PRESSURE BIOSCIENCES INC - Quarter Report: 2008 September (Form 10-Q)
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
x
Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange
Act
of 1934
For
the quarterly period ended
September
30, 2008
or
o
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange
Act
of 1934
For
the transition period from _____________ to _____________
Commission
file number
0-21615
PRESSURE
BIOSCIENCES, INC.
(Exact
Name of Registrant as Specified in its Charter)
Massachusetts
|
|
04-2652826
|
(State
or Other Jurisdiction of
|
|
(I.R.S.
Employer
|
Incorporation
or Organization)
|
|
Identification
No.)
|
14
Norfolk Avenue
South
Easton, Massachusetts
(Address
of Principal Executive Offices)
02375
(Zip
Code)
(508)
230-1828
(Registrant’s
Telephone Number, Including Area Code)
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, a non-accelerated filer, or a smaller reporting company.
See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer o
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Exchange
Act Rule 12b-2 of the Exchange Act).
o
Yes x
No
The
number of shares outstanding of the Issuer’s common stock as of October 31, 2008
was 2,195,283.
TABLE
OF
CONTENTS
|
Page
|
|
PART
I - FINANCIAL INFORMATION
|
|
|
|
|
|
Item
1. Financial Statements (Unaudited)
|
|
|
Consolidated
Balance Sheets as of September 30, 2008 and December 31,
2007
|
1
|
|
|
||
Consolidated
Statements of Operations for the Three Months and Nine Months Ended
September 30, 2008 and 2007
|
2
|
|
|
||
Consolidated
Statements of Comprehensive Loss for the Three Months and Nine Months
Ended September 30, 2008 and 2007
|
3
|
|
|
||
Consolidated
Statements of Cash Flows for the Nine Months Ended September 30,
2008 and
2007
|
4
|
|
|
||
Notes
to Consolidated Financial Statements
|
5
|
|
|
||
Item
2. Management's Discussion and Analysis of Financial Condition and
Results
of Operations
|
14
|
|
|
||
Item
4T. Controls and Procedures
|
26
|
|
|
||
PART
II - OTHER INFORMATION
|
||
Item
4. Submission of Matters to a Vote of Security Holders
|
27
|
|
|
||
Item
6. Exhibits
|
28
|
Item
1. Financial Statements
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(UNAUDITED)
September 30,
|
December 31,
|
||||||
2008
|
2007
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
and cash equivalents
|
$
|
1,952,734
|
$
|
5,424,486
|
|||
Accounts
receivable
|
174,437
|
118,471
|
|||||
Inventories
|
606,789
|
172,548
|
|||||
Deposits
|
114,510
|
553,483
|
|||||
Prepaid
income taxes
|
6,600
|
56,863
|
|||||
Income
tax receivable
|
251,261
|
249,541
|
|||||
Prepaid
expenses and other current assets
|
200,848
|
94,783
|
|||||
Total
current assets
|
3,307,179
|
6,670,175
|
|||||
PROPERTY
AND EQUIPMENT, NET
|
271,908
|
257,797
|
|||||
OTHER
ASSETS
|
|||||||
Intangible
assets, net
|
291,816
|
328,290
|
|||||
TOTAL
ASSETS
|
$
|
3,870,903
|
$
|
7,256,262
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable
|
$
|
321,950
|
$
|
152,729
|
|||
Accrued
employee compensation
|
371,052
|
377,190
|
|||||
Accrued
professional fees and other expenses
|
177,274
|
186,840
|
|||||
Income
taxes payable
|
3,082
|
4,519
|
|||||
Deferred
revenue
|
22,685
|
15,075
|
|||||
Total
current liabilities
|
896,043
|
736,353
|
|||||
LONG
TERM LIABILITIES
|
|||||||
Deferred
revenue
|
10,650
|
6,767
|
|||||
TOTAL
LIABILITIES
|
906,693
|
743,120
|
|||||
COMMITMENTS
AND CONTINGENCIES (Note 5)
|
|||||||
STOCKHOLDERS'
EQUITY
|
|||||||
Preferred
stock; 1,000,000 shares authorized; 0 outstanding
|
-
|
-
|
|||||
Common
stock, $.01 par value; 20,000,000 shares authorized; 2,195,283
shares
issued and outstanding on September 30, 2008 and 2,192,175 shares
issued
and outstanding on December 31, 2007
|
21,953
|
21,922
|
|||||
Additional
paid-in capital
|
6,745,614
|
6,284,616
|
|||||
Retained
(deficit) earnings
|
(3,803,357
|
)
|
206,604
|
||||
Total
stockholders' equity
|
2,964,210
|
6,513,142
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
3,870,903
|
$
|
7,256,262
|
The
accompanying notes are an integral part of these consolidated financial
statements
1
CONSOLIDATED
STATEMENTS OF OPERATIONS
(UNAUDITED)
For the Three Months Ended
September 30,
|
For the Nine Months Ended
September 30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
REVENUE:
|
|||||||||||||
PCT
Products, services, other
|
$
|
222,825
|
$
|
106,787
|
$
|
421,996
|
$
|
281,084
|
|||||
Grant
revenue
|
42,837
|
31,265
|
96,226
|
190,715
|
|||||||||
Total
revenue
|
265,662
|
138,052
|
518,222
|
471,799
|
|||||||||
COSTS
AND EXPENSES:
|
|||||||||||||
Cost
of PCT products and services
|
130,533
|
42,276
|
267,416
|
131,558
|
|||||||||
Research
and development
|
376,552
|
519,303
|
1,329,155
|
1,518,851
|
|||||||||
Selling
and marketing
|
399,380
|
379,448
|
1,384,147
|
986,801
|
|||||||||
General
and administrative
|
466,883
|
578,238
|
1,603,803
|
1,683,782
|
|||||||||
Total
operating costs and expenses
|
1,373,348
|
1,519,265
|
4,584,521
|
4,320,992
|
|||||||||
Operating
loss from continuing operations
|
(1,107,686
|
)
|
(1,381,213
|
)
|
(4,066,299
|
)
|
(3,849,193
|
)
|
|||||
OTHER
INCOME:
|
|||||||||||||
Realized
gain on securities available for sale
|
-
|
-
|
-
|
2,028,720
|
|||||||||
Interest
income
|
9,481
|
75,732
|
56,338
|
227,816
|
|||||||||
Total
other income
|
9,481
|
75,732
|
56,338
|
2,256,536
|
|||||||||
Loss
from continuing operations before income taxes
|
(1,098,205
|
)
|
(1,305,481
|
)
|
(4,009,961
|
)
|
(1,592,657
|
)
|
|||||
Income
tax benefit from continuing operations
|
-
|
209,503
|
-
|
253,539
|
|||||||||
Loss
from continuing operations
|
(1,098,205
|
)
|
(1,095,978
|
)
|
(4,009,961
|
)
|
(1,339,118
|
)
|
|||||
DISCONTINUED
OPERATIONS:
|
|||||||||||||
Gain
on sale of net assets related to discontinued operations (net of
income
tax of $218,060)
|
-
|
-
|
-
|
1,155,973
|
|||||||||
Net
loss
|
$
|
(1,098,205
|
)
|
$
|
(1,095,978
|
)
|
$
|
(4,009,961
|
)
|
$
|
(183,145
|
)
|
|
Loss
per share from continuing operations - basic and diluted
|
$
|
(0.50
|
)
|
$
|
(0.53
|
)
|
$
|
(1.83
|
)
|
$
|
(0.65
|
)
|
|
Income
per share from discontinued operations - basic and diluted
|
-
|
-
|
-
|
0.56
|
|||||||||
Net
loss per share - basic and diluted
|
$
|
(0.50
|
)
|
$
|
(0.53
|
)
|
$
|
(1.83
|
)
|
$
|
(0.09
|
)
|
|
Weighted
average number of shares used to calculate (loss) income per share
- basic
and diluted
|
2,195,283
|
2,065,425
|
2,193,692
|
2,065,425
|
The
accompanying notes are an integral part of these consolidated financial
statements
2
CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED
)
For the Three Months Ended
September 30,
|
For the Nine Months Ended
September 30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Net loss
|
$
|
(1,098,205
|
)
|
$
|
(1,095,978
|
)
|
$
|
(4,009,961
|
)
|
$
|
(183,145
|
)
|
|
Holding
gain
|
-
|
-
|
-
|
(27,479
|
)
|
||||||||
Reclassification
of unrealized gain to realized gain on securities during
the period
|
-
|
-
|
-
|
(2,028,720
|
)
|
||||||||
Unrealized
loss on marketable securities
|
-
|
-
|
-
|
(2,056,199
|
)
|
||||||||
Income
tax benefit related to items of other comprehensive loss
|
-
|
-
|
-
|
671,323
|
|||||||||
Total
other comprehensive loss, net of taxes
|
-
|
-
|
-
|
(1,384,876
|
)
|
||||||||
Comprehensive
loss
|
$
|
(1,098,205
|
)
|
$
|
(1,095,978
|
)
|
$
|
(4,009,961
|
)
|
$
|
(1,568,021
|
)
|
The
accompanying notes are an integral part of these consolidated financial
statements
3
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(UNAUDITED)
For the Nine Months Ended
September 30,
|
|||||||
2008
|
2007
|
||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(4,009,961
|
)
|
$
|
(183,145
|
)
|
|
Less
gain on sale of discontinued operations
|
-
|
(1,155,973
|
)
|
||||
Loss
from continuing operations
|
$
|
(4,009,961
|
)
|
$
|
(1,339,118
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
154,320
|
130,436
|
|||||
Stock-based
compensation expense
|
451,279
|
252,469
|
|||||
Realized
gain on sale of marketable securities
|
-
|
(2,028,720
|
)
|
||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable
|
(55,966
|
)
|
(37,647
|
)
|
|||
Inventories
|
(434,241
|
)
|
(218,451
|
)
|
|||
Deposits
|
438,973
|
(354,203
|
)
|
||||
Accounts
payable
|
169,221
|
86,570
|
|||||
Accrued
employee compensation
|
(6,138
|
)
|
38,220
|
||||
Deferred
revenue and other accrued expenses
|
1,927
|
(18,026
|
)
|
||||
Prepaid
expenses and other current assets and other current
liabilities
|
(58,959
|
)
|
465,221
|
||||
Net
cash used in operating activities from continuing
operations
|
(3,349,545
|
)
|
(3,023,249
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Additions
to property and equipment
|
(131,957
|
)
|
(120,039
|
)
|
|||
Proceeds
from sale of marketable securities
|
-
|
2,033,397
|
|||||
Net
cash (used in) provided by investing activities from continuing
operations
|
(131,957
|
)
|
1,913,358
|
||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from the issuance of common stock
|
9,750
|
-
|
|||||
Net
cash provided by financing activities from continuing
operations
|
9,750
|
-
|
|||||
CASH
FLOWS FROM DISCONTINUED OPERATIONS:
|
|||||||
Cash
flows from investing activities
|
-
|
1,780,071
|
|||||
Net
cash provided by discontinued operations
|
-
|
1,780,071
|
|||||
CHANGE
IN CASH AND CASH EQUIVALENTS:
|
(3,471,752
|
)
|
670,180
|
||||
Cash
and cash equivalents, beginning of period
|
5,424,486
|
5,335,282
|
|||||
Cash
and cash equivalents, end of period
|
$
|
1,952,734
|
$
|
6,005,462
|
|||
SUPPLEMENTAL
INFORMATION:
|
|||||||
Income
taxes paid
|
$
|
2,790
|
$
|
20,800
|
|||
Income
taxes received
|
49,798
|
723,801
|
The
accompanying notes are an integral part of these consolidated financial
statements
4
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF SEPTEMBER 30, 2008
1)
|
Business
Overview and Management
Plans
|
We
are a
life sciences company focused on the development and commercialization of a
novel, enabling, platform technology called pressure cycling technology (“PCT”).
