PRESSURE BIOSCIENCES INC - Quarter Report: 2008 June (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 June
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 July 31, 2008
was 2,195,283
TABLE
OF
CONTENTS
|
Page
|
|
PART
I - FINANCIAL INFORMATION
|
|
|
|
|
|
Item
1. Financial Statements (Unaudited)
|
|
|
Consolidated
Balance Sheets as of June 30, 2008 and December 31, 2007
|
1
|
|
|
|
|
Consolidated
Statements of Operations for the Three Months and Six Months Ended
June
30, 2008 and 2007
|
2
|
|
|
|
|
Consolidated
Statements of Comprehensive (Loss) Income for the Three Months and
Six
Months Ended June 30, 2008 and 2007
|
3
|
|
|
|
|
Consolidated
Statements of Cash Flows for the Six Months Ended June 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
|
15
|
|
|
|
|
Item
4T. Controls and Procedures
|
26
|
|
|
|
|
PART
II - OTHER INFORMATION
|
|
|
|
|
|
Item
6. Exhibits
|
27
|
Item
1. Financial Statements
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(UNAUDITED)
June 30,
|
December 31,
|
||||||
2008
|
2007
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
and cash equivalents
|
$
|
2,835,771
|
$
|
5,424,486
|
|||
Accounts
receivable
|
122,958
|
118,471
|
|||||
Inventories
|
676,516
|
172,548
|
|||||
Deposits
|
15,472
|
553,483
|
|||||
Prepaid
income taxes
|
58,463
|
56,863
|
|||||
Income
tax receivable
|
249,541
|
249,541
|
|||||
Prepaid
expenses and other current assets
|
217,977
|
94,783
|
|||||
Total
current assets
|
4,176,698
|
6,670,175
|
|||||
PROPERTY
AND EQUIPMENT, NET
|
308,926
|
257,797
|
|||||
OTHER
ASSETS
|
|||||||
Intangible
assets, net
|
303,974
|
328,290
|
|||||
TOTAL
ASSETS
|
$
|
4,789,598
|
$
|
7,256,262
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable
|
$
|
244,722
|
$
|
152,729
|
|||
Accrued
employee compensation
|
326,966
|
377,190
|
|||||
Accrued
professional fees and other expenses
|
213,868
|
186,840
|
|||||
Income
taxes payable
|
6,745
|
4,519
|
|||||
Deferred
revenue
|
10,681
|
15,075
|
|||||
Total
current liabilities
|
802,982
|
736,353
|
|||||
LONG
TERM LIABILITIES
|
|||||||
Deferred
revenue
|
5,486
|
6,767
|
|||||
TOTAL
LIABILITIES
|
808,468
|
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 June 30, 2008 and 2,192,175 shares issued
and
outstanding on December 31, 2007
|
21,953
|
21,922
|
|||||
Additional
paid-in capital
|
6,664,329
|
6,284,616
|
|||||
Retained
(deficit) earnings
|
(2,705,152
|
)
|
206,604
|
||||
Total
stockholders' equity
|
3,981,130
|
6,513,142
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
4,789,598
|
$
|
7,256,262
|
The
accompanying notes are an integral part of these consolidated financial
statements
1
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(UNAUDITED)
For the Three Months Ended
|
For the Six Months Ended
|
||||||||||||
June
30,
|
June
30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
REVENUE:
|
|||||||||||||
PCT
Products, services, other
|
$
|
117,698
|
$
|
136,355
|
$
|
199,171
|
$
|
174,297
|
|||||
Grant
revenue
|
2,486
|
65,772
|
53,389
|
159,451
|
|||||||||
Total
revenue
|
120,184
|
202,127
|
252,560
|
333,748
|
|||||||||
COSTS
AND EXPENSES:
|
|||||||||||||
Cost
of PCT products and services
|
88,434
|
57,629
|
136,883
|
89,282
|
|||||||||
Research
and development
|
461,672
|
538,015
|
952,603
|
999,547
|
|||||||||
Selling
and marketing
|
521,606
|
350,823
|
984,767
|
607,354
|
|||||||||
General
and administrative
|
635,672
|
624,462
|
1,136,920
|
1,105,544
|
|||||||||
Total
operating costs and expenses
|
1,707,384
|
1,570,929
|
3,211,173
|
2,801,727
|
|||||||||
Operating
loss from continuing operations
|
(1,587,200
|
)
|
(1,368,802
|
)
|
(2,958,613
|
)
|
(2,467,979
|
)
|
|||||
OTHER
INCOME:
|
|||||||||||||
Realized
gain on securities available for sale
|
-
|
1,301,247
|
-
|
2,028,720
|
|||||||||
Interest
income
|
16,549
|
80,482
|
46,857
|
152,084
|
|||||||||
Total
other income
|
16,549
|
1,381,729
|
46,857
|
2,180,804
|
|||||||||
(Loss)
income from continuing operations before income taxes
|
(1,570,651
|
)
|
12,927
|
(2,911,756
|
)
|
(287,175
|
)
|
||||||
Income
tax benefit from continuing operations
|
-
|
3,516
|
-
|
44,035
|
|||||||||
(Loss)
income from continuing operations
|
(1,570,651
|
)
|
16,443
|
(2,911,756
|
)
|
(243,140
|
)
|
||||||
DISCONTINUED
OPERATIONS:
|
|||||||||||||
Gain
on sale of net assets related to discontinued operations (net of
income
tax of $218,060)
|
-
|
1,534,476
|
-
|
1,155,973
|
|||||||||
Net
(loss) income
