|
|
|
and Warrants |
|
|
Compensation |
|
|
|
Outstanding |
|
|
Expense |
|
January 1, 2007 |
|
|
2,054,221 |
|
|
$ |
10,002,154 |
|
Granted in the period |
|
|
1,485,000 |
|
|
|
9,253,316 |
|
Expensed in the period |
|
|
|
|
|
|
(3,296,699 |
) |
|
|
|
|
|
|
|
March 31, 2007 |
|
|
3,539,221 |
|
|
$ |
15,958,771 |
|
|
|
|
|
|
|
|
Amendment of the 2006 Incentive Compensation Plan
On February 27, 2007, our board of directors approved
an amendment to the 2006 Incentive Compensation Plan to increase the number of shares of common stock reserved for issuance under
the plan from 2,000,000 to 3,900,000. The amendment was previously approved by our stockholders.
10
ITEM 2. Managements Discussion and Analysis or Plan of Operation.
The following discussion of our financial condition and results of operations should be read
in conjunction with our financial statements and the related notes, and the other financial
information included in this report.
Forward-Looking Statements
The forward-looking comments contained in this report involve risks and uncertainties. Our
actual results may differ materially from those discussed here due to factors such as, among
others, limited operating history, difficulty in developing, exploiting and protecting proprietary
technologies, results of clinical studies, intense competition and substantial regulation in the
healthcare industry. Additional factors that could cause or contribute to such differences can be
found in the following discussion and in the Risks Factors set forth below.
Plan of Operation
Overview
We are a medical device company actively researching and developing an extra-corporeal
platform to perform functions of various human organs. Our prototype systems apply modern
electronics and engineering principals to reduce the size, cost and power requirements of
conventional extracorporeal therapies including kidney dialysis. Our platform may also improve the
quality of therapy delivered ultimately leading to better patient outcomes and reduced healthcare
costs.
License Agreement
On September 1, 2006, we entered into the License Agreement pursuant to which we obtained
exclusive rights to our technology relating to the treatment of kidney failure, congestive heart
failure and other medical devices, with no geographic restrictions, that will last for a period of
ninety-nine years or until the expiration of its proprietary rights in each item of intellectual
property, if earlier. As consideration for granting the license, we agreed to reimburse designated
costs and expenses of our licensor, and pay a minimum royalty of 7% of net sales, with an annual
minimum royalty of $250,000. As a result, we have become a developmental stage company focused on
researching, developing, and commercializing technology and products related to the treatment of
kidney failure and congestive heart failure.
Description of Business
For the coming year we plan to test and develop the technology for our extra-corporeal
platform and other medical devices. In its simplest configuration, our product platform can be used
as an ultrafiltration machine which will remove a predetermined amount of water from a patients
blood stream. Removal of excess water by ultrafiltration has been shown to be an effective therapy
for management of fluid overload under physician supervision. We can also add additional components
to our platform to configure a full dialysis machine, which can remove metabolic waste (urea,
creatinine) and toxins from the blood. Dialysis has been shown to be an effective therapy for
treatment of kidney failure.
We will also plan our Validation and Verification strategy including bench testing, clinical
testing, and regulatory strategy in the US and abroad. The products we plan to bring to market
include:
|
|
|
Portable kidney dialysis for use in the clinic, hospital, or at home |
|
|
|
|
Wearable Artifical Kidney (WAK) for chronic treatment of End Stage Renal Disease (ESRD) |
|
|
|
|
Portable ultrafiltration for management of fluid overload under physician supervision |
|
|
|
|
Wearable Ultrafiltration Device (WUD) for chronic treatment of fluid overload under physician supervision. |
Product Applications
Our Wearable Artificial Kidney (WAK) is a breakthrough technology for the chronic treatment of
End Stage Renal Disease (ESRD). We have successfully demonstrated a prototype system that weighs
less than 6 kg., is battery operated, and can be worn by
11
an ambulatory patient. Our miniature,
wearable device will enable continuous (24 x 7) renal replacement therapy on a chronic basis at
home. Continuous therapy has previously been shown to reduce mortality, reduce morbidity, and
improve quality of life in ESRD patients. Our WAK is the first practical device to provide
continuous, chronic therapy, because:
|
|
|
Reduced size, weight, and power consumption allows us to deploy a wearable package so that
the treatment does not interfere with normal activities of daily life. |
|
|
|
|
Reduced fluid requirements make the WAK easy to use for consumers and reduce utility
requirements (water, electricity) at home. |
|
|
|
|
Novel vascular access makes the WAK safe and effective for home use. |
Packaged differently, the same attributes (portability, size, weight, fluid and power
reduction) make the WAK a very attractive alternative to conventional Continuous Renal Replacement
Therapy (CRRT) machines for hospitalized patients. Our miniature system can also be configured to
treat fluid overload under physician supervision.