PCT uses cycles of hydrostatic pressure between ambient and ultra-high levels
(up to 35,000 psi and greater) to control bio-molecular
interactions.
Our
pressure cycling technology uses internally developed instrumentation that
is
capable of cycling pressure between ambient and ultra-high levels at controlled
temperatures to rapidly and repeatedly control the interactions of
bio-molecules. Our instrument, the Barocycler®, and our internally developed
consumables product line, which includes PULSE (Pressure Used to Lyse Samples
for Extraction) Tubes as well as application specific kits, which include
consumable products and reagents, together make up the PCT Sample Preparation
System (“PCT SPS”).
We
have
experienced negative cash flows from operations with respect to our pressure
cycling technology business since its inception. As of September 30, 2008,
we
had a cash balance of approximately $1.9 million. In July 2008, we
implemented a number of cost reduction initiatives, including the delay of
certain research and development projects, reduction in travel and meeting
attendance for all personnel, continued reduction in investor relations
activities, decreases in the base salary of most of our employees and all of
our
executive officers, and a reduction in our workforce which included the
re-alignment of our sales force from seven full time sales directors to three.
We have also delayed the hiring of new personnel to fill previously vacated
positions. We believe that implementing such changes to our business plan allow
us to extend our existing cash balances through the first quarter of 2009.
We
need
substantial additional capital to fund our current operations beyond the first
quarter of 2009. While we are in discussions with potential investors, to date
we have been unable to secure additional equity or debt financing on acceptable
terms. If we remain unable to secure additional financing in the near-term,
we
expect to implement a number of additional cost reduction initiatives, such
as
further reductions in the cost of our workforce and the discontinuation of
a
number of business initiatives to further reduce our rate of cash utilization
and extend our existing cash balances. We believe that these additional cost
reduction initiatives, if undertaken, will provide us with additional time
to
continue our pursuit of additional funding sources and also strategic
alternatives. In the event that we are unable to obtain financing on acceptable
terms, we may be required to limit or cease our operations, pursue a plan to
sell our operating assets, or otherwise modify our business strategy, which
could materially harm our future business prospects . The accompanying financial
statements are prepared on the basis that the Company will continue to operate
as a going concern, and does not reflect any adjustments to reflect a possible
liquidation or sale of the Company.
2)
|
Interim
Financial Reporting
|
The
accompanying unaudited consolidated financial statements of Pressure
BioSciences, Inc. have been prepared in accordance with accounting principles
generally accepted in the United States of America (“generally accepted
accounting principles” or “GAAP”) for interim financial information and with the
instructions to the Quarterly Report on Form 10-Q. Accordingly, they do not
include all of the information and footnotes required by generally accepted
accounting principles for complete financial statements. In the opinion of
management, all adjustments (consisting of only normal recurring adjustments)
considered necessary for a fair presentation have been included. Operating
results for the three months and nine months ended September 30, 2008 are not
necessarily indicative of the results that may be expected for the year ending
December 31, 2008. For further information, refer to the audited consolidated
financial statements and footnotes thereto included in the Company’s Annual
Report on Form 10-K (the “Form 10-K”) for the fiscal year ended December 31,
2007.
3)
|
Summary
of Significant Accounting
Policies
|
Principles
of Consolidation
The
consolidated financial statements include the accounts of Pressure BioSciences,
Inc., and its wholly-owned subsidiary PBI BioSeq, Inc.
Use
of Estimates
To
prepare our consolidated financial statements in conformity with generally
accepted accounting principles, we are required to make significant estimates
and assumptions that affect the reported amounts of assets and liabilities
and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. In addition, significant estimates were made in projecting
future cash flows to quantify impairment of assets, deferred tax assets and
the
costs associated with fulfilling our warranty obligations for the instruments
that we sell, and in our calculation of fair value of stock options awarded.
We
base our estimates on historical experience and on various other assumptions
that we believe to be reasonable under the circumstances, the results of which
form the basis for making judgments about the carrying values of assets and
liabilities that are not readily apparent from other sources. Actual results
could differ from the estimates and assumptions used.
5
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF SEPTEMBER 30, 2008
Revenue
Recognition
We
recognize revenue in accordance with the Securities and Exchange Commission’s
(“SEC”) Staff Accounting Bulletin (“SAB”) No. 104, Revenue
Recognition
("SAB
104"). Revenue is recognized when realized or earned when all the following
criteria have been met: persuasive evidence of an arrangement exists; delivery
has occurred and risk of loss has passed to the customer; the seller’s price to
the buyer is fixed or determinable; and collectibility is reasonably
assured.
Our
current instruments, the Barocycler NEP3229 and NEP2320, require a basic level
of instrumentation expertise to set-up for initial operation. To support a
favorable first experience for our customers, we send a representative to the
customer site to install every Barocycler that we sell through our domestic
sales force. The installation process includes uncrating and setting up the
instrument and conducting introductory user training. Product revenue related
to
current Barocycler instrumentation is recognized upon the installation of our
instrumentation at the customer location. Product revenue related to sales
of
PCT products to our foreign distributors is recognized upon shipment through
a
common carrier. We provide for the expected costs of warranty upon the
recognition of revenue for the sales of our instrumentation. Our sales
arrangements do not provide our customers with a right of return. Product
revenue related to our consumable products such as PULSE Tubes and application
specific kits is recorded upon shipment through a common carrier. Shipping
costs are included in the costs of sales. Any shipping costs billed to customers
are recognized as revenue.
In
accordance with the Financial Accounting Standards Board (“FASB”) Statement of
Financial Accounting Standards (“SFAS”) No. 13, “Accounting
for Leases”,
we
account for our lease agreements under the operating method. We record revenue
over the life of the lease term and we record depreciation expense on a
straight-line basis over the thirty-six month estimated useful life of the
Barocycler instrument. The depreciation expense associated with assets under
lease agreement is included in the “Cost of PCT products and services” line item
in our consolidated statements of operations. Many of our lease and rental
agreements allow the lessee to purchase the instrument at any point during
the
term of the agreement with partial, or full, credit for rental payments
previously made. We pay all maintenance costs associated with the instrument
during the term of the leases.
Revenue
from government grants is recorded when expenses are incurred under the grant
in
accordance with the terms of the grant award.
Our
transactions sometimes involve multiple elements (i.e., products and services).
Revenue under multiple element arrangements is recognized in accordance with
Emerging Issues Task Force (“EITF”) Issue No. 00-21, “Accounting
for Revenue Arrangements with Multiple Deliverables”.
Under
this method, if an element is determined to be a separate unit of accounting,
the revenue for the element is based on fair value and determined by vendor
specific objective evidence (“VSOE”), and recognized at the time of delivery. If
an arrangement includes undelivered elements that are not essential to the
functionality of the delivered elements, we defer the fair value of the
undelivered elements with the residual revenue allocated to the delivered
elements. Fair value is determined based upon the price charged when the element
is sold separately. If there is not sufficient evidence of the fair value of
the
undelivered elements, no revenue is allocated to the delivered elements and
the
total consideration received is deferred until delivery of those elements for
which objective and reliable evidence of the fair value is not available. We
provide certain customers with extended service contracts and, to the extent
VSOE is established, these service revenues are recognized ratably over the
life
of the contract which is generally one to four years.
Cash
and Cash Equivalents
Our
policy is to invest available cash in short-term, investment grade
interest-bearing obligations, including money market funds, and bank and
corporate debt instruments. Securities purchased with initial maturities of
three months or less are valued at cost plus accrued interest, which
approximates fair market value, and are classified as cash equivalents.
Research
and Development
Research
and development costs, which are comprised of costs incurred in performing
research and development activities including wages and associated employee
benefits, facilities, consumable products and overhead costs that are expensed
as incurred. Our research activities are performed at our laboratories in
Woburn, Massachusetts and Rockville, Maryland and in conjunction with the
collaboration partner sites. In support of our research and development
activities we utilize our Barocycler instruments that are capitalized as fixed
assets and depreciated over their expected useful life.
6
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF SEPTEMBER 30, 2008
Inventories
Inventories
are valued at the lower of cost or market. The composition of inventory as
of September 30, 2008 and December 31, 2007 is as follows:
September 30,
|
December 31,
|
||||||
2008
|
2007
|
||||||
Raw
materials
|
$
|
88,097
|
$
|
28,115
|
|||
Finished
goods
|
518,692
|
144,433
|
|||||
Total
|
$
|
606,789
|
$
|
172,548
|
Our
finished goods inventory as of September 30, 2008 included 32 Barocycler
instruments. Our finished goods inventory as of December 31, 2007 included
8
Barocycler instruments.
Property
and Equipment
Property
and equipment are stated at cost, less accumulated depreciation. For financial
reporting purposes, depreciation is recognized using the straight-line method,
allocating the cost of the assets over their estimated useful lives of three
years for certain laboratory equipment, from three to five years for management
information systems and office equipment, and three years for all PCT finished
units classified as fixed assets.
Intangible
Assets
We
have
classified as intangible assets, costs associated with the fair value of
acquired intellectual property. Intangible assets including patents are
amortized on a straight-line basis over sixteen years. We perform a
quarterly review of our intangible assets for impairment. When impairment
is indicated, any excess of carrying value over fair value is recorded as a
loss. An impairment analysis of intangible assets was performed as of December
31, 2007 and we reviewed the analysis as of September 30, 2008. We have
concluded that there is no impairment of intangible assets.
Long-Lived
Assets and Deferred Costs
In
accordance with FASB SFAS No. 144, “Accounting
for the Impairment or Disposal of Long-Lived Assets”,
if
indicators of impairment exist, we assess the recoverability of the affected
long-lived assets by determining whether the carrying value of such assets
can
be recovered through the undiscounted future operating cash flows. If impairment
is indicated, we measure the amount of such impairment by comparing the carrying
value of the asset to the fair value of the asset and record the impairment
as a
reduction in the carrying value of the related asset and a charge to operating
results. While our current and historical operating losses and cash flow are
indicators of impairment, we performed an impairment test as of December 31,
2007 and we reviewed the analysis as of September 30, 2008. We have concluded
that there is no impairment of long-lived assets.
Concentrations
Credit
Risk
Our
financial instruments that potentially subject us to concentrations of credit
risk consist primarily of cash, cash equivalents and trade receivables. We
have
cash investment policies which, among other things, limit investments to
investment-grade securities. We perform ongoing credit evaluations of our
customers, and the risk with respect to trade receivables is further mitigated
by the fact that many of our customers are government institutions and
university laboratories.
7
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF SEPTEMBER 30, 2008
The
following tables illustrate the level of concentration as a percentage of total
revenues during the three and nine months ended September 30, 2008 and
2007:
For the Three Months Ended
|
|||||||
September 30,
|
|||||||
2008
|
2007
|
||||||
Top
Five Customers
|
79
|
%
|
97
|
%
|
|||
Federal
Agencies
|
31
|
%
|
51
|
%
|
For the Nine Months Ended
|
|||||||
September 30,
|
|||||||
2008
|
2007
|
||||||
Top
Five Customers
|
62
|
%
|
70
|
%
|
|||
Federal
Agencies
|
27
|
%
|
70
|
%
|
The
following table illustrates the level of concentration as a percentage of total
accounts receivable balance as of September 30, 2008 and December 31, 2007:
September 30,
|
December 31,
|
||||||
2008
|
2007
|
||||||
Top
Five Customers
|
85
|
%
|
94
|
%
|
|||
Federal
Agencies
|
4
|
%
|
41
|
%
|
Product
Supply
Source
Scientific, LLC has been our sole contract manufacturer for all of our PCT
instrumentation. We have initiated several engineering initiatives to position
us for greater independence from any one supplier, and we are in the process
of
developing a network of manufacturers and sub-contractors to reduce our reliance
on any single supplier. Until we develop a network of manufacturers and
subcontractors, obtaining alternative sources of supply or manufacturing
services could involve significant delays and other costs and challenges, and
may not be available to us on reasonable terms, if at all. The failure of a
supplier or contract manufacturer to provide sufficient quantities, acceptable
quality and timely products at an acceptable price, or an interruption of
supplies from such a supplier could harm our business and prospects.
