AIM ImmunoTech Inc. - Quarter Report: 2007 June (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
Quarterly
Report Pursuant to Section 13 or 15(d)
of
the
Securities Exchange Act of 1934
For
the
Quarterly Period Ended June 30, 2007
Commission
File Number: 0-27072
HEMISPHERx
BIOPHARMA, INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
52-0845822
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
incorporation
or organization)
|
Identification
No.)
|
1617
JFK Boulevard, Suite 660, Philadelphia, PA 19103
(Address
of principal executive offices) (Zip Code)
(215)
988-0080
(Registrant's
telephone number, including area code)
Not
Applicable
(Former
name, former address and former fiscal year, if changed since last
report)
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for
the past 90 days. x
Yes o No
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of accelerated
filer and large accelerated filer in Rule 12b-2 of the Exchange Act. (Check
one):
o
Large
accelerated
filer x
Accelerated
file
o
Non-accelerated
filer
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).o
Yes x
No
72,826,971
shares of common stock were issued and outstanding as of August 7, 2007.
1
PART
I -
FINANCIAL INFORMATION
ITEM
1:
Financial Statements
HEMISPHERx
BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated
Balance Sheets
(in
thousands,
except
share and per share data)
December
31,
|
June
30,
|
||||||
2006
|
2007
|
||||||
(unaudited)
|
|||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
3,646
|
$
|
6,989
|
|||
Short
term investments (Note 4)
|
18,375
|
14,670
|
|||||
Inventory,
net
|
957
|
598
|
|||||
Accounts
and other receivables, net of reserves of $1 and $1, respectively
|
93
|
83
|
|||||
Prepaid
expenses and other current assets
|
168
|
159
|
|||||
Total
current assets
|
23,239
|
22,499
|
|||||
Property
and equipment, net
|
4,720
|
4,672
|
|||||
Patent
and trademark rights, net
|
857
|
885
|
|||||
Construction
in progress
|
624
|
896
|
|||||
Royalty
interest
|
601
|
573
|
|||||
Deferred
financing costs
|
38
|
-
|
|||||
Advance
receivable (Note 5)
|
1,300
|
-
|
|||||
Other
assets
|
52
|
52
|
|||||
Total
assets
|
$
|
31,431
|
$
|
29,577
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,548
|
$
|
1,733
|
|||
Accrued
expenses
|
1,261
|
1,123
|
|||||
Current
portion of long-term debt (Note 5)
|
3,871
|
-
|
|||||
Total
current liabilities
|
6,680
|
2,856
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders'
equity:
|
|||||||
Preferred
stock, par value $0.01 per share, authorized
5,000,000; issued and outstanding; none
|
-
|
-
|
|||||
Common
stock, par value $0.01 per share, authorized
200,000,000 shares; issued and outstanding
66,816,764 and 72,723,813 respectively
|
67
|
73
|
|||||
Additional
paid-in capital
|
191,689
|
202,408
|
|||||
Accumulated
other comprehensive income
|
46
|
316
|
|||||
Accumulated
deficit
|
(167,051
|
)
|
(176,076
|
)
|
|||
Total
stockholders' equity
|
24,751
|
26,721
|
|||||
Total
liabilities and stockholders' equity
|
$
|
31,431
|
$
|
29,577
|
See
accompanying notes to condensed consolidated financial statements.
2
HEMISPHERX
BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated
Statements of Operations
(in
thousands, except share and per share data)
(Unaudited)
Three months ended June 30, | |||||||
2006
|
2007
|
||||||
Revenues:
|
|||||||
Sales
of product net
|
$
|
197
|
$
|
196
|
|||
Clinical
treatment programs
|
50
|
38
|
|||||
Total
revenues
|
247
|
234
|
|||||
Costs
and expenses:
|
|||||||
Production/cost
of goods sold
|
398
|
315
|
|||||
Research
and development
|
2,588
|
2,534
|
|||||
General
and administrative
|
2,086
|
1,543
|
|||||
Total
costs and expenses
|
5,072
|
4,392
|
|||||
Interest
and other income
|
205
|
416
|
|||||
Interest
expense
|
(326
|
)
|
(44
|
)
|
|||
Financing
costs (Note 5)
|
(135
|
)
|
(139
|
)
|
|||
Net
loss
|
$
|
(5,081
|
)
|
$
|
(3,925
|
)
|
|
Basic
and diluted loss per share (Note 2)
|
$
|
(.08
|
)
|
$
|
(.05
|
)
|
|
Weighted
average shares outstanding, basic and diluted
|
64,033,333
|
72,192,229
|
|||||
See
accompanying notes to consolidated financial statements.
3
HEMISPHERX
BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated
Statements of Operations
(in
thousands, except share and per share data)
(Unaudited)
Six months ended June 30, | |||||||
2006
|
2007
|
||||||
Revenues:
|
|||||||
Sales
of product net
|
$
|
380
|
$
|
416
|
|||
Clinical
treatment programs
|
103
|
73
|
|||||
Total
revenues
|
483
|
489
|
|||||
Costs
and expenses:
|
|||||||
Production/cost
of goods sold
|
697
|
551
|
|||||
Research
and development
|
5,018
|
5,710
|
|||||
General
and administrative
|
5,178
|
3,326
|
|||||
Total
costs and expenses
|
10,893
|
9,587
|
|||||
Interest
and other income
|
160
|
465
|
|||||
Interest
expense
|
(410
|
)
|
(115
|
)
|
|||
Financing
costs (Note 5)
|
(340
|
)
|
(277
|
)
|
|||
Net
loss
|
$
|
(11,000
|
)
|
$
|
(9,025
|
)
|
|
Basic
and diluted loss per share (Note 2)
|
$
|
(.18
|
)
|
$
|
(.13
|
)
|
|
Weighted
average shares outstanding, basic and diluted
|
60,132,309
|
70,518,087
|
See
accompanying notes to consolidated financial statements.
4
HEMISPHERx
BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated
Statements of Changes in Stockholders' Equity and Comprehensive loss
(in
thousands except share data)
(Unaudited)
Common
stock
shares
|
Common
Stock $.001 Par
Value
|
Additional
paid-in
capital
|
Accumulated
other comprehensive
income
|
Accumulated
deficit
|
Total
stockholders’ equity
|
||||||||||||||
Balance
at December 31, 2006
|
66,816,764
|
$
|
67
|
$
|
191,689
|
$
|
46
|
$
|
(167,051
|
)
|
$
|
24,751
|
|||||||
Interest
payments
|
64,769
|
-
|
124
|
-
|
-
|
124
|
|||||||||||||
Private
placement, net of issuance costs
|
5,750,530
|
6
|
10,264
|
-
|
-
|
10,270
|
|||||||||||||
Stock
issued for settlement of accounts payable
|
91,750
|
-
|
167
|
-
|
-
|
167
|
|||||||||||||
Equity
based compensation
|
-
|
-
|
164
|
-
|
-
|
164
|
|||||||||||||
Net
comprehensive income (loss)
|
-
|
-
|
-
|
270
|
(9,025
|
)
|
(8,755
|
)
|
|||||||||||
Balance
at June 30, 2007
|
72,723,813
|
$
|
73
|
$
|
202,408
|
$
|
316
|
$
|
(176,076
|
)
|
$
|
26,721
|
See
accompanying notes to consolidated financial statements.
5
HEMISPHERx
BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated
Statements of Cash Flows
For
the
Six Months Ended June 30, 2006 and 2007
(in
thousands)
(Unaudited)
2006
|
2007
|
||||||
Cash
flows from operating activities:
|
|||||||
Net
loss
|
$
|
(11,000
|
)
|
$
|
(9,025
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
of property and
equipment
|
70
|
123
|
|||||
Amortization
of patent and trademark
rights, and royalty interest
|
56
|
83
|
|||||
Financing
cost related to debt discounts
|
340
|
277
|
|||||
Equity
based compensation
|
2,263
|
164
|
|||||
Common
stock issued in payment of interest expense
|
101
|
115
|
|||||
Changes
in assets and liabilities:
|
|||||||
Inventory
|
497
|
359
|
|||||
Accounts
and other receivables
|
(93
|
)
|
(154
|
)
|
|||
Prepaid
expenses and other
current
assets
|
26
|
9
|
|||||
Accounts
payable
|
937
|
353
|
|||||
Accrued
expenses
|
484
|
(139
|
)
|
||||
Net
cash used in operating
activities
|
$
|
(6,319
|
)
|
$
|
(7,835
|
)
|
|
Cash
flows from investing activities:
|
|||||||
Purchase
of property plant and
equipment
|
$
|
(1,508
|
)
|
$
|
(75
|
)
|
|
Additions
to patent and trademark
rights
|
(36
|
)
|
(82
|
)
|
|||
Maturity
of short term
investments
|
12,548
|
6,778
|
|||||
Purchase
of short term investments
|
(18,884
|
)
|
(2,803
|
)
|
|||
Construction
in Progress
|
275
|
(272
|
)
|
||||
Net
cash (used in) provided by investing activities
|
$
|
(7,605
|
)
|
$
|
3,546
|
6
HEMISPHERX
BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated
Statements of Cash Flows (Continued)
For
the
Six Months Ended June 30, 2006 and 2007
(in
thousands)
(Unaudited)
2006
|
2007
|
||||||
Cash
flows from financing activities:
|
|||||||
Payment
of long-term debt
|
$
|
-
|
$
|
(4,102
|
)
|
||
Collection
of advance receivable
|
-
|
1,464
|
|||||
Proceeds
from exercise of stock warrants
|
672
|
-
|
|||||
Proceeds
from sale of stock, net of issuance costs
|
11,980
|
10,270
|
|||||
Net
cash provided by financing
activities
|
$
|
12,652
|
$
|
7,632
|
|||
Net
(decrease) increase in cash and cash equivalents
|
(1,272
|
)
|
3,343
|
||||
|
|||||||
Cash
and cash equivalents at beginning of period
|
3,827
|
3,646
|
|||||
Cash
and cash equivalents at end of period
|
$
|
2,555
|
$
|
6,989
|
|||
Supplemental
disclosures of non-cash investing and financing cash flow
information:
|
|||||||
Issuance
of common stock for
accounts
payable and accrued
expenses
|
$
|
146
|
$
|
167
|
|||
Issuance
of common stock for
debt
conversion and debt
payments
|
$
|
834
|
$
|
-
|
|||
Unrealized
gains on investments
|
$
|
79
|
$
|
316
|
See
accompanying notes to consolidated financial statements.
