UNITED
STATES
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,
2009 or
o
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act
of 1934
For
the transition period from _____________ to _____________
Commission file
number 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
|
02375
|
(Address
of Principal Executive Offices)
|
(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 has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
Yes ¨ No ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See 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 June 30, 2009
was 2,195,283.
TABLE OF
CONTENTS
|
Page
|
PART
I - FINANCIAL INFORMATION
|
|
|
|
Item
1. Financial Statements (Unaudited)
|
|
Consolidated
Balance Sheets as of June 30, 2009 and December 31, 2008
|
1
|
|
|
Consolidated
Statements of Operations for the Three Months and Six Months Ended June
30, 2009 and 2008
|
2
|
|
|
Consolidated
Statements of Cash Flows for the Six Months Ended June 30, 2009 and
2008
|
3
|
|
|
Notes
to Consolidated Financial Statements
|
4
|
|
|
Item
2. Management's Discussion and Analysis of Financial Condition and Results
of Operations
|
15
|
|
|
Item
4T. Controls and Procedures
|
25
|
|
|
PART
II - OTHER INFORMATION
|
|
|
|
Item
6. Exhibits
|
26
|
PART I. FINANCIAL
INFORMATION
Item 1. Financial Statements
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(UNAUDITED)
|
|
June
30,
|
|
|
December
31,
|
|
|
|
2009
|
|
|
2008
|
|
ASSETS
|
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
1,489,015 |
|
|
$ |
868,208 |
|
Restricted
cash
|
|
|
20,000 |
|
|
|
50,000 |
|
Accounts
receivable, net of allowances of $54,600 at June 30, 2009 and $0 at
December 31, 2008
|
|
|
156,340 |
|
|
|
209,117 |
|
Inventories
|
|
|
751,065 |
|
|
|
571,831 |
|
Deposits
|
|
|
13,872 |
|
|
|
382,236 |
|
Prepaid
income taxes
|
|
|
3,176 |
|
|
|
6,600 |
|
Income
tax receivable
|
|
|
623,262 |
|
|
|
- |
|
Prepaid
expenses and other current assets
|
|
|
66,162 |
|
|
|
235,111 |
|
Total
current assets
|
|
|
3,122,892 |
|
|
|
2,323,103 |
|
PROPERTY
AND EQUIPMENT, NET
|
|
|
246,818 |
|
|
|
252,249 |
|
|
|
|
|
|
|
|
|
|
OTHER
ASSETS
|
|
|
|
|
|
|
|
|
Intangible
assets, net
|
|
|
255,342 |
|
|
|
279,658 |
|
TOTAL
ASSETS
|
|
$ |
3,625,052 |
|
|
$ |
2,855,010 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
199,477 |
|
|
$ |
263,486 |
|
Accrued
employee compensation
|
|
|
153,093 |
|
|
|
161,374 |
|
Accrued
professional fees and other
|
|
|
235,184 |
|
|
|
278,982 |
|
Deferred
revenue
|
|
|
161,667 |
|
|
|
16,705 |
|
Total
current liabilities
|
|
|
749,421 |
|
|
|
720,547 |
|
LONG
TERM LIABILITIES
|
|
|
|
|
|
|
|
|
Deferred
revenue
|
|
|
3,380 |
|
|
|
10,821 |
|
TOTAL
LIABILITIES
|
|
|
752,801 |
|
|
|
731,368 |
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES (Note 4)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
stock, $.01 par value; 1,000,000 shares authorized; 156,980 shares issued
and outstanding on June 30, 2009 and 0 shares on December 31,
2008
|
|
|
1,570 |
|
|
|
- |
|
Common
stock, $.01 par value; 20,000,000 shares authorized; 2,195,283 shares
issued and outstanding on June 30, 2009 and on December 31,
2008
|
|
|
21,953 |
|
|
|
21,953 |
|
Warrants
to acquire preferred stock and common stock
|
|
|
882,253 |
|
|
|
- |
|
Additional
paid-in capital
|
|
|
8,230,293 |
|
|
|
6,803,530 |
|
Accumulated
deficit
|
|
|
(6,263,818 |
) |
|
|
(4,701,841 |
) |
Total
stockholders' equity
|
|
|
2,872,251 |
|
|
|
2,123,642 |
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
$ |
3,625,052 |
|
|
$ |
2,855,010 |
|
The
accompanying notes are an integral part of these consolidated financial
statements
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(UNAUDITED)
|
|
For
the Three Months Ended
|
|
|
For
the Six Months Ended
|
|
|
|
June
30,
|
|
|
June
30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVENUE:
|
|
|
|
|
|
|
|
|
|
|
|
|
PCT
Products, services, other
|
|
$ |
159,202 |
|
|
$ |
117,698 |
|
|
$ |
381,344 |
|
|
$ |
199,171 |
|
Grant
revenue
|
|
|
111,179 |
|
|
|
2,486 |
|
|
|
195,799 |
|
|
|
53,389 |
|
Total
revenue
|
|
|
270,381 |
|
|
|
120,184 |
|
|
|
577,143 |
|
|
|
252,560 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COSTS
AND EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of PCT products and services
|
|
|
90,820 |
|
|
|
88,434 |
|
|
|
231,063 |
|
|
|
136,883 |
|
Research
and development
|
|
|
315,046 |
|
|
|
461,672 |
|
|
|
622,270 |
|
|
|
952,603 |
|
Selling
and marketing
|
|
|
252,464 |
|
|
|
521,606 |
|
|
|
530,880 |
|
|
|
984,767 |
|
General
and administrative
|
|
|
427,384 |
|
|
|
635,672 |
|
|
|
858,174 |
|
|
|
1,136,920 |
|
Total
operating costs and expenses
|
|
|
1,085,714 |
|
|
|
1,707,384 |
|
|
|
2,242,387 |
|
|
|
3,211,173 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
(815,333 |
) |
|
|
(1,587,200 |
) |
|
|
(1,665,244 |
) |
|
|
(2,958,613 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
1,284 |
|
|
|
16,549 |
|
|
|
3,687 |
|
|
|