Computation
of Loss per Share
Basic
loss per share is computed by dividing loss available to common shareholders
by
the weighted average number of common shares outstanding. Diluted loss per
share
is computed by dividing loss available to common shareholders by the weighted
average number of common shares outstanding plus additional common shares that
would have been outstanding if dilutive potential common shares had been issued.
For purposes of this calculation, stock options are considered common stock
equivalents in periods in which they have a dilutive effect. Stock options
that
are anti-dilutive are excluded from this calculation.
The
following table illustrates our computation of loss per share for the three
months and nine months ended September 30, 2008 and 2007:
For the Three Months Ended
September 30,
|
For the Nine Months Ended
September 30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Numerator:
|
|||||||||||||
Loss
from continuing operations - basic and diluted
|
$
|
(1,098,205
|
)
|
$
|
(1,095,978
|
)
|
$
|
(4,009,961
|
)
|
$
|
(1,339,118
|
)
|
|
Denominator:
|
|||||||||||||
Weighted
average shares outstanding - basic and diluted
|
2,195,283
|
2,065,425
|
2,193,692
|
2,065,425
|
|||||||||
Loss
per share from continuing operations - basic and diluted
|
$
|
(0.50
|
)
|
$
|
(0.53
|
)
|
$
|
(1.83
|
)
|
$
|
(0.65
|
)
|
|
Shares
excluded from calculations
|
28,975
|
167,757
|
124,879
|
170,024
|
Accounting
for Income Taxes
Effective
January 1, 2007, we adopted the provisions of FASB Interpretation
No. 48, “Accounting for
Uncertainty in Income Taxes - an Interpretation of FASB Statement
No. 109”
(“FIN
48”). FIN 48 clarifies the accounting for uncertainty in income
taxes recognized in an enterprise’s financial statements in accordance with
SFAS No. 109, “Accounting
for Income Taxes”.
This
interpretation prescribes a recognition threshold and measurement attribute
for
the financial statement recognition and measurement of a tax position taken
or
expected to be taken in a tax return. FIN 48 also provides guidance on
de-recognition of tax benefits, classification on the balance sheet, interest
and penalties, accounting in interim periods, disclosure, and transition.
8
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF SEPTEMBER 30, 2008
We
account for income taxes under the asset and liability method, which requires
recognition of deferred tax assets, subject to valuation allowances, and
liabilities for the expected future tax consequences of events that have been
included in the financial statements or tax returns. Deferred income taxes
reflect the net tax effects of temporary differences between the carrying
amounts of asset and liabilities for financial reporting and income tax
purposes. A valuation allowance is established if it is more likely than not
that all or a portion of the net deferred tax assets will not be realized.
Accounting
for Stock-Based Compensation
We
maintain equity compensation plans under which grants of incentive stock options
and non-qualified stock options are granted to employees, independent members
of
our Board of Directors and outside consultants. We recognize equity compensation
expense over the requisite service period using the Black-Scholes formula to
estimate the fair value of the stock options on the date of grant. Since January
1, 2006, we have accounted for our stock option expense in accordance with
the
provisions of SFAS No. 123 (revised 2004), “Share-Based
Payment”,
or SFAS
123R.
We
recognized stock-based compensation expense of $81,285 and $99,876 for the
three
months ended September 30, 2008 and 2007, respectively. The following table
summarizes the effect of this stock-based compensation expense within each
of
the line items of our costs and expenses within our Consolidated Statements
of
Operations:
For the Three Months Ended, September 30,
|
|||||||
2008
|
2007
|
||||||
Cost
of PCT products and services
|
-
|
$
|
1,759
|
||||
Research
and development
|
34,262
|
36,023
|
|||||
Selling
and marketing
|
11,823
|
19,698
|
|||||
General
and administrative
|
35,200
|
42,396
|
|||||
Total
stock-based compensation expense
|
$
|
81,285
|
$
|
99,876
|
We
recognized stock-based compensation expense of $451,279 and $252,469 for the
nine months ended September 30, 2008 and 2007, respectively. The following
table
summarizes the effect of this stock-based compensation expense within each
of
the line items of our costs and expenses within our Consolidated Statements
of
Operations:
For the Nine Months Ended, September 30,
|
|||||||
2008
|
2007
|
||||||
Cost
of PCT products and services
|
$
|
-
|
$
|
4,746
|
|||
Research
and development
|
131,132
|
100,450
|
|||||
Selling
and marketing
|
87,055
|
39,191
|
|||||
General
and administrative
|
233,092
|
108,082
|
|||||
Total
stock-based compensation expense
|
$
|
451,279
|
$
|
252,469
|
The
provisions of SFAS 123R require that we make an estimate of our forfeiture
rate
and adjust the expense that we recognize to reflect the estimated number of
stock options that will go unexercised. Our historical forfeiture rate has
been
approximately 5%, so we used this rate as our assumption in calculating future
stock-based compensation expense.
During
the three months ended September 30, 2008 and 2007, the total fair value of
stock options awarded was $147,757 and $79,295, respectively. During the nine
months ended September 30, 2008 and 2007, the total fair value of stock options
awarded was $375,865 and $460,617, respectively.
As
of
September 30, 2008, the total estimated fair value of unvested stock options
to
be amortized over their remaining vesting period was $491,885. The non-cash,
stock based compensation expense associated with the vesting of these options
will be $99,318 in 2008, $246,874 in 2009, $110,079 in 2010 and $35,614 in
2011.
9
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF SEPTEMBER 30, 2008
Fair
Value of Financial Instruments
Due
to
their short maturities, the carrying amounts for cash and cash equivalents,
accounts receivable, accounts payable, and accrued expenses approximate their
fair value. Long-term liabilities are primarily related to liabilities
transferred under contractual arrangements with carrying values that approximate
fair value.
Reclassifications
Investment
in Marketable Securities
As
of
September 30, 2008, we had no investments in marketable securities. During
the
nine months ended September 30, 2007, we sold our remaining 513,934 shares
of
Panacos Pharmaceuticals, Inc. to generate a realized gain of $2,028,720, on
proceeds of $2,033,397. During 2007, we accounted for this investment in
accordance with the provisions of SFAS 115 “Accounting
for Certain Investments in Debt and Equity Securities”
as
securities available for sale.
Advertising
Advertising
costs are expensed as incurred. During the three months ended September 30,
2008
and 2007, we incurred $21,354 and $9,436 respectively in advertising expense.
During the nine months ended September 30, 2008 and 2007, we incurred $47,456
and $24,897 respectively in advertising expense.
Rent
Expense
Rental
costs are expensed as incurred. During the three months ended September 30,
2008
and 2007, we incurred $39,896 and $21,620, respectively in rent expense for
the
use of our corporate office and research and development facilities. During
the
nine months ended September 30, 2008 and 2007, we incurred $111,614 and $63,058,
respectively in rent expense for the use of our corporate office and research
and development facilities.
4)
|
Discontinued
Operations
|
In
June 2004, we transferred certain assets and liabilities of our PBI Source
Scientific, Inc. subsidiary to a newly formed limited liability company
known as Source Scientific, LLC. At the time of the transfer, we owned 100%
of
the ownership interests of Source Scientific, LLC. We subsequently sold 70%
of
our ownership interests of Source Scientific, LLC to Mr. Richard Henson and
Mr. Bruce A. Sargeant pursuant to a purchase agreement (the “Source
Scientific Agreement”). As a result of the sale of 70% of our ownership
interests, Mr. Henson and Mr. Sargeant each owned 35% and we owned the
remaining 30% of Source Scientific, LLC. Under the Source Scientific Agreement,
we received notes receivable in the aggregate amount of $900,000 (the “Notes”)
payable at the end of three years bearing 8% interest. The Source Scientific
Agreement offered Mr. Henson and Mr. Sargeant the option (“the
Option”) to purchase our 30% ownership interest in Source Scientific, LLC until
May 31, 2007, at an escalating premium (10-50%) over our initial ownership
value, provided that they first paid off the Notes in their
entirety.
On
May
29, 2007, we executed a consent agreement with Mr. Henson and Mr. Sargeant,
Source Scientific LLC, and BIT Analytical Instruments, Inc. (“the Consent
Agreement”) pursuant to which the Notes were repaid in full in the aggregate
amount of $1,201,534 in principal and interest, and Mr. Henson and Mr. Sargeant
exercised their Option (through BIT Analytical Instruments, Inc.) to purchase
our remaining 30% ownership interest in Source Scientific, LLC for an aggregate
price of $578,573. As a result of these transactions we no longer retained
any
direct or indirect ownership interest in Source Scientific, LLC.
Upon
execution of the Consent Agreement we accounted for the total gain on the sale
of our ownership interests in Source Scientific, LLC as discontinued operations.
During the three and nine months ended September 30, 2007, we recorded a gain
on
sale of net assets related to discontinued operations, net of income tax of
$1,534,476 and $1,155,973, respectively.
5)
|
Commitments
and Contingencies
|
Operating
Leases
Our
corporate offices are currently located at 14 Norfolk Avenue, South Easton,
Massachusetts 02375. In November 2007, we signed an 18 month lease
agreement commencing in February 2008, pursuant to which we lease approximately
5,500 square feet of office space, with an option for an additional 18 months.
We pay approximately $6,500 per month for the use of these facilities.
10
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF SEPTEMBER 30, 2008
On
June
1, 2006, we entered into a lease agreement with Scheer Partners and the Maryland
Economic Development Corporation, pursuant to which we lease laboratory and
office space in Rockville, MD. In August 2007, we extended this lease agreement
through May 31, 2009. We pay approximately $3,300 per month for the use of
these
facilities.
On
March
1, 2006, we entered into a sub-lease agreement with Proteome Systems, pursuant
to which we lease approximately 650 square feet of laboratory space plus 100
square feet of office space from Proteome Systems in Woburn, Massachusetts.
The
lease period extends through December 31, 2008 and we pay approximately $3,200
per month for the use of these facilities.
Royalty
Commitments
In
1996,
we acquired our initial equity interest in BioSeq, Inc., which at the time
was
developing our original pressure cycling technology. BioSeq, Inc. acquired
its pressure cycling technology from BioMolecular Assays, Inc. (“BMA”) under a
technology transfer and patent assignment agreement. In 1998, we purchased
all of the remaining outstanding capital stock of BioSeq, Inc., and at such
time, the technology transfer and patent assignment agreement was amended to
require us to pay BioMolecular Assays, Inc. a 5% royalty on our sales of
products or services that incorporate or utilize the original pressure cycling
technology that BioSeq, Inc. acquired from BMA. We are also required to
pay BMA 5% of the proceeds from any sale, transfer or license of all or any
portion of the original pressure cycling technology. These payment
obligations terminate in 2016. During the three months ended September 30,
2008 and 2007, we incurred approximately $10,236 and $5,518, respectively in
royalty expense associated with our obligation to BMA. During the nine months
ended September 30, 2008 and 2007, we incurred approximately $18,687 and
$14,021, respectively in royalty expense associated with our obligation to
BMA.