7
HEMISPHERx
BIOPHARMA, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1: BASIS OF PRESENTATION
The
consolidated financial statements include the financial statements of Hemispherx
Biopharma, Inc. and its wholly-owned subsidiaries. The Company has three
domestic subsidiaries BioPro Corp., BioAegean Corp. and Core Biotech Corp.,
all
of which are incorporated in Delaware and are dormant. The Company’s foreign
subsidiary, Hemispherx Biopharma Europe N.V./S.A., established in Belgium in
1998, has limited or no activity. All significant intercompany balances and
transactions have been eliminated in consolidation.
In
the
opinion of management, all adjustments necessary for a fair presenta-tion of
such consolidated financial statements have been included. Such adjust-ments
consist of normal recurring items. Interim results are not necessarily
indicative of results for a full year.
The
interim consolidated financial statements and notes thereto are presented as
permitted by the Securities and Exchange Commission (SEC), and do not contain
certain information which will be included in our annual consolidated financial
statements and notes thereto.
These
consolidated financial statements should be read in conjunction with our
consolidated financial statements included in our annual report on Form 10-K
for the
year
ended December 31, 2006, as filed with the SEC on March
19, 2007.
NOTE
2: NET
LOSS PER SHARE
Basic
and diluted net loss per share is computed using the weighted average number
of
shares of common stock outstanding during the period. Equivalent common shares,
consisting of stock options and warrants including the Company’s convertible
debentures, which amounted to 30,005,360 and 17,530,415 shares, are excluded
from the calculation of diluted net loss per share for the six months ended
June
30, 2006 and 2007, respectively, since their effect is antidilutive.
NOTE
3: EQUITY BASED COMPENSATION
The
fair
value of each option award is estimated on the date of grant using a
Black-Scholes option valuation model. Expected volatility is based on the
historical volatility of the price of the Company’s stock. The risk-free
interest rate is based on U.S. Treasury issues with a term equal to the expected
life of the option. The Company uses historical data to estimate expected
dividend yield, expected life and forfeiture rates. The fair values of the
options granted, were estimated based on the following weighted average
assumptions:
Six
Months Ended June 30,
|
||||
2006
|
2007
|
|||
Risk-free
interest rate
|
4.3%
- 4.6%
|
4.46
- 4.90%
|
||
Expected
dividend yield
|
-
|
-
|
||
Expected
lives
|
2.5-5
yrs
|
5
yrs
|
||
Expected
volatility
|
72.1%-79.3%
|
76.74
- 77.57%
|
||
Weighted
average grant date fair value of options and warrants issued
|
$2,503,000
|
|
$140,037
|
8
Stock
option activity during the six months ended June 30, 2007, is as
follows:
Stock
option activity for employees:
Number
of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
December 31, 2006
|
2,001,969
|
$
|
2.51
|
8.01
|
|||||||||
Options
granted
|
64,120
|
2.14
|
9.50
|
||||||||||
Options
forfeited
|
(411
|
)
|
-
|
-
|
|||||||||
Outstanding
June 30, 2007
|
2,065,678
|
2.50
|
7.85
|
-
|
|||||||||
Exercisable
June 30, 2007
|
1,951,692
|
2.52
|
8.45
|
-
|
The
weighted-average grant-date fair value of options granted during the six months
ended June 30, 2007 was $123,202.
Unvested
stock option activity for employees:
Number
of
Options
|
Weighted
Average
Exercise
Price
|
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
December 31, 2006
|
113,986
|
$
|
2.26
|
9.05
|
|||||||||
Options
granted
|
-
|
-
|
-
|
||||||||||
Options
forfeited
|
-
|
-
|
-
|
-
|
|||||||||
Outstanding
June 30, 2007
|
113,986
|
$
|
2.26
|
8.80
|
-
|
Stock
option activity for non-employees:
Number
of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
December 31, 2006
|
1,326,732
|
$
|
2.63
|
8.18
|
|||||||||
Options
granted
|
33,750
|
$
|
2.37
|
9.50
|
|||||||||
Options
forfeited
|
-
|
-
|
-
|
||||||||||
Outstanding
June 30, 2007
|
1,360,482
|
$
|
2.63
|
7.95
|
-
|
||||||||
Exercisable
June 30, 2007
|
1,323,382
|
$
|
2.64
|
8.35
|
-
|
The
weighted-average grant-date fair value of options granted during the six months
ended June 30, 2007 was $97,870.
9
Unvested
stock option activity for non-employees during the year:
Number
of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
December 31, 2006
|
37,100
|
$
|
2.28
|
9.81
|
|||||||||
Options
granted
|
-
|
-
|
-
|
||||||||||
Options
forfeited
|
-
|
-
|
-
|
-
|
|||||||||
Outstanding
June 30, 2007
|
37,100
|
$
|
2.28
|
9.56
|
-
|
The
impact on the Company’s results of operations of recording equity based
compensation for the six months ended June 30, 2007 was to increase general
and
administrative expenses by approximately $164,000 and reduce earnings per share
by $0.00 per basic and diluted share.
As
of
June 30, 2007, there was $79,000 of unrecognized equity based compensation
cost
related to options granted under the Equity Incentive Plan.
Note
4: SHORT TERM INVESTMENTS
Securities
classified as available for sale consisted of:
June
30, 2007
|
|||||||||||||
Name
of Security
|
Cost
|
Market
Value
|
Unrealized
Gain (Loss)
|
Maturity
Date
|
|||||||||
General
Electric Cap Corp
|
$
|
1,240,000
|
$
|
1,275,000
|
$
|
35,000
|
July,
2007
|
||||||
General
Electric Cap Serv
|
1,202,000
|
1,233,000
|
31,000
|
September,
2007
|
|||||||||
HSBC
Finance
|
1,000,000
|
1,028,000
|
28,000
|
August,
2007
|
|||||||||
FHLMC
|
1,051,000
|
1,078,000
|
27,000
|
November,
2007
|
|||||||||
FHLMC
|
960,000
|
985,000
|
25,000
|
October,
2007
|
|||||||||
FNMA
|
800,000
|
816,000
|
16,000
|
December,
2007
|
|||||||||
FNMA
|
3,000,000
|
3,067,000
|
67,000
|
November,
2007
|
|||||||||
FHLMC
|
3,099,000
|
3,163,000
|
64,000
|
December,
2007
|
|||||||||
HSBC
Finance
|
1,004,000
|
1,016,000
|
12,000
|
December,
2007
|
|||||||||
General
Electric
|
998,000
|
1,009,000
|
11,000
|
December,
2007
|
|||||||||
$
|
14,354,000
|
$
|
14,670,000
|
$
|
316,000
|
10
December
31, 2006
|
|||||||||||||
Name
of security
|
Cost
|
Market
Value
|
Unrealized
Gain(Loss)
|
Maturity
Date
|
|||||||||
|
|||||||||||||
AIG
Discount Commercial
|
$
|
972,000
|
$
|
983,000
|
$
|
11,000
|
April,
2007
|
||||||
Natexis
Banques Popolare
|
969,000
|
979,000
|
10,000
|
May,
2007
|
|||||||||
American
General Finance
|
965,000
|
974,000
|
9,000
|
June,
2007
|
|||||||||
Daimler
Chrysler
|
965,000
|
974,000
|
9,000
|
June,
2007
|
|||||||||
LaSalle
Bank
|
965,000
|
974,000
|
9,000
|
June,
2007
|
|||||||||
General
Electric
|
1,240,000
|
1,242,000
|
2,000
|
July,
2007
|
|||||||||
HSBC
Finance
|
1,000,000
|
1,000,000
|
-
|
August,
2007
|
|||||||||
American
General Finance
|
976,000
|
987,000
|
11,000
|
September,
2007
|
|||||||||
General
Electric
|
965,000
|
974,000
|
9,000
|
September,
2007
|
|||||||||
General
Electric
|
1,202,000
|
1,200,000
|
(2,000
|
)
|
September,
2007
|
||||||||
FHLMC
|
960,000
|
960,000
|
-
|
October,
2007
|
|||||||||
FHLMC
|
1,051,000
|
1,051,000
|
-
|
November,
2007
|
|||||||||
FNMA
|
3,000,000
|
2,991,000
|
(9,000
|
)
|
November,
2007
|
||||||||
FHLMC
|
3,099,000
|
3,086,000
|
(13,000
|
)
|
December,
2007
|
||||||||
$
|
18,329,000
|
$
|
18,375,000
|
$
|
46,000
|
No
investment securities were pledged to secure public funds at June 30, 2007
and
December 31, 2006, respectively.
The
table
below indicates the length of time individual securities have been in a
continuous unrealized loss position at June 30, 2007 and December 31,
2006.
June
30, 2007
|
||||||||||||||||||||||
Less
Than 12 Months
|
12
Months Or Longer
|
Total
|
||||||||||||||||||||
Name
of
Security
|
Number
of
Securities
|
Fair
Value
|
Unrealized
Loss
|
Fair
Value
|
Unrealized
Loss
|
Fair
Value
|
Unrealized
Loss
|
|||||||||||||||
General
Electric Cap Corp
|
1
|
1,275,000
|
-
|
-
|
-
|
1,275,000
|
-
|
|||||||||||||||
General
Electric Cap Serv
|
1
|
1,233,000
|
-
|
-
|
-
|
1,233,000
|
-
|
|||||||||||||||
HSBC
Finance
|
1
|
1,028,000
|
-
|
-
|
-
|
1,028,000
|
-
|
|||||||||||||||
FHLMC
|
1
|
1,078,000
|
-
|
-
|
-
|
1,078,000
|
-
|
|||||||||||||||
FHLMC
|
1
|
985,000
|
-
|
-
|
-
|
985,000
|
-
|
|||||||||||||||
FNMA
|
1
|
816,000
|
-
|
-
|
-
|
816,000
|
-
|
|||||||||||||||
FNMA
|
1
|
3,067,000
|
-
|
-
|
-
|
3,067,000
|
-
|
|||||||||||||||
FHLMC
|
1
|
3,163,000
|
-
|
-
|
-
|
3,163,000
|
-
|
|||||||||||||||
HSBC
Finance
|
1
|
1,016,000
|
-
|
-
|
-
|
1,016,000
|
-
|
|||||||||||||||
General
Electric
|
1
|
1,009,000
|
-
|
-
|
-
|
1,009,000
|
-
|
|||||||||||||||
Total
Temporary Impairment
|
||||||||||||||||||||||
Securities
|
10
|
$
|
14,670,000
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
14,670,000
|
$
|
-
|
11
December
31, 2006
|
||||||||||||||||||||||
Less
than 12 months
|
12
months or longer
|
Total
|
||||||||||||||||||||
Name
of Security
|
Number
of Securities
|
Fair
Value
|
Unrealized
Loss
|
Fair
Value
|
Unrealized
Loss
|
Fair
Value
|
Unrealized
Loss
|
|||||||||||||||
AIG
Discount Commercial
|
1
|
$
|
983,000
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
983,000
|
$
|
-
|
|||||||||
Natexis
Banques Popolare
|
1
|
979,000
|
-
|
-
|
-
|
979,000
|
-
|
|||||||||||||||
American
General Finance
|
1
|
974,000
|
-
|
-
|
-
|
974,000
|
-
|
|||||||||||||||
Daimler
Chrysler
|
1
|
974,000
|
-
|
-
|
-
|
974,000
|
-
|
|||||||||||||||
LaSalle
Bank
|
1
|
974,000
|
-
|
-
|
-
|
974,000
|
-
|
|||||||||||||||
General
Electric
|
1
|
1,242,000
|
-
|
-
|
-
|
1,242,000
|
-
|
|||||||||||||||
HSBC
Finance
|
1
|
1,000,000
|
-
|
-
|
-
|
1,000,000
|
-
|
|||||||||||||||
American
General Finance
|
1
|
987,000
|
-
|
-
|
-
|
987,000
|
-
|
|||||||||||||||
General
Electric
|
1
|
974,000
|
-
|
-
|
-
|
974,000
|
-
|
|||||||||||||||
General
Electric
|
1
|
1,200,000
|
(2,000
|
)
|
-
|
-
|
1,200,000
|
(2,000
|
)
|
|||||||||||||
FHLMC
|
1
|
960,000
|
-
|
-
|
-
|
960,000
|
-
|
|||||||||||||||
FHLMC
|
1
|
1,051,000
|
-
|
-
|
-
|
1,051,000
|
-
|
|||||||||||||||
FNMA
|
1
|
2,991,000
|
(9,000
|
)
|
-
|
-
|
2,991,000
|
(9,000
|
)
|
|||||||||||||
FHLMC
|
1
|
3,086,000
|
(13,000
|
)
|
-
|
-
|
3,086,000
|
(13,000
|
)
|
|||||||||||||
Total
Temporary Impairment Securities
|
14
|
$
|
18,375,000
|
$
|
(24,000
|
)
|
$
|
-
|
$
|
-
|
$
|
18,375,000
|
$
|
(24,000
|
)
|
In
management's opinion, the unrealized losses reflect changes in interest rates
subsequent to the acquisition of specific securities. The Company has the
ability to hold these securities until maturity or market price recovery.