Research and Development
R&D Team
We acquired the exclusive license to our platform technology on September 1, 2006, and have
commenced planning and implementing our research and development efforts. We have recruited an
experienced scientific team to execute our research and development plan. The goals of our research
and development efforts will include:
|
|
|
Improving the chemicals used in the dialysis process. The current chemicals have been
used for decades. We believe new chemicals that last longer and can be used in smaller
quantities would further reduce the cost and weight of our product. |
|
|
|
|
Developing software to allow physicians to customize the function of the device to meet
the specific dialysis needs of each patient. |
|
|
|
|
Adapting the extra-corporeal platform technology underlying our Wearable Artificial
Kidney to other medical uses. We believe our technology is a platform for a number of other
devices that can be used to treat other diseases and will offer substantive value
propositions for patients and healthcare providers. |
|
|
|
|
Expanding our recruiting and retaining an experienced team of scientists and engineers. |
Clinical Studies
The feasibility of the WAK prototype was demonstrated in a porcine model during 2004 and 2005.
The feasibility of the WAK prototype for treatment of fluid overload in humans was demonstrated by
the treatment of six volunteers in Vicenza, Italy in July and August 2006. We demonstrated the
feasibility of the WAK prototype for dialysis treatment in humans by the treatment of eight
volunteers in London in March 2007. We are planning additional clinical trials over the next few
years, culminating in a pivotal study to support a regulatory submission.
We incurred approximately $1.1 million and $1.3 million in research and development expenses
for the three months ended March 31, 2007 and the year ended December 31, 2006, respectively. We
expect our research and development expenses to increase as a result of additional headcount in the
areas of product development and quality assurance and regulatory affairs, a higher level of
third-party consulting activity and other related expenses.
Managements Discussion and Analysis
Results of Operations for the three months ended March 31, 2007
We have not generated any revenues since inception. We incurred net loss of $4.9 million for
the three months ended March 31, 2007, compared to a net loss of $6,203 for the three months ended
March 31, 2006. The increase in net loss was primarily due to
(i) research, development and other expenses related to advancing our kidney and congestive
heart failure treatment technologies, (ii)
12
stock compensation expense related to options and
warrants granted to directors, officer, employees and consultants, and (iii) legal and audit fees.
At March 31, 2007, we had positive working capital of $23.8 million compared to positive working
capital of $25.4 million for beginning of the year.
Liquidity and Capital Resources
We expect to incur operating losses and negative cash flows for the foreseeable future. During
the fourth quarter of 2006 we raised approximately $27.3 million (net of placement fees of $2.1
million) through a private placement. Our ability to execute on our
current business plan is dependent upon our ability to develop and market our products, and, ultimately, to
generate revenue.
At March 31, 2007 we had cash, cash equivalents and marketable securities of approximately
$25,142,365. We are expending cash at a rate of approximately $0.8 million per month, and at
present rates can satisfy our cash requirements for approximately three years. At present rates, we
will not have to raise additional funds in the next twelve months.
Off-Balance Sheet Arrangements
As of March 31, 2007, we had no off-balance sheet arrangements that have or are reasonably
likely to have a current or future effect on our financial condition, results of operations or cash
flows.
Legal Proceedings
We are involved in an arbitration against National Quality Care, Inc. concerning our License
Agreement, as described in our most recent annual report. From time to time, we may be involved in
litigation relating to claims arising out of our operations in the normal course of business. As of
the date of this report we are not currently involved in any legal proceeding that we believe would
have a material adverse effect on our business, financial condition or operating results.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations is based upon
our financial statements, which have been prepared in accordance with accounting principles
generally accepted in the United States. Generally accepted accounting principles require
management to make estimates, judgments and assumptions that affect the reported amounts of assets,
liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities. We
base our estimates on experience and on various other assumptions that we believe to be reasonable
under the circumstances, the results of which form the basis for making judgments about the
carrying values of assets and liabilities that may not be readily apparent from other sources. Our
actual results may differ from those estimates.