In
connection with our acquisition of BioSeq, Inc., we licensed certain limited
rights to the original pressure cycling technology back to BMA. This
license is non-exclusive and limits the use of the original pressure cycling
technology by BMA solely for molecular applications in scientific research
and
development and in scientific plant research and development. BMA is
required to pay us a royalty equal to 20% of any license or other fees and
royalties, but not including research support and similar payments, it receives
in connection with any sale, assignment, license or other transfer of any rights
granted to BMA under the license. BMA must pay us these royalties until the
expiration of the patents held by BioSeq, Inc. in 1998, which we anticipate
will
be in 2016. We have not received any royalty payments from BMA under this
license.
Purchase
Commitments
On
September 18, 2008, we submitted a purchase order to Source Scientific, LLC,
the
manufacturer of the Company’s PCT Barocycler instrumentation, for 50 Barocycler
NEP2320 units. Pursuant to the terms of the purchase order, we placed a deposit
with Source Scientific, LLC, of approximately $100,000, representing
approximately 25% of the expected total value of the order, upon submission
of
the purchase order. On November 12, 2008, we placed an additional deposit of
approximately $100,000 with Source Scientific, LLC to provide them with funds
required to commence manufacturing of the NEP2320 units ordered. The purchase
price for the 50 Barocycler NEP2320 units is based upon a fixed bill of
materials. We expect that the NEP2320 units will be completed and ready for
sale
to our customers during the first quarter of 2009, we will be billed for the
unpaid purchase price of each unit at the time each unit is completed and ready
for sale. As of December 31, 2007 we had $379,000 on deposit with Source for
54
remaining units pursuant to open purchase orders.
Indemnification
In
connection with our sale of substantially all of the assets of Boston Biomedica,
Inc. (“BBI Core Businesses”) to SeraCare Life Sciences, Inc. in September 2004,
we continue to be exposed to possible indemnification claims in amounts up
to
the purchase price of approximately $29 million. Our indemnification obligations
for breaches of some representations and warranties relating to compliance
with
environmental laws extend until September 14, 2009, representations and
warranties relating to tax matters extend for the applicable statute of
limitations period (which varies depending on the nature of claim), and
representations and warranties relating to our due organization, subsidiaries,
authorization to enter into and perform the transactions contemplated by the
Asset Purchase Agreement and brokers fees, extend indefinitely.
Severance
and Change of Control Agreements
Each
of
our executive officers is entitled to receive a severance payment if terminated
by the Company without cause. The severance benefits would include a payment
in
an amount equal to one year of each executive officer’s annualized base salary
compensation plus accrued paid time off. Additionally, each executive officer
will be entitled to receive medical and dental insurance coverage for one year
following the date of termination. The total commitment related to these
agreements in the aggregate is approximately $1.0 million.
11
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF SEPTEMBER 30, 2008
Each
of
our executive officers, other than Mr. Richard T. Schumacher, our President
and
Chief Executive Officer, is entitled to receive a change of control payment
in
an amount equal to one year of such executive officer’s annualized base salary
compensation, accrued paid time off, and medical and dental coverage, in the
event of a change of control of the Company. In the case of Mr. Schumacher,
this
payment would be equal to two years of annualized base salary compensation,
accrued paid time off, and two years of medical and dental coverage. The total
commitment related to these agreements in the aggregate is approximately $1.3
million.
6)
|
Stockholders’
Equity
|
Preferred
Stock
In
1996,
our Board of Directors authorized the issuance of 1,000,000 shares of preferred
stock with a par value of $0.01. As of September 30, 2008 none of these shares
have been issued.
Shareholders
Rights Plan
On
March
3, 2003, our Board of Directors adopted a shareholder rights plan (“the Rights
Plan”) and declared a distribution of one Right for each outstanding share of
our Common Stock to shareholders of record at the close of business on March
21,
2003 (the “Rights”). Initially, the Rights will trade automatically with the
common stock and separate Right Certificates will not be issued. The
Rights Plan is designed to deter coercive or unfair takeover tactics and to
ensure that all of our shareholders receive fair and equal treatment in the
event of an unsolicited attempt to acquire the Company. The Rights Plan was
not
adopted in response to any effort to acquire the Company and the Board is not
aware of any such effort. The Rights will expire on February 27, 2013 unless
earlier redeemed or exchanged. Each Right entitles the registered holder,
subject to the terms of a Rights Agreement, to purchase from the Company one
one-thousandth of a share of the Company’s Series A Junior Participating
Preferred Stock at a purchase price of $45.00 per one one-thousandth of a share,
subject to adjustment. In general, the Rights will not be exercisable until
a
subsequent distribution date which will only occur if a person or group acquires
beneficial ownership of 15% or more of our common stock or announces a tender
or
exchange offer that would result in such person or group owning 15% or more
of
the common stock. With respect to any person or group who currently beneficially
owns 15% or more of our common stock, the Rights will not become exercisable
unless and until such person or group acquires beneficial ownership of
additional shares of common stock.
Subject
to certain limited exceptions, if a person or group acquires beneficial
ownership of 15% or more of our outstanding common stock or if a current 15%
beneficial owner acquires additional shares of common stock, each holder of
a
Right (other than the 15% holder whose Rights become void once such holder
reaches the 15% threshold) will thereafter have a right to purchase, upon
payment of the purchase price of the Right, that number of shares of our common
stock which at the time of such transaction will have a market value equal
to
two times the purchase price of the Right. In the event that, at any time
after a person or group acquires 15% or more of our common stock, we are
acquired in a merger or other business combination transaction or 50% or more
of
our consolidated assets or earning power are sold, each holder of a Right will
thereafter have the right to purchase, upon payment of the purchase price of
the
Right, that number of shares of common stock of the acquiring company which
at
the time of such transaction will have a market value of two times the purchase
price of the Right.
Our
Board
of Directors may exchange the Rights (other than Rights owned by such person
or
group which have become void), in whole or in part, at an exchange ratio of
one
share of common stock per Right (subject to adjustment). At any time prior
to the time any person or group acquires 15% or more of our common stock, the
Board of Directors may redeem the Rights in whole, but not in part, at a price
of $0.001 per Right.
Stock
Options
On
June
16, 2005, our stockholders approved our 2005 Equity Incentive Plan (the “Plan”)
pursuant to which an aggregate of 1,000,000 shares of our common stock were
reserved for issuance upon exercise of stock options or other equity awards
made
under the Plan. On September 25, 2008, our stockholders approved an
amendment to our 2005 Equity Incentive Plan pursuant to which the number of
shares reserved for issuance upon exercise of stock options or other equity
awards made under the plan was increased from 1,000,000 shares to 1,500,000
shares. Under the Plan, we may award stock options, shares of common stock,
and
other equity interests in the Company to employees, officers, directors,
consultants, and advisors, and to any other persons the Board of Directors
deems
appropriate. As of September 30, 2008, options to acquire 989,500 shares were
outstanding under the Plan.
12
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF SEPTEMBER 30, 2008
We
also
have 244,000 stock options outstanding under our 1999 Non-qualified Plan and
6,500 stock options outstanding under our 1994 Incentive Stock Option Plan.
As
of September 30, 2008, there were 4,800 shares available for future grant under
the 1999 Non-qualified Plan. The 1994 Incentive Stock Option Plan expired;
therefore, there are no shares available for future grants under this
plan.
The
following tables summarize information concerning stock options outstanding
and
exercisable:
Weighted
|
Weighted
|
||||||||||||
Average price
|
Average price
|
||||||||||||
Shares
|
per share
|
Exercisable
|
per share
|
||||||||||
Balance
outstanding, 12/31/2007
|
1,120,500
|
$
|
3.45
|
691,166
|
$
|
3.23
|
|||||||
Granted
|
171,500
|
3.60
|
|||||||||||
Exercised
|
(3,000
|
)
|
3.25
|
||||||||||
Expired
|
-
|
||||||||||||
Forfeited
|
(49,000
|
)
|
4.56
|
||||||||||
Balance
outstanding, 9/30/2008
|
1,240,000
|
$
|
3.43
|
929,834
|
$
|
3.35
|
|
|
Options Outstanding
|
|
Options Exercisable
|
|
||||||||||||||
|
|
|
|
Weighted Average
|
|
|
|
Weighted Average
|
|
||||||||||
|
|
|
|
Remaining
|
|
|
|
|
|
Remaining
|
|
|
|
||||||
Range of Exercise
|
Number of
|
Contractual
|
Exercise
|
Number of
|
Contractual
|
Exercise
|
|||||||||||||
Prices
|
|
Options
|
|
Life
|
|
Price
|
|
Options
|
|
Life
|
|
Price
|
|
||||||
$2.50 - $2.70
|
159,000
|
3.9
|
$
|
2.64
|
159,000
|
3.9
|
$
|
2.64
|
|||||||||||
2.71 - 3.08
|
427,500
|
6.7
|
2.92
|
343,000
|
5.9
|
2.96
|
|||||||||||||
3.09
- 3.95
|
381,500
|
7.6
|
3.71
|
245,500
|
7.5
|
3.71
|
|||||||||||||
3.96
- 5.93
|
272,000
|
8.2
|
4.30
|
182,334
|
7.8
|
4.19
|
|||||||||||||
$2.50
- $5.93
|
1,240,000
|
7.0
|
$
|
3.43
|
929,834
|
6.4
|
$
|
3.35
|
The
aggregate intrinsic value of options outstanding and exercisable as of September
30, 2008 and December 31, 2007 is illustrated in the table below:
September 30,
|
December 31,
|
||||||
2008
|
2007
|
||||||
Stock
options, outstanding
|
$
|
-
|
$
|
2,162,565
|
|||
Stock
options, exercisable
|
-
|
1,486,007
|
Sale
of Common Stock
On
November 21, 2007, we completed a private placement pursuant to which we sold
an
aggregate of 126,750 shares of common stock, $0.01 par value (the “Shares”), for
a purchase price of $5.00 per share, resulting in gross proceeds to us of
approximately $633,750 (the “Private Placement”). The Shares were issued and
sold to a total of 8 accredited investors pursuant to a Securities Purchase
Agreement entered into as of November 21, 2007 (the “Securities Purchase
Agreement”).
The
Shares were issued in the Private Placement without registration under the
Securities Act of 1933, as amended (the “Securities Act”), in reliance upon the
exemption from registration set forth in Rule 506 of Regulation D (“Regulation
D”) promulgated under the Securities Act. We based such reliance upon
representations made by each purchaser of Shares, including, but not limited
to,
representations as to the purchaser’s status as an “accredited investor” (as
defined in Rule 501(a) under Regulation D) and the purchaser’s investment
intent. The Shares were not offered or sold by any form of general solicitation
or general advertising, as such terms are used in Rule 502 under Regulation
D.
The Shares may not be offered or sold in the United States absent an effective
registration statement or an exemption from the registration requirements under
applicable federal and state securities laws.
In
connection with the Private Placement, we filed a Registration Statement on
Form
S-3 (the “Registration Statement”) covering the resale of the Shares purchased
in the Private Placement, which became effective on January 22,
2008.