Management believes that the unrealized losses represent temporary impairment
of
the securities.
Comprehensive
Income
The
Company reports comprehensive income, which includes net loss, as well as
certain other items, which result in a charge to equity during the period.
Three
months ended June 30
(in
thousands)
|
Six
months ended June 30
(in
thousands)
|
||||||||||||
2006
|
2007
|
2006
|
2007
|
||||||||||
Unrealized
gains (losses) during the period
|
$
|
33
|
$
|
248
|
$
|
164
|
$
|
491
|
|||||
Realized
loss (gains) during the period
|
(3
|
)
|
(198
|
)
|
86
|
(221
|
)
|
||||||
Other
comprehensive income(loss)
|
$
|
30
|
$
|
50
|
$
|
250
|
$
|
270
|
There
are
no income tax effects allocated to comprehensive income as the Company has
no
tax liabilities due to net operating losses.
12
Note
5: DEBENTURE FINANCING
Long
term debt consists of the following:
|
|||||||
(in
thousands)
|
|||||||
December
31, 2006
|
June
30, 2007
|
||||||
October
2003
|
$
|
2,071
|
$
|
-
|
|||
January
2004
|
1,031
|
-
|
|||||
July
2004
|
1,000
|
-
|
|||||
Total
|
4,102
|
-
|
|||||
Less
Discounts
|
(231
|
)
|
-
|
||||
Total
|
3,871
|
-
|
|||||
Less
current portion
|
3,871
|
-
|
|||||
Long
term debt
|
$
|
-
|
$
|
-
|
In
June
2007, the Company retired all remaining debt related to its convertible
debentures issued in October 2003, January 2004 and July 2004. Of the
outstanding debt of approximately $4,102,000, only $2,638,000 was required
to be
paid in new funds to retire the debentures, with the balance being covered
by
the Company’s advance receivable held as collateral by one of the debenture
holders.
October
2003 Debentures
The
discount on the October 2003 Debentures is fully amortized; therefore, the
Company did not record any financing costs for the three and six months ended
June 30, 2006 and 2007, respectively. Interest expense for the three months
ended June 30, 2006 and 2007, with regard to the October 2003 Debentures was
approximately $36,000 for each period respectively. For the six months ended
June 30, 2006 and 2007, interest expense related to these debentures was $72,000
for each period respectively.
January
2004 Debentures
The
discount on the January 2004 Debentures is fully amortized; therefore, the
Company did not record financing costs for the three months ended June 30,
2006
and 2007, respectively. Financing costs for the six months ended June 30, 2006
and 2007, was approximately $49,000 and $0, respectively. Interest expense
for
the three months ended June 30, 2006 and 2007, with regard to the January 2004
Debentures was approximately $29,000 and $18,000, respectively. For the six
months ended June 30, 2006 and 2007, interest expense related to these
debentures was $97,000 and $36,000, respectively.
July
2004 Debentures
The
Company recorded financing costs for the three months ended June 30, 2006 and
2007, with regard to the July 2004 Debentures of $116,000 for each period
respectively. For the six months ended June 30, 2007, the Company recorded
financing costs of $253,000 and $231,000, respectively. Interest expense for
the
three months ended June 30, 2006 and 2007, with regard to the July 2004
Debentures was approximately $19,000 and $17,000, respectively. For the six
months ended June 30, 2006 and 2007, interest expense related to these
debentures was $45,000 and $35,000, respectively.
13
NOTE
6: EQUITY FINANCING
For
the
six months ended June 30, 2007, Fusion Capital has purchased from the Company
5,750,530 shares for aggregate gross proceeds of approximately $10,270,000
pursuant to the April 2006 common stock purchase agreement between the Company
and Fusion Capital.
NOTE
7: RECENT
ACCOUNTING PRONOUNCEMENTS
The
Company adopted the provisions of FASB Interpretation No. 48, "Accounting for
Uncertainty in Income Taxes" ("FIN 48") effective January 1, 2007. The purpose
of FIN 48 is to clarify and set forth consistent rules for accounting for
uncertain tax positions in accordance with Statement of Financial Accounting
Standards No. 109, "Accounting for Income Taxes". The cumulative effect of
applying the provisions of this interpretation are required to be reported
separately as an adjustment to the opening balance of retained earnings in
the
year of adoption. The adoption of this standard did not have an impact on the
financial condition or the results of our operations.
On
February 15, 2007, the FASB issued FASB Statement No. 159, The Fair Value Option
for Financial Assets and Financial Liabilities - Including an Amendment of
FASB
Statement No. 115. This standard permits an entity to choose to measure many
financial instruments and certain other items at fair value. This option is
available to all entities, including not-for-profit organizations. Most of
the
provisions in Statement 159 are elective; however, the amendment to FASB
Statement No. 115, Accounting for Certain Investments in Debt and Equity
Securities, applies to all entities with available-for-sale and trading
securities. Some requirements apply differently to entities that do not report
net income. The FASB's stated objective in issuing this standard is as follows:
"to improve financial reporting by providing entities with the opportunity
to
mitigate volatility in reported earnings caused by measuring related assets
and
liabilities differently without having to apply complex hedge accounting
provisions".
The
fair
value option established by Statement 159 permits all entities to choose to
measure eligible items at fair value at specified election dates. A business
entity will report unrealized gains and losses on items for which the fair
value
option has been elected in earnings (or another performance indicator if the
business entity does not report earnings) at each subsequent reporting date.
A
not-for-profit organization will report unrealized gains and losses in its
statement of activities or similar statement. The fair value option: (a) may
be
applied instrument by instrument, with a few exceptions, such as investments
otherwise 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.
Statement
159 is effective as of the beginning of an entity's first fiscal year that
begins after November 15, 2007.
The
impact of this statement has not been determined.
ITEM
2: Management's
Discussion and Analysis of Financial Condition and Results of
Operations.
Special
Note Regarding Forward-Looking Statements
Certain
statements in this document constitute "forwarding-looking statements" within
the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities and Exchange Act of 1995 (collectively, the
"Reform Act"). Certain, but not necessarily all, of such forward-looking
statements can be identified by the use of forward-looking terminology such
as
"believes," "expects," "may," "will," "should," or "anticipates" or the negative
thereof or other variations thereon or comparable terminology, or by discussions
of strategy that involve risks and uncertainties. All statements other than
statements of historical fact, included in this report regarding our financial
position, business strategy and plans or objectives for future operations are
forward-looking statements. Without limiting the broader description of
forward-looking statements above, we specifically note that statements regarding
potential drugs, their potential therapeutic effect, the possibility of
obtaining regulatory approval, our ability to manufacture and sell any products,
market acceptance or our ability to earn a profit from sales or licenses of
any
drugs or our ability to discover new drugs in the future are all forward-looking
in nature.
14
Such
forward-looking statements involve known and unknown risks, uncertainties and
other factors, including but not limited to, the risk factors discussed below,
which may cause the actual results, performance or achievements of Hemispherx
and its subsidiaries to be materially different from any future results,
performance or achievements expressed or implied by such forward-looking
statements and other factors referenced in this report. We do not undertake
and
specifically decline any obligation to publicly release the results of any
revisions which may be made to any forward-looking statement to reflect events
or circumstances after the date of such statements or to reflect the occurrence
of anticipated or unanticipated events.
Overview
General
We
are a
biopharmaceutical company engaged in the clinical development, manufacture
and
marketing of new drug entities based on natural immune system enhancing
technologies for the treatment of viral and immune based acute and chronic
disorders. We were founded in the early 1970s, as a contract researcher for
the
National Institutes of Health. Since that time, we have established a strong
foundation of laboratory, pre-clinical, and clinical data with respect to the
development of nucleic acids to enhance the natural antiviral defense system
of
the human body and to aid the development of therapeutic products for the
treatment of acute and chronic diseases. We own a U.S. Food and Drug
Administration (“FDA”) approved GMP (good manufacturing practice) manufacturing
facility in New Jersey. Our flagship products include Ampligen® and Alferon N
Injection®.
Ampligen®
is an experimental drug currently undergoing clinical development for the
treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS” or
“CFS”), and clinical testing for treatment/prevention of avian and seasonal
influenza. We have completed Phase III clinical trials using Ampligen® to treat
ME/CFS patients and are currently in the process of preparing and filing a
New
Drug Application (“NDA”) with the FDA.
Alferon
N
Injection® is the registered trademark for our injectable formulation of natural
alpha interferon, which is approved by the FDA for the treatment of genital
warts. Alferon N Injection® is also in clinical development for treating West
Nile Virus (“WNV”).