46,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
before income taxes
|
|
|
(814,049 |
) |
|
|
(1,570,651 |
) |
|
|
(1,661,557 |
) |
|
|
(2,911,756 |
) |
Income
tax benefit
|
|
|
- |
|
|
|
- |
|
|
|
623,262 |
|
|
|
- |
|
Net
loss
|
|
|
(814,049 |
) |
|
|
(1,570,651 |
) |
|
|
(1,038,295 |
) |
|
|
(2,911,756 |
) |
Accrued
preferred stock dividend
|
|
|
(33,880 |
) |
|
|
- |
|
|
|
(33,880 |
) |
|
|
- |
|
Net
loss to common shareholders
|
|
$ |
(847,929 |
) |
|
$ |
(1,570,651 |
) |
|
$ |
(1,072,175 |
) |
|
$ |
(2,911,756 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
per common share - basic and diluted
|
|
$ |
(0.39 |
) |
|
$ |
(0.72 |
) |
|
$ |
(0.49 |
) |
|
$ |
(1.33 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of shares used to calculate loss per share - basic and
diluted
|
|
|
2,195,283 |
|
|
|
2,193,598 |
|
|
|
2,195,283 |
|
|
|
2,192,883 |
|
The
accompanying notes are an integral part of these consolidated financial
statements
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(UNAUDITED)
|
|
For
the Six Months Ended
|
|
|
|
June
30,
|
|
|
|
2009
|
|
|
2008
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
Net
loss to common shareholders
|
|
$ |
(1,072,175 |
) |
|
$ |
(2,911,756 |
) |
|
|
|
|
|
|
|
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
94,679 |
|
|
|
98,079 |
|
Stock-based
compensation expense
|
|
|
252,861 |
|
|
|
369,994 |
|
Bad
debt expense
|
|
|
55,600 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Restricted
cash
|
|
|
30,000 |
|
|
|
- |
|
Accounts
receivable
|
|
|
(2,823 |
) |
|
|
(4,487 |
) |
Inventories
|
|
|
(179,234 |
) |
|
|
(503,968 |
) |
Deposits
|
|
|
368,364 |
|
|
|
538,011 |
|
Income
tax receivable
|
|
|
(623,262 |
) |
|
|
- |
|
Accounts
payable
|
|
|
(64,009 |
) |
|
|
91,993 |
|
Accrued
employee compensation
|
|
|
(8,281 |
) |
|
|
(50,224 |
) |
Deferred
revenue and other accrued expenses
|
|
|
93,723 |
|
|
|
21,353 |
|
Prepaid
expenses and other current assets
|
|
|
172,373 |
|
|
|
(122,568 |
) |
Net
cash used in operating activities
|
|
|
(882,184 |
) |
|
|
(2,473,573 |
) |
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Additions
to property and equipment
|
|
|
(64,932 |
) |
|
|
(124,892 |
) |
Net
cash used in investing activities
|
|
|
(64,932 |
) |
|
|
(124,892 |
) |
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Net
proceeds from the issuance of common stock
|
|
|
- |
|
|
|
9,750 |
|
Net
proceeds from the issuance of preferred stock
|
|
|
1,567,923 |
|
|
|
- |
|
Net
cash provided by financing activities
|
|
|
1,567,923 |
|
|
|
9,750 |
|
|
|
|
|
|
|
|
|
|
Change
in cash and cash equivalents
|
|
|
620,807 |
|
|
|
(2,588,715 |
) |
Cash
and cash equivalents, beginning of period
|
|
|
868,208 |
|
|
|
5,424,486 |
|
Cash
and cash equivalents, end of period
|
|
$ |
1,489,015 |
|
|
$ |
2,835,771 |
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL
INFORMATION:
|
|
|
|
|
|
|
|
|
Income
taxes paid
|
|
$ |
- |
|
|
$ |
2,790 |
|
Income
taxes received
|
|
|
- |
|
|
|
834 |
|
The
accompanying notes are an integral part of these consolidated financial
statements
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2009
1) Business
Overview and Management Plans
Pressure
BioSciences, Inc. (“PBI or the Company”) is 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 instrumentation that is capable of cycling
pressure between ambient and ultra-high levels (up to 35,000 psi or greater), at
user-defined temperatures, to rapidly and repeatedly control the interactions of
bio-molecules. Our pressure-generating instrument is called the
Barocycler®. Our PCT-related consumables product line includes PULSE
(Pressure Used to Lyse Samples for Extraction) Tubes, MicroTubes, and
application specific (“ProteoSolve”) kits. Our Barocycler instrument,
together with our consumable processing tubes and kits 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, 2009,
we had cash of approximately $1.5 million. During 2008, we undertook
a number of cost reduction measures: including a comprehensive restructuring
program - to significantly reduce costs, centralize core operations, and refocus
our business strategy in specific areas where our products have found
significant market acceptance. The restructuring program included: a
reduction in personnel of eight full-time employees (40% of the workforce),
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, a shutdown of our R&D
facility in Rockville, MD, a consolidation of our R&D activities in
Massachusetts, and delay of several research & development and marketing
programs. These initiatives have significantly decreased our rate of
cash utilization, from just under $1 million per quarter in the second half of
2008 to an average of approximately $600,000 per quarter during
2009. We also believe that these actions, taken together with the
proceeds we received from our $1.8 million equity financing completed in
February 2009, will enable us to extend our cash resources into the second
quarter of 2010.
