Cytosorbents Corp - Quarter Report: 2009 March (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
x QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934 |
For the
quarterly period ended March 31,
2009
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: 000-51038
MedaSorb Technologies
Corporation
(Exact
Name of Registrant as Specified in Its Charter)
Nevada
|
98-0373793
|
(State
or Other Jurisdiction of
Incorporation
Or Organization)
|
(I.R.S.
Employer Identification
No.)
|
7 Deer Park Drive, Suite K,
Monmouth Junction, New Jersey 08852
(Address
of Principal Executive Offices)
(732)
329-8885
(Registrant’s
Telephone Number, Including Area Code)
(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 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. þ
Yes ¨
No
Indicate
by check mark whether the Registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
definition of “accelerated filer, large accelerated filer”, and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
|
Non-accelerated
filer ¨
(Do not check if a
smaller reporting company) |
Smaller
reporting company þ
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). ¨
Yes þ
No
As of May
14, 2009 there were 32,810,819 shares of the issuer’s common stock
outstanding.
MedaSorb
Technologies Corporation
(a
development stage company)
FORM
10-Q
TABLE
OF CONTENTS
Page
|
|
PART
I. FINANCIAL INFORMATION
|
|
Item
1. Financial Statements (March 31, 2009 and 2008 are
unaudited)
|
|
Consolidated
Balance Sheets
|
3
|
Consolidated
Statements of Operations
|
4
|
Consolidated
Statements of Changes in Stockholders’ Equity (Deficit)
|
5
|
Consolidated
Statements of Cash Flows
|
6
|
Notes
to Consolidated Financial Statements
|
8
|
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
13
|
Item
3. Quantitative and Qualitative Disclosures about Market
Risk
|
14
|
Item
4(T). Controls and Procedures
|
14
|
PART
II. OTHER INFORMATION
|
|
Item
1. Legal Proceedings
|
15
|
Item
1A. Risk Factors
|
15
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
15 |
Item
3. Defaults of Senior Securities
|
15 |
Item
4. Submission of Matters to a Vote of Security Holders
|
15 |
Item
5. Other Information
|
15 |
Item
6. Exhibits
|
15 |
PART
I — FINANCIAL INFORMATION
Item 1. Financial
Statements.
MEDASORB
TECHNOLOGIES CORPORATION
(a
development stage company)
CONSOLIDATED
BALANCE SHEETS
March 31,
|
December
31, |
|||||||
2009
|
2008
|
|||||||
(Unaudited)
|
||||||||
ASSETS
|
||||||||
Current
Assets:
|
||||||||
Cash
and cash equivalents
|
$ | 2,154,795 | $ | 2,749,208 | ||||
Short-term
investments
|
— | 199,607 | ||||||
Prepaid
expenses and other current assets
|
89,230 | 117,003 | ||||||
Total
current assets
|
2,244,025 | 3,065,818 | ||||||
Property
and equipment - net
|
48,679 | 52,057 | ||||||
Other
assets
|
264,980 | 269,310 | ||||||
Total
long-term assets
|
313,659 | 321,367 | ||||||
Total
Assets
|
$ | 2,557,684 | $ | 3,387,185 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
||||||||
Current
Liabilities:
|
||||||||
Accounts
payable
|
$ | 767,926 | $ | 885,465 | ||||
Accrued
expenses and other current liabilities
|
75,141 | 92,239 | ||||||
Notes
payable
|
50,000 | |||||||
Total
current liabilities
|
893,067 | 977,704 | ||||||
Notes
payable
|
— | 50,000 | ||||||
Total
long term liabilities
|
— | 50,000 | ||||||
Total
liabilities
|
893,067 | 1,027,704 | ||||||
Stockholders’
Equity (Deficit):
|
||||||||
10%
Series B Preferred Stock, Par Value $0.001, 200,000 shares authorized at
March 31, 2009 and December 31, 2008, respectively; 56,640.89 and
55,558.64 shares issued and outstanding, respectively
|
56 | 55 | ||||||
10%
Series A Preferred Stock, Par Value $0.001, 12,000,000 shares authorized
at March 31, 2009 and December 31, 2008, respectively; 8,563,100 and
8,793,060 shares issued and outstanding, respectively
|
8,563 | 8,793 | ||||||
Common
Stock, Par Value $0.001, 500,000,000 and 500,000,000 Shares authorized at
March 31, 2009 and December 31, 2008, 30,510,819 and 25,263,517 shares
issued and outstanding, respectively
|
30,511 | 25,264 | ||||||
Additional
paid-in capital
|
78,017,693 | 77,786,850 | ||||||
Deficit
accumulated during the development stage
|
(76,392,206 | ) | (75,461,481 | ) | ||||
Total
stockholders' equity (deficit)
|
1,664,617 | 2,359,481 | ||||||
Total
Liabilities and Stockholders' Equity (Deficit)
|
$ | 2,557,684 | $ | 3,387,185 |
See
accompanying notes to consolidated financial statements.