15
New
Accounting Pronouncements
We
adopted the provisions of FASB Interpretation No. 48, "Accounting for
Uncertainty in Income Taxes" ("FIN 48") effective January 1, 2007. The purpose
of FIN 48 is to clarify and set forth consistent rules for accounting for
uncertain tax positions in accordance with Statement of Financial Accounting
Standards No. 109, "Accounting for Income Taxes". The cumulative effect of
applying the provisions of this interpretation are required to be reported
separately as an adjustment to the opening balance of retained earnings in
the
year of adoption. The adoption of this standard did not have an impact on our
financial condition or the results of our operations.
On
February 15, 2007, the FASB issued FASB Statement No. 159, The Fair Value Option
for Financial Assets and Financial Liabilities - Including an Amendment of
FASB
Statement No. 115. This standard permits an entity to choose to measure many
financial instruments and certain other items at fair value. This option is
available to all entities, including not-for-profit organizations. Most of
the
provisions in Statement 159 are elective; however, the amendment to FASB
Statement No. 115, Accounting for Certain Investments in Debt and Equity
Securities, applies to all entities with available-for-sale and trading
securities. Some requirements apply differently to entities that do not report
net income. The FASB's stated objective in issuing this standard is as follows:
"to improve financial reporting by providing entities with the opportunity
to
mitigate volatility in reported earnings caused by measuring related assets
and
liabilities differently without having to apply complex hedge accounting
provisions".
The
fair
value option established by Statement 159 permits all entities to choose to
measure eligible items at fair value at specified election dates. A business
entity will report unrealized gains and losses on items for which the fair
value
option has been elected in earnings (or another performance indicator if the
business entity does not report earnings) at each subsequent reporting date.
A
not-for-profit organization will report unrealized gains and losses in its
statement of activities or similar statement. The fair value option: (a) may
be
applied instrument by instrument, with a few exceptions, such as investments
otherwise 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.
Statement
159 is effective as of the beginning of an entity's first fiscal year that
begins after November 15, 2007. The impact of this statement has not been
determined.
Disclosure
About Off-Balance
Sheet Arrangements
None.
Critical
Accounting Policies
There
have been no material changes in our critical accounting policies and estimates
from those disclosed in Item 7 of our Annual Report on Form 10-K for the year
ended December 31, 2006.
16
RESULTS
OF OPERATIONS
Three
months ended June 30, 2006 versus three months ended June 30,
2007
Net
loss
Our
net
loss of approximately $3,925,000 for the three months ended June 30, 2007 was
23% lower when compared to the same period in 2006. This $1,156,000 reduction
in
loss was primarily due to:
1) |
Lower
General & Administrative expenses of $543,000 principally related to a
reduction in non-cash equity based compensation and lower accounting
fees,
|
2) |
An
increase of $211,000 in interest and other income due to higher interest
earned in the current period from the maturities of our marketable
securities as compared to the previous
period,
|
3) |
Lower
interest expense of $295,000 relating to the amortization of debt
discounts on our convertible debentures and the incurring of liquidated
damages in 2006 payable to our debenture holders resulting from us
failing
to timely file our 2005 Annual Report on Form
10-K.
|
Net
loss
per share was $0.05 for the current period versus $0.08 for the same period
in
2006.
Revenues
Revenues
for the three months ended June 30, 2007 were $234,000 as compared to revenues
of $247,000 for the same period in 2006. Ampligen® sold under the cost recovery
clinical program was down $12,000 or 24% and Alferon N Injection®
sales
were flat as compared to the prior period. Ampligen® sold under the cost
recovery clinical program is a product of physicians and ME/CFS patients
applying to us to enroll in the program. This program has been in effect for
several years and is offered as a treatment option to patients severely affected
by CFS. As the name “cost recovery” implies, we have no gain or profit on these
sales. The benefits to us include 1) physicians and patients becoming familiar
with Ampligen® and 2) collection of clinical data relating to the patients’
treatment and results. We are altering our marketing strategy for Alferon N
Injection®
by
relaunching the product via a collaborative marketing initiative between
Hemispherx and a national Specialty Pharmacy network encompassing specialty
pharmacists, pharmacies and targeted physician specialists. Such an effort
is intended to focus our efforts in the most appropriate and productive market
segment for the product. It is anticipated that such an initiative may
generate a positive impact on Alferon® revenues in an efficient, cost effective
manner.
Production
costs/cost of goods sold
Production/cost
of goods sold decreased approximately $83,000 or 21% for the three months ended
June 30, 2007 compared to the same period in 2006. This decrease was primarily
due to: 1) lower production costs of approximately $17,000 relating to excess
production capacity during the prior period as more effort was directed toward
Ampligen® research and development and 2) a decrease in costs of goods sold of
approximately $66,000. Cost of goods sold for the three months ended June 30,
2006 and 2007 were $151,000 and $85,000 respectively. The primary reason for
this decrease can be attributed to a fall in the number of vials sold during
the
current period.
17
Research
and Development costs
Overall
research and development costs for the three months ended June 30, 2007 were
$2,534,000 as compared to $2,588,000 for the same period a year ago representing
a slight decrease of $54,000.
Our
research and development costs include the direct cost associated with our
effort to develop our lead product, Ampligen®, as a therapy in treating acute
and chronic diseases. In addition to the costs related to the collection and
processing of clinical data, our current expenditures include the costs of
establishing our in-house polymer production facility and costs related to
preparing and completing our NDA for the use of Ampligen® in treating
CFS.
We
have
filed certain sections of our Ampligen® NDA with the FDA for review and comment.
As expected, the FDA reviewers have requested clarification in some areas and
additional information in certain pre-clinical, chemistry, manufacturing and
medical sections. We have engaged the services of additional Clinical Research
Organizations (CROs) to assist in the responding to the various inquiries as
well as conducting additional clinical exams and lab work. We have also added
additional research personnel to assist the CROs. These personnel have
experience at major pharmaceutical companies, i.e., J&J, Merck and
GlaxoSmithKline. As previously reported, this process is affecting the
finalization and completion of the NDA. We believe that in the long run, it
may
accelerate the review process; however, we cannot offer guidance on when the
NDA
will be deemed complete or when the review will be completed.
As
previously reported, we are actively engaged in broad-based experimental studies
assessing the efficacy of our product, Ampligen®, Alferon N Injection® and
Alferon® LDO against influenza viruses as an adjuvant and/or single agent
antiviral with the Defence R&D Canada, the National Institute of Infectious
Disease in Tokyo and various research affiliates of the National Institutes
of
Health in the United States.
In
June
2007, we met with Dr. Hasegawa of the National Institute of Infectious Diseases
in Japan and representatives of the Research Foundation of Microbial Diseases
in
Osaka University (Biken) to discuss the results of Dr. Hasegawa’s work in using
Ampligen® as an adjuvant to make flu vaccines more effective. Further
discussions are scheduled as to the extent and terms of a collaboration effort
with Biken to develop a more effective flu vaccine using Ampligen® as an
adjuvant.
In
June
2007, we initiated a clinical trial in Australia using Ampligen® in combination
with seasonal flu vaccines. This trial is expected to continue for several
months, is being conducted in Australia’s winter season and focuses on
populations at risk for virulent cases of influenza, especially those over
the
age of 60 years who historically may have weakened immune systems. The
Australian clinical trial was prompted by the results from the pre-clinical
work
conducted by Dr. Hasegawa of the National Institute of Infectious diseases
of
Japan (see above comments). Thirty patients are anticipated to be enrolled
in
the Australian study, which will utilize a two dose Ampligen® regimen of 2mg per
dose. This study is being monitored by Clinical Network Services Pty. Ltd.
located in Brisbane, Australia. The clinical trials center of St. Vincent’s
Hospital based in Darling Hurst, Australia will be conducting the trial.
Prospective patients are being screened to be included in the clinical trials
starting in August 2007.
18
General
and Administrative Expenses
General
and Administrative (“G&A”) expenses for the three months ended June 30, 2006
and 2007 were approximately $2,086,000 and $1,543,000, respectively, reflecting
a decrease of $543,000 or 26%. This
decrease related primarily to a reduction in non-cash equity based compensation
of $290,000 compared to the same period in 2006 as fewer stock options were
granted to employees in the current period. Also, our accounting fees were
down
$428,000 from the same period a year ago primarily due to the charges incurred
in 2006 related to the restatement of our financial statements. These decreases
were slightly offset by increases in various other areas of G&A expense.
Interest
and Other Income
Interest
and other income for the three months ended June 30, 2006 and 2007 increased
approximately $211,000 as compared to the same period a year earlier. The
increase in interest and other income during the current period can primarily
be
attributed to higher interest realized on the maturity of our marketable
securities as compared to the same period a year earlier. All funds in excess
of
our immediate need are invested in short-term securities.
Interest
Expense and Financing Costs
Interest
expense and non-cash financing costs were approximately $183,000 for the three
months ended June 30, 2007 versus $461,000 for the same period a year
ago.
The main
reason for the decrease in interest expense and financing costs of $278,000
can
be attributed to the incurring of liquidated damages in 2006 payable to our
debenture holders resulting from our failure to timely file our 2005 Annual
Report on Form 10-K.
Six
months ended June 30, 2006 versus six months ended June 30,
2007
Net
loss
Our
net
loss of approximately $9,025,000 for the six months ended June 30, 2007 was
18%
lower when compared to the same period in 2006. This $1,975,000 reduction in
loss was primarily due to:
1) |
Lower
General & Administrative expenses of $1,852,000 principally related to
a reduction in non-cash equity based compensation and lower accounting
fees with an offsetting increase in professional fees, salaries and
wages
and directors fees,
|
2) |
An
increase of $305,000 in interest and other income due to higher interest
earned upon the maturity of our marketable securities as compared
the same
period a year ago,
|
3) |
Lower
interest expense of $295,000 relating to the amortization of debt
discounts on our convertible debentures and the incurring of liquidated
damages in 2006 payable to our debenture holders resulting from us
failing
to timely file our 2005 Annual Report on Form
10-K,
|
4) |
Higher
Research and Development costs of $692,000 primarily due to an increase
in
the use of consultants related to the preparation and completion
of our
NDA for the use of Ampligen® in treating CFS.
|
Net
loss
per share was $0.13 for the current period versus $0.18 for the same period
in
2006.
19
Revenues
Revenues
for the six months ended June 30, 2007 were $489,000 as compared to revenues
of
$483,000 for the same period in 2006. Ampligen® sold under the cost recovery
clinical program was down $30,000 or 29% while Alferon N Injection®
sales
were up $36,000 to $416,000 during the current period. The increase in Alferon
N
Injection®
sales
was due to a price increase instituted this year. Correspondingly, we have
experienced a decline in the number of vials sold during the current quarter
versus the same period a year ago as we continue to evidence increased
competition from rival products.