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. 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, 2009 are not necessarily indicative of the
results that may be expected for the year ending December 31,
2009. 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,
2008.
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 are 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, in our calculation of fair value of stock options awarded, and our
allocation of the proceeds from the equity financing between the preferred stock
and warrants sold. 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.
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2009
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 highly trained technical
representative to the customer site to install every Barocycler that we sell,
lease, or rent through our domestic sales force. The installation process
includes uncrating and setting up the instrument, followed by introductory user
training. Product revenue related to current Barocycler instrumentation is
recognized upon the completion of the installation and introductory training
process of the instrumentation at the customer location, for domestic
installations. Product revenue related to sales of PCT
instrumentation 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, MicroTubes, and
application specific kits is recorded upon shipment through a common
carrier. Shipping costs are included in sales and marketing
expense. 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 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 - are expensed as
incurred. Our research and development activities are performed at our facility
in Massachusetts in conjunction with our 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.
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2009
Inventories
Inventories
are valued at the lower of cost or market. The composition of inventory as
of June 30, 2009 and December 31, 2008 is as follows:
|
|
June
30,
|
|
|
December
31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
Raw
materials
|
|
$ |
122,852 |
|
|
$ |
83,451 |
|
Finished
goods
|
|
|
628,213 |
|
|
|
488,380 |
|
Total
|
|
$ |
751,065 |
|
|
$ |
571,831 |
|
Our
finished goods inventory as of June 30, 2009 included 56 Barocycler instruments,
of which 40 instruments were placed into finished goods inventory in the first
quarter of 2009. Our finished goods inventory as of December 31, 2008
included 34 Barocycler instruments. We transferred one unit from
inventory to our laboratory facility for internal use.
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, 2008, and we reviewed the analysis as of June 30, 2009. No
triggering event for impairment has come to our attention to cause us to record
an impairment of intangible assets as of June 30, 2009.
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, 2008 and we
reviewed the analysis as of June 30, 2009. 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, large pharmaceutical and biotechnology companies, and
academic laboratories.
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2009
The
following tables illustrate the level of concentration as a percentage of total
revenues during the three months and six months ended June 30, 2009 and
2008:
|
|
For
the Three Months Ended
|
|
|
|
June
30,
|
|
|
|
2009
|
|
|
2008
|
|
Top
Five Customers
|
|
|
78 |
% |
|
|
89 |
% |
Federal
Agencies
|
|
|
48 |
% |
|
|
4 |
% |
|
|
For
the Six Months Ended
|
|
|
|
June
30,
|
|
|
|
2009
|
|
|
2008
|
|
Top
Five Customers
|
|
|
60 |
% |
|
|
69 |
% |
Federal
Agencies
|
|
|
38 |
% |
|
|
22 |
% |
The
following table illustrates the level of concentration as a percentage of net
accounts receivable balance as of June 30, 2009 and December 31,
2008:
|
|
June
30,
|
|
|
December
31,
|
|
|
|
2009
|
|
|
2008
|
|
Top
Five Customers
|
|
|
70 |
% |
|
|
81 |
% |
Federal
Agencies
|
|
|
15 |
% |
|
|
1 |
% |
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 continuing to
develop a network of manufacturers and sub-contractors to reduce our reliance on
any single supplier for PCT components. Until we develop a network of
manufacturers and subcontractors, obtaining alternative sources of supply or
manufacturing services could involve significant delays and other costs and
challenges, and may not be available to us on reasonable terms, if at all. The
failure of a supplier or contract manufacturer to provide sufficient quantities,
acceptable quality and timely products at an acceptable price, or an
interruption of supplies from such a supplier could harm our business and
prospects.
Computation
of Loss per Share
Basic
loss per share is computed by dividing loss available to common shareholders by
the weighted average number of common shares outstanding. Diluted
loss per share is computed by dividing loss available to common shareholders by
the weighted average number of common shares outstanding plus additional common
shares that would have been outstanding if dilutive potential common shares had
been issued. For purposes of this calculation, convertible preferred
stock, common stock dividends, warrants to acquire preferred stock convertible
into common stock, and warrants and options to acquire common stock, are all
considered common stock equivalents in periods in which they have a dilutive
effect and are excluded from this calculation in periods in which these are
anti-dilutive.
The
following table illustrates our computation of loss per share for the three
months and six months ended June 30, 2009 and 2008:
|
|
For
the Three Months Ended
|
|
|
For
the Six Months Ended
|
|
|
|
June
30,
|
|
|
June
30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(814,049 |
) |
|
$ |
(1,570,651 |
) |
|
$ |
(1,038,295 |
) |
|
$ |
(2,911,756 |
) |
Accrued
preferred stock dividend
|
|
|
(33,880 |
) |
|
|
- |
|
|
|
(33,880 |
) |
|
|
- |
|
Loss
- basic and diluted
|
|
$ |
(847,929 |
) |
|
$ |
(1,570,651 |
) |
|
$ |
(1,072,175 |
) |
|
$ |
(2,911,756 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding - basic and diluted
|
|
|
2,195,283 |
|
|
|
2,193,598 |
|
|
|
2,195,283 |
|
|
|
2,192,883 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
per common share - basic and diluted
|
|
$ |
(0.39 |
) |
|
$ |
(0.72 |
) |
|
$ |
(0.49 |
) |
|
$ |
(1.33 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
excluded from calculations
|
|
|
215,586 |
|
|
|
145,313 |
|
|
|
105,478 |
|
|
|
187,970 |
|
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2009
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 assets 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. If substantial changes in the company’s ownership should
occur, as defined in Section 382 of the Internal Revenue Code, there could be
sufficient limitations on the amount of net loss carryforwards that could be
used to offset future taxable income.