3
MEDASORB
TECHNOLOGIES CORPORATION
(a
development stage company)
CONSOLIDATED
STATEMENTS OF
OPERATIONS
OPERATIONS
Period from
|
||||||||||||
January 22,1997
|
||||||||||||
(date of inception)
to |
Three months ended March
31, |
|||||||||||
March 31, 2009
|
2009
|
2008
|
||||||||||
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
||||||||||
Revenue
|
$ | — | $ | — | $ | — | ||||||
Expenses:
|
||||||||||||
Research
and development
|
44,780,318 | 488,555 | 355,127 | |||||||||
Legal,
financial and other consulting
|
7,048,758 | 48,733 | 57,924 | |||||||||
General
and administrative
|
22,537,781 | 228,334 | 233,524 | |||||||||
Change
in fair value of management and incentive units
|
(6,055,483 | ) | — | — | ||||||||
Total
expenses
|
68,311,374 | 765,622 | 646,575 | |||||||||
Other
(income)/expense:
|
||||||||||||
Gain
on disposal of property and equipment
|
(21,663 | ) | — | — | ||||||||
Gain
on extinguishment of debt
|
(216,617 | ) | — | — | ||||||||
Interest
expense (income), net
|
5,593,782 | (5,471 | ) | (525 | ) | |||||||
Penalties
associated with non-registration of Series
A Preferred Stock
|
361,495 | — | — | |||||||||
Total
other (income)/expense, net
|
5,716,997 | (5,471 | ) | (525 | ) | |||||||
Loss
before benefit from income taxes
|
(74,028,371 | ) | (760,151 | ) | (646,050 | ) | ||||||
Benefit
from income taxes
|
(248,529 | ) | — | — | ||||||||
Net
loss
|
(73,779,842 | ) | (760,151 | ) | (646,050 | ) | ||||||
Preferred
stock dividend
|
2,612,364 | 170,574 | 200,487 | |||||||||
Net
loss available to common shareholders
|
$ | (76,392,206 | ) | $ | (930,725 | ) | $ | (846,537 | ) | |||
Basic
and diluted net loss per common share
|
$ | (0.03 | ) | $ | (0. 03 | ) | ||||||
Weighted
average number of shares of
|
||||||||||||
common
stock outstanding
|
29,072,876 | 25,044,932 |
See
accompanying notes to consolidated financial statements.
4
MEDASORB
TECHNOLOGIES CORPORATION
(a
development stage company)
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS'
EQUITY
(DEFICIT)
Period
from
December
31, 2008 to
March
31, 2009
(Unaudited)
Members
Equity
|
Deferred
|
Common Stock
|
Preferred Stock B
|
Preferred Stock A
|
Additional
Paid-In
|
Deficit
Accumulated
During the
Development
|
Total
Stockholders'
|
|||||||||||||||||||||||||||||||||||||
(Deficiency)
|
Com pensation
|
Shares
|
Par
value |
Shares
|
Par
Value |
Shares
|
Par
Value |
Capital
|
Stage
|
Equity (Deficit)
|
||||||||||||||||||||||||||||||||||
Balance
at December 31, 2008
|
$ | — | $ | — | 25,263,517 | $ | 25,264 | 55,558.64 | $ | 55 | 8,793,060 | $ | 8,793 | $ | 77,786,850 | $ | (75,461,481 | ) | $ | 2,359,481 | ||||||||||||||||||||||||
Stock
based compensation – employees, consultants and directors
|
— | — | — | 65,287 | — | 65,287 | ||||||||||||||||||||||||||||||||||||||
Issuance
of Series A Preferred Stock as dividends
|
— | — | — | 211,706 | 211 | 32,069 | (32,280 | ) | — | |||||||||||||||||||||||||||||||||||
Issuance
of Series B Preferred Stock as dividends
|
— | — | — | — | 1,382.94 | 1 | 138,293 | (138,294 | ) | — | ||||||||||||||||||||||||||||||||||
Conversion
of Series A and Series B into Common
|
5,247,302 | 5,247 | (300.69 | ) | (441,666 | ) | (441 | ) | (4,806 | ) | — | — | ||||||||||||||||||||||||||||||||
Net
loss
|
— | — | — | — | — | (760,151 | ) | (760,151 | ) | |||||||||||||||||||||||||||||||||||
Balance
at March 31, 2009
|
— | — | 30,510,819 | 30,511 | 56,640.89 | 56 | 8,563,100 | 8,563 | 78,017,693 | (76,392,206 | ) | 1,664,617 |
5
MEDASORB
TECHNOLOGIES
CORPORATION
CORPORATION
(a
development stage company)
CONSOLIDATED
STATEMENTS OF
CASH
FLOWS
Period from
|
||||||||||||
January
22,1997 |
Three
months |
Three
months |
||||||||||
(date of
inception) to |
ended
|
Ended
|
||||||||||
March 31, 2009
|
March 31,
2009 |
March 31,
2008 |
||||||||||
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (73,779,842 | ) | $ | (760,151 | ) | $ | (646,050 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Common
stock issued as inducement to convert convertible notes payable and
accrued interest
|
3,351,961 | — | — | |||||||||
Issuance
of common stock to consultant for services
|
30,000 | — | — | |||||||||
Depreciation
and amortization
|
2,353,380 | 12,614 | 25,925 | |||||||||
Amortization
of debt discount
|
1,000,000 | — | — | |||||||||
Gain
on disposal of property and equipment
|
(21,663 | ) | — | — | ||||||||
Gain
on extinguishment of debt
|
(216,617 | ) | — | — | ||||||||
Interest
expense paid with Series B Preferred Stock in connection with conversion
of notes payable
|
3,147 | |||||||||||
Abandoned
patents
|
183,556 | — | — | |||||||||
Bad
debts - employee advances
|
255,882 | — | — | |||||||||
Contributed
technology expense
|
4,550,000 | — | — | |||||||||
Consulting
expense
|
237,836 | — | — | |||||||||
Management
unit expense
|
1,334,285 | — | — | |||||||||
Expense
for issuance of warrants
|
518,763 | — | — | |||||||||
Expense
for issuance of options
|
1,318,782 | 65,287 | 118,704 | |||||||||
Amortization
of deferred compensation
|
74,938 | — | — | |||||||||
Penalties
in connection with non-registration event
|
361,496 | — | — | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
(360,778 | ) | 27,773 | 12,769 | ||||||||
Other
assets
|
(61,630 | ) | 5,003 | (2,500 | ) | |||||||
Accounts
payable and accrued expenses
|
2,662,279 | (134,637 | ) | 231,345 | ||||||||
Accrued
interest expense
|
1,823,103 | — | — | |||||||||
Dividend/penalty
payable
|
— | — | — | |||||||||
Net
cash used by operating activities
|
(54,381,122 | ) | (784,111 | ) | (259,807 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Proceeds
from sale of property and equipment
|
32,491 | — | — | |||||||||
Purchases
of property and equipment
|
(2,226,932 | ) | (6,411 | ) | (1,330 | ) | ||||||
Patent
costs
|
(431,228 | ) | (3,498 | ) | (3,708 | ) | ||||||
Purchases
of short-term investments
|
(393,607 | ) | — | — | ||||||||
Proceeds
from sale of short-term investments
|
393,607 | 199,607 | — | |||||||||
Loan
receivable
|
(1,632,168 | ) | — | — | ||||||||
Net
cash used by investing activities
|
(4,257,837 | ) | 189,698 | (5,038 | ) | |||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from issuance of common stock
|
400,490 | — | — | |||||||||
Proceeds
from issuance of preferred stock
|
9,579,040 | — | — | |||||||||
Equity
contributions - net of fees incurred
|
41,711,198 | — | — | |||||||||
Proceeds
from borrowings
|
8,603,631 | — | 100,000 | |||||||||
Proceeds
from subscription receivables
|
499,395 | — | — | |||||||||
Net
cash provided by financing activities
|
60,793,754 | — | 100,000 |
See
accompanying notes to consolidated financial statements.