|
$
|
(1,570,651
|
)
|
$
|
1,550,919
|
$
|
(2,911,756
|
)
|
$
|
912,833
|
|||
(Loss)
income per share from continuing operations - basic
|
$
|
(0.72
|
)
|
$
|
0.01
|
$
|
(1.33
|
)
|
$
|
(0.12
|
)
|
||
Income
per share from discontinued operations - basic
|
-
|
0.74
|
-
|
0.56
|
|||||||||
Net
(loss) income per share - basic
|
$
|
(0.72
|
)
|
$
|
0.75
|
$
|
(1.33
|
)
|
$
|
0.44
|
|||
(Loss)
income per share from continuing operations - diluted
|
$
|
(0.72
|
)
|
$
|
0.01
|
$
|
(1.33
|
)
|
$
|
(0.12
|
)
|
||
Income
per share from discontinued operations - diluted
|
-
|
0.67
|
-
|
0.56
|
|||||||||
Net
(loss) income per share - diluted
|
$
|
(0.72
|
)
|
$
|
0.68
|
$
|
(1.33
|
)
|
$
|
0.44
|
|||
Weighted
average number of shares used to calculate (loss) income per share
-
basic
|
2,193,598
|
2,065,425
|
2,192,883
|
2,065,425
|
|||||||||
Weighted
average number of shares used to calculate (loss) income per share
-
diluted
|
2,193,598
|
2,296,930
|
2,192,883
|
2,065,425
|
The
accompanying notes are an integral part of these consolidated financial
statements
2
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF COMPREHENSIVE (LOSS) INCOME
(UNAUDITED)
For the Three Months Ended
|
For the Six Months Ended
|
||||||||||||
June
30,
|
June
30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Net
(loss) income
|
$
|
(1,570,651
|
)
|
$
|
1,550,919
|
$
|
(2,911,756
|
)
|
$
|
912,833
|
|||
Holding
gain
|
-
|
(329,625
|
)
|
-
|
(27,479
|
)
|
|||||||
Reclassification
of unrealized gain to realized gain on securities during the
period
|
-
|
(1,301,247
|
)
|
-
|
(2,028,720
|
)
|
|||||||
Unrealized
loss on marketable securities
|
-
|
(1,630,872
|
)
|
-
|
(2,056,199
|
)
|
|||||||
Income
tax benefit related to items of other comprehensive loss
|
-
|
548,413
|
-
|
671,323
|
|||||||||
Total
other comprehensive loss, net of taxes
|
-
|
(1,082,459
|
)
|
-
|
(1,384,876
|
)
|
|||||||
Comprehensive
(loss) income
|
$
|
(1,570,651
|
)
|
$
|
468,460
|
$
|
(2,911,756
|
)
|
$
|
(472,043
|
)
|
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 Six Months Ended
|
|||||||
June
30,
|
|||||||
2008
|
2007
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
(loss) income
|
$
|
(2,911,756
|
)
|
$
|
912,833
|
||
Less
gain on sale of discontinued operations
|
-
|
(1,155,973
|
)
|
||||
Loss
from continuing operations
|
$
|
(2,911,756
|
)
|
$
|
(243,140
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
98,079
|
77,933
|
|||||
Stock-based
compensation expense
|
369,994
|
152,593
|
|||||
Realized
gain on sale of marketable securities
|
-
|
(2,028,720
|
)
|
||||
Changes
in operating assets and liabilities:
|
|||||||
Accounts
receivable
|
(4,487
|
)
|
(38,152
|
)
|
|||
Inventories
|
(503,968
|
)
|
(219,173
|
)
|
|||
Deposits
|
538,011
|
(49,700
|
)
|
||||
Accounts
payable
|
91,993
|
176,766
|
|||||
Accrued
employee compensation
|
(50,224
|
)
|
21,215
|
||||
Deferred
revenue and other accrued expenses
|
21,353
|
(11,065
|
)
|
||||
Prepaid
expenses and other current assets and other current
liabilities
|
(122,568
|
)
|
(96,426
|
)
|
|||
Net
cash used in operating activities from continuing
operations
|
(2,473,573
|
)
|
(2,257,869
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Additions
to property and equipment
|
(124,892
|
)
|
(87,207
|
)
|
|||
Proceeds
from sale of marketable securities
|
-
|
2,033,397
|
|||||
Net
cash (used in) provided by investing activities from continuing
operations
|
(124,892
|
)
|
1,946,190
|
||||
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:
|
(2,588,715
|
)
|
1,468,392
|
||||
Cash
and cash equivalents, beginning of period
|
5,424,486
|
5,335,282
|
|||||
Cash
and cash equivalents, end of period
|
$
|
2,835,771
|
$
|
6,803,674
|
|||
SUPPLEMENTAL
INFORMATION:
|
|||||||
Income
taxes paid
|
$
|
2,790
|
$
|
20,800
|
|||
Income
taxes received
|
834
|
-
|
The
accompanying notes are an integral part of these consolidated financial
statements
4
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 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 the ProteoSolve–lrs kit for the detergent-free
extraction of proteins from lipid-rich samples, 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 June 30, 2008, we had
a
cash balance of approximately $2.8 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 will allow us to extend our
existing cash balances into the middle of 2009, without significantly impacting
our short-term commercialization efforts.