In the
first half of 2009, we recorded a benefit for income taxes of $623,262 due to
provisions in the American Recovery and Reinvestment Act of 2009 relating to net
operating loss carry-backs. The cash has been received during the
second half of 2009. There was no provision for an income tax benefit
during the same period in 2008. Aside from the impact of the passage
of this congressional act, we do not expect any additional income tax benefits
relating to carry-backs to prior periods. If we are successful in
commercializing PCT and in generating operating income, then we may be able to
utilize certain net operating losses we may have at the time against such future
operating profits.
Accounting
for Stock-Based Compensation
We
maintain equity compensation plans under which 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 $106,957 and $251,789 for the
three months ended June 30, 2009 and 2008, 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,
|
|
|
|
2009
|
|
|
2008
|
|
Research
and development
|
|
$ |
46,885 |
|
|
$ |
53,633 |
|
Selling
and marketing
|
|
|
17,366 |
|
|
|
42,200 |
|
General
and administrative
|
|
|
42,706 |
|
|
|
155,956 |
|
Total
stock-based compensation expense
|
|
$ |
106,957 |
|
|
$ |
251,789 |
|
We
recognized stock-based compensation expense of $252,860 and $369,994 for the six
months ended June 30, 2009 and 2008, 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,
|
|
|
|
2009
|
|
|
2008
|
|
Research
and development
|
|
$ |
99,857 |
|
|
$ |
96,870 |
|
Selling
and marketing
|
|
|
38,574 |
|
|
|
75,232 |
|
General
and administrative
|
|
|
114,429 |
|
|
|
197,892 |
|
Total
stock-based compensation expense
|
|
$ |
252,860 |
|
|
$ |
369,994 |
|
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2009
The
provisions of SFAS 123R require that we make an estimate of our forfeiture rate
and adjust the expense that we recognize to reflect the estimated number of
stock options that will go unexercised. Our historical forfeiture rate has been
approximately 5%, so we used this rate as our assumption in calculating future
stock-based compensation expense.
During
the three months ended June 30, 2009 and 2008, the total fair value of stock
options awarded was $6,890 and $100,556, respectively. During the six
months ended June 30, 2009 and 2008, the total fair value of stock options
awarded was $258,620 and $228,108, respectively.
As of
June 30, 2009, the total estimated fair value of unvested stock options to be
amortized over their remaining vesting period was $372,077. The
non-cash, stock based compensation expense associated with the vesting of these
options is expected to be $153,945 in 2009, $177,568 in 2010 and $40,564 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
Certain
prior year amounts have been reclassified to conform to our current year
presentation.
Advertising
Advertising
costs are expensed as incurred. During the three months ended June
30, 2009, we did not incur any advertising expenses but in the same period last
year, we incurred $19,585 in advertising expense. During the six
months ended June 30, 2009 and 2008, we incurred $304 and $26,102 respectively
in advertising expense.
Rent
Expense
Rental
costs are expensed as incurred. During the three months ended June
30, 2009 and 2008, we incurred $19,416 and $39,505, respectively in rent expense
for the use of our corporate office and research and development
facilities. During the six months ended June 30, 2009 and 2008, we
incurred $43,989 and $71,718, respectively in rent expense for the use of our
corporate office and research and development facilities.
4) 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 12
months. We exercised the renewal option to extend the lease term
until July 14, 2010. We pay approximately $6,500 per month for the
use of these facilities.
Effective
January 1, 2009, we terminated our lease agreement with Scheer Partners and the
Maryland Economic Development Corporation, pursuant to which we leased
laboratory and office space in Rockville, MD. We paid approximately
$3,300 per month for the use of these facilities through December 31, 2008 with
no further obligation.
Effective
January 31, 2009, we terminated our sub-lease agreement with Proteome Systems,
pursuant to which we leased approximately 650 square feet of laboratory space
plus 100 square feet of office space from Proteome Systems in Woburn,
Massachusetts. We paid approximately $3,200 per month for the use of
these facilities through January 31, 2009 with no further
obligation.
In
connection with the reduction of staff levels and consolidation of operations in
Rockville, MD and Woburn, MA, the Company moved its research and development
activities within Massachusetts.
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2009
Royalty
Commitments
In 1996,
we acquired our initial equity interest in BioSeq, Inc., which at the time was
developing our original pressure cycling technology. BioSeq, Inc. acquired
its pressure cycling technology from BioMolecular Assays, Inc. (“BMA”) under a
technology transfer and patent assignment agreement. In 1998, we purchased
all of the remaining outstanding capital stock of BioSeq, Inc., and at such
time, the technology transfer and patent assignment agreement was amended to
require us to pay BMA a 5% royalty on our sales of products or services that
incorporate or utilize the original pressure cycling technology that BioSeq,
Inc. acquired from BMA. We are also required to pay BMA 5% of the proceeds
from any sale, transfer or license of all or any portion of the original
pressure cycling technology. These payment obligations terminate in
2016. During the three months ended June 30, 2009 and 2008, we incurred
$6,176 and $5,451, respectively in royalty expense associated with our
obligation to BMA. During the six months ended June 30, 2009 and
2008, we incurred $15,002 and $8,451, respectively in royalty expense associated
with our obligation to BMA.