We consider our critical accounting policies to be those that involve significant
uncertainties, require judgments or estimates that are more difficult for management to determine
or that may produce materially different results when using different assumptions. We consider the
following accounting policies to be critical:
Marketable Securities
We classify investments with maturity dates greater than three months when purchased as
marketable securities. Investments, including auction rate securities and certificates of deposit,
with maturity dates greater than three months when purchased and which have readily determined fair
values are classified as available-for-sale investments and reflected in current assets as
marketable securities at fair market value. Auction rate securities are recorded at cost, which
equals fair market value, as the rate on such securities generally resets every 7, 28 or 35 days.
Our investment policy requires that all investments be investment grade quality and no more than
ten percent of our portfolio may be invested in any one security or with one institution.
Identifiable Intangibles
Certain costs associated with obtaining and licensing patents and trademarks are capitalized
as incurred and are amortized on a straight-line basis over the shorter of their estimated useful
lives or their legal lives of 17 to 20 years. Amortization of such costs begins once the patent or
trademark has been issued. We evaluate the recoverability of our patent costs and trademarks
quarterly based on estimated undiscounted future cash flows.
13
Stock-Based Compensation
Statements of Financial Accounting Standards (SFAS) No. 123 (revised 2004), Share-Based
Payment, (SFAS 123(R)) and Securities and Exchange Commission issued Staff Accounting Bulletin
(SAB) No. 107 (SAB 107) require the measurement and recognition of compensation expense for all
share-based payment awards made to employees and directors based on estimated fair values. We have
applied the provisions of SAB 107 in its adoption of SFAS 123(R).
Recent Accounting Pronouncements
In March 2006, the FASB issued SFAS No. 156, Accounting for Servicing of Financial Assets an
amendment of FASB Statement No. 140 (SFAS 156). The provisions of SFAS 156 are effective for fiscal
years beginning after September 15, 2006. This statement was issued to simplify the accounting for
servicing rights and to reduce the volatility that results from using different measurement
attributes. We have adopted SFAS 156 in January 2007. There was no impact on our results of
operations and financial position upon adoption.
In July 2006, the FASB released FASB Interpretation No. 48, Accounting for Uncertainty in
Income Taxes, an interpretation of FASB Statement No. 109 (FIN 48). FIN 48 clarifies the accounting
and reporting for uncertainties in income tax law. This Interpretation prescribes a comprehensive
model for the financial statement recognition, measurement, presentation and disclosure of
uncertain tax positions taken or expected to be taken in income tax returns. This statement is
effective for fiscal years beginning after December 15, 2006. We have adopted FIN 48 in January
2007. There was no impact on our results of operations and financial position upon adoption.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS 157
establishes a framework for measuring fair value in generally accepted accounting principles, and
expands disclosures about fair value measurements. SFAS 157 is effective for financial statements
issued for fiscal years beginning after November 15, 2007. We are required to adopt the provision
of SFAS 157, as applicable, beginning in fiscal year 2008. We are currently in the process of
evaluating the expected effect of SFAS 157 on our results of operations and financial position.
In February 2007, the Financial Accounting Standards Board (FASB) issued FASB Statement No.
159, The Fair Value Option for Financial Assets and Financial Liabilities Including an Amendment
of FASB Statement No. 115, Accounting for Certain Investments in Debt and Equity Securities (SFAS
No. 159). SFAS No. 159 permits an entity to choose to measure many financial instruments and
certain items at fair value. The objective of this standard is to improve financial reporting by
providing entities with the opportunity to mitigate volatility in reporting earnings caused by
measuring related assets and liabilities differently without having to apply complex hedge
accounting provisions. SFAS No. 159 permits all entities to choose to measure eligible items at
fair value at specified election dates. Entities will report unrealized gains and losses on items
for which the fair value option has been elected in earnings at each subsequent reporting date. The
fair value option: (a) may be applied instrument by instrument, with a few exceptions, such as
investments accounted for by the equity method; (b) is irrevocable (unless a new election date
occurs); and (c) is applied only to entire instruments and not to portions of instruments. SFAS No.