The
extent to which we increase, or decrease, our operational costs over the coming
quarters is dependent upon our judgment of the investment required to
successfully commercialize PCT and our ability to secure additional funding
through equity or debt financings. If we are unable to increase the number
of
installations of PCT Systems and if we are unable to secure additional funding
through equity or debt financings, we will undertake additional cost reduction
measures.
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 six months ended June 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 JUNE 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
ProteoSolve-lrs 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 JUNE 30, 2008
Inventories
Inventories
are valued at the lower of cost or market. The composition of inventory as
of June 30, 2008 and December 31, 2007 is as follows:
June
30,
|
December
31,
|
||||||
2008
|
2007
|
||||||
Raw
materials
|
$
|
55,916
|
$
|
28,115
|
|||
Finished
goods
|
620,600
|
144,433
|
|||||
Total
|
$
|
676,516
|
$
|
172,548
|
Our
finished goods inventory balance as of June 30, 2008 and December 31, 2007
included 47 and 8 Barocycler instruments, respectively.
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 June 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 June 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 JUNE 30, 2008
The
following tables illustrate the level of concentration as a percentage of total
revenues during the three and six months ended June 30, 2008 and
2007:
For the Three Months Ended
|
|||||||
June
30,
|
|||||||
2008
|
2007
|
||||||
Top
Five Customers
|
89
|
%
|
97
|
%
|
|||
Federal
Agencies
|
4
|
%
|
66
|
%
|
For the Six Months Ended
|
|||||||
June
30,
|
|||||||
2008
|
2007
|
||||||
Top
Five Customers
|
69
|
%
|
88
|
%
|
|||
Federal
Agencies
|
22
|
%
|
60
|
%
|
The
following table illustrates the level of concentration as a percentage of total
accounts receivable balance as of June 30, 2008 and December 31, 2007:
June 30,
|
December 31,
|
||||||
2008
|
2007
|
||||||
Top
Five Customers
|
93
|
%
|
94
|
%
|
|||
Federal
Agencies
|
44
|
%
|
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 broader 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) income per share is computed by dividing (loss) income available to
common shareholders by the weighted average number of common shares outstanding.
Diluted (loss) income per share is computed by dividing (loss) income 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) income per share for the three months and six months ended June 30,
2008 and 2007:
For the Three Months Ended
|
For the Six Months Ended
|
||||||||||||
June 30,
|
June 30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Numerator:
|
|||||||||||||
Loss
(income) from continuing operations - basic and diluted
|
$
|
(1,570,651
|
)
|
$
|
16,443
|
$
|
(2,911,756
|
)
|
$
|
(243,140
|
)
|
||
Denominator:
|
|||||||||||||
Weighted
average shares outstanding - basic
|
2,193,598
|
2,065,425
|
2,192,883
|
2,065,425
|
|||||||||
Net
effect of dilutive common stock equivalents-based on treasury stock
method
using average market price
|
-
|
231,505
|
-
|
-
|
|||||||||
Weighted
average shares outstanding - diluted
|
2,193,598
|
2,296,930
|
2,192,883
|
2,065,425
|
|||||||||
(Loss)
income per share from continuing operations - basic
|
$
|
(0.72
|
)
|
$
|
0.01
|
$
|
(1.33
|
)
|
$
|
(0.12
|
)
|
||
(Loss)
income per share from continuing operations - diluted
|
$
|
(0.72
|
)
|
$
|
0.01
|
$
|
(1.33
|
)
|
$
|
(0.12
|
)
|
||
Shares
excluded from calculations
|
145,313
|
-
|
187,970
|
169,076
|
8
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2008
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.