13
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. In some cases, forward-looking statements
are identified by terms such as “may”, “will”, “should”, “could”, “would”,
“expects”, “plans”, “anticipates”, “believes”, “estimates”, “projects”,
“predicts”, “potential”, and similar expressions intended to identify
forward-looking statements. Such statements include, without limitation,
statements regarding:
-
|
our
ability to raise additional equity or debt financing on acceptable
terms,
if at all;
|
|
-
|
our
belief that we have sufficient liquidity to finance our current operations
through the end of the first quarter of 2009 due to certain cost
reduction
initiatives we have undertaken;
|
|
-
|
our
need to take additional cost reduction measures, cease operations
or sell
our operating assets, if we are unable to obtain additional financing
in
the near-term;
|
|
-
|
the
amount of cash necessary to operate our business;
|
|
|
-
|
our
plans and expectations with respect to our pressure cycling technology
(PCT) operations, including our expected amount of research and
development, selling and marketing and general and administrative
expense;
|
-
|
the
anticipated timing of commencement and completion of our recently
placed
purchase order for 50 Barocycler NEP2320 units;
|
|
|
-
|
potential
applications and growth for our PCT products;
|
|
-
|
market
acceptance and the potential for commercial success of our PCT
products;
|
-
|
the
expected development and success of new product
offerings;
|
|
-
|
the
expected benefits and results from our research and development efforts;
|
|
-
|
the
expected benefits and results from our collaboration
program;
|
|
-
|
the
anticipated uses of grant revenue and our expectation of increased
grant
revenue in future periods;
|
|
|
-
|
general
economic conditions; and
|
|
-
|
the
anticipated future financial performance and business operations
of our
company.
|
These
forward-looking statements are only predictions and involve known and unknown
risks, uncertainties, and other factors that may cause our actual results,
levels of activity, performance, or achievements to be materially different
from
any future results, levels of activity, performance, or achievements expressed
or implied by such forward-looking statements. Also, these forward-looking
statements represent our estimates and assumptions only as of the date of this
Report. Except as otherwise required by law, we expressly disclaim any
obligation or undertaking to release publicly any updates or revisions to any
forward-looking statement contained in this Report to reflect any change in
our
expectations or any change in events, conditions, or circumstances on which
any
of our forward-looking statements are based or to conform to actual
results.
Factors
that could cause or contribute to differences in our future financial and
operating results include those discussed in the risk factors set forth in
Item
6 of our Annual Report on Form 10-K for the year ended December 31, 2007, as
well as those discussed elsewhere in this Report, including the following:
If
we fail to obtain substantial additional capital, we may not be able to continue
our business.
Our
business will be harmed if we are unable to secure substantial additional
capital to fund our current operations beyond the first quarter of 2009. While
we are in discussions with potential investors, to date we have been unable
to
secure additional equity or debt financing on acceptable terms. If we remain
unable to secure additional financing in the near-term, we expect to implement
a
number of additional cost reduction initiatives, such as further reductions
in
the cost of our workforce and the discontinuation of a number of business
initiatives to further reduce our rate of cash utilization and extend our
existing cash balances. We believe that these additional cost reduction
initiatives, if undertaken, will provide us with additional time to continue
our
pursuit of additional funding sources and also strategic alternatives. If
adequate funds are not available to us on satisfactory terms, we will be
required to limit or cease our operations, or otherwise modify our business
strategy, which could materially harm our future business prospects. If we
are
able to obtain additional funds by selling any of our equity securities, the
percentage ownership of our stockholders will be reduced, stockholders may
experience substantial dilution, the price of our common stock may decline,
or
the equity securities issued may have rights, preferences or privileges senior
to the common stock.
14
Our
actual results and performance, including our ability to raise additional
capital, may be adversely affected by current economic conditions.
Our
actual results and performance could be adversely affected by the current
economic conditions in the global economy, which pose a risk to the overall
demand for our products from our customers who may elect to defer or cancel
purchases of our products in response to tighter credit markets, negative
financial news and general uncertainty in the economy. In addition, our ability
to obtain additional financing, on acceptable terms, if at all, may be adversely
affected by the crisis in the credit markets and the uncertainty in the current
economic climate.
We
qualify all of our forward-looking statements by these cautionary statements.
You should read this section in combination with the section entitled
Management’s Discussion and Analysis of Financial Condition and Results of
Operations for the year ended December 31, 2007 included in our Annual
Report on Form 10-K for the year ended December 31, 2007.
15
OVERVIEW
We
are a
life sciences company focused on the development and commercialization of a
novel, enabling, platform technology called pressure cycling technology (“PCT”).
PCT uses cycles of hydrostatic pressure between ambient and ultra-high levels
(up to 35,000 psi and greater) to control bio-molecular
interactions.
Our
pressure cycling technology uses internally developed instrumentation that
is
capable of cycling pressure between ambient and ultra-high levels at controlled
temperatures to rapidly and repeatedly control the interactions of
bio-molecules. Our instrument, the Barocycler®, and our internally developed
consumables product line, which includes PULSE (Pressure Used to Lyse Samples
for Extraction) Tubes as well as application specific kits, which include
consumable products and reagents, together make up the PCT Sample Preparation
System (“PCT SPS”).
Our
pressure cycling technology employs a unique approach that we believe has the
potential for broad applications in a number of established and emerging life
sciences areas, including;
-
|
sample
preparation for genomic, proteomic, metabolomic, lipidomic, and small
molecule studies;
|
-
|
pathogen
inactivation;
|
-
|
protein
purification;
|
-
|
control
of chemical (enzymatic) reactions; and
|
-
|
immunodiagnostics.
|
Since
we
began operations as Pressure BioSciences in February 2005, we have focused
substantially all of our research and development and commercialization efforts
on sample preparation for genomic, proteomic, metabolomic, lipidomic, and small
molecule studies.
Our
business strategy is to commercialize pressure cycling technology in the area
of
sample preparation for genomic, proteomic, metabolomic, lipidomic, and small
molecule studies (“sample preparation”). We also plan to pursue the further
development and commercialization of PCT in other life sciences applications,
which could include working with various strategic partners that have greater
scientific and regulatory expertise in the respective applications than we
do.
To
support our current strategy, our primary focus is the execution of our
commercialization plan for PCT in sample preparation. If we are successful
commercializing our technology in the sample preparation market, we believe
that
our financial results will be positively affected by a combination of the
revenue from the sale, lease, and rental of the Barocycler instruments, and
by
the recurring revenue streams that we hope to realize from the sale of the
single-use PULSE Tubes, PCT-dependent kits, and extended
service contracts on our instrumentation. We believe the recurring revenue
streams that could be generated from our instruments in the field are a very
important component of our future financial success. Therefore, we believe
that
in the short-term it is more important for us to focus on increasing the number
of installed Barocyclers in the field than it is for us to record revenue in
the
current period. To this end, we have offered our prospective customers the
opportunity to lease or rent the Barocycler instruments, and in some cases
we
have engaged in short-term reagent rental agreements. Under a reagent rental
agreement we provide the customer with a Barocycler instrument in exchange
for a
minimum purchase commitment of consumable products. While these lease, rental
and reagent rental arrangements do not provide us with the immediate revenue
of
an instrument sale, they do serve to expand the utilization of PCT and they
provide a stream of revenue in the form of rental payments and consumable
purchases. We define sales, leases, rentals and reagent rentals of Barocycler
instruments as revenue-generating installations.
We
also
derive revenue from Small Business Innovation Research (“SBIR”) grants awarded
to us by the National Institutes of Health (NIH). Since we began our operations
as Pressure BioSciences, we have been awarded two SBIR Phase I grants in the
aggregate amount of $300,000, and one SBIR Phase II grant, in the amount of
$850,000. These grants have funded experiments to demonstrate the feasibility
of
using pressure cycling technology in various applications in the life sciences.
We have several SBIR Phase I and II grants under review at the present time.
Our
$850,000 SBIR Phase II grant was awarded to us in June 2008, and is to be billed
over two years. This grant will help fund continuing experiments directed
towards the development and commercialization of novel, automated, and
reproducible methods for the extraction of clinically important protein
biomarkers, sub-cellular molecular complexes, and organelles (such as
mitochondria) from cells and tissues using the our patented pressure cycling
technology.
In
furtherance of our commercialization strategy, throughout 2007 and early 2008
we
increased spending in all major areas of our business. Although we continued
to
receive very positive feedback from our prospective customers our
commercialization plans had not developed as quickly as we had hoped and our
revenues in the first half of 2008 failed to meet our internal expectations.
The
underperformance of our sales, relative to our internal plans, combined with
our
view of the unfavorable condition of the capital markets prompted us to
implement a number of cost reduction initiatives, in July 2008. These cost
reduction initiatives include the delay of certain research and development
projects, reduction in travel and meeting attendance for all personnel,
continued reduction in investor relations activities, decreases in the base
salary of most of our employees and all of our executive officers, and a
reduction in our workforce which included the re-alignment of our domestic
sales
force from seven full time sales directors to three. We have also delayed the
hiring of new personnel to fill previously vacated positions. We believe that
implementing such changes to our business plan allow us to extend our existing
cash balances through the first quarter of 2009.
16
We
need
substantial additional capital to fund our current operations beyond the first
quarter of 2009. To provide us with some flexibility in structuring the terms
of
potential financings, in accordance with Nasdaq Marketplace Rule 4350(i)(1)(D),
we obtained approval from our stockholders at our special meeting in lieu of
an
annual meeting held on September 25, 2008 to issue, in connection with one
or
more capital raising transactions, up to 4,500,000 shares of common stock
(including pursuant to preferred stock, options, warrants, convertible debt
or
other securities exercisable for or convertible into common stock), upon such
terms as our Board of Directors shall deem to be in the best interests of our
company, for an aggregate consideration of not more than $18,000,000 in cash
and
at a price not less than 80% of the market price of the our common stock at
the
time of issuance, such issuances of common stock or other securities exercisable
for or convertible into common stock to occur, if at all, in the three month
period commencing with the date of the stockholder approval.
In
June
2008, we engaged Emerging Growth Equities, Ltd (“EGE”), an investment banking
firm located in King of Prussia, PA, to assist us in identifying potential
and
suitable investors in a private placement of our securities. To date, they
have
not been successful in raising any funds for us. In October 2008, we revised
the
terms of our engagement with EGE to reduce their fees from 3% in cash and 3%
in
warrants, to 0% cash and 0% warrants, on any funds that the Company raises,
without the help of EGE.
While
we
are in discussions with potential investors, to date we have been unable to
secure additional equity or debt financing on acceptable terms. If we remain
unable to secure additional financing in the near-term, we expect to implement
a
number of additional cost reduction initiatives, such as further reductions
in
the cost of our workforce and the discontinuation of a number of business
initiatives to further reduce our rate of cash utilization and extend our
existing cash balances. We believe that these additional cost reduction
initiatives, if undertaken, will provide us with additional time to continue
our
pursuit of additional funding sources and also strategic alternatives. In the
event that we are unable to obtain financing on acceptable terms, we may be
required to limit or cease our operations, pursue a plan to sell our operating
assets, or otherwise modify our business strategy, which could materially harm
our future business prospects.
17
RESULTS
OF OPERATIONS
Three
Months Ended September 30, 2008 and 2007
Revenue
We
recognized revenue of $265,662, for the three months ended September 30, 2008,
as compared to $138,052 for the same period in the prior year.
PCT
Products, Services, Other.
Revenue
from the sale of PCT products and services was $222,825 for the three months
ended September 30, 2008 as compared to $106,787 for the same period in the
prior year. During the third quarter of 2008 we completed the installation
of 17
Barocycler instruments, as compared to eight in the same period of 2007. During
the third quarter of 2008, eight of the installations that we completed were
sales to our international distributors, as compared to four in the same period
of 2007. The increase in revenue was due to this increase in the number of
Barocycler units sold during the period and an increase in rental revenue from
units previously installed under lease or rental agreements, partially offset
by
minimal decreases in consumable and extended service contract revenues.
We
expect
the number of units installed will continue to increase in future periods as
we
continue to commercialize our technology, although we may experience some delays
in customer purchases due to current economic conditions in the global economy.