6
Net
change in cash and cash equivalents
|
2,154,795 | (594,413 | ) | (164,845 | ) | |||||||
Cash
and cash equivalents - beginning of period
|
— | 2,749,208 | 211,613 | |||||||||
Cash
and cash equivalents - end of period
|
$ | 2,154,795 | $ | 2,154,795 | $ | 46,768 | ||||||
Supplemental
disclosure of cash flow information:
|
||||||||||||
Cash
paid during the period for interest
|
$ | 590,189 | $ | — | $ | — | ||||||
Supplemental
schedule of noncash investing and financing activities:
|
||||||||||||
Note
payable principal and interest conversion to equity
|
$ | 10,376,714 | $ | — | $ | — | ||||||
Issuance
of member units for leasehold improvements
|
$ | 141,635 | $ | — | $ | — | ||||||
Issuance
of management units in settlement of cost of raising
capital
|
$ | 437,206 | $ | — | $ | — | ||||||
Change
in fair value of management units for cost of raising
capital
|
$ | 278,087 | $ | — | $ | — | ||||||
Exchange
of loan receivable for member units
|
$ | 1,632,168 | $ | — | $ | — | ||||||
Issuance
of equity in settlement of accounts payable
|
$ | 1,609,446 | $ | — | $ | — | ||||||
Issuance
of common stock in exchange for stock subscribed
|
$ | 399,395 | $ | — | $ | — | ||||||
Costs
paid from proceeds in conjunction with issuance preferred
stock
|
$ | 768,063 | $ | — | $ | — | ||||||
Preferred
stock dividends
|
$ | 2,612,364 | $ | 170,574 | $ | 200,487 | ||||||
Net
effect of conversion of common stock to preferred stock prior to
merger
|
$ | 559 | $ | — | $ | — |
During
the three months ended March 31, 2009 and 2008, 300.69 and -0- Series B
Preferred Shares were converted into 830,636 and -0- Common shares,
respectively. During the three months ended March 31, 2009 and 2008,
441,666 and -0- Series A Preferred Shares were converted into 4,416,666 and -0-
Common shares, respectively. For the period from January 22,
1997 (date of inception) to March 31, 2009, 300.69 Series B Preferred Shares and
1,004,944 Series A Preferred Shares were converted into 830,636 and 5,040,408
Common Shares, respectively.
See
accompanying notes to consolidated financial statements.
7
MedaSorb
Technologies Corporation
Notes
to Consolidated Financial Statements
(UNAUDITED)
March
31, 2009
1. BASIS OF
PRESENTATION
The
accompanying unaudited condensed consolidated financial statements have been
prepared in accordance with the requirements of Form 10-Q of the Securities and
Exchange Commission (the “Commission”) and include the results of MedaSorb
Technologies Corporation (the “Parent”), formerly known as Gilder Enterprises,
Inc., and CytoSorbents, Inc. (f/k/a MedaSorb Technologies, Inc.), its
wholly-owned operating subsidiary (the “Subsidiary”), collectively referred to
as “the Company.” Accordingly, certain information and footnote disclosures
required in financial statements prepared in accordance with accounting
principles generally accepted in the United States of America have been
condensed or omitted. Interim statements are subject to possible adjustments in
connection with the annual audit of the Company's accounts for the year ended
December 31, 2009. In the opinion of the Company’s management, the accompanying
unaudited consolidated financial statements contain all adjustments (consisting
only of normal recurring adjustments) which the Company considers necessary for
the fair presentation of the Company's consolidated financial position as of
March 31, 2009 and the results of its operations and cash flows for the three
month periods ended March 31, 2009 and 2008, and for the period January 22, 1997
(date of inception) to March 31, 2009. Results for the three months ended are
not necessarily indicative of results that may be expected for the entire year.
The unaudited condensed consolidated financial statements should be read in
conjunction with the audited financial statements of the Company and the notes
thereto as of and for the year ended December 31, 2008 as included in the
Company’s Form 10-K filed with the Commission on April 10, 2009.