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 $251,789 and $40,838 for the
three months ended June 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, June 30,
|
|||||||
2008
|
2007
|
||||||
Cost
of PCT products and services
|
$
|
-
|
$
|
367
|
|||
Research
and development
|
53,633
|
14,934
|
|||||
Selling
and marketing
|
42,200
|
3,498
|
|||||
General
and administrative
|
155,956
|
22,039
|
|||||
Total
stock-based compensation expense
|
$
|
251,789
|
$
|
40,838
|
We
recognized stock-based compensation expense of $369,994 and $152,593 for the
six
months ended June 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 Six Months Ended, June 30,
|
|||||||
2008
|
2007
|
||||||
Cost
of PCT products and services
|
$
|
-
|
$
|
2,987
|
|||
Research
and development
|
96,870
|
64,428
|
|||||
Selling
and marketing
|
75,232
|
19,492
|
|||||
General
and administrative
|
197,892
|
65,686
|
|||||
Total
stock-based compensation expense
|
$
|
369,994
|
$
|
152,593
|
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 historical rate as our assumption in
calculating future stock-based compensation expense.
During
the three months ended June 30, 2008 and 2007, the total fair value of stock
options awarded was $100,556 and $113,518, respectively. During the six months
ended June 30, 2008 and 2007, the total fair value of stock options awarded
was
$228,108 and $381,322, respectively.
9
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2008
As
of
June 30, 2008, the total estimated fair value of unvested stock options to
be
amortized over their remaining vesting period was $523,772. The non-cash, stock
based compensation expense associated with the vesting of these options will
be
$194,358 in 2008, $234,056 in 2009, $90,750 in 2010 and $4,608 in
2011.
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
June 30, 2008, we had no investments in marketable securities. During the six
months ended June 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 June 30, 2008
and
2007, we incurred $19,585 and $15,461, respectively in advertising expense.
During the six months ended June 30, 2008 and 2007, we incurred $26,102 and
$15,461, respectively in advertising expense.
Rent
Expense
Rental
costs are expensed as incurred. During the three months ended June 30, 2008
and
2007, we incurred $39,505 and $20,919, respectively in rent expense for the
use
of our corporate office and research and development facilities. During the
six
months ended June 30, 2008 and 2007, we incurred $71,718 and $41,439,
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 six months ended June 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.
10
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2008
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.
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. 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 BioMolecular Assays, Inc. We
are also required to pay BioMolecular Assays, Inc. 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 June 30, 2008 and 2007, we incurred approximately $5,451
and
$6,403, respectively in royalty expense associated with our obligation to BMA
Laboratories. During the six months ended June 30, 2008 and 2007, we incurred
approximately $8,451 and $8,503, respectively in royalty expense associated
with
our obligation to BMA Laboratories.
In
connection with our acquisition of BioSeq, Inc., we licensed certain limited
rights to the original pressure cycling technology back to BioMolecular Assays,
Inc. This license is non-exclusive and limits the use of the
original pressure cycling technology by BioMolecular Assays, Inc. solely for
molecular applications in scientific research and development and in scientific
plant research and development. BioMolecular Assays, Inc. 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
BioMolecular Assays, Inc. under the license. BioMolecular Assays, Inc. 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 BioMolecular Assays, Inc. under this license.
Purchase
Commitments
We
have
taken delivery of all Barocycler instruments previously under open commitments.
As of June 30, 2008 we have no open purchase commitments to Source Scientific,
LLC. 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.
11
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2008
Severance
and Change of Control Agreements
Each
of
our executive officers, Mr. Schumacher, Mr. Myles, Dr. Ting, Dr. Lazarev, Dr.
Lawrence, and Mr. Potter, 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 $1.2 million.
Each
of
our executive officers, other than Mr. Schumacher, 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 $1.5 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 June 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. 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 June 30, 2008, options to acquire 940,666
shares were outstanding under the Plan.
12
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 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 June 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
|
87,000
|
4.43
|
|||||||||||
Exercised
|
(3,000
|
)
|
3.25
|
||||||||||
Expired
|
-
|
||||||||||||
Forfeited
|
(13,334
|
)
|
4.07
|
||||||||||
Balance
outstanding, 6/30/2008
|
1,191,166
|
$
|
3.52
|
908,166
|
$
|
3.34
|
Options Outstanding
|
Options Exercisable
|
||||||||||||||||||
Weighted Average
|
Weighted Average
|
||||||||||||||||||
Range of Exercise
Prices
|
Number of
Options
|
Remaining
Contractual
Life
|
Exercise
Price
|
Number of
Options
|
Remaining
Contractual
Life
|
Exercise
Price
|
|||||||||||||
$2.50
- $2.70
|
159,000
|
4.2
|
$
|
2.64
|
159,000
|
4.2
|
$
|
2.64
|
|||||||||||
2.71
- 3.08
|
343,000
|
6.2
|
2.96
|
343,000
|
6.2
|
2.96
|
|||||||||||||
3.09
- 3.95
|
383,166
|
7.9
|
3.71
|
227,166
|
7.8
|
3.74
|
|||||||||||||
3.96
- 5.93
|
306,000
|
8.6
|
4.35
|
179,000
|
8.0
|
4.20
|
|||||||||||||
$2.50
- $5.93
|
1,191,166
|
7.1
|
$
|
3.52
|
908,166
|
6.6
|
$
|
3.34
|
The
aggregate intrinsic value of options outstanding and exercisable as of June
30,
2008 and December 31, 2007 is illustrated in the table below:
June 30, 2008
|
December 31, 2007
|
||||||
Stock
options, outstanding
|
$
|
-
|
$
|
2,162,565
|
|||
Stock
options, exercisable
|
163,470
|
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.