Furthermore, we may realize some difficulties in signing up new international
distribution partners if we are unable to secure additional funding through
equity or debt financings. We also expect that some portion of future
installations will continue to be for the smaller, lower priced, Barocycler
NEP2320 model and some will be placed under lease or short-term rental
agreements. Therefore, we expect that the average revenue per installation
will
continue to fluctuate from period to period as we continue to drive our
installed base and commercialize PCT. We also expect that as we continue to
expand the installed based of Barocycler instruments in the field we will
realize increasing revenues from the sale of consumable products and extended
service contracts. In the short-term, these recurring revenue streams may
continue to fluctuate from period to period.
Grant
revenue.
During
the three months ended September 30, 2008 and 2007, we recorded $42,837 and
$31,265 of grant revenue, respectively. The grant revenue recorded during the
third quarter of 2008 was entirely related to the $850,000 SBIR Phase II grant
that we were awarded in June 2008. We expect grant revenues to increase over
the
next several quarters as the amount of time and expense incurred in connection
with this Phase II grant continues to increase. The level of grant revenue
that
we recognize in any given quarter is dependent upon the level of resources
we
devote to grant related work in the period.
Cost
of PCT Products and Services
The
cost
of PCT products and services was $130,533 for the three months ended September
30, 2008 compared to $42,276 for the comparable period in 2007. This increase
in
cost of PCT products and services is due primarily to the increase in the number
of units installed under sale, lease or rental arrangements during the period.
Costs of PCT products and services as a percentage of revenue increased from
40.0% to 58.6% for the three months ended September 30, 2008 compared to the
three months ended September 30, 2007. The increase in the cost of PCT products
and services as a percentage of revenue was due primarily to two factors; eight
of the seventeen units that we installed during the third quarter of 2008 were
sold to our international distributors at discounted prices, and, four of the
Barocycler units that we sold during the third quarter of 2007 were prototype
NEP2320 units that had been previously expensed, in the research and development
line within our consolidated statement of operations, as they were developed
and
built.
The
relationship between our cost of PCT products and services and PCT revenue
will
depend greatly on the mix of instruments we sell, the quantity of such
instruments, and the mix of consumable products that we sell in a given period.
Research
and Development
Research
and development expenditures decreased to $376,552 in the third quarter of
2008
as compared to $519,303 in the same period in 2007. During the third quarter
of
2008 we delayed certain engineering initiatives to reduce our overall operating
expense. During the same period in 2007 we incurred substantial costs related
to
the development of prototype NEP2320 instrumentation.
Research
and development expense recognized in the third quarter of 2008 and 2007
included $34,262 and $36,023, respectively, of non-cash, stock-based
compensation expense. We expect the level of stock-based compensation expense
for the fourth quarter of 2008 to be higher than the amount recorded during
the
third quarter of 2008 due to a grant of stock options to employees and directors
at the end of the third quarter of 2008.
We
will
need to reduce our expenses in all areas of our operations, including research
and development, if we are unable to raise additional capital.
18
Selling
and Marketing
Selling
and marketing expenses increased to $399,380 for the three months ended
September 30, 2008 from $379,448 for the comparable period in 2007. This
increase in selling and marketing expense was primarily the result of our
increase in the size of our domestic sales force, the addition of a Vice
President of Sales in February 2008, and the continued emphasis on strategic
marketing programs.
During
the third quarter of 2008 and 2007, selling and marketing expense included
$11,823 and $19,698, respectively, of non-cash, stock-based compensation
expense. We expect the level of stock-based compensation expense for the fourth
quarter of 2008 to be higher than the amount recorded during the third quarter
of 2008 due to a grant of stock options to employees and directors at the end
of
the third quarter of 2008.
We
will
need to reduce our expenses in all areas of our operations, including selling
and marketing, if we are unable to raise additional capital.
General
and Administrative
General
and administrative costs totaled $466,883 for the three months ended September
30, 2008, as compared to $578,238 for the comparable period in 2007. The
decrease is due to an overall decrease in investor relations spending and our
Sarbanes-Oxley compliance costs, partially offset by an increase in legal costs
related to general SEC compliance and patent and trademark work that was
performed during the quarter.
During
the third quarter of 2008 and 2007, general and administrative expense included
$35,200 and $42,396, respectively, of non-cash, stock-based compensation
expense. We expect the level of stock-based compensation expense for the fourth
quarter of 2008 to be higher than the amount recorded during the third quarter
of 2008 due to a grant of stock options to employees and directors at the end
of
the third quarter of 2008.
We
will
need to reduce our expenses in all areas of our operations, including general
and administrative, if we are unable to raise additional capital.
Operating
Loss from Continuing Operations
Our
operating loss from continuing operations was $1,107,686 for the three months
ended September 30, 2008 as compared to an operating loss from continuing
operations of $1,381,213 for the comparable period in 2007. The decrease in
the
operating loss that we reported was due to our cost cutting measures that we
initiated in July 2008 and the increase in revenue recorded.
We
will
need to reduce our expenses in all areas of our operations if we are unable
to
raise additional capital.
Interest
Income
Interest
income totaled $9,481 for the three months ended September 30, 2008 as compared
to interest income of $75,732 in the prior year period. The decrease is due
to
lower average cash balances and lower yields on these balances during the third
quarter of 2008, as compared to the third quarter of 2007.
Income
Taxes from Continuing Operations
In
the
quarter ended September 30, 2008, we did not record a benefit for income taxes
from continuing operations. During the same period in 2007, we recorded a
benefit for income taxes of $209,503.
We
do not
expect to record any income tax benefit for the foreseeable future due to the
fact that we are no longer able to carry back current losses against taxable
income from prior periods and because we expect our operating losses to continue
for several years. If we are successful commercializing PCT and if we are able
to generate operating income, then we may be able to utilize the net operating
loss carry-forwards that we generate.
Net
loss
During
the third quarter of 2008 we recorded a net loss of $1,098,205 as compared
to a
net loss of $1,095,978 in the third quarter of 2007. While our overall level
of
operating costs in the third quarter of 2008 was lower than the spending
incurred during the third quarter of 2007, these costs were not offset by the
benefit from income taxes, during 2008, as was the case in 2007. We expect
our
net loss for the full year of 2008 to be higher than the net loss reported
for
the full year in 2007.
19
Nine
Months Ended September 30, 2008 and 2007
Revenue
We
recognized revenue of $518,222, for the nine months ended September 30, 2008,
as
compared to $471,799 for the same period in the prior year.
PCT
Products, Services, Other.
Revenue
from the sale of PCT products and services was $421,996 for the nine months
ended September 30, 2008 as compared to $281,084 for the same period in the
prior year. During the first nine months of 2008 we completed the installation
of 31 Barocycler instruments, as compared to 13 in the same period of 2007.
During the nine months ended September 30, 2008, twelve of the installations
that we completed were sales to our international distributors, as compared
to
four in the same period of 2007. The increase in revenue was due to an increase
in the number of instruments sold and an increase in sales of consumable
products extended service contracts as compared to the nine months ended
September 30, 2007.
We
expect
the number of units installed will continue to increase in future periods as
we
continue to commercialize our technology, although we may experience some delays
in customer purchases due to current economic conditions in the global economy.
Furthermore, we may realize some difficulties in signing up new international
distribution partners if we are unable to secure additional funding through
equity or debt financings. We also expect that some portion of future
installations will continue to be for the smaller, lower priced, Barocycler
NEP2320 model and some will be placed under lease or short-term rental
agreements. Therefore, we expect that the average revenue per installation
will
continue to fluctuate from period to period as we continue to drive our
installed base and commercialize PCT. We also expect that as we continue to
expand the installed based of Barocycler instruments in the field we will
realize increasing revenues from the sale of consumable products and extended
service contracts. In the short-term, these recurring revenue streams may
continue to fluctuate from period to period.
Grant
revenue.
During
the nine months ended September 30, 2008 and 2007, we recorded $96,226 and
$190,715 of grant revenue, respectively. This decrease in grant revenue was
due
to a shift in resources from grant related activities to other research and
development projects when the remaining Phase I grant was completed during
the
second quarter of 2008. During the third quarter of 2008 we began working on
our
$850,000 SBIR Phase II grant and we expect grant revenues to increase over
the
next several quarters as the amount of time and expense incurred in connection
with this Phase II grant continues to increase. The level of grant revenue
that
we recognize in any given quarter is dependent upon the level of resources
we
devote to grant related work in the period.
Cost
of PCT Products and Services
The
cost
of PCT products and services was $267,416 for the nine months ended September
30, 2008 compared to $131,558 for the comparable period in 2007. This increase
in cost of PCT products and services was primarily due to our increase in sales
of Barocycler units. Costs of PCT products and services as a percentage of
revenue increased from 46.8% to 63.4% for the nine months ended September 30,
2008 compared to the nine months ended September 30, 2007. The increase in
the
cost of PCT products and services as a percentage of revenue was due primarily
to two factors; 12 of the 31 units that we installed during the nine months
ended September 30, 2008 were sold to our international distributors at
discounted prices, and, four of the Barocycler units that we sold during the
third quarter of 2007 were prototype NEP2320 units that had been previously
expensed, as they were developed and built.
The
relationship between our cost of PCT products and services and PCT revenue
will
continue to depend greatly on the mix of instruments we sell, the quantity
of
such instruments, and the mix of consumable products that we sell in a given
period.
Research
and Development
Research
and development expenditures decreased to $1,329,155 in the first nine months
of
2008 from $1,518,851 in the same period in 2007. Research and development costs
in 2007 included significant spending associated with the design and development
of the Barocycler NEP2320. The decrease was due in part to the completion of
the
Barocycler NEP2320 and the delay of other research and development costs
associated with the cost cutting measures that we initiated in July 2008.
Research
and development expense recognized in the first nine months of 2008 and 2007
included $131,132 and $100,450, respectively, of non-cash, stock-based
compensation expense.
We
will
need to reduce our expenses in all areas of our operations, including research
and development, if we are unable to raise additional capital.
20
Selling
and Marketing
Selling
and marketing expenses increased to $1,384,147 for the nine months ended
September 30, 2008 from $986,801 for the comparable period in 2007. This
increase in selling and marketing expense was primarily the result of our
increase in the size of our domestic sales force, the addition of a Vice
President of Sales in February 2008 and the continued emphasis on strategic
marketing programs.
During
the first nine months of 2008 and 2007, selling and marketing expense included
$87,055 and $39,191, respectively, of non-cash, stock-based compensation
expense.
We
will
need to reduce our expenses in all areas of our operations, including selling
and marketing, if we are unable to raise additional capital.
General
and Administrative
General
and administrative costs totaled $1,603,803 for the nine months ended September
30, 2008, as compared to $1,683,782 for the comparable period in 2007. The
decrease is due to a reduction in investor relations spending, Sarbanes-Oxley
compliance costs and other cost reduction efforts, partially offset by an
increase in legal costs related to general SEC compliance and patent and
trademark work that was performed during 2008.
During
the first nine months of 2008 and 2007, general and administrative costs
included $233,092 and $108,082, respectively, of non-cash, stock-based
compensation expense. The increase is due primarily to the $100,556 that was
recorded in connection with the grant of non-qualified, fully-vested stock
options to purchase 10,000 shares of our common stock to each of our four
independent directors in April 2008.
We
will
need to reduce our expenses in all areas of our operations, including general
and administrative, if we are unable to raise additional capital.