The
accompanying consolidated financial statements have been prepared on a going
concern basis, which contemplates the realization of assets and satisfaction of
liabilities in the normal course of business. The Company has experienced
negative cash flows from operations since inception and has a deficit
accumulated during the development stage at March 31, 2009 of $76,392,206. The
Company is not currently generating revenue and is dependent on the proceeds of
present and future financings to fund its research, development and
commercialization program. The Company is continuing its fund-raising
efforts. Although the Company has historically been successful in raising
additional capital through equity and debt financings, there can be no assurance
that the Company will be successful in raising additional capital in the future
or that it will be on favorable terms. Furthermore, if the Company is
successful in raising the additional financing, there can be no assurance that
the amount will be sufficient to complete the Company's plans. These
consolidated financial statements do not include any adjustments related to the
outcome of this uncertainty.
The
Company is a development stage company and has not yet generated any revenues.
Since inception, the Company's expenses relate primarily to research and
development, organizational activities, clinical manufacturing, regulatory
compliance and operational strategic planning. Although the Company has
made advances on these matters, there can be no assurance that the Company will
continue to be successful regarding these issues, nor can there be any assurance
that the Company will successfully implement its long-term strategic
plans.
The
Company has developed an intellectual property portfolio, including 25 issued
and multiple pending patents, covering materials, methods of
production, systems incorporating the technology and multiple medical
uses.
2. PRINCIPAL BUSINESS ACTIVITY AND
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
Nature
of Business
The
Company, through its subsidiary, is engaged in the research, development and
commercialization of medical devices with its platform blood purification
technology incorporating a proprietary adsorbent polymer technology. The
Company is focused on developing this technology for multiple applications in
the medical field, specifically to provide improved blood purification for the
treatment of acute and chronic health complications associated with blood
toxicity. As of March 31, 2009, the Company has not commenced commercial
operations and, accordingly, is in the development stage. The Company has
yet to generate any revenue and has no assurance of future revenue.
Principles
of Consolidation
The
consolidated financial statements include the accounts of the Parent, MedaSorb
Technologies Corporation, and its wholly-owned subsidiary, CytoSorbents, Inc.
All significant intercompany transactions and balances have been eliminated in
consolidation.
8
Development
Stage Corporation
The
accompanying consolidated financial statements have been prepared in accordance
with the provisions of Statement of Financial Accounting Standard (SFAS) No. 7,
"Accounting and Reporting by Development Stage Enterprises."
Cash
and Cash Equivalents
The
Company considers all highly liquid
investments purchased with an original maturity of three months or less to be
cash equivalents.
Short
Term Investments
Short-term
investments include short-term bank certificates of deposit with original
maturities of between three and twelve months. These short-term notes
are classified as held to maturity and are valued at cost, which
approximates fair value. These investments are considered Level 1
investments under SFAS 157.
Property
and Equipment
Property
and equipment are recorded at cost less accumulated depreciation. Depreciation
of property and equipment is provided for by the straight-line method over the
estimated useful lives of the related assets. Leasehold improvements are
amortized over the lesser of their economic useful lives or the term of the
related leases. Gains and losses on depreciable assets retired or sold are
recognized in the statements of operations in the year of disposal. Repairs and
maintenance expenditures are expensed as incurred.
Patents
Legal
costs incurred to establish patents are capitalized. When patents are issued,
capitalized costs are amortized on the straight-line method over the related
patent term. In the event a patent is abandoned, the net book value of the
patent is written off.
Impairment
or Disposal of Long-Lived Assets
The
Company assesses the impairment of patents and other long-lived assets under
SFAS No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets”
whenever events or changes in circumstances indicate that the carrying value may
not be recoverable. For long-lived assets to be held and used, the Company
recognizes an impairment loss only if its carrying amount is not recoverable
through its undiscounted cash flows and measures the impairment loss based on
the difference between the carrying amount and fair value.
Research
and Development
All
research and development costs, payments to laboratories and research
consultants are expensed when incurred.
Income
Taxes
Income
taxes are accounted for under the asset and liability method prescribed by SFAS
No. 109, “Accounting for Income Taxes.” Deferred income taxes are recorded for
temporary differences between financial statement carrying amounts and the tax
basis of assets and liabilities. Deferred tax assets and liabilities reflect the
tax rates expected to be in effect for the years in which the differences are
expected to reverse. A valuation allowance is provided if it is more likely than
not that some or all of the deferred tax asset will not be realized. Under
Section 382 of the Internal Revenue Code the net operating
losses generated prior to the reverse merger may be limited due to
the change in ownership. Additionally, net operating losses generated subsequent
to the reverse merger may be limited in the event of changes in
ownership.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities. Actual results
could differ from these estimates. Significant estimates in these financials are
the valuation of options granted and the valuation of preferred shares issued as
stock dividends.
Concentration
of Credit Risk
The
Company maintains cash balances, at times, with financial institutions in excess
of amounts insured by the Federal Deposit Insurance Corporation. Management
monitors the soundness of these institutions in an effort to minimize its
collection risk of these balances.
Financial
Instruments
The
carrying values of cash and
cash equivalents, short-term investments, accounts payable and other debt
obligations approximate their fair values due to their short-term
nature.
Stock-Based
Compensation
The
Company accounts for its stock-based compensation under the recognition
requirements of Statement of Financial Accounting Standards (“SFAS”) No. 123(R).
“Accounting for Stock-Based
Compensation”, for employees and directors whereby each option granted is
valued at fair market value on the date of grant. Under SFAS No. 123, the fair
value of each option is estimated on the date of grant using the Black-Scholes
option pricing model.
The
Company also follows the guidance in EITF 96-18 “Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services” for equity instruments issued to
consultants.
9
Net
Loss Per Common Share
Basic EPS
is computed by dividing income (loss) available to common stockholders by the
weighted average number of common shares outstanding during the period. Diluted
EPS gives effect to all dilutive potential common shares outstanding during the
period. The computation of Diluted EPS does not assume conversion, exercise or
contingent exercise of securities that would have an anti-dilutive effect on
earnings. (See Note 6)
Effects
of Recent Accounting Pronouncements
In December 2007, the FASB issued SFAS
No. 141(R), “Business Combinations” (“SFAS 141(R)”). This Statement replaces
SFAS No. 141, “Business Combinations” (“SFAS 141”). This Statement retains the
fundamental requirements in SFAS 141 that the acquisition method of accounting
(which SFAS 141 called the purchase method) be used for all business
combinations and for an acquirer to be identified for each business combination.