13
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2008
In
connection with the Private Placement, we agreed to prepare and file a
Registration Statement on Form S-3 (the “Registration Statement”) covering the
resale of the Shares purchased in the Private Placement, and to use our
commercially reasonable efforts to cause such Registration Statement to be
declared effective as promptly as possible after the filing thereof and to
keep
the Registration Statement continuously effective under the Securities Act
until
all shares covered by such Registration Statement have been sold, or may be
sold
without volume restrictions pursuant to Rule 144 (or any successor Rule under
the Securities Act). The Registration Statement was declared effective by the
SEC on January 22, 2008.
14
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 when needed
or at
acceptable terms;
|
|
-
|
our
belief that we have sufficient liquidity to finance operations at
the
current level into mid-2009 due to certain cost reduction initiatives
we
have undertaken;
|
|
|
-
|
our
plans and expectations with respect to our pressure cycling technology
(PCT) operations;
|
|
-
|
potential
growth in the market for our PCT products;
|
|
-
|
market
acceptance and the potential for commercial success of our PCT
products;
|
|
-
|
our
belief that PCT provides a superior solution for sample
preparation;
|
-
|
the
expected development and success of new product
offerings;
|
|
|
-
|
the
potential applications for PCT;
|
-
|
the
expected benefits and results from our research and development efforts;
|
|
-
|
the
anticipated impact of the reduction in workforce including the
re-alignment of our sales force from seven full time sales directors
to
three;
|
|
-
|
the
expected benefits and results from our collaboration
program;
|
|
-
|
our
expectation of increased grant revenue during the remainder of 2008
and
our expectation of obtaining additional research grants from the
government in the future;
|
|
|
-
|
the
amount of cash necessary to operate our business;
|
-
|
the
availability of net operating losses to offset potential future operating
income;
|
|
|
-
|
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. 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 the ProteoSolve-lrs kit
for
the detergent-free extraction of proteins from lipid-rich samples, 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). In 2006 and 2007, we received
two SBIR Phase I grants in the aggregate amount of $300,000. 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. In June 2008, we were
notified that the Company was awarded its first Phase II SBIR Grant from the
NIH. The grant is for $850,000 to be billed over two years and 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 condition of the capital markets prompted us to implement 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 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 will allow us to extend
our
existing cash balances into the middle of 2009, without significantly impacting
our short-term commercialization efforts.
16
The
extent to which we increase, or decrease, our operational costs over the coming
quarters is dependent upon our judgment of the investment required to
successfully commercialize PCT and our ability to secure additional funding
through equity or debt financings. If we are unable to increase the number
of
installations of PCT Systems and if we are unable to secure additional funding
through equity or debt financings, we will undertake additional cost reduction
measures.
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 the Company’s securities. The
engagement of EGE contemplates a private placement of the Company’s securities
exempt from the registration requirements under Regulation D promulgated under
the Securities Act of 1933, as amended of up to $8,000,000, or more at the
Company’s discretion. We can provide no assurance that any such equity or debt
offerings will occur, or that additional financing will be available to us
on
acceptable or affordable terms.
17
RESULTS
OF OPERATIONS
Three
Months Ended June 30, 2008 and 2007
Revenue
We
recognized revenue of $120,184, for the three months ended June 30, 2008, as
compared to $202,127 for the same period in the prior year.
PCT
Products, Services, Other.
Revenue
from the sale of PCT products and services was $117,698 for the three months
ended June 30, 2008 as compared to $136,355 for the same period in the prior
year. During the second quarter of 2008 we completed the installation of seven
Barocycler instruments at customer locations, as compared to four in the same
period of 2007. The decrease in revenue, despite an increase in the number
of
installations was due in part to a shift in product mix; three of the seven
installations in the second quarter of 2008 were sales of the less expensive
NEP2320 whereas all four installations in the second quarter of 2007 were sales
of our more expensive NEP3229. Also contributing to this decrease was the fact
that two of our seven installations were made pursuant to short-term rental
agreements, which generally range from three to twelve months in length. These
agreements have a minimal impact on current period revenues but provide a
revenue stream over the life of the respective agreements in the form of rental
payments and purchases of our consumable products.