Production
costs/cost of goods sold
Production/cost
of goods sold was approximately $551,000 during the current period representing
a decrease of approximately $146,000 or 21% as compared to the same period
in
2006. This decrease was primarily due to lower production costs of $77,000
relating to excess production capacity during the prior period as more effort
was directed toward Ampligen® research and development and the NDA; and a
decrease in costs of goods sold of $69,000. Costs of goods sold for the six
months ended June 30, 2006 and 2007 was $247,000 and $178,000, respectively.
This decrease can be attributed to reduction of the number of vials sold as
compared to the prior period.
Research
and Development costs
Overall
research and development costs for the six months ended June 30, 2007 were
$5,710,000 as compared to $5,018,000 for the same period a year ago representing
an increase of $692,000.
These
costs
are
primarily related to the collection and processing of clinical data, including
the costs of establishing our in-house polymer production facility and the
costs
of preparing and completing our NDA for the use of Ampligen® in treating CFS.
The increase can be attributed to an
increase in the use of consultants related to the above areas.
General
and Administrative Expenses
General
and Administrative (“G&A”) expenses for the six months ended June 30, 2006
and 2007 were approximately $5,178,000 and $3,326,000, respectively, reflecting
a decrease of $1,852,000 or 36%. This
decrease related primarily to a reduction in non-cash equity based compensation
of $2,098,000 compared to the same period in 2006 as fewer stock options were
granted to employees in the current period as well as lower accounting fees
of
$404,000 as compared to the prior period primarily due to the restatement of
our
financial statements for the period 2003 through 2005. These decreases were
offset by various increases in other areas of general and administrative
expense.
Interest
and Other Income and Expense
Interest
and other income for the six months ended June 30, 2006 and 2007 increased
approximately $305,000 as compared to the same period a year earlier. The
increase in interest and other income during the current period was mainly
due
to higher interest earned upon the maturity of our marketable securities as
compared the same period a year ago.
20
Interest
Expense and Financing Costs
Interest
expense and non-cash financing costs were approximately $392,000 for the six
months ended June 30, 2007 versus $750,000 for the same period a year
ago.
The main
reason for the decrease in interest expense and financing costs of $358,000
can
be attributed to decreased amortization charges on debt discounts and
the
incurring of liquidated damages in 2006 payable to our debenture holders
resulting from our failure to timely file our 2005 Annual Report on Form 10-K
as
we were in violation of provisions within our debenture agreements.
Liquidity
and Capital Resources
Cash
used
in operating activities for the six months ended June 30, 2007 was $7,835,000.
Cash provided by investing activities for the six months ending June 30, 2007,
amounted to $3,546,000, primarily from the maturity and purchase of short-term
investments. Cash provided by financing activities for the six months ended
June
30, 2007 amounted to $7,632,000. This was primarily due to proceeds received
from the sale of our common stock of approximately $10,270,000. This was offset
by the net repayment of our outstanding debt of $2,638,000 in June 2007. As
of
July 31, 2007 we had approximately $19,900,000 in
cash
and cash equivalents and short-term investments, or a decrease of approximately
$2,129,000 from December 31, 2006. We anticipate that these funds should be
sufficient to meet our operating cash requirements for the next 15 months.
In
June
2007, the Company retired all remaining debt related to its convertible
debentures issued in October 2003, January 2004 and July 2004. Of the
outstanding debt of approximately $4,102,000, only $2,638,000 was required
to be
paid in new funds to retire the debentures, with the balance being covered
by
other cash and securities already held as collateral for the
debentures.
Equity
Financing
On
April
12, 2006, we entered into a common stock purchase agreement (the “2006 Purchase
Agreement”) with Fusion Capital Fund II, LLC (“Fusion Capital”), pursuant to
which Fusion Capital has agreed, under certain conditions, to purchase on each
trading day $100,000 of our common stock up to an aggregate of $50.0 million
over a period of approximately 25 months. Pursuant to the terms of the
Registration Rights Agreement, dated as of April 12, 2006, we registered
12,386,723 shares issuable to or issued to Fusion Capital under the Purchase
Agreement. Through July 31, 2007, we have sold to Fusion Capital an aggregate
of
9,789,748 shares under the common stock purchase agreement for aggregate gross
proceeds of $18,389,129 and issued 440,127 Commitment Shares.
Under
the
rules of the American Stock Exchange, in the event that we elect to sell more
than 12,386,723 shares to Fusion Capital, we were required to seek stockholder
approval. This approval was obtained on September 20, 2006. We also will be
required to file a new registration statement and have it declared effective
by
the SEC in the event we elect to sell to Fusion Capital more than the 12,386,723
shares previously registered.
We
are
using the proceeds from this financing for general corporate purposes.
Because
of our long-term capital requirements, we may seek to access the public equity
market whenever conditions are favorable, even if we do not have an immediate
need for additional capital at that time. Any additional funding may result
in
significant dilution and could involve the issuance of securities with rights,
which are senior to those of existing stockholders. We may also need additional
funding earlier than anticipated, and our cash requirements, in general, may
vary materially from those now planned, for reasons including, but not limited
to, changes in our research and development programs, clinical trials,
competitive and technological advances, the regulatory processes, including
the
commercializing of Ampligen® products.
21
There
can
be no assurances that we will raise adequate funds from these or other sources,
which may have a material adverse effect on our ability to develop our products.
Also,
we
have the ability to curtail discretionary spending, including some research
and
development activities, if required to conserve cash.
ITEM
3: Quantitative and Qualitative Disclosures About Market
Risk
We
had
approximately $21,659,000 in cash and cash equivalents and short-term
investments at June 30, 2007. To the extent that our cash and cash equivalents
and short term investments exceed our near term funding needs, we generally
invest the excess cash in three to twelve month interest bearing financial
instruments. We employ established conservative policies and procedures to
manage any risks with respect to investment exposure.
Our
financial instruments that are exposed to concentrations of credit risk consist
primarily of cash and cash equivalents. We place our cash and cash equivalents
with what management believes to be high credit quality institutions. At times
such investments may be in excess of the FDIC insurance limit.
We
have
not entered into, and do not expect to enter into, financial instruments for
trading or hedging purposes.
Item
4: Controls and Procedures
Our
Chairman of the Board (serving as the principal executive officer) and the
Chief
Financial Officer performed an evaluation of our disclosure controls and
procedures, which have been designed to permit us to effectively identify and
timely disclose important information. They concluded that the controls and
procedures were effective as of June 30, 2007 to ensure that material
information was accumulated and communicated to our management, including our
Chief Executive Officer and Chief Financial Officer, as appropriate to allow
timely decisions regarding required disclosure. During the quarter ended June
30, 2007, we have made no change in our internal controls over financial
reporting that has materially affected, or is reasonably likely to materially
affect, our internal controls over financial reporting.
Part
II - OTHER INFORMATION
Item
1. Legal Proceedings
We
reported in our Form 10-Q for the period ending March 31, 2007 that in January
2007 we filed an application in South Africa for the dissolution of Ribotech
(PTY) Ltd. We have since determined to withdraw, and have withdrawn, this
application.
See
our Form 10-Q for the period ending March 31, 2007 for previously reported
legal
proceedings.
22
ITEM
1A. Risk Factors.
The
following cautionary statements identify important factors that could cause
our
actual result to differ materially from those projected in the forward-looking
statements made in this Form 10-Q. Among the key factors that have a direct
bearing on our results of operations are:
Risks
Associated With Our Business
No
assurance of successful product development
Ampligen®
and related products. The development of Ampligen® and
our
other related products is subject to a number of significant risks.
Ampligen® may
be
found to be ineffective or to have adverse side effects, fail to receive
necessary regulatory clearances, be difficult to manufacture on a commercial
scale, be uneconomical to market or be precluded from commercialization by
proprietary right of third parties. Our products are in various stages of
clinical and pre-clinical development and, require further clinical studies
and
appropriate regulatory approval processes before any such products can be
marketed. We do not know when, if ever, Ampligen® or
our
other products will be generally available for commercial sale for any
indication. Generally, only a small percentage of potential therapeutic products
are eventually approved by the FDA for commercial sale.
We
are in
the registration process for an NDA with the FDA for approval to use Ampligen®
in the treatment of Chronic Fatigue Syndrome. We can provide no guidance as
to
the tentative date at which the compilation and filing of the NDA will be
complete, as significant factors are outside our control including, without
limitation, the ability and willingness of the independent clinical
investigators to complete the requisite reports at an acceptable regulatory
standard, the ability to collect overseas generated data, and the time required
for our New Brunswick staff/facilities to interface with Hollister-Stier to
assure compliance with manufacturing regulatory standards. Also, the timing
of
the FDA review process of the NDA is subject to the control of the FDA and
could
result in one of the following events; 1) approval to market Ampligen® for use
in treating ME/CFS patients 2) require more research, development, and clinical
work, 3) approval to market as well as conduct more testing, or 4) reject our
NDA application. Given these variables, we are unable to project when material
net cash inflows are expected to commence from the sale of Ampligen®.
Alferon
N
Injection®. Although Alferon N Injection® is approved for marketing in the
United States for the intra-lesional treatment of refractory or recurring
external genital warts in patients 18 years of age or older; to date it has
not
been approved for other indications. We face many of the risks discussed above,
with regard to developing this product for use to treat other
ailments.
Our
drug and related technologies are investigational and subject to regulatory
approval. If we are unable to obtain regulatory approval, our operations will
be
significantly affected.
All
of
our drugs and associated technologies, other than Alferon N Injection®, are
investigational and must receive prior regulatory approval by appropriate
regulatory authorities for general use and are currently legally available
only
through clinical trials with specified disorders. At present, Alferon N
Injection® is only approved for the intra-lesional treatment of refractory or
recurring external genital warts in patients 18 years of age or older. Use
of
Alferon N Injection® for other indications will require regulatory
approval.
23
Our
products, including Ampligen®, are subject to extensive regulation by numerous
governmental authorities in the U.S. and other countries, including, but not
limited to, the FDA in the U.S., the Health Protection Branch (“HPB”) of Canada,
and the Agency for the Evaluation of Medicinal Products (“EMEA”) in Europe.
Obtaining regulatory approvals is a rigorous and lengthy process and requires
the expenditure of substantial resources. In order to obtain final regulatory
approval of a new drug, we must demonstrate to the satisfaction of the
regulatory agency that the product is safe and effective for its intended uses
and that we are capable of manufacturing the product to the applicable
regulatory standards. We require regulatory approval in order to market
Ampligen® or any other proposed product and receive product revenues or
royalties. We cannot assure you that Ampligen® will ultimately be demonstrated
to be safe or efficacious. In addition, while Ampligen® is authorized for use in
clinical trials including a cost recovery program in the United States and
Europe, we cannot assure you that additional clinical trial approvals will
be
authorized in the United States or in other countries, in a timely fashion
or at
all, or that we will complete these clinical trials. If Ampligen® or one of our
other products does not receive regulatory approval in the U.S. or elsewhere,
our operations most likely will be materially adversely affected.