This Statement also establishes principles and requirements for how the
acquirer: a) recognizes and measures in its financial statements the
identifiable assets acquired, the liabilities assumed, and any non-controlling
interest in the acquiree; b) recognizes and measures the goodwill acquired in
the business combination or a gain from a bargain purchase and c) determines
what information to disclose to enable users of the financial statements to
evaluate the nature and financial effects of the business combination. SFAS
141(R) will apply prospectively to business combinations for which the
acquisition date is on or after the beginning of the first annual reporting
period beginning on or after December 15, 2008. An entity may not apply it
before that date. The provisions of SFAS 141(R) did not have a significant
impact on the Company's statements of operations or financial
position.
In March 2008, the FASB issued SFAS No.
161, “Disclosures about Derivative Instruments and Hedging Activities,” and
Amendment of FASB Statement No. 133. SFAS 161 amends SFAS 133, “Accounting for
Derivative Instruments and Hedging Activities,” to amend and expand the
disclosure requirements of SFAS 133 to provide greater transparency about (i)
how and why an entity uses derivative instruments, (ii) how derivative
instruments and related hedge items are accounted for under SFAS 133 and its
related interpretations, and (iii) how derivative instruments and related hedged
items affect an entity's financial position, results of operations and cash
flows. To meet those objectives, SFAS 161 requires qualitative disclosures about
objectives and strategies for using derivatives, quantitative disclosures about
fair value amounts of gains and losses on derivative instruments and disclosures
about credit-risk-related contingent features in derivative agreements. SFAS 161
is effective for fiscal years and interim periods beginning after November 15,
2008. The provisions of SFAS 161 did not have a significant impact on the
Company's statements of operations or financial
position.
3. CONVERTIBLE
NOTES
The
Company has outstanding Promissory Notes in the aggregate principal amount of
$50,000, due in September 2009, which bear interest at the rate of 10% per
annum. The holder of the Promissory notes has the option to convert, on an
all-or-none basis, the entire principal and outstanding interest of their Notes
into the Series B Preferred Stock issued in June 2008. In addition,
pursuant to the terms of such Promissory Notes, upon such conversion, each note
holder will receive five-year warrants to purchase that number of shares of
Common Stock equal to the quotient obtained by dividing (x) 25% of the principal
amount of the Promissory Note being converted, by (y) $0.0362, the purchase
price per share of Common Stock issuable upon conversion of the Series B
Preferred Stock.
4. STOCKHOLDERS' EQUITY
(DEFICIT)
During
the three months ended March 31, 2009 the Company recorded non-cash stock
dividends totaling $170,574 in connection with the issuance of 1,382.94 shares
of Series B Preferred Stock and 211,706 shares of Series A Preferred Stock as a
stock dividend to its preferred shareholders as of March 31, 2009. The Company
has estimated the fair value of the shares issued as stock dividends based upon
the last completed financing transaction involving the underlying common shares
in June 2008.
During
the three months ended March 31, 2009, the Company issued stock options to
employees, consultants and directors resulting in aggregate compensation expense
of $8,378, of which $584 and $7,794 is presented in research and development
expenses and general and administrative expenses, respectively.
The
summary of the stock option activity for the three months ended March 31, 2009
is as follows:
Weighted
|
Weighted
|
||||||
Average
|
Average
|
||||||
Exercise
|
Remaining
|
||||||
Shares
|
per Share
|
Life (Years)
|
|||||
Outstanding,
January 1, 2009
|
18,158,846
|
$
|
1.05
|
9.1
|
|||
Granted
|
5,118,858
|
$
|
0.123
|
9.7
|
|||
Cancelled
|
—
|
$
|
—
|
—
|
|||
Exercised
|
—
|
$ |
—
|
—
|
|||
Outstanding
March 31, 2009
|
23,277,704
|
$
|
0.84
|
9.1
|
10
The fair
value of each stock option was valued using the Black Scholes pricing model
which takes into account as of the grant date the exercise price (ranging from
$0.084 to $0.168 per share) and expected life of the stock option ( ranging from
5-10 years), the current price of the underlying stock and its expected
volatility (approximately 25 percent), expected dividends (-0- percent) on the
stock and the risk free interest rate (2.7 percent) for the term of the stock
option.
At March
31, 2009, the aggregate intrinsic value of options outstanding and currently
exercisable amounted to approximately $10,500.
The
summary of the status of the Company’s non-vested options for the three months
ended March 31, 2009 is as follows:
Weighted
|
||||||
Average
|
||||||
Grant
Date |
||||||
Shares
|
Fair
Value |
|||||
Non-vested,
January 1, 2009
|
6,280,604
|
$
|
0.05
|
|||
Granted
|
5,118,858
|
$
|
0.003
|
|||
Cancelled
|
—
|
—
|
||||
Vested
|
(3,163,762
|
) |
$
|
0.053
|
||
Exercised
|
—
|
—
|
||||
Non-vested,
March 31, 2009
|
8,235,700
|
$
|
.02
|
As of
March 31, 2009, approximately $258,499 of total unrecognized compensation cost
related to stock options is expected to be recognized over a weighted average
period of 1.2 years.