159 is effective as of the beginning of an entitys first fiscal year that begins after November
15, 2007, which for us would be our fiscal year beginning January 1, 2008. Early adoption is
permitted as of the beginning of the previous fiscal year provided that the entity makes that
choice in the first 120 days of that fiscal year and also elects to apply to provision of FASB
Statement No. 157, Fair Value Measurements. We are currently evaluating the impact that the
adoption of SFAS No. 159 will have on our consolidated financial statements.
In December 2006, the FASB issued FSP 00-19-2, Accounting for Registration Payment Arrangements
(FSP 00-19-2) which
addresses accounting for registration payment arrangements. FSP 00-19-2 specifies that the
contingent obligation to make future
payments or otherwise transfer consideration under a registration payment arrangement, whether
issued as a separate agreement or
included as a provision of a financial instrument or other agreement, should be separately
recognized and measured in accordance with
FASB Statement No. 5, Accounting for Contingencies. FSP 00-19-2 further clarifies that a
financial instrument subject to a
registration payment arrangement should be accounted for in accordance with other applicable
generally accepted accounting
principles without regard to the contingent obligation to transfer consideration pursuant to the
registration payment. FSP 00-19-2 is
effective immediately for registration payment arrangements and the financial instruments subject
to those arrangements that are
entered into or modified subsequent to December 21, 2006. For registration payment arrangement and
related financial instruments
entered into prior to December 21, 2006, FSP 00-19-2 is effective for financial statements issued
for fiscal years beginning after
December 15, 2006 and interim periods within those financial years. Companies are required to
report transition through a cumulative-effect adjustment to the opening balance of retained
earnings as of the first interim period for the fiscal year in which FSP 00-19-2 is
adopted. We have early adopted FSP 00-19-2 in 2006. There was no impact on our financial statements
upon adoption.
14
In September 2006, the Securities and Exchange Commission (SEC) issued Staff
Accounting Bulletin No. (SAB) 108 (Topic 1N),
Considering the Effects of Prior Year Misstatement when Quantifying Misstatements in Current Year
Financial Statements,. SAB
No. 108 requires SEC registrants (i) to quantify misstatements using a combined approach that
considers both the balance-sheet and
income-statement approaches, (ii) to evaluate whether either approach results in quantifying an
error that is material in light of
relevant quantitative and qualitative factors, and (iii) to adjust their financial statements if
the new combined approach results in a
conclusion that an error is material. SAB No. 108 is effective for fiscal years ending after
November 15, 2006, which for us was our fiscal year ended December 31, 2006. The adoption of SAB
No. 108 did not have any effect on our financial position and
results of operations.
ITEM 3. Controls and Procedures.
We conducted an evaluation, under the supervision and with the participation of our President
and Chief Operating Officer (principal executive officer) and Chief Financial Officer (principal
financial officer), of our disclosure controls and procedures (as defined in Rule 13a-15(e) under
the Exchange Act) as of March 31, 2007. Based upon this evaluation, our President and Chief
Operating Officer and Chief Financial Officer concluded that our disclosure controls and procedures
were effective to ensure that required material information is included in this quarterly report
for the period ended March 31, 2007.
There were no changes in our internal control over financial reporting during the quarter
ended March 31, 2007 that has materially affected, or is reasonably likely to materially affect,
our internal control over financial reporting
15
PART II OTHER INFORMATION
ITEM 1. Legal Proceedings.
Not applicable.
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds.
On February 27, 2007, we issued to 10 consultants a total of 835,000 stock options and
warrants to purchase our common stock with an exercise price of $7.00 per share in exchange for
consulting services. These securities were issued without registration pursuant to the exemption
afforded by Section 4(2) of the Securities Act of 1933, as a transaction by us not involving any
public offering.
ITEM 3. Defaults Upon Senior Securities
Not applicable.
ITEM 4. Submission of Matters to a Vote of Security Holders.
Not applicable.
ITEM 5. Other Information.
Not applicable.
ITEM 6. Exhibits.
|
|
|
No. |
|
Description of Exhibit |
31.1
|
|
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.1
|
|
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.2
|
|
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
16
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.
|
|
|
|
|
|
|
|
Date: May 11, 2007 |
By: |
/s/ ROBERT S. STEFANOVICH
|
|
|
|
Robert S. Stefanovich |
|
|
|
Interim Chief Financial Officer
(Principal Financial Officer and
Principal Accounting Officer) |
|
|
17