In
connection with our acquisition of BioSeq, Inc., we licensed certain limited
rights to the original pressure cycling technology back to BMA. This
license is non-exclusive and limits the use of the original pressure cycling
technology by BMA solely for molecular applications in scientific research and
development and in scientific plant research and development. BMA is
required to pay us a royalty equal to 20% of any license or other fees and
royalties, but not including research support and similar payments, it receives
in connection with any sale, assignment, license or other transfer of any rights
granted to BMA under the license. BMA must pay us these royalties
until the expiration of the patents held by BioSeq, Inc. in 1998, which we
anticipate will be in 2016. We have not received any royalty payments from
BMA under this license.
Battelle
Memorial Institute
In
December 2008, we entered into an exclusive patent license agreement with the
Battelle Memorial Institute ("Battelle"). The licensed technology is described
in the patent application filed by Battelle on July 31, 2008 (US serial number
12/183,219). This application includes subject matter related to a method and a
system for improving the analysis of protein samples, including through an
automated system utilizing pressure and a pre-selected agent to obtain a
digested sample in a significantly shorter period of time than current methods,
while maintaining the integrity of the sample throughout the preparatory
process. Pursuant to the terms of the agreement we paid Battelle a
non-refundable initial fee. In addition to royalty payments on net
sales on “licensed products”, we are obligated to make minimum royalty payments
for each year that we retain the rights outlined in the patent license agreement
and we are required to have our first commercial sale of the licensed products
within one year following the issuance of the patent covered by the licensed
technology.
Purchase
Commitments
On
September 18, 2008, we submitted a purchase order to Source Scientific, LLC, the
manufacturer of the Company’s PCT Barocycler instrumentation, for 50 Barocycler
NEP2320 units. Pursuant to the terms of the purchase order, we placed a deposit
with Source Scientific, LLC, of approximately $100,000, representing
approximately 25% of the expected total value of the order, upon submission of
the purchase order. On November 12, 2008, we placed an additional
deposit of approximately $100,000 with Source Scientific, LLC to provide them
with funds required to commence manufacturing of the NEP2320 units
ordered. The purchase price for the 50 Barocycler NEP2320 units is
based upon a fixed bill of materials. We were billed for the unpaid
purchase price of each unit at the time each unit was completed and ready for
sale.
As of
December 31, 2008 we had approximately $163,000 on deposit with Source
Scientific, LLC for 40 remaining units pursuant to open purchase
orders. In addition, in December 2008, we put the remaining $203,758
amount of the purchase order in an escrow account, which funds were to be
released to pay the remaining balance due when units were
completed. The amount held in escrow is included as a component
within the line item Deposits on the balance sheet. As of June 30,
2009, we had no funds on deposit with Source Scientific, LLC because the
remaining units pursuant to the purchase order were completed and received by
the Company during the first quarter of 2009.
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.
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2009
Severance and Change of Control
Agreements
Each of
our executive officers is entitled to receive a severance payment if terminated
by the Company without cause. The severance benefits would include a
payment in an amount equal to one year of each executive officer’s annualized
base salary compensation plus accrued paid time off. Additionally,
each executive officer will be entitled to receive medical and dental insurance
coverage for one year following the date of termination. The total
commitment related to these agreements in the aggregate is approximately $1.0
million.
Each of our executive officers, other
than Mr. Richard T. Schumacher, our President and Chief Executive Officer, is
entitled to receive a change of control payment in an amount equal to one year
of such executive officer’s annualized base salary compensation, accrued paid
time off, and medical and dental coverage, in the event of a change of control
of the Company. In the case of Mr. Schumacher, this payment would be
equal to two years of annualized base salary compensation, accrued paid time
off, and two years of medical and dental coverage. The total
commitment related to these agreements in the aggregate is approximately $1.3
million.
5) 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, 2009, 608,696 shares of
preferred stock have been designated as Series A Convertible Preferred Stock,
par value $0.01 per share (“Series A Convertible Preferred Stock”), of which
156,980 shares are issued and outstanding, and 20,000 shares of preferred stock
have been designated as Series A Junior Participating Preferred Stock, none of
which are issued and outstanding.
On
February 12, 2009, we completed a private placement, pursuant to which we sold
an aggregate of 156,980 units for a purchase price of $11.50 per unit (the
“Purchase Price”), resulting in gross proceeds to us of $1,805,270 (the “Private
Placement”). Each unit consisted of (i) one share of a
newly created series of preferred stock, designated “Series A Convertible
Preferred Stock,” par value $0.01 per share (the “Series A Convertible
Preferred Stock”) convertible into 10 shares of our common stock, (ii) a
warrant to purchase one share of Series A Convertible Preferred Stock at an
exercise price equal to $12.50 per share, with a term expiring 15 months after
the date of closing (“15 Month Preferred Stock
Warrant”); and (iii) a warrant to purchase 10 shares of common stock at
an exercise price equal to $2.00 per share, with a term expiring 30 months after
the date of closing (the “30 Month Common Stock
Warrants”). We did not pay any placement fees associated with
this transaction but the expenses related to the offering totaled approximately
$233,000.