Although
preliminary in vitro testing indicates that Ampligen® enhances the effectiveness
of different drug combinations on avian influenza, preliminary testing in the
laboratory is not necessarily predictive of successful results in clinical
testing or human treatment.
Ampligen®
is undergoing pre-clinical testing for possible treatment of avian flu. Although
preliminary in vitro testing indicates that Ampligen® enhances the effectiveness
of different drug combinations on avian flu, preliminary testing in the
laboratory is not necessarily predictive of successful results in clinical
testing or human treatment. No assurance can be given that similar results
will
be observed in clinical trials. Use of Ampligen® in the treatment of avian flu
requires prior regulatory approval. Only the FDA can determine whether a drug
is
safe, effective or promising for treating a specific application. As discussed
in the prior risk factor, obtaining regulatory approvals is a rigorous and
lengthy process.
In
addition, Ampligen® is being tested on two strains of avian influenza virus.
There are a number of strains and strains mutate. No assurance can be given
that
Ampligen® will be effective on any strains that might infect
humans.
We
may continue to incur substantial losses and our future profitability is
uncertain.
We
began
operations in 1966 and last reported net profit from 1985 through 1987. Since
1987, we have incurred substantial operating losses, as we pursued our clinical
trial effort to get our experimental drug, Ampligen®, approved. As of June 30,
2007, our accumulated deficit was approximately $176,076,000. We have not yet
generated significant revenues from our products and may incur substantial
and
increased losses in the future. We cannot assure that we will ever achieve
significant revenues from product sales or become profitable. We require, and
will continue to require, the commitment of substantial resources to develop
our
products. We cannot assure that our product development efforts will be
successfully completed or that required regulatory approvals will be obtained
or
that any products will be manufactured and marketed successfully, or be
profitable.
24
We
may require additional financing which may not be
available.
The
development of our products will require the commitment of substantial resources
to conduct the time-consuming research, preclinical development, and clinical
trials that are necessary to bring pharmaceutical products to market. As of
July
31, 2007, we had approximately $19,900,000 in
cash
and cash equivalents and short-term investments. We anticipate, but cannot
assure, that these
funds will be sufficient to meet our operating cash requirements for the next
15
months.
On
April
12, 2006, we entered into a common stock purchase agreement with Fusion Capital
pursuant to which Fusion Capital has agreed, under certain conditions and with
certain limitations, to purchase on each trading day $100,000 of our common
stock up to an aggregate of $50,000,000 over a 25 month period (see Part I,
Item
2.
“Management's Discussion and Analysis of Financial Condition and Results of
Operations; Liquidity and Capital Resources”).
We
only
have the right to receive $100,000 per trading day under the agreement with
Fusion Capital unless our stock price exceeds $1.90 by at least $0.10, in which
case the daily amount may be increased under certain conditions as the price
of
our common stock increases. Fusion Capital shall not have the right nor the
obligation to purchase any shares of our common stock on any trading days that
the market price of our common stock is less than $1.00. We have registered
an
aggregate of 13,201,840 shares purchasable by Fusion Capital pursuant to the
common stock purchase agreement (inclusive of up to 643,502 additional
Commitment Shares) and, through August 6, 2007, we have sold to Fusion Capital
an aggregate of 9,789,748 shares under the common stock purchase agreement
for
aggregate gross proceeds of approximately $18,389,000. Assuming a purchase
price
of $1.28 per share (the closing sale price of the common stock on August 6,
2007) and the purchase by Fusion Capital of the remaining 1,953,473 shares
(after issuing the remaining 203,375 Commitment Shares), total gross proceeds
to
us from the remaining shares would only be $2,500,445 ($20,889,445 in the
aggregate under the common stock purchase agreement). Accordingly, depending
upon the future market price of our common stock, we most likely will realize
less than the maximum $50,000,000 proceeds from the sale of stock under the
Purchase Agreement.
In
the
event we elect to issue additional shares to Fusion Capital, we will be required
to file a new registration statement and have it declared effective by the
Securities and Exchange Commission. In addition, Fusion Capital cannot purchase
more than 27,386,723 shares, inclusive of Commitment Shares under the common
stock purchase agreement.
The
extent to which we rely on Fusion Capital as a source of funding will depend
on
a number of factors including, the prevailing market price of our common stock
and the extent to which we are able to secure working capital from other
sources.
If
obtaining sufficient financing from Fusion Capital were to prove unavailable
or
prohibitively dilutive and if we are unable to commercialize and sell Ampligen®
and/or increase sales of Alferon N Injection® or our other products, we will
need to secure another source of funding in order to satisfy our working capital
needs. Even if we are able to access the full $50,000,000 under the common
stock
purchase agreement with Fusion Capital, we may need to raise additional funds
through additional equity or debt financing or from other sources in order
to
complete the necessary clinical trials and the regulatory approval processes
including the commercializing of Ampligen® products. There can be no assurances
that we will raise adequate funds which may have a material adverse effect
on
our ability to develop our products. Also, we have the ability to curtail
discretionary spending, including some research and development activities,
if
required to conserve cash.
25
We
may not be profitable unless we can protect our patents and/or receive approval
for additional pending patents.
We
need
to preserve and acquire enforceable patents covering the use of Ampligen® for a
particular disease in order to obtain exclusive rights for the commercial sale
of Ampligen® for such disease. We obtained all rights to Alferon N Injection®,
and we plan to preserve and acquire enforceable patents covering its use for
existing and potentially new diseases. Our success depends, in large part,
on
our ability to preserve and obtain patent protection for our products and to
obtain and preserve our trade secrets and expertise. Certain of our know-how
and
technology is not patentable, particularly the procedures for the manufacture
of
our experimental drug, Ampligen®, which is carried out according to standard
operating procedure manuals. We have been issued certain patents including
those
on the use of Ampligen® and Ampligen® in combination with certain other drugs
for the treatment of HIV. We also have been issued patents on the use of
Ampligen® in combination with certain other drugs for the treatment of chronic
Hepatitis B virus, chronic Hepatitis C virus, and a patent which affords
protection on the use of Ampligen® in patients with Chronic Fatigue Syndrome. We
have not yet been issued any patents in the United States for the use of
AmpligenÒ
as a
sole treatment for any of the cancers, which we have sought to target. With
regard to Alferon N Injection®, we have acquired from ISI its patents for
natural alpha interferon produced from human peripheral blood leukocytes and
its
production process and we have filed a patent application for the use of
Alferon® LDO in treating viral diseases including avian influenza. We cannot
assure that our competitors will not seek and obtain patents regarding the
use
of similar products in combination with various other agents, for a particular
target indication prior to our doing such. If we cannot protect our patents
covering the use of our products for a particular disease, or obtain additional
patents, we may not be able to successfully market our products.
The
patent position of biotechnology and pharmaceutical firms is highly uncertain
and involves complex legal and factual questions.
To
date,
no consistent policy has emerged regarding the breadth of protection afforded
by
pharmaceutical and biotechnology patents. There can be no assurance that new
patent applications relating to our products or technology will result in
patents being issued or that, if issued, such patents will afford meaningful
protection against competitors with similar technology. It is generally
anticipated that there may be significant litigation in the industry regarding
patent and intellectual property rights. Such litigation could require
substantial resources from us and we may not have the financial resources
necessary to enforce the patent rights that we hold. No assurance can be made
that our patents will provide competitive advantages for our products or will
not be successfully challenged by competitors. No assurance can be given that
patents do not exist or could not be filed which would have a materially adverse
effect on our ability to develop or market our products or to obtain or maintain
any competitive position that we may achieve with respect to our products.
Our
patents also may not prevent others from developing competitive products using
related technology.
26
There
can be no assurance that we will be able to obtain necessary licenses if we
cannot enforce patent rights we may hold. In addition, the failure of third
parties from whom we currently license certain proprietary information or from
whom we may be required to obtain such licenses in the future, to adequately
enforce their rights to such proprietary information, could adversely affect
the
value of such licenses to us.
If
we
cannot enforce the patent rights we currently hold we may be required to obtain
licenses from others to develop, manufacture or market our products. There
can
be no assurance that we would be able to obtain any such licenses on
commercially reasonable terms, if at all. We currently license certain
proprietary information from third parties, some of which may have been
developed with government grants under circumstances where the government
maintained certain rights with respect to the proprietary information developed.
No assurances can be given that such third parties will adequately enforce
any
rights they may have or that the rights, if any, retained by the government
will
not adversely affect the value of our license.
There
is
no guarantee that our trade secrets will not be disclosed or known by our
competitors.
To
protect our rights, we require certain employees and consultants to enter into
confidentiality agreements with us. There can be no assurance that these
agreements will not be breached, that we would have adequate and enforceable
remedies for any breach, or that any trade secrets of ours will not otherwise
become known or be independently developed by competitors.
If
our distributors do not market our products successfully, we may not generate
significant revenues or become profitable.
We
have
limited marketing and sales capability. We are dependent upon existing and,
possibly future, marketing agreements and third party distribution agreements
for our prod-ucts in order to generate significant revenues and become
profitable. As a result, any revenues received by us will be dependent on the
efforts of third parties, and there is no assurance that these efforts will
be
successful. Our agreement with Accredo offers the potential to provide some
marketing and distribution capacity in the United States while agreements with
Biovail Corporation and Laboratorios Del Dr. Esteve S.A. may provide a sales
force in Canada, Spain and Portugal.
We
cannot
assure that our U.S. or foreign marketing partners will be able to successfully
distribute our products, or that we will be able to establish future marketing
or third party distribution agreements on terms acceptable to us, or that the
cost of establishing these arrangements will not exceed any product revenues-.
The failure to continue these arrangements or to achieve other such arrangements
on satisfactory terms could have a materially adverse effect on us.
There
are no long-term agreements with suppliers of required materials. If we are
unable to obtain the required raw materials, we may be required to scale back
our operations or stop manufacturing Alferon N Injection® and/or
Ampligen®.
A
number
of essential materials are used in the production of Alferon N Injection®,
including human white blood cells. We do not have long-term agreements for
the
supply of any of such materials. There can be no assurance we can enter into
long-term supply agreements covering essential materials on commercially
reasonable terms, if at all.
27
There
are
a limited number of manufacturers in the United States available to provide
the
polymers for use in manufacturing Ampligen®. At present, we do not have any
agreements with third parties for the supply of any of these polymers. We have
established relevant manufacturing operations within our New Brunswick, New
Jersey facility for the production of Ampligen® polymers from raw materials in
order to obtain polymers on a more consistent manufacturing basis. The
establishment of an Ampligen® polymers production line within our own
facilities, may delay certain steps in the commercialization process,
specifically, our Ampligen®
NDA
Registration process with the FDA.