Operating
Loss from Continuing Operations
Our
operating loss from continuing operations was $4,066,299 for the nine months
ended September 30, 2008 as compared to $3,849,193 for the comparable period
in
2007. This increase in operating loss from continuing operations for the nine
months ended September 30, 2008 was primarily due to an increase in non-cash,
stock-based compensation expense of $451,279 recorded in the nine months ended
September 30, 2008, as compared to $252,469 in the comparable period in 2007.
Aside from the increase in non-cash, stock-based compensation expense our
operating loss decreased due to the cost cutting measures that we implemented
in
July 2008 and the increase in revenues that we realized during the first nine
months of the year, as compared to the prior year period.
We
will
need to reduce our expenses in all areas of our operations if we are unable
to
raise additional capital.
Realized
gain of sale on securities held for sale
In
the
nine months ended September 30, 2007 we completed the liquidation of our
investment in Panacos Pharmaceuticals and realized a gain on securities sold
of
$2,028,720.
Interest
Income
Interest
income totaled $56,338 for the nine months ended September 30, 2008 as compared
to interest income of $227,816 in the prior year period. The decrease is due
to
lower average cash balances and lower yields on these balances during 2008,
as
compared to 2007.
Income
Taxes from Continuing Operations
In
the
nine months ended September 30, 2008, we did not record a benefit for income
taxes from continuing operations. During the same period in 2007, we recorded
a
benefit for income taxes of $253,539.
We
do not
expect to record any income tax benefit for the foreseeable future due to the
fact that we are no longer able to carry back current losses against taxable
income from prior periods and because we expect our operating losses to continue
for several years. If we are successful commercializing PCT and if we are able
to generate operating income, then we may be able to utilize the net operating
loss carry-forwards that we generate.
21
Gain
on Assets Related to Discontinued Operations
During
2008 there were no charges for discontinued operations. During the first nine
months of 2007, we realized a gain on the sale of Source Scientific, LLC of
$1,155,973. This gain is comprised of the $378,503 charge that we recorded
in
the first quarter of 2007 under the provisions of Staff Accounting Bulletin
(“SAB”) Topic 5E, “Accounting
for Divestiture of a Subsidiary or Other Business Operation
(“SAB
Topic 5E”) and the gain of $1,534,476, net of income taxes of $218,060, that we
recorded during the second quarter of 2007, the period in which we completed
the
sale. We recorded this gain in connection with the receipt on May 29, 2007
of
$1,780,071 from Mr. Richard W. Henson and Mr. Bruce A. Sargeant, the principals
of Source Scientific, LLC, as full payment for their purchase of our remaining
interest in that business.
Upon
completion of the transaction, we accounted for the total gain on the sale
of
our ownership interests in Source Scientific, LLC as discontinued operations.
The charge that we recorded during the first quarter of 2007, under the
provisions of SAB Topic 5E, was reclassified as discontinued operations to
reflect this change.
Net
loss
During
the nine months ended September 30, 2008, we recorded a net loss of $4,009,961
as compared to a net loss of $183,145 in the same period in 2007. The net loss
is the result of increased operating loss from continuing operations in the
first nine months of 2008 relative to the same period in 2007. Additionally,
although we expect our revenue to increase, our net loss in 2008 will not be
mitigated by the gain on sale of marketable securities, gain on sale of assets
from discontinued operations, and the benefit from income taxes, as was the
case
in 2007. We therefore expect our net loss for the full year of 2008 to be higher
than the net loss reported for the full year in 2007.
LIQUIDITY
AND FINANCIAL CONDITION
As
of
September 30, 2008, our working capital position was $2,411,136 the primary
components of which were cash and cash equivalents, accounts receivable,
inventory, prepaid expenses, deposits, and income taxes receivable. Our working
capital balance was partially offset by accounts payable, accrued employee
compensation, and other accrued expenses. As of December 31, 2007, our working
capital balance was $5,933,822, the primary components of which were cash and
cash equivalents, income taxes receivable, prepaid expenses, and deposits.
We
expect to continue to fund our operations from our working capital balance.
In
July
2008, we implemented a number of cost reduction initiatives, including the
delay
of certain research and development projects, reduction in travel and meeting
attendance for all personnel, continued reduction in investor relations
activities, decreases in the base salary of most of our employees and all of
our
executive officers, and a reduction in our workforce which includes the
re-alignment of our sales force from seven full time sales directors to three.
We have also delayed the hiring of new personnel to fill previously vacated
positions. We believe that implementing such changes to our business plan
allowed us to extend our existing cash balances through the first quarter of
2009.
We
need
substantial additional capital to fund our current operations beyond the first
quarter of 2009. To provide us with some flexibility in structuring the terms
of
potential financings, in accordance with Nasdaq Marketplace Rule 4350(i)(1)(D),
we obtained approval from our stockholders at our special meeting in lieu of
an
annual meeting held on September 25, 2008 to issue, in connection with one
or
more capital raising transactions, up to 4,500,000 shares of common stock
(including pursuant to preferred stock, options, warrants, convertible debt
or
other securities exercisable for or convertible into common stock), upon such
terms as our Board of Directors shall deem to be in the best interests of our
company, for an aggregate consideration of not more than $18,000,000 in cash
and
at a price not less than 80% of the market price of the our common stock at
the
time of issuance, such issuances of common stock or other securities exercisable
for or convertible into common stock to occur, if at all, in the three month
period commencing with the date of the stockholder approval.
In
June
2008, we engaged Emerging Growth Equities, Ltd. (“EGE”), an investment banking
firm, to assist us in raising equity financing to support our research and
development activities, commercialization efforts, working capital requirements,
and general corporate purposes. The engagement of EGE contemplates a private
placement of our securities exempt from the registration requirements under
Regulation D promulgated under the Securities Act of 1933, as amended (the
"Act") of up to $8,000,000 or more at our discretion (the “Financing”). We have
agreed to pay EGE a cash fee of 8% of the gross proceeds from the Financing
and
to issue EGE warrants to purchase 8% of the number of securities issued in
the
Financing. The warrants will have a five year term and an exercise price equal
to the price of the securities issued in the Financing. However, EGE will
receive a lower fee of 3% of the gross proceeds from the Financing and warrants
to purchase 3% of the number of securities issued in the Financing with respect
to all investors that they do not introduce to us. EGE is also entitled to
a
retainer of $7,500 per month for three months.
22
Either
EGE or we may terminate the engagement in general with prior written notice.
If
during the 12 month period following termination of the engagement we sell
securities to any investor introduced to us by EGE, we will pay a declining
fee
to EGE based upon the number of months elapsed since the date of termination,
commencing with a cash fee of 8% of the gross proceeds received from such
investors, plus warrants to purchase 8% of the number of securities issued
to
such investors in the first month following termination of the engagement and
with such fees being reduced by 1/12 for each month following such termination.
We have also agreed to customary indemnification of EGE in connection with
the
Financing. Notwithstanding our engagement of EGE, we can provide no assurance
that any such equity offerings will occur, or that additional financing will
be
available to us of acceptable or affordable terms. To date, they have not been
successful in raising any funds for us. In October 2008, we revised the terms
of
our engagement with EGE to reduce their fees from 3% in cash and 3% in warrants,
to 0% cash and 0% warrants, on any funds that we raise without the help of
EGE.
While
we
are in discussions with potential investors, to date we have been unable to
secure additional equity or debt financing on acceptable terms. If we remain
unable to secure additional financing in the near-term, we expect to implement
a
number of additional cost reduction initiatives, such as further reductions
in
the cost of our workforce and the discontinuation of a number of business
initiatives to further reduce our rate of cash utilization and extend our
existing cash balances. We believe that these additional cost reduction
initiatives, if undertaken, will provide us with additional time to continue
our
pursuit of additional funding sources and also strategic alternatives. In the
event that we are unable to obtain financing on acceptable terms, we may be
required to limit or cease our operations, pursue a plan to sell our operating
assets, or otherwise modify our business strategy, which could materially harm
our future business prospects. There can be no assurance that we will obtain
additional financing on acceptable terms or at all.
Net
cash
used in continuing operations for the nine months ended September 30, 2008
was
$3,349,545 as compared to net cash used in continuing operations of $3,023,249
for the nine months ended September 30, 2007.
Net
cash
used in investing activities for the nine months ended September 30, 2008 was
$131,957 as compared to cash provided of $1,913,358 for the same period in
the
prior year. The cash used in the nine months of 2008 was the result of the
purchase of furniture and fixtures associated with our move to new corporate
offices and Barocycler instruments that we purchased and installed under
collaboration or lease agreements. The cash generated in the same period in
2007
was from the liquidation of shares of Panacos common stock, partially offset
by
purchases of fixed assets.
Net
cash
provided by financing activities for the nine months ended September 30, 2008
was due to an exercise of employee stock options to purchase 3,000 shares of
our
common stock.
Net
cash
provided by discontinued operations during 2007 of $1,780,071 was due to the
completion of the divestiture of Source Scientific, LLC.
COMMITMENTS
AND CONTINGENCIES
Operating
Leases
Our
corporate offices are currently located at 14 Norfolk Avenue, South Easton,
Massachusetts 02375. In November 2007, we signed an 18 month lease
agreement commencing in February 2008, pursuant to which we lease approximately
5,500 square feet of office space, with an option for an additional 18 months.
We pay approximately $6,500 per month for the use of these facilities.
On
June
1, 2006, we entered into a lease agreement with Scheer Partners and the Maryland
Economic Development Corporation, pursuant to which we lease laboratory and
office space in Rockville, MD. In August 2007, we extended this lease agreement
through May 31, 2009. We pay approximately $3,300 per month for the use of
these
facilities.
On
March
1, 2006, we entered into a sub-lease agreement with Proteome Systems, pursuant
to which we lease approximately 650 square feet of laboratory space plus 100
square feet of office space from Proteome Systems in Woburn, Massachusetts.
The
lease period extends through December 31, 2008 and we pay approximately $3,200
per month for the use of these facilities.
23
Royalty
Commitments
In
1996,
we acquired our initial equity interest in BioSeq, Inc., which at the time
was
developing our original pressure cycling technology. BioSeq, Inc. acquired
its pressure cycling technology from BioMolecular Assays, Inc. (“BMA”) under a
technology transfer and patent assignment agreement. In 1998, we purchased
all of the remaining outstanding capital stock of BioSeq, Inc., and at such
time, the technology transfer and patent assignment agreement was amended to
require us to pay BMA a 5% royalty on our sales of products or services
that incorporate or utilize the original pressure cycling technology that
BioSeq, Inc. acquired from BioMolecular Assays, Inc. We are also required
to pay BMA 5% of the proceeds from any sale, transfer or license of all or
any
portion of the original pressure cycling technology. These payment
obligations terminate in 2016. During the three months ended September 30,
2008 and 2007, we incurred $10,236 and $5,518, respectively in royalty expense
associated with our obligation to BMA. During the nine months ended September
30, 2008 and 2007, we incurred approximately $18,687 and $14,021, respectively
in royalty expense associated with our obligation to BMA.
In
connection with our acquisition of BioSeq, Inc., we licensed certain limited
rights to the original pressure cycling technology back to BMA. This
license is non-exclusive and limits the use of the original pressure cycling
technology by BMA solely for molecular applications in scientific research
and
development and in scientific plant research and development. BMA is
required to pay us a royalty equal to 20% of any license or other fees and
royalties, but not including research support and similar payments, it receives
in connection with any sale, assignment, license or other transfer of any rights
granted to BMA under the license. BMA must pay us these royalties until the
expiration of the patents held by BioSeq, Inc. in 1998, which we anticipate
will
be 2016. We have not received any royalty payments from BMA under this
license.