The
proceeds from the sale of each unit was allocated between the Series A
Convertible Preferred Stock, the 15 Month Preferred Stock Warrant and the 30
Month Common Stock Warrant based on the relative estimated fair value of each
security. The estimated fair value of the warrants were determined
using the Black-Scholes formula, resulting in an allocation of the gross
proceeds of $882,253 to the total warrants issued. The allocation of
the gross proceeds to the Series A Convertible Preferred Stock was
$923,017. In accordance with the provisions of Emerging Industry Task
Force Issue 00-27: Application of Issue No. 98-5 to Certain Convertible
Instruments, an additional adjustment between Additional Paid in Capital and
Accumulated Deficit of $489,803 was recorded to reflect an implicit non-cash
dividend related to the allocation of proceeds between the stock and warrants
issued.
Series A Convertible
Preferred Stock
Each
share of Series A Convertible Preferred Stock will receive a cumulative dividend
at the rate of 5% per annum of the Purchase Price, payable semi-annually on June
30 and December 31, commencing on June 30, 2009 (with the first payment to be
pro-rated based on the number of days occurring between the date of issuance and
June 30, 2009). Dividends may be paid in cash or in shares of common
stock at our option, subject to certain conditions. The shares of
Series A Convertible Preferred Stock also are entitled to a liquidation
preference, such that in the event of any voluntary or involuntary liquidation,
dissolution or winding up of our company, the holders of Series A Convertible
Preferred Stock will be paid out of the assets of the Company available for
distribution to the our stockholders before any payment shall be paid to the
holders of common stock, an amount per share equal to the Purchase Price, plus
accrued and unpaid dividends. The Board has not approved nor
determined the method of payment for the June 30, 2009 dividend.
Each
share of Series A Convertible Preferred Stock is convertible into 10 shares of
common stock at any time at the option of the holder, subject to adjustment for
stock splits, stock dividends, recapitalizations and similar transactions (the
“Conversion
Ratio”). Unless waived under certain circumstances by the holder of
Series A Convertible Preferred Stock, such holder’s shares of Series A
Convertible Preferred Stock may not be converted if upon such conversion the
holder’s beneficial ownership would exceed certain thresholds. Each
share of Series A Convertible Preferred Stock will automatically be converted
into shares of common stock at the Conversion Ratio then in
effect: (i) if, after 12 months from the closing of the Private
Placement, the common stock trades on the Nasdaq Capital Market (or other
primary trading market or exchange on which the common stock is then traded) at
a price equal to $4.00 for 20 out of 30 consecutive trading days with average
daily trading volume of at least 10,000 shares or (ii) upon a registered public
offering by the Company at a per share price equal to $2.30 with aggregate gross
proceeds to the Company of not less than $10 million.
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2009
The
holders of Series A Convertible Preferred Stock are not entitled to vote on any
matters presented to the stockholders of the Company for their action or
consideration at any meeting of stockholders of the Company (or by written
consent of stockholders in lieu of meeting), except that the holders of Series A
Convertible Preferred Stock may vote separately as a class on any matters that
would amend, alter or repeal any provision of our Restated Articles of
Organization, as amended, in a manner that adversely affects the powers,
preferences or rights of the Series A Convertible Preferred Stock and such
holders may also vote on any matters required by law.
At any
time after February 11, 2014, upon 30 days written notice, we have the right to
redeem the outstanding shares of Series A Convertible Preferred Stock at a price
equal to the Purchase Price, plus all accrued and unpaid dividends
thereon. The redemption price may be paid in two annual
installments.
Warrants
The
warrants have the following exercise prices and terms: (i) the 15
Month Preferred Stock Warrants have an exercise price equal to $12.50 per share,
with a term expiring on May 12, 2010; and (ii) the 30 Month Common Stock
Warrants have an exercise price equal to $2.00 per share, with a term expiring
on August 12, 2011. Unless waived under
certain circumstances by the holder of the warrant, such holder’s warrants may
not be exercised if upon such exercise the holder’s beneficial ownership would
exceed certain thresholds.
Each of
the 15 Month Preferred Stock Warrants and the 30 Month Common Stock Warrants
permit the holder to conduct a “cashless exercise” at any time after the holder
of the warrant becomes an “affiliate” (as defined in the Securities Purchase
Agreement) of the Company.
The
warrant exercise price and/or number of shares issuable upon exercise of the
applicable warrant will be subject to adjustment for stock dividends, stock
splits or similar capital reorganizations, as set forth in the
warrants.
Subject
to the terms and conditions of the applicable warrants, the Company has the
right to call for cancellation of the 15 Month Preferred Stock Warrants if the
volume weighted average price of our common stock on the Nasdaq Capital Market
(or other primary trading market or exchange on which our common stock is then
traded) equals or exceeds $1.75 for either (i) 10 consecutive trading days or
(ii) 15 out of 25 consecutive trading days. Subject to the
terms and conditions of the 30 Month Common Stock Warrant, the Company has the
right to call for cancellation the 30 Month Common Stock Warrant if the volume
weighted average price for our common stock on the Nasdaq Capital Market (or
other primary trading market or exchange on which our common stock is then
traded) equals or exceeds $2.80 for either (i) 10 consecutive trading days or
(ii) 15 out of 25 consecutive trading days.
Common
Stock
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
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.
PRESSURE
BIOSCIENCES, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
AS
OF JUNE 30, 2009
Subject
to certain limited exceptions, if a person or group acquires beneficial
ownership of 15% or more of our outstanding common stock or if a current 15%
beneficial owner acquires additional shares of common stock, each holder of a
Right (other than the 15% holder whose Rights become void once such holder
reaches the 15% threshold) will thereafter have a right to purchase, upon
payment of the purchase price of the Right, that number of shares of our common
stock which at the time of such transaction will have a market value equal to
two times the purchase price of the Right. In the event that, at any time
after a person or group acquires 15% or more of our common stock, we are
acquired in a merger or other business combination transaction or 50% or more of
our consolidated assets or earning power are sold, each holder of a Right will
thereafter have the right to purchase, upon payment of the purchase price of the
Right, that number of shares of common stock of the acquiring company which at
the time of such transaction will have a market value of two times the purchase
price of the Right.