As of
March 31, 2009, the Company has the following warrants to purchase common stock
outstanding:
Number of Shares
|
Warrant
Exercise
|
Warrant
|
|||
To be Purchased
|
Price per Share
|
Expiration Date
|
|||
15,569
|
$
|
6.64
|
March
31, 2010
|
||
816,691
|
$
|
4.98
|
June
30, 2011
|
||
1,200,000
|
$
|
0.90
|
June
30, 2011
|
||
900,000
|
$
|
0.40
|
June
30, 2011
|
||
339,954
|
$
|
2.00
|
September
30, 2011
|
||
52,080
|
$
|
2.00
|
July
31, 2011
|
||
400,000
|
$
|
0.40
|
October
31, 2011
|
||
240,125
|
$
|
1.25
|
October
24, 2016
|
||
3,986,429
|
$
|
0.035
|
June
25,2013
|
As of
March 31, 2009, the Company has the following warrants to purchase Series A
Preferred Stock outstanding:
Number of
|
Warrant
Exercise |
Warrant
|
|||
Shares to be
|
Price per
|
Expiration
|
|||
Purchased
|
Preferred
Share |
Date
|
|||
525,000
|
$
|
1.00
|
June
30, 2011
|
If the
holder of warrants for preferred stock exercises in full, the holder will
receive additional five-year warrants to purchase a total of 210,000 shares of
common stock at $0.40 per share.
As
of March 31, 2009, the Company has the following warrant to purchase Series B
Preferred Stock outstanding:
Number of
|
Warrant
Exercise |
Warrant
|
|||
Shares to be
|
Price per
|
Expiration
|
|||
Purchased
|
Preferred
Share |
Date
|
|||
15,000
|
$
|
100.00
|
September
25, 2009
|
11
5. COMMITMENTS AND
CONTINGENCIES
Employment
Agreements
The
Company has employment agreements with certain key executives through December
2009. The agreements provide for annual base salaries of varying
amounts.
Litigation
The
Company is involved in various claims and legal actions. Management
is of the opinion that these claims and legal actions have no merit, and their
ultimate outcome will not have a material adverse impact on the
consolidated financial position of the Company and/or the results of its
operations.
Royalty
Agreements
Pursuant
to an agreement dated August 11, 2003, an existing investor agreed to make a $4
million equity investment in the Company. These amounts were received by the
Company in 2003. In connection with this agreement, the Company granted the
investor a future royalty of 3% on all gross revenues received by the Company
from the sale of its CytoSorb device. The Company has not generated any revenue
from this product and has not incurred any royalty costs through March 31, 2009.
The amount of future revenue subject to the royalty agreement could not be
reasonably estimated nor has a liability been incurred, therefore, an accrual
for royalty payments has not been included in the consolidated financial
statements.
License
Agreements
In an
agreement dated September 1, 2006, the Company entered into a license agreement
which provides the Company the exclusive right to use its patented technology
and proprietary know how relating to adsorbent polymers for a period of 18
years. Under the terms of the agreement, MedaSorb has agreed to pay royalties of
2.5% to 5% on the sale of certain of its products if and when those products are
sold commercially for a term not greater than 18 years commencing with the first
sale of such product. The Company
has not generated any revenue from its products and has not incurred any royalty
costs through March 31, 2009. The amount of future revenue subject to the
license agreement could not be reasonably estimated nor has a liability been
incurred, therefore, an accrual for royalty payments has not been included in
the consolidated financial statements.
Warrant
agreement
As
inducement to invest additional funds in the private placement of Series B
Preferred Stock, additional consideration was granted to the participants of the
Series B Preferred Stock offering in the event that litigation is commenced
against Medasorb prior to June 30, 2018, claiming patent infringement on certain
of the Company’s issued patents. In the event this litigation arises
the Company may be required to issue warrants to purchase in the aggregate up to
a maximum of ten million shares of Common Stock subject to certain
adjustments. Through March 31, 2009 no such litigation has arisen and
due to the deemed low probability of this potential outcome; the Company has not
booked a contingent liability for this agreement.
6.
NET LOSS PER SHARE
Basic
loss per share and diluted loss per share for the three months ended March 31,
2009 and 2008 have been computed by dividing the net loss for each respective
period by the weighted average number of shares outstanding during that period.
All outstanding warrants and options representing 31,228,552 and 9,076,921
incremental shares at March 31, 2009 and 2008, respectively, as well as shares
issuable upon conversion of Series A and Series B Preferred Stock and Preferred
Stock Warrants representing 239,010,409 and 7,205,996 incremental shares at
March 31, 2009 and 2008, respectively, as well as shares issuable upon potential
long-term Note conversion into Series B Preferred Stock and Common Warrants
representing approximately 1,726,519 shares have been excluded from the
computation of diluted loss per share as they are anti-dilutive.
7.
SUBSEQUENT EVENTS
During
April 2009 a total of 230,000 shares of Series A Preferred Stock were converted
into 2,300,000 shares of Common Stock.
12
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations.
These
unaudited condensed consolidated financial statements and management’s
discussion should be read in conjunction with the audited financial statements
of the Company and the notes thereto as of and for the year ended December 31,
2008 as included in the Company’s Form 10-K filed with the Securities and
Exchange Commission (the “Commission”) on April 10, 2009.
Forward-looking
statements
Statements contained in this
Quarterly Report on Form 10-Q, other than the historical financial information,
constitute forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All such forward-looking statements
involve known and unknown risks, uncertainties or other factors which may cause
actual results, performance or achievement of the Company to be materially
different from any future results, performance or achievement expressed or
implied by such forward-looking statements. Primary risk factors include, but
are not limited to: ability to successfully develop
commercial operations; the ability to obtain adequate financing in the future
when needed; dependence on key personnel; acceptance of the Company's medical
devices in the marketplace; obtaining government approvals, including required
FDA approvals; compliance with governmental regulations; reliance on research
and testing facilities of various universities and institutions; product
liability risks; limited manufacturing experience; limited marketing, sales and
distribution experience; market acceptance of the Company's products;
competition; unexpected changes in technologies and technological advances; and
other factors detailed in the Company's Current Report on Form 10-K filed with
the Commission on April 10, 2009.