If
we are
unable to obtain or manufacture the required polymers, we may be required to
scale back our operations or stop manufacturing. The costs and availability
of
products and materials we need for the production of Ampligen® and the
commercial production of Alferon N Injection® and other products which we may
commercially produce are subject to fluctuation depending on a variety of
factors beyond our control, including competitive factors, changes in
technology, and FDA and other governmental regulations and there can be no
assurance that we will be able to obtain such products and materials on terms
acceptable to us or at all.
There
is no assurance that successful manufacture of a drug on a limited scale basis
for investigational use will lead to a successful transition to commercial,
large-scale production.
Small
changes in methods of manufacturing, including commercial scale-up, may affect
the chemical structure of Ampligen® and other RNA drugs, as well as their safety
and efficacy, and can, among other things, require new clinical studies and
affect orphan drug status, particularly, market exclusivity rights, if any,
under the Orphan Drug Act. The transition from limited production of
pre-clinical and clinical research quantities to production of commercial
quantities of our products will involve distinct management and technical
challenges and will require additional management and technical personnel and
capital to the extent such manufacturing is not handled by third parties. There
can be no assurance that our manufacturing will be successful or that any given
product will be determined to be safe and effective, capable of being
manufactured economically in commercial quantities or successfully
marketed.
We
have limited manufacturing experience and capacity.
Ampligen®
has been only produced in limited quantities for use in our clinical trials
and
we are dependent upon third party suppliers for substantially all of the
production process. The failure to continue these arrangements or to achieve
other such arrangements on satisfactory terms could have a material adverse
affect on us. Also, to be successful, our products must be manufactured in
commercial quantities in compliance with regulatory requirements and at
acceptable costs. To the extent we are involved in the production process,
our
current facilities are not adequate for the production of our proposed products
for large-scale commercialization, and we currently do not have adequate
personnel to conduct commercial-scale manufacturing. We intend to utilize
third-party facilities if and when the need arises or, if we are unable to
do
so, to build or acquire commercial-scale manufacturing facilities. We will
need
to comply with regulatory requirements for such facilities, including those
of
the FDA pertaining to current Good Manufacturing Practices (“cGMP”) regulations.
There can be no assurance that such facilities can be used, built, or acquired
on commercially acceptable terms, or that such facilities, if used, built,
or
acquired, will be adequate for our long-term needs.
28
We
may not be profitable unless we can produce Ampligen® or other products in
commercial quantities at costs acceptable to us.
We
have
never produced Ampligen® or any other products in large commercial quantities.
We must manufacture our products in compliance with regulatory requirements
in
large commercial quantities and at acceptable costs in order for us to be
profitable. We intend to utilize third-party manufacturers and/or facilities
if
and when the need arises or, if we are unable to do so, to build or acquire
commercial-scale manufacturing facili-ties. If we cannot manufacture commercial
quantities of Ampligen® or enter into third party agreements for its manufacture
at costs acceptable to us, our operations will be significantly affected. Also,
each production lot of Alferon N Injection® is subject to FDA review and
approval prior to releasing the lots to be sold. This review and approval
process could take considerable time, which would delay our having product
in
inventory to sell.
Rapid
technological change may render our products obsolete or
non-competitive.
The
pharmaceutical and biotechnology industries are subject to rapid and substantial
technological change. Technological competition from pharmaceutical and
biotechnology companies, universities, governmental entities and others
diversifying into the field is intense and is expected to increase. Most of
these entities have significantly greater research and development capabilities
than us, as well as substantial marketing, financial and managerial resources,
and represent significant competition for us. There can be no assurance that
developments by others will not render our products or technologies obsolete
or
noncompetitive or that we will be able to keep pace with technological
developments.
Our
products may be subject to substantial competition.
Ampligen®.
Competitors may be developing technologies that are, or in the future may be,
the basis for competitive products. Some of these potential products may have
an
entirely different approach or means of accomplishing similar therapeutic
effects to products being developed by us. These competing products may be
more
effective and less costly than our products. In addition, conventional drug
therapy, surgery and other more familiar treatments may offer competition to
our
products. Furthermore, many of our competitors have significantly greater
experience than us in pre-clinical testing and human clinical trials of
pharmaceutical products and in obtaining FDA, HPB and other regulatory approvals
of products. Accordingly, our competitors may succeed in obtaining FDA, HPB
or
other regulatory product approvals more rapidly than us. There are no drugs
approved for commercial sale with respect to treating ME/CFS in the United
States. The dominant competitors with drugs to treat disease indications in
which we plan to address include Gilead Pharmaceutical, Pfizer, Bristol-Myers,
Abbott Labs, Glaxo Smith Kline, Merck and Schering-Plough Corp. These potential
competitors are among the largest pharmaceutical companies in the world, are
well known to the public and the medical community, and have substantially
greater financial resources, product development, and manufacturing and
marketing capabilities than we have. Although we believe our principal advantage
is the unique mechanism of action of Ampligen® on the immune system, we cannot
assure that we will be able to compete.
ALFERON
N
Injection®. Many competitors are among the largest pharmaceutical companies in
the world, are well known to the public and the medical community, and have
substantially greater financial resources, product development, and
manufacturing and marketing capabilities than we have. Alferon N Injection®
currently competes with Schering’s injectable recombinant alpha interferon
product (INTRON® A) for the treatment of genital warts. 3M Pharmaceuticals also
offer competition from its immune-response modifier, Aldara®, a
self-administered topical cream, for the treatment of external genital and
perianal warts. In addition, Medigene recently received FDA approval for a
self-administered ointment, VeregenTM, which is indicated for the topical
treatment of external genital and perianal warts. Alferon N Injection® also
competes with surgical, chemical, and other methods of treating genital warts.
We cannot assess the impact products developed by our competitors, or advances
in other methods of the treatment of genital warts, will have on the commercial
viability of Alferon N Injection®. If and when we obtain additional approvals of
uses of this product, we expect to compete primarily on the basis of product
performance. Our competitors have developed or may develop products (containing
either alpha or beta interferon or other therapeutic compounds) or other
treatment modalities for those uses. There can be no assurance that, if we
are
able to obtain regulatory approval of Alferon N Injection® for the treatment of
new indications, we will be able to achieve any significant penetration into
those markets. In addition, because certain competitive products are not
dependent on a source of human blood cells, such products may be able to be
produced in greater volume and at a lower cost than Alferon N Injection®.
Currently, our wholesale price on a per unit basis of Alferon N Injection® is
higher than that of the competitive recombinant alpha and beta interferon
products.
29
General.
Other companies may succeed in developing products earlier than we do, obtaining
approvals for such products from the FDA more rapidly than we do, or developing
products that are more effective than those we may develop. While we will
attempt to expand our technological capabilities in order to remain competitive,
there can be no assurance that research and development by others or other
medical advances will not render our technology or products obsolete or
non-competitive or result in treatments or cures superior to any therapy we
develop.
Possible
side effects from the use of Ampligen® or Alferon N Injection® could adversely
affect potential revenues and physician/patient acceptability of our
product.
Ampligen®.
We believe that Ampligen® has been generally well tolerated with a low incidence
of clinical toxicity, particularly given the severely debilitating or life
threatening diseases that have been treated. A mild flushing reaction has been
observed in approximately 15% of patients treated in our various studies. This
reaction is occasionally accompanied by a rapid heart beat, a tightness of
the
chest, urticaria (swelling of the skin), anxiety, shortness of breath,
subjective reports of ''feeling hot'', sweating and nausea. The reaction is
usually infusion-rate related and can generally be controlled by reducing the
rate of infusion. Other adverse side effects include liver enzyme level
elevations, diarrhea, itching, asthma, low blood pressure, photophobia, rash,
transient visual disturbances, slow or irregular heart rate, decreases in
platelets and white blood cell counts, anemia, dizziness, confusion, elevation
of kidney function tests, occasional temporary hair loss and various flu-like
symptoms, including fever, chills, fatigue, muscular aches, joint pains,
headaches, nausea and vomiting. These flu-like side effects typically subside
within several months. One or more of the potential side effects might deter
usage of Ampligen® in certain clinical situations and therefore, could adversely
affect potential revenues and physician/patient acceptability of our product.
30
Alferon
N
Injection®. At present, Alferon N Injection® is only approved for the
intra-lesional (within the lesion) treatment of refractory or recurring external
genital warts in adults. In clinical trials conducted for the treatment of
genital warts with Alferon N Injection®, patients did not experience serious
side effects; however, there can be no assurance that unexpected or unacceptable
side effects will not be found in the future for this use or other potential
uses of Alferon N Injection® which could threaten or limit such product’s
usefulness.
We
may be subject to product liability claims from the use of Ampligen®, Alferon N
Injection®, or other of our products which could negatively affect our future
operations.
We
face
an inherent business risk of exposure to product liability claims in the event
that the use of Ampligen® or other of our products results in adverse effects.
This liability might result from claims made directly by patients, hospitals,
clinics or other consumers, or by pharmaceutical companies or others
manufacturing these products on our behalf. Our future operations may be
negatively affected from the litigation costs, settlement expenses and lost
product sales inherent to these claims. While we will continue to attempt to
take appro-priate precautions, we cannot assure that we will avoid significant
product liability exposure. Although we currently maintain product liability
insurance coverage, there can be no assurance that this insurance will provide
adequate coverage against Ampligen® and/or Alferon N Injection® product
liability claims. A successful product liability claim against us in excess
of
Ampligen®’s $1,000,000 in insurance coverage; $3,000,000 in aggregate, or in
excess of Alferon N Injection®’s $5,000,000 in insurance coverage; $5,000,000 in
aggregate; or for which coverage is not provided could have a negative effect
on
our business and financial condition.
The
loss of services of key personnel including Dr. William A. Carter could hurt
our
chances for success.
Our
success is dependent on the continued efforts of Dr. William A. Carter because
of his position as a pioneer in the field of nucleic acid drugs, his being
the
co-inventor of Ampligen®, and his knowledge of our overall activities, including
patents and clinical trials. The loss of Dr. Carter’s services could have a
material adverse effect on our operations and chances for success. We have
secured key man life insurance in the amount of $2,000,000 on the life of Dr.
Carter and we have an employment agreement with Dr. Carter that, as amended,
runs until December 31, 2010. However, Dr. Carter has the right to terminate
his
employment upon not less than 30 days prior written notice. The loss of Dr.
Carter or other personnel or the failure to recruit additional personnel as
needed could have a materially adverse effect on our ability to achieve our
objectives.
Uncertainty
of health care reimbursement for our products.