We
expect
the number of units installed will continue to increase in future periods as
we
continue to commercialize our technology. 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.
Grant
revenue.
During
the three months ended June 30, 2008 and 2007, we recorded $2,486 and $65,772
of
grant revenue, respectively, in connection with our two SBIR Phase I grants.
This decrease in grant revenue during the second quarter of 2008 as compared
to
the same period in 2007 was due to the completion of billing of our two Phase
I
grants. We expect grant revenues to increase in the remaining quarters of 2008
as the work on our recently awarded SBIR Phase II grant will begin in the third
quarter and continue at varying levels for the next six to eight quarters.
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 $88,434 for the three months ended June 30,
2008 compared to $57,629 for the comparable period in 2007. This increase in
cost of PCT products and services despite a decrease in revenue is due to an
adjustment of approximately $40,000 to reduce our estimated warranty liability
during 2007. Aside from this adjustment our cost of PCT products and services,
as a percentage of PCT revenue in the second quarter of 2008 is consistent
with
the same period in 2007.
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 $461,672 in the second quarter of
2008
as compared to $538,015 in the same period in 2007. During the second 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 second quarter of 2008 and 2007
included $53,633 and $14,934, respectively, of non-cash, stock-based
compensation expense. We expect the level of stock-based compensation expense
for the remaining quarters of 2008 to be similar to the amount recorded during
the current quarter.
We
plan
to maintain our current headcount in research and development until we secure
additional funding through equity or debt financings. We believe that with
our
existing staff, we can continue to pursue what we believe to be our most
important research and development programs.
18
Selling
and Marketing
Selling
and marketing expenses increased to $521,606 for the three months ended June
30,
2008 from $350,823 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 second quarter of 2008 and 2007, selling and marketing expense included
$42,200 and $3,498, respectively, of non-cash, stock-based compensation expense.
We expect the level of stock-based compensation expense for the remaining
quarters of 2008 to be similar to the amount recorded during the current
quarter.
We
expect
selling and marketing expense to decrease in the third and fourth quarter,
until
we secure additional funding through equity or debt financings. As part of
our
cost reduction measures we re-aligned our domestic sales force from seven full
time sales directors to three. We believe this re-alignment, and our other
cost
reduction measures, provides us with a manageable balance between the need
to
conserve our cash resources and the need to support our short-term
commercialization plans.
General
and Administrative
General
and administrative costs totaled $635,672 for the three months ended June 30,
2008, as compared to $624,462 for the comparable period in 2007. The increase
is
due to a charge of $100,556 of non-cash stock-based compensation expense 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. Aside from this non-cash charge our general and
administrative spending decreased due to an overall decrease in investor
relations spending, Sarbanes-Oxley compliance costs, and other cost reduction
efforts.
We
expect
that general and administrative spending, excluding stock-based compensation
expense, in the remaining quarters of 2008 will approximate the level of
spending incurred during the second quarter.
Operating
Loss from Continuing Operations
Our
operating loss from continuing operations was $1,587,200 for the three months
ended June 30, 2008 as compared to an operating loss from continuing operations
of $1,368,802 for the comparable period in 2007. The operating loss from
continuing operations for the three months ended June 30, 2008 included $251,789
of non-cash, stock-based compensation expense as compared to $40,838 in the
comparable period in 2007. Aside from non-cash, stock-based compensation
expense, our operating loss during the second quarter of 2008 was approximately
the same as the operating loss during the second quarter of 2007. These results
are partially due to our cost reduction measures implemented during the second
quarter of 2008, such as the delaying several research and development projects
and delaying the hiring of new personnel to fill previously vacated positions,
partially offset by increased spending in sales and marketing and a decrease
in
gross profit due to the overall decrease in grant related revenue.
The
extent to which we increase, or decrease, our operational costs over the coming
quarters is dependent upon our judgment of the investment required to
successfully commercialize PCT and our ability to secure additional funding
through equity or debt financings. We expect that the gross profit from
increasing revenues will partially mitigate the impact of our increased
spending, if any, on our overall operating loss.
Realized
gain of sale on securities held for sale
In
the
three months ended June 30, 2007 we completed the liquidation of our investment
in Panacos Pharmaceuticals and realized a gain on securities sold of
$1,301,247.
Interest
Income
Interest
income totaled $16,549 for the three months ended June 30, 2008 as compared
to
interest income of $80,482 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
quarter ended June 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 $3,516.
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.
19
Gain
on Assets Related to Discontinued Operations
During
the second quarter of 2008 there were no charges for discontinued operations.