Our Board
of Directors may exchange the Rights (other than Rights owned by such person or
group which have become void), in whole or in part, at an exchange ratio of one
share of common stock per Right (subject to adjustment). At any time prior
to the time any person or group acquires 15% or more of our common stock, the
Board of Directors may redeem the Rights in whole, but not in part, at a price
of $0.001 per Right.
Stock
Options
On June
16, 2005, our stockholders approved our 2005 Equity Incentive Plan (the “Plan”)
pursuant to which an aggregate of 1,000,000 shares of our common stock were
reserved for issuance upon exercise of stock options or other equity awards made
under the Plan. On September 25, 2008, our stockholders approved an
amendment to the 2005 Equity Incentive Plan pursuant to which the number of
shares reserved for issuance upon exercise of stock options or other equity
awards made under the plan was increased from 1,000,000 shares to 1,500,000
shares. Under the Plan, we may award stock options, shares of common
stock, and other equity interests in the Company to employees, officers,
directors, consultants, and advisors, and to any other persons the Board of
Directors deems appropriate.
As of
June 30, 2009, options to acquire 1,300,500 shares were outstanding under the
Plan. We also have 244,000 stock options outstanding under our 1999
Non-Qualified Stock Option Plan. As of June 30, 2009, there were
4,800 shares available for future grant under the 1999 Non-qualified
Plan.
The
following tables summarize information concerning stock options and warrants
outstanding and exercisable:
|
|
Stock
Options
|
|
|
Warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
price
|
|
|
|
|
|
Average
price
|
|
|
Total
|
|
|
|
|
|
|
Shares
|
|
|
per
share
|
|
|
Shares
|
|
|
per
share
|
|
|
Shares
|
|
|
Exercisable
|
|
Balance
outstanding, 12/31/2007
|
|
|
1,120,500 |
|
|
$ |
3.45 |
|
|
|
- |
|
|
|
|
|
|
1,120,500 |
|
|
|
691,166 |
|
Granted
|
|
|
231,500 |
|
|
|
2.94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(3,000 |
) |
|
|
3.25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(1,500 |
) |
|
|
3.25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(125,001 |
) |
|
|
4.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
outstanding, 12/31/2008
|
|
|
1,222,499 |
|
|
$ |
3.30 |
|
|
|
- |
|
|
|
|
|
|
1,222,499 |
|
|
|
932,334 |
|
Granted
|
|
|
460,000 |
|
|
|
0.78 |
|
|
|
3,139,600 |
|
|
|
1.63 |
|
|
|
3,599,600 |
|
|
|
|
|
Exercised
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(137,999 |
) |
|
|
3.40 |
|
|
|
|
|
|
|
|
|
|
|
(137,999 |
) |
|
|
|
|
Balance
outstanding, 6/30/2009
|
|
|
1,544,500 |
|
|
$ |
2.54 |
|
|
|
3,139,600 |
|
|
$ |
1.63 |
|
|
|
4,684,100 |
|
|
|
4,216,280 |
|
|
|
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
|
|
$0.77
- $2.70
|
|
|
679,000 |
|
|
|
7.3 |
|
|
$ |
1.24 |
|
|
|
342,346 |
|
|
|
5.9 |
|
|
$ |
1.67 |
|
2.71
- 3.08
|
|
|
319,500 |
|
|
|
5.7 |
|
|
|
2.93 |
|
|
|
265,000 |
|
|
|
5.0 |
|
|
|
2.97 |
|
3.09
- 3.95
|
|
|
302,000 |
|
|
|
6.9 |
|
|
|
3.67 |
|
|
|
272,667 |
|
|
|
6.8 |
|
|
|
3.69 |
|
3.96
- 5.93
|
|
|
244,000 |
|
|
|
7.5 |
|
|
|
4.24 |
|
|
|
196,667 |
|
|
|
7.2 |
|
|
|
4.20 |
|
$0.77
- $5.93
|
|
|
1,544,500 |
|
|
|
6.9 |
|
|
$ |
2.54 |
|
|
|
1,076,680 |
|
|
|
6.2 |
|
|
$ |
2.96 |
|
The
aggregate intrinsic value of options outstanding and exercisable as of June 30,
2009 and December 31, 2008 has been negative due the stock price as of period
end compared to the option weighted average exercise price.
6) Subsequent
Events
We
performed a review of events subsequent to the balance sheet date through August
10, 2009, the date the financial statements were issued.
ITEM
2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. In some cases, forward-looking statements
are identified by terms such as “may”, “will”, “should”, “could”, “would”,
“expects”, “plans”, “anticipates”, “believes”, “estimates”, “projects”,
“predicts”, “potential”, and similar expressions intended to identify
forward-looking statements. Such statements include, without limitation,
statements regarding:
|
-
|
our
ability to raise additional equity or debt financing on acceptable terms,
if at all;
|
|
-
|
our
belief that we have sufficient liquidity to finance operations into the
second quarter of 2010;
|
|
-
|
our
need to take additional cost reduction measures, cease operations or sell
our operating assets, if we are unable to obtain sufficient additional
financing in the future;
|
|
-
|
the
amount of cash necessary to operate our business;
|
|
-
|
the
anticipated uses of grant revenue and increased grant revenue in future
periods;
|
|
-
|
our
plans and expectations with respect to our pressure cycling technology
(PCT) operations;
|
|
-
|
the
expected tax benefits we may receive due to the American Recovery and
Reinvestment Act of 2009;
|
|
-
|
our
ability to utilize net operating losses in the future;
|
|
-
|
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
1 of our Annual Report on Form 10-K for the year ended December 31, 2008, as
well as those discussed elsewhere in this Report, including the
following:
If
we fail to obtain substantial additional capital, we may not be able to continue
our business.