Purchase
Commitments
On
September 18, 2008, we submitted a purchase order to Source Scientific, LLC,
the
manufacturer of the Company’s PCT Barocycler instrumentation, for 50 Barocycler
NEP2320 units. Pursuant to the terms of the purchase order, we placed a deposit
with Source Scientific, LLC, of approximately $100,000, representing
approximately 25% of the expected total value of the order, upon submission
of
the purchase order. On November 12, 2008, we placed an additional deposit of
approximately $100,000 with Source Scientific, LLC to provide them with funds
required to commence manufacturing of the NEP2320 units ordered. The purchase
price for the 50 Barocycler NEP2320 units is based upon a fixed bill of
materials. We expect that the NEP2320 units will be completed and ready for
sale
to our customers during the first quarter of 2009, we will be billed for the
unpaid purchase price of each unit at the time each unit is completed and ready
for sale. As of December 31, 2007 we had $379,000 on deposit with Source for
54
remaining units pursuant to open purchase orders.
Indemnification
In
connection with our sale of substantially all of the assets of Boston Biomedica,
Inc. (“BBI Core Businesses”) to SeraCare Life Sciences, Inc. in September 2004,
we continue to be exposed to possible indemnification claims in amounts up
to
the purchase price of approximately $29 million. Our indemnification obligations
for breaches of some representations and warranties relating to compliance
with
environmental laws extend until September 14, 2009, representations and
warranties relating to tax matters extend for the applicable statute of
limitations period (which varies depending on the nature of claim), and
representations and warranties relating to our due organization, subsidiaries,
authorization to enter into and perform the transactions contemplated by the
Asset Purchase Agreement, and brokers fees, extend indefinitely.
Severance
and Change of Control Agreements
Each
of
our executive officers is entitled to receive a severance payment if terminated
by the Company without cause. The severance benefits would include a payment
in
an amount equal to one year of each executive officer’s annualized base salary
compensation plus accrued paid time off. Additionally, each executive officer
will be entitled to receive medical and dental insurance coverage for one year
following the date of termination. The total commitment related to these
agreements in the aggregate is approximately $1.0 million.
Each
of
our executive officers, other than Mr. Richard T. Schumacher, our President
and
Chief Executive Officer, is entitled to receive a change of control payment
in
an amount equal to one year of such executive officer’s annualized base salary
compensation, accrued paid time off, and medical and dental coverage, in the
event of a change of control of the Company. In the case of Mr. Schumacher,
this
payment would be equal to two years of annualized base salary compensation,
accrued paid time off, and two years of medical and dental coverage. The total
commitment related to these agreements in the aggregate is approximately $1.3
million.
RECENT
ACCOUNTING STANDARDS
In
September 2006, the FASB issued Statement of Financial Accounting Standards
No. 157, “Fair Value Measurements”, (“SFAS 157”). SFAS 157 defines fair
value, establishes a framework for measuring the fair value of assets and
liabilities, and expands disclosure requirements regarding the fair value
measurement. SFAS 157 does not expand the use of fair value measurements. This
statement, as issued, is effective for financial statements issued for fiscal
years beginning after November 15, 2007, and interim periods within those
fiscal years. FASB Staff Position (FSP) FAS No. 157-2 was issued in February
2008 and deferred the effective date of SFAS 157 for nonfinancial assets and
liabilities to fiscal years beginning after November 2008. As such, the Company
adopted SFAS 157 as of January 1, 2008 for financial assets and liabilities
only. There was no significant effect on the Company’s financial statements. The
Company does not believe that the adoption of SFAS 157 to non-financial assets
and liabilities will significantly effect its financial statements.
24
In
December 2007, the FASB issued SFAS 141 (revised 2007), “Business
Combinations”
(“SFAS
141(R)”) and SFAS No. 160, “Non-controlling
Interests in Consolidated Financial Statements – an amendment of ARB
No. 51”
(“SFAS
160”).
SFAS
141(R) significantly changes the accounting for business combinations. Under
SFAS 141(R), an acquiring entity will be required to recognize all the assets
acquired and liabilities assumed in a transaction at the acquisition-date at
fair value with limited exceptions. SFAS 141(R) further changes the accounting
treatment for certain specific items, including:
- |
Acquisition
costs will be generally expensed as incurred;
|
- |
Noncontrolling
interests (formerly known as “minority interests” – see SFAS 160
discussion below) will be valued at fair value at the acquisition
date;
|
- |
Acquired
contingent liabilities will be recorded at fair value at the acquisition
date and subsequently measured at either the higher of such amount
or the
amount determined under existing guidance for non-acquired contingencies;
|
- |
In-process
research and development will be recorded at fair value as an
indefinite-lived intangible asset at the acquisition date;
|
- |
Restructuring
costs associated with a business combination will be generally expensed
subsequent to the acquisition date; and
|
-
|
Changes
in deferred tax asset valuation allowances and income tax uncertainties
after the acquisition date generally will affect income tax expense.
|
SFAS
141(R) includes a substantial number of new disclosure requirements. SFAS 141(R)
applies prospectively to business combinations for which the acquisition date
is
on or after January 1, 2009.
SFAS
160
establishes new accounting and reporting standards for the non-controlling
interest in a subsidiary and for the deconsolidation of a subsidiary.
Specifically, this statement requires the recognition of non-controlling
interests (minority interests) as equity in the consolidated financial
statements and separate from the parent’s equity. The amount of net income
attributable to non-controlling interests will be included in consolidated
net
income on the face of the income statement. SFAS 160 clarifies that changes
in a
parent’s ownership interest in a subsidiary that does not result in
deconsolidation are treated as equity transactions if the parent retains its
controlling financial interest. In addition, this statement requires that a
parent recognize a gain or loss in net income when a subsidiary is
deconsolidated. Such gain or loss will be measured using the fair value of
the
non-controlling equity investment on the deconsolidation date. SFAS 160 also
includes expanded disclosure requirements regarding the interests of the parent
and its non-controlling interest.
SFAS
160
is effective for fiscal years, and interim periods within such year, beginning
January 1, 2009. Early adoption of both SFAS 141(R) and SFAS 160 is
prohibited. We do not expect that either SFAS 141(R) or SFAS 160 will have
a
material affect on our consolidated results of operations and financial
condition.
25
ITEM
4T. CONTROLS AND PROCEDURES
We
maintain disclosure controls and procedures that are designed to ensure that
information required to be disclosed in our Securities Exchange Act of 1934
reports is recorded, processed, summarized and reported within the time periods
specified in the SEC’s rules and forms, and that such information is accumulated
and communicated to our management, including our President and Chief Executive
Officer (Principal Executive Officer) and Chief Financial Officer (Principal
Financial Officer), as appropriate, to allow timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and procedures,
management recognized that any controls and procedures, no matter how well
designed and operated, can provide only reasonable assurance of achieving the
desired control objectives, as ours are designed to do, and management
necessarily was required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures.
As
of
September 30, 2008, we carried out an evaluation, under the supervision and
with
the participation of our management, including our President and Chief Executive
Officer (Principal Executive Officer) and Chief Financial Officer (Principal
Financial Officer) of the effectiveness of the design and operation of our
disclosure controls and procedures, as defined in Rules 13a-15(e) and
15d-15(e) under the Securities Exchange Act of 1934. Based upon that evaluation,
our President and Chief Executive Officer (Principal Executive Officer) and
Chief Financial Officer (Principal Financial Officer) concluded that our
disclosure controls and procedures are effective in enabling us to record,
process, summarize, and report information required to be included in our
periodic SEC filings within the required time period and to ensure that
information required to be disclosed in such reports that we file or submit
under the Securities Exchange Act of 1934 is accumulated and communicated to
our
management, including our President and Chief Executive Officer (Principal
Executive Officer) and Chief Financial Officer (Principal Financial Officer)
to
allow timely decisions regarding required disclosure.
There
have been no changes in our internal control over financial reporting that
occurred during the period covered by this Report that have materially affected,
or are reasonably likely to materially affect, our internal control over
financial reporting.
26
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On
September 25, 2008, we held a Special Meeting in Lieu of Annual Meeting of
Stockholders (the “Meeting”). At the Meeting, Richard T. Schumacher was
re-elected to the Board of Directors as a Class III director, with a term
expiring in 2011. The remaining members of the Board of Directors whose terms
continued after the meeting are J. Donald Payne, P. Thomas Vogel, R. Wayne
Fritzsche, and Dr. Calvin A. Saravis. The stockholders also approved an
amendment to the Company’s 2005 Equity Incentive Plan to increase the number of
shares of Common Stock authorized for issuance under the Plan from 1,000,000
to
1,500,000 shares. Lastly, the stockholders approved a proposal, for purposes
of
complying with Nasdaq Marketplace Rule 4350(i)(1)(D), authorizing the Company
to
issue, in connection with one or more capital raising transactions to finance
the company, up to 4,500,000 shares of common stock of Pressure BioSciences,
subject to the terms, conditions and limitations set out in the Proxy Statement
for the Meeting. At the meeting, a total of 1,829,203 shares or 83% of the
Common Stock issued and outstanding as of the record date, were represented
in
person or by proxy. The voting results with respect to each of the proposals
were as follows:
1. A
proposal to elect one Class III Director to hold office until the 2011 Annual
Meeting of Stockholders and until his successor is duly elected and
qualified:
|
For
|
|
Withheld
|
|
Abstain
|
|
Richard
T. Schumacher
|
|
1,805,032
|
|
24,171
|
|
0
|
2. A
proposal to amend the Company’s 2005 Equity Incentive Plan to increase the
number of shares of common stock available for issuance under the plan from
1,000,000 to 1,500,000.
Against
|
Abstained
|
Broker Non-Votes
|
||||
837,976
|
|
139,643
|
|
3,416
|
|
848,168
|
3. A
proposal, for purposes of complying with Nasdaq Marketplace Rule 4350(i)(1)(D),
to authorize the Company to issue, in connection with one or more capital
raising transactions to finance the Company, up to 4,500,000 shares of common
stock of Pressure BioSciences, subject to the terms, conditions and limitations
set out in the Proxy Statement for the Meeting.
|
Against
|
|
Abstained
|
|
Broker Non-Votes
|
|
910,135
|
|
67,359
|
|
3,541
|
|
848,168
|
27
|
|
Reference
|
|
10.1
|
Amendment
No. 1 to Pressure Biosciences, Inc. 2005 Equity Incentive Plan (filed
as
Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with
Commission on September 29, 2008 and incorporated herein by
reference).
|
||
|
|
|
|
31.1
|
Principal
Executive Officer Certification Pursuant to Item 601(b)(31) of Regulation
S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act
of
2002
|
|
Filed
herewith
|
|
|
|
|
31.2
|
Principal
Financial Officer Certification Pursuant to Item 601(b)(31) of Regulation
S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act
of
2002
|
|
Filed
herewith
|
|
|
|
|
32.1
|
Principal
Executive Officer Certification Pursuant to Item 601(b)(32) of Regulation
S-K, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of
2002
|
|
Filed
herewith
|
|
|
|
|
32.2
|
Principal
Financial Officer Certification Pursuant to Item 601(b)(32) of Regulation
S-K, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of
2002
|
|
Filed
herewith
|
28
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
caused this report to be signed on its behalf by the undersigned thereunto
duly
authorized.
|
PRESSURE
BIOSCIENCES, INC.
|
|
|
|
|
Date: November
14, 2008
|
By:
|
/s/ Richard
T. Schumacher
|
|
Richard
T. Schumacher
President
& Chief Executive Officer
(Principal
Executive Officer)
|
Date:
November 14, 2008
|
By:
|
/s/ Edward
H. Myles
|
|
Edward
H. Myles
Senior
Vice President of Finance & Chief Financial Officer and
Treasurer
(Principal
Financial and Accounting Officer)
|