During the first half 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 second quarter of 2008 we recorded a net loss of $1,570,651 as compared
to
net income of $1,550,919 in the second quarter of 2007. While our overall level
of operating costs in the second quarter of 2008 was similar to the level of
spending in the second quarter of 2007, these costs were not offset by the
gain
on sale of marketable securities, gain on sale of assets from discontinued
operations, and 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.
Six
Months Ended June 30, 2008 and 2007
Revenue
We
recognized revenue of $252,560, for the six months ended June 30, 2008, as
compared to $333,748 for the same period in the prior year.
PCT
Products, Services, Other.
Revenue
from the sale of PCT products and services was $199,171 for the six months
ended
June 30, 2008 as compared to $174,297 for the same period in the prior year.
During the first half of 2008 we completed the installation of fourteen
Barocycler instruments at customer locations, as compared to five in the same
period of 2007. The modest increase in revenue, despite a significant increase
in the number of installations was due in part to a shift in product mix; four
of the fourteen installations in the first half of 2008 were sales of the less
expensive NEP2320 whereas all five installations in the first half of 2007
were
sales of the more expensive NEP3229. Also contributing to this trend was
the fact that six of our fourteen installations in the first half of 2008 were
made pursuant to short-term rental agreements, which generally range from three
to twelve months in length. These agreements have a minimal impact on current
period revenues but provide a revenue stream over the life of the respective
agreements in the form of rental payments and purchases of our consumable
products.
We
expect
the number of units installed will continue to increase in future periods as
we
continue to commercialize our technology. We also expect that some portion
of
future installations will 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.
Grant
revenue.
During
the six months ended June 30, 2008 and 2007, we recorded $53,389 and $159,451
of
grant revenue, respectively, in connection with our two SBIR Phase I grants.
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. We expect grant
revenues to increase in the remaining quarters of 2008 as the work on our
recently awarded SBIR Phase II grant will begin in the third quarter and
continue, at varying levels, for the next six to eight quarters. 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 $136,883 for the six months ended June 30,
2008
compared to $89,282 for the comparable period in 2007. This increase in cost
of
PCT products and services was primarily due to an adjustment of approximately
$40,000 to reduce our estimated warranty liability during 2007. Aside from
this
adjustment our cost of PCT products and services, as a percentage of PCT revenue
decreased in the first half of 2008 as compared to the first half of 2007.
This
increase in our gross margin during the first half of 2008 as compared to the
first half of 2007 is due to a favorable shift in the mix of the products that
we sold. During the first half of 2008 four of the fourteen instruments that
we
installed were NEP2320 instruments that were sold during the period. Although
the NEP2320 is a less expensive alternative for our customers it typically
yields a higher gross margin when we sell at, or near, list price. We did not
sell any NEP2320’s during the first half of 2007. Revenues from the sale of
consumable products, such as PULSE Tubes and ProteoSolve kits also increased
in
the first six months of 2008 as compared to the same period in 2007. Our
consumable products typically yield higher gross margins than our Barocycler
instruments.
20
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 $952,603 in the first half of 2008
as
compared to $999,547 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 partially offset by increases in
compensation-related costs due to the planned expansion of our research and
development capabilities in the second half of 2007 and early 2008.
Research
and development expense recognized in the first half of 2008 and 2007 included
$96,870 and $64,428, respectively, of non-cash, stock-based compensation
expense. We expect the level of stock-based compensation expense for the
remaining quarters of 2008 to be similar to the amount recorded in the second
quarter.
We
plan
to maintain our current headcount in research and development until we secure
additional funding through equity or debt financings. We believe that with
our
existing staff, we can continue to pursue what we believe to be our most
important research and development programs.
Selling
and Marketing
Selling
and marketing expenses increased to $984,767 for the six months ended June
30,
2008 from $607,354 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 half of 2008 and 2007, selling and marketing expense included $75,232
and $19,492, respectively, of non-cash, stock-based compensation expense. We
expect the level of stock-based compensation expense for the remaining quarters
of 2008 to be similar to the amount recorded in the second quarter.
We
expect
selling and marketing expense to decrease in the third and fourth quarter,
until
we secure additional funding through equity or debt financings. As part of
our
cost reduction measures we re-aligned our domestic sales force from seven full
time sales directors to three. We believe this re-alignment, and our other
cost
reduction measures, provides us with a manageable balance between the need
to
conserve our cash resources and the need to support our short-term
commercialization plans.
General
and Administrative
General
and administrative costs totaled $1,136,920 for the six months ended June 30,
2008, as compared to $1,105,544 for the comparable period in 2007. The increase
is primarily due to the fact that stock-based compensation expense recorded
in
general and administrative costs increased to $197,892 in the first half of
2008, as compared to $65,686 in the first half of 2007. Of this increase in
stock-based compensation, $100,556 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. Aside
from
these non-cash charges our general and administrative spending decreased due
to
an overall decrease in investor relations spending, Sarbanes-Oxley compliance
costs and other cost reduction efforts.