Our
ability to successfully commercialize our products will depend, in part, on
the
extent to which reimbursement for the cost of such products and related
treatment will be available from government health administration authorities,
private health coverage insurers and other organizations. Significant
uncertainty exists as to the reimbursement status of newly approved health
care
products, and from time to time legislation is proposed, which, if adopted,
could further restrict the prices charged by and/or amounts reimbursable to
manufacturers of pharmaceutical products. We cannot predict what, if any,
legislation will ultimately be adopted or the impact of such legislation on
us.
There can be no assurance that third party insurance companies will allow us
to
charge and receive payments for products sufficient to realize an appropriate
return on our investment in product development.
31
There
are risks of liabilities associated with handling and disposing of hazardous
materials.
Our
business involves the controlled use of hazardous materials, carcinogenic
chemicals, flammable solvents and various radioactive compounds. Although we
believe that our safety procedures for handling and disposing of such materials
comply in all material respects with the standards prescribed by applicable
regulations, the risk of accidental contamination or injury from these materials
cannot be completely eliminated. In the event of such an accident or the failure
to comply with applicable regulations, we could be held liable for any damages
that result, and any such liability could be significant. We do not maintain
insurance coverage against such liabilities.
Risks
Associated With an Investment in Our Common Stock
The
market price of our stock may be adversely affected by market
volatility.
The
market price of our common stock has been and is likely to be volatile. In
addition to general economic, political and market conditions, the price and
trading volume of our stock could fluctuate widely in response to many factors,
including:
· |
announcements
of the results of clinical trials by us or our
competitors;
|
· |
adverse
reactions to products;
|
· |
governmental
approvals, delays in expected governmental approvals or withdrawals
of any
prior governmental approvals or public or regulatory agency concerns
regarding the safety or effectiveness of our
products;
|
· |
changes
in U.S. or foreign regulatory policy during the period of product
development;
|
· |
developments
in patent or other proprietary rights, including any third party
challenges of our intellectual property
rights;
|
· |
announcements
of technological innovations by us or our
competitors;
|
· |
announcements
of new products or new contracts by us or our
competitors;
|
· |
actual
or anticipated variations in our operating results due to the level
of
development expenses and other
factors;
|
· |
changes
in financial estimates by securities analysts and whether our earnings
meet or exceed the estimates;
|
· |
conditions
and trends in the pharmaceutical and other
industries;
|
new
accounting standards; and
· |
the
occurrence of any of the risks described in these "Risk
Factors."
|
Our
common stock is listed for quotation on the American Stock Exchange. For the
12-month period ended July 31, 2007, the price of our common stock has ranged
from $1.24 to $2.49 per share. We expect the price of our common stock to remain
volatile. The average daily trading volume of our common stock varies
significantly. Our relatively low average volume and low average number of
transactions per day may affect the ability of our stockholders to sell their
shares in the public market at prevailing prices and a more active market may
never develop.
In
the
past, following periods of volatility in the market price of the securities
of
companies in our industry, securities class action litigation has often been
instituted against companies in our industry. If we face securities litigation
in the future, even if without merit or unsuccessful, it would result in
substantial costs and a diversion of management attention and resources, which
would negatively impact our business.
32
Our
stock price may be adversely affected if a significant amount of shares, are
sold in the public market.
We
have
registered 13,201,840 for sale by Fusion Capital and 143,658 shares by others,
and may, in the future, register an additional 15,000,000 shares for sale by
Fusion Capital under the common stock purchase agreement. As of August 6, 2007,
approximately 710,358 shares of our common stock, constituted "restricted
securities" as defined in Rule 144 under the Securities Act, 68,628 of which
have been registered. Also, we have registered 6,571,072 shares issuable upon
exercise of 135% of certain Warrants and upon exercise of certain other
warrants. Registration of the shares permits the sale of the shares in the
open
market or in privately negotiated transactions without compliance with the
requirements of Rule 144. To the extent the exercise price of the warrants
is
less than the market price of the common stock, the holders of the warrants
are
likely to exercise them and sell the underlying shares of common stock and
to
the extent that the conversion price and exercise price of these securities
are
adjusted pursuant to anti-dilution protection, the securities could be
exercisable or convertible for even more shares of common stock. We also may
issue shares to be used to meet our capital requirements or use shares to
compensate employees, consultants and/or directors. We are unable to estimate
the amount, timing or nature of future sales of outstanding common stock. Sales
of substantial amounts of our common stock in the public market could cause
the
market price for our common stock to decrease. Furthermore, a decline in the
price of our common stock would likely impede our ability to raise capital
through the issuance of additional shares of common stock or other equity
securities.
The
sale of our common stock to Fusion Capital may cause dilution and the sale
of
the shares of common stock acquired by Fusion Capital and other shares
registered for selling stockholders could cause the price of our common stock
to
decline.
The
sale
by Fusion Capital and other selling stockholders of our common stock will
increase the number of our publicly traded shares, which could depress the
market price of our common stock. Moreover, the mere prospect of sales by Fusion
Capital and other selling stockholders could depress the market price for our
common stock. The issuance of shares to Fusion Capital under the common stock
purchase agreement will dilute the equity interest of existing stockholders
and
could have an adverse effect on the market price of our common
stock.
The
purchase price for the common stock to be sold to Fusion Capital pursuant to
the
common stock purchase agreement will fluctuate based on the price of our common
stock. All shares sold to Fusion Capital are to be freely tradable. Fusion
Capital may sell none, some or all of the shares of common stock purchased
from
us at any time. We expect that the shares offered by Fusion Capital will be
sold
over a period of in excess of two years. Depending upon market liquidity at
the
time, a sale of shares by Fusion at any given time could cause the trading
price
of our common stock to decline. The sale of a substantial number of shares
of
our common stock to Fusion Capital pursuant to the purchase agreement, or
anticipation of such sales, could make it more difficult for us to sell equity
or equity-related securities in the future at a time and at a price that we
might otherwise wish to effect sales.
33
Provisions
of our Certificate of Incorporation and Delaware law could defer a change of
our
management which could discourage or delay offers to acquire
us.
Provisions
of our Certificate of Incorporation and Delaware law may make it more difficult
for someone to acquire control of us or for our stockholders to remove existing
management, and might discourage a third party from offering to acquire us,
even
if a change in control or in management would be beneficial to our stockholders.
For example, our Certificate of Incorporation allows us to issue shares of
preferred stock without any vote or further action by our stockholders. Our
Board of Directors has the authority to fix and determine the relative rights
and preferences of preferred stock. Our Board of Directors also has the
authority to issue preferred stock without further stockholder approval. As
a
result, our Board of Directors could authorize the issuance of a series of
preferred stock that would grant to holders the preferred right to our assets
upon liquidation, the right to receive dividend payments before dividends are
distributed to the holders of common stock and the right to the redemption
of
the shares, together with a premium, prior to the redemption of our common
stock. In this regard, in November 2002, we adopted a stockholder rights plan
and, under the Plan, our Board of Directors declared a dividend distribution
of
one Right for each outstanding share of Common Stock to stockholders of record
at the close of business on November 29, 2002. Each Right initially entitles
holders to buy one unit of preferred stock for $30.00. The Rights generally
are
not transferable apart from the common stock and will not be exercisable unless
and until a person or group acquires or commences a tender or exchange offer
to
acquire, beneficial ownership of 15% or more of our common stock. However,
for
Dr. Carter, our chief executive officer, who already beneficially owns 7.9%
of
our common stock, the Plan’s threshold will be 20%, instead of 15%. The Rights
will expire on November 19, 2012, and may be redeemed prior thereto at $.01
per
Right under certain circumstances.
Because
the risk factors referred to above could cause actual results or outcomes to
differ materially from those expressed in any forward-looking statements made
by
us, you should not place undue reliance on any such forward-looking statements.
Further, any forward-looking statement speaks only as of the date on which
it is
made and we undertake no obligation to update any forward-looking statement
or
statements to reflect events or circumstances after the date on which such
statement is made or reflect the occurrence of unanticipated events. New factors
emerge from time to time, and it is not possible for us to predict which will
arise. In addition, we cannot assess the impact of each factor on our business
or the extent to which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any forward-looking
statements. Our research in clinical efforts may continue for the next several
years and we may continue to incur losses due to clinical costs incurred in
the
development of Ampligen® for commercial application. Possible losses may
fluctuate from quarter to quarter as a result of differences in the timing
of
significant expenses incurred and receipt of licensing fees and/or cost recovery
treatment revenues in Europe, Canada and in the United States.
ITEM
2: Unregistered Sales of Equity Securities and Use of
Proceeds
During
the quarter ended June 30, 2007, we issued 1) 1,952,417 shares pursuant to
the
2006 Purchase Agreement with Fusion Capital, 2) an aggregate of 63,340 shares
for services performed and an aggregate of 43,177 shares for the payment of
interest.
34
All
of
the foregoing transactions
were conducted pursuant
to the exemption from registration provided by Section 4(2) of the Securities
Act of 1933.
We
did
not repurchase any of our securities during the quarter ended June 30,
2007.
ITEM
3: Defaults upon Senior Securities
None.
ITEM
4: Submission of Matters to a Vote of Security Holders
At
the
Company's Annual Meeting of Stockholders on June 20, 2007, stockholders approved
the following:
Election
of Directors:
Nominees
|
For
|
|
Withheld
|
||||
William
A. Carter
|
50,927,906
|
2,192,977
|
|||||
Richard
C. Piani
|
51,334,221
|
1,786,662
|
|||||
Ransom
W. Etheridge
|
51,325,450
|
1,795,433
|
|||||
William
M. Mitchell.
|
51,411,401
|
1,709,482
|
|||||
Iraj-Eqhbal
Kiani, Ph.D.
|
51,050,302
|
2,07,0581
|
|||||
Steven
D. Spence
|
51,307,350
|
1,813,533
|
Ratification
of the appointment of McGladrey & Pullen, LLP as the Company’s independent
accountants:
For:
52,750,720 Against:
311,323 Abstain:
58,840
Approval
of the Hemispherx 2007 Equity Incentive Plan:
For:
5,788,350 Against:
2,855,141 Abstain:
58,085 Broker non-votes:44,901,317
Total
shares voted: 53,120,883 out of 71,608,110
eligible
to vote.
ITEM
5: Other Information
None.
ITEM
6: Exhibits
(a)
Exhibits
31.1
|
Certification
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from
the
Company's Chief Executive Officer
|
|
31.2
|
Certification
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from
the
Company's Chief Financial Officer
|
|
32.1
|
Certification
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from
the
Company's Chief Executive Officer
|
|
32.2
|
Certification
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from
the
Company's Chief Financial
Officer
|
35
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.
HEMISPHERx BIOPHARMA, INC. | ||
|
|
|
/S/ William A. Carter | ||
William A. Carter, M.D. |
||
Chief Executive Officer & President |
|
|
|
/S/ Robert E. Peterson | ||
Robert E. Peterson |
||
Chief Financial Officer | ||
Date: August 9, 2007 |
36