Plan
of Operations
We are a
development stage company and expect to remain so for at least the next twelve
months. We have not generated revenues to date and do not expect to do so until
we commercialize and receive the necessary regulatory approvals to sell our
proposed products. We will seek to commercialize a blood purification technology
that efficiently removes middle molecular weight toxins from circulating blood
and physiologic fluids.
We are
focusing our efforts on the commercialization of our CytoSorb™ product. The
first indication for CytoSorb™ will be in the adjunctive treatment of sepsis
(bacterial infection of the blood), which causes systematic inflammatory
response syndrome. CytoSorb™ has been designed to prevent or reduce the
accumulation of high concentrates of cytokines in the bloodstream associated
with sepsis. It is intended for short term use as an adjunctive device to the
standard treatment of sepsis. To date, we have manufactured the CytoSorb™ device
on a limited basis for testing purposes, including for use in clinical studies.
We believe that current state of the art blood purification technology (such as
dialysis) is incapable of effectively clearing the toxins intended to be
adsorbed by our CytoSorb™ device.
Following
the sepsis indication, we intend to continue our research in other acute
conditions where CytoSorb™ has indicated potential in preliminary studies to
prevent or reduce the accumulation of cytokines in the bloodstream. These
conditions include the prevention of post-operative complications of cardiac
surgery (cardiopulmonary bypass surgery) and damage to organs donated for
transplant prior to organ harvest. We are also exploring the potential benefits
the CytoSorb™ device may have in removing drugs from blood.
In
December 2006, we submitted a proposed pilot study for approval to the FDA with
respect to our CytoSorb™ device. In the first quarter of 2007, we
received approval from the FDA to conduct a limited study of five patients in
the adjunctive treatment of sepsis. Based on management’s belief that proceeding
with the approved limited study would add at least one year to the approval
process for the United States, we made a determination to focus our efforts on
obtaining regulatory approval in Europe before proceeding with the
FDA.
We
estimate that the market potential in Europe for our products is substantially
equivalent to that in the U.S. Given the opportunity to conduct a much larger
clinical study in Europe, and management’s belief that the path to a CE Mark
should be faster than FDA approval, we decided to target Europe as the
introductory market for our CytoSorb™ product. To accomplish the European
introduction, in July 2007 we prepared and filed a request for a clinical trial
with a German Central Ethics Committee. We received approval of the final study
design in October of 2007.
We
received approval from the German Ethics Committee in October of 2007 to conduct
a clinical study of up to 80 patients with acute respiratory distress syndrome
or acute lung injury in the setting of sepsis. By December 31, 2008 we had
initiated and opened for enrollment seven (7) hospital units to participate in
our clinical study and had identified an additional six (6) sites that may be
added to our study to accelerate enrollment. As of March 2009 we have increased
the number of hospital units participating in our study to ten
(10).
In April
2009, we submitted a protocol revision to expand the options for
anti-coagulation that the clinical sites may use, and to increase the total
number of patients that may be enrolled from 80 to 100 patients. This
revision has been approved by the German Ethics Committee. We believe that the
revised protocol will enable more potential sites to participate in the study,
and may help accelerate patient enrollment through greater access to potential
candidates. Further, while we do not anticipate enrolling more than 80
patients, we now have the flexibility to enroll up to 100 patients if
needed.
Additionally,
we have updated blood sampling and handling procedures to minimize non-device
related artifacts that may potentially arise if the samples are not processed
appropriately.
To date
we have enrolled twenty three (23) patients in the clinical study, which have
been randomized yielding eleven (11) treated and twelve (12) control
(non-treated) patients. We hope to enroll approximately sixty (60) additional
patients. While we do not anticipate enrolling the entire 100 patients
that we are now entitled to enroll, the approved increase allows us some
flexibility in the event any of the enrolled patients are not able to complete
the study due to withdrawal or inability to complete post treatment follow-up.
In conducting the German Clinical study we have utilized our CytoSorb™ device in
over 75 treatments to date with no Serious Adverse Events attributable to the
device.
We expect
to complete the patient enrollment by the end of 2009. Concurrent with the
clinical study, we expect to commence the CE Mark submission process. Assuming a
successful outcome of the study, management believes it will take an additional
6-9 months following its submission for CE Mark approval to receive the European
regulatory approval. Assuming availability of adequate and timely funding, and a
successful outcome to the study, management anticipates obtaining CE Mark
approval in the first half of 2010, at the earliest.
The
clinical protocol for our European clinical study has been designed to allow us
to gather information to support future U.S. studies. In the event we receive
the CE Mark and are able to successfully commercialize our products in the
European market, we will review our plans for the United States to determine
whether to conduct clinical trials in support of 510K or PMA registration. No
assurance can be given that our proposed CytoSorb™ product will work as intended
or that we will be able to obtain CE Mark (or FDA) approval to sell CytoSorb™.
Even if we ultimately obtain CE Mark approval, because we cannot control the
timing of responses from regulators to our submissions, there can be no
assurance as to when such approval will be obtained.
13
Our
research and development costs were, $488,555 and $355,127, for the three months
ended March 31, 2009 and 2008 respectively. We have experienced substantial
operating losses since inception. As of March 31, 2009, we had an accumulated
deficit of $76,392,206 which included losses of $760,151 for the three month
period ended March 31, 2009. In comparison, we had losses of $646,050 for the
three month period ended March 31, 2008. Historically, our losses have resulted
principally from costs incurred in the research and development of our polymer
technology, and general and administrative expenses, which together were
$716,889 and $588,651 for the three month periods ended March 31, 2009 and 2008,
respectively.
Off-balance Sheet
Arrangements
We have
no off-balance sheet arrangements.