We
expect
that general and administrative spending, excluding stock-based compensation
expense, in the remaining quarters of 2008 to approximate the level of spending
in incurred during the second quarter.
Operating
Loss from Continuing Operations
Our
operating loss from continuing operations was $2,958,613 for the six months
ended June 30, 2008 as compared to $2,467,979 for the comparable period in
2007.
The operating loss from continuing operations for the six months ended June
30,
2008 included $369,994 of non-cash, stock-based compensation expense as compared
to $152,593 in the comparable period in 2007. The remaining increase in
operating loss from continuing operations was primarily the result of the
increases in activities within our selling and marketing function and a decrease
in gross profit due to the decrease in grant revenue recorded in the first
half
of 2008 as compared to the first half of 2007.
21
The
extent to which we increase, or decrease, our operational costs over the coming
quarters is dependent upon our judgment of the investment required to
successfully commercialize PCT and our ability to secure additional funding
through equity or debt financings. We expect that the gross profit from
increasing revenues will partially mitigate the impact of our increased
spending, if any, on our overall operating loss.
Realized
gain of sale on securities held for sale
In
the
six months ended June 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 $46,857 for the six months ended June 30, 2008 as compared to
interest income of $152,084 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
six months ended June 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 $44,035.
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.
Gain
on Assets Related to Discontinued Operations
During
the first half of 2008 there were no charges for discontinued operations. During
the first half 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 first half of 2008 we recorded a net loss of $2,911,756 as compared to
net
income of $912,833 in the first half of 2007. The net loss is the result of
increased operating loss from continuing operations in the first half 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
June 30, 2008, our working capital position was $3,373,716, 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
the
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 will
allow us to extend our existing cash balances into the middle of 2009, without
significantly impacting our short-term commercialization efforts.
22
The
extent to which we increase, or decrease, our operational costs over the coming
quarters is dependent upon our judgment of the investment required to
successfully commercialize PCT and our ability to secure additional funding
through equity or debt financings. If we are unable to increase the number
of
installations of PCT Systems and if we are unable to secure additional funding
through equity or debt financings, we will undertake additional cost reduction
measures.
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 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 specifically
identified potential investors with whom we have a prior relationship. EGE
is
also entitled to a retainer of $7,500 per month for three months.
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.
Net
cash
used in continuing operations for the six months ended June 30, 2008 was
$2,473,573 as compared to net cash used in continuing operations of $2,257,869
for the six months ended June 30, 2007.
Net
cash
used in investing activities for the six months ended June 30, 2008 was $124,892
as compared to cash provided of $1,946,190 for the same period in the prior
year. The cash used in the first half 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 six months ended June 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. 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 BioMolecular Assays, Inc. We
are also required to pay BioMolecular Assays, Inc. 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 June 30, 2008 and 2007, we incurred $5,451 and $6,403,
respectively in royalty expense associated with our obligation to BMA
Laboratories. During the six months ended June 30, 2008 and 2007, we incurred
approximately $8,451 and $8,503, respectively in royalty expense associated
with
our obligation to BMA Laboratories.
In
connection with our acquisition of BioSeq, Inc., we licensed certain limited
rights to the original pressure cycling technology back to BioMolecular Assays,
Inc. This license is non-exclusive and limits the use of the
original pressure cycling technology by BioMolecular Assays, Inc. solely for
molecular applications in scientific research and development and in scientific
plant research and development. BioMolecular Assays, Inc. 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
BioMolecular Assays, Inc. under the license. BioMolecular Assays, Inc. 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 BioMolecular Assays, Inc. under this license.
Purchase
Commitments
We
have
taken delivery of all Barocycler instruments previously under open commitments.
As of June 30, 2008 we have no open purchase commitments to Source Scientific,
LLC. 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, Mr. Schumacher, Mr. Myles, Dr. Ting, Dr. Lazarev, Dr.
Lawrence, and Mr. Potter, 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 $1.2 million.
Each
of
our executive officers, other than Mr. Schumacher, 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 $1.5 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. As
of June 30, 2008, the Company’s financial assets subject to SFAS 157 consisted
of held to maturity investments in marketable securities and investments in
non-publicly traded companies; financial liabilities consisted of derivatives
for forward contracts. The Company determined fair value for the investments
in
marketable securities and the derivative liabilities based on quoted market
prices in active markets (i.e., Level 1 as defined under SFAS 157); fair value
for investments in non-publicly traded companies was based on third party
valuation models (i.e., Level 2 as defined under SFAS 157). 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
June 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
|
|
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
|
27
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: August
14, 2008
|
By:
|
/s/
Richard
T. Schumacher
|
|
Richard
T. Schumacher
President
& Chief Executive Officer
(Principal
Executive Officer)
|
|
|
|
Date:
August 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)
|
28