Liquidity and Capital
Resources
Since
inception, our operations have been financed through the private placement of
our debt and equity securities. At December 31, 2008 we had cash of $2,749,208.
As of March 31, 2009 we had cash on hand of $2,154,795, and current liabilities
of $893,067.
We
believe that we have sufficient cash to fund our operations through the third
quarter of 2009, following which we will need additional funding before we can
complete our clinical studies and commercialize our products. We will
continue to seek funding for the long term needs of the Company. There can be no
assurance that financing will be available on acceptable terms or at all. If
adequate funds are unavailable, we may have to suspend, delay or eliminate one
or more of our research and development programs or product launches or
marketing efforts or cease operations.
Our
Annual Report dated December 31, 2008 was prepared assuming we will continue as
a going concern, and the auditors’ report on those financial statements
expresses substantial doubt about our ability to continue as a going
concern.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Not
applicable to smaller reporting companies.
Item 4(T). Controls and
Procedures.
Management's
annual report on internal control over financial reporting
Management
of Medasorb is responsible for establishing and maintaining adequate internal
control over financial reporting under the supervision of the President and
Chief Executive Officer and the Chief Financial Officer. Internal control over
financial reporting is a process designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted
accounting principles.
Management
evaluated the design and operation of our internal control over financial
reporting as of March 31, 2009, based on the framework and criteria
established in Internal
Control – Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO), and has concluded that such
internal control over financial reporting is effective. There are no material
weaknesses that have been identified by management.
An
evaluation was performed, under the supervision of, and with the participation
of, our management, including our Chief Executive Officer and Chief Financial
Officer, of the effectiveness of the design and operation of the Company’s
disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-(e) to
the Securities and Exchange Act of 1934). Based on that evaluation, the
Company’s management, including our Chief Executive Officer and Chief Financial
Officer, concluded that the Company’s disclosure controls and procedures were
adequate and effective, as of March 31, 2009, to ensure that information
required to be disclosed by the Company in the reports that it files or submits
under the Securities Exchange Act of 1934, is recorded, processed, summarized,
and reported within the time periods specified in the Commission’s rules and
forms, and that such information is accumulated and communicated to management,
including our Chief Executive Officer and Chief Financial Officer, as
appropriate, to allow timely decisions regarding required
disclosure.
We do not
expect that our disclosure controls and procedures or internal control over
financial reporting will prevent all errors and all fraud. A control system, no
matter how well conceived and operated, can provide only reasonable assurance
that the objectives of the system are met and cannot detect all deviations.
Because of the inherent limitations in all control systems, no evaluation of
control can provide absolute assurance that all control issues and instances of
fraud or deviations, if any, within the Company have been detected.
This
report does not include an attestation report of the company's registered public
accounting firm regarding internal control over financial reporting.
Management's report was not subject to attestation by the company's registered
public accounting firm pursuant to temporary rules of the Securities and
Exchange Commission that permit the company to provide only management's report
in this report.
Changes
in internal control over financial reporting
There
were no significant changes in our internal controls over financial reporting
that occurred subsequent to our evaluation of our internal control over
financial reporting for the three months ended March 31, 2009 that has
materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
14
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
In February 2008, Alkermes, Inc.
commenced an action against us in the United States District Court for the
District of Massachusetts, alleging that our use of the name MedaSorb infringes
on Alkermes’ registered trademark “MEDISORB.” In the action, Alkermes sought an
injunction against our further use of the name MedaSorb. Pursuant to a
Settlement Agreement dated June 18, 2008, the Company will continue to use
the name MedaSorb Technologies Corporation for the near term, but its
wholly-owned subsidiary, through which the Company conducts all of its
operational activities, has ceased using the “MedaSorb” name to avoid any
potential confusion with Alkermes’ similarly named product . The operating
subsidiary has been renamed CytoSorbents, Inc. as of November
2008.
Item
1A. Risk Factors
Not
required to be provided by smaller reporting companies.
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
In
February 2009, our Series B Preferred Shareholders voted to approve to waive any
Event of Default and liability due upon an Event of Default pursuant to Section
6(ix) of the Certificate of Designation of Series B Preferred Shares that shall
arise from or in connection with the occurrence of a Non-Registration Event as
provided in Section 11.4 of the Series B Subscription Agreement. The
Registration Statement has been filed but it has not been declared effective as
of the date of this filing. A copy of the Resolution of the Series B
Preferred Shareholders to Waive the Registration Penalty is attached as Exhibit
10.1 hereto.
Item
5. Other Information
None.
Item
6. Exhibits.
Number
|
Description
|
|
10.1
|
Resolution
of the Series B Preferred Shareholders to Waive Registration
Penalties
|
|
31.1
|
Certification
of Phillip Chan, Chief Executive Officer of the Registrant, pursuant to
Rules 13a-14(a) and 15(d)-14(a) of the Securities Exchange Act of
1934
|
|
31.2
|
Certification
of David Lamadrid, Chief Financial Officer of the Registrant, pursuant to
Rules 13a-14(a) and 15(d)-14(a) of the Securities Exchange Act of
1934
|
|
32.1
|
Certification
of Phillip Chan, Chief Executive Officer of the Registrant, pursuant to
Rules 13a-14(B) and 15(d)-14(b) of the Securities Exchange Act of
1934
|
|
32.2
|
Certification
of David Lamadrid, Chief Financial Officer of the Registrant, pursuant to
Rules 13a-14(B) and 15(d)-14(b) of the Securities Exchange Act of
1934
|
15
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.
MEDASORB
TECHNOLOGIES CORPORATION
|
||
Dated:
May 13,
2008
|
By:
|
/s/ David
Lamadrid
|
Name:
David Lamadrid
|
||
Title:
Chief Financial Officer
|
||
(On
behalf of the registrant and as
principal accounting
officer)
|
16