Based on
our current projections, we believe our current cash resources, which include
the funds we received from the private placement completed in February 2009, are
sufficient to fund our normal operations into the second quarter of
2010.
We will
need additional capital sooner than we currently expect if we experience
unforeseen costs or expenses, unanticipated liabilities or delays in
implementing our business plan, developing our products and achieving commercial
sales. We also believe that we will need substantial capital to accelerate the
growth and development of our pressure cycling technology products and services
in the sample preparation area, as well as for applications in other areas of
life sciences.
Our
actual results and performance, including our ability to raise additional
capital, may be adversely affected by current economic conditions.
Our
actual results and performance could be adversely affected by the current
economic conditions in the global economy, which pose a risk to the overall
demand for our products from our customers who may elect to defer or cancel
purchases of our products in response to tighter credit markets, negative
financial news, and general uncertainty in the economy. In addition,
our ability to obtain additional financing, on acceptable terms, if at all, may
be adversely affected by the crisis in the credit markets and the uncertainty in
the current economic climate.
We
qualify all of our forward-looking statements by these cautionary statements.
You should read this section in combination with the section entitled
Management’s Discussion and Analysis of Financial Condition and Results of
Operations for the year ended December 31, 2008 included in our Annual
Report on Form 10-K for the year ended December 31, 2008.
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 instrumentation that is capable of cycling
pressure between ambient and ultra-high levels (up to 35,000 psi or greater) at
controlled temperatures to rapidly and repeatedly control the interactions of
bio-molecules. Our pressure-generating instrument is called the
Barocycler®. Our PCT-related consumables product line includes PULSE
(Pressure Used to Lyse Samples for Extraction) Tubes as well as application
specific (“ProteoSolve”) kits. Our Barocycler instrument, together
with our consumable products and reagents, make up the PCT Sample Preparation
System (“PCT SPS”). In the second quarter of 2009, we introduced for
sale our PCT MicroTube Adapter Kit for use with our Barocycler
instruments. The PCT MicroTube Adapter Kit, in combination with the
PCT SPS, can reliably and reproducibly control the enzymatic digestion of
proteins while reducing the time of digestion from hours to minutes with the
same or better quality as other, currently available techniques. The
PCT MicroTube Adapter Kit comes complete with an ergonomically designed,
space-saving work station containing PCT MicroTubes and PCT MicroCaps, as well
as tools and hardware, to enable the user to process from one to forty eight
samples simultaneously in the PCT SPS.
We have
experienced negative cash flows from operations with respect to our pressure
cycling technology business since our inception. As of June 30, 2009, we had
cash of approximately $1.5 million. During 2008, we took a number of
cost reduction measures, including a comprehensive restructuring program to
significantly reduce costs, centralize core operations, and refocus our business
strategy in specific areas where our products have found significant market
acceptance. The restructuring program included: a reduction in personnel of
eight full-time employees (40% of the workforce), 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, a shutdown of our R&D facility in Rockville, MD, a
consolidation of our R&D activities in Massachusetts, and delay of several
research & development and marketing programs. These initiatives
have significantly decreased our rate of cash utilization, from just under $1
million per quarter in the second half of 2008 to an average of approximately
$600,000 per quarter during 2009. We also believe that these actions,
taken together with the proceeds we received from our $1.8 million equity
financing completed in February 2009, will enable us to extend our cash
resources into the second quarter of 2010.
We hold
13 United States and 6 foreign patents covering multiple applications of PCT in
the life sciences field. Our pressure cycling technology employs a unique
approach that we believe has the potential for broad use in a number of
established and emerging life sciences areas, including;
|
-
|
sample
preparation for genomic, proteomic, and small molecule
studies;
|
|
-
|
control
of chemical (particularly enzymatic) reactions;
and
|
|
-
|
Immunodiagnostics
(clinical laboratory testing).
|
Since we
began operations as Pressure BioSciences in February 2005, we have installed 96
Barocycler instruments, including 22 instruments in the first half of 2009, 41
instruments in 2008, 20 instruments in 2007, 8 instruments in 2006, and 5
instruments in 2005. Our customers include researchers at academic
laboratories and government agencies, as well as biotechnology, pharmaceutical
and other life sciences companies in the United States, and six foreign
distribution partners.
RESULTS OF
OPERATIONS
Three
Months Ended June 30, 2009 and 2008
Revenue
We
recognized revenue of $270,381 for the three months ended June 30, 2009, as
compared to $120,184 for the same period in the prior year.
PCT Products, Services,
Other. Revenue from the sale of PCT products and services was $159,202
for the three months ended June 30, 2009 as compared to $117,698 for the same
period in the prior year. During the second quarter of 2009, we
completed the installation of twelve Barocycler instruments, as compared to
seven in the same period of 2008. Nine of the twelve instruments were
domestic installations and three were international sales, compared to four
domestic installations and three international sales for the same quarter in
2008. The increase in revenue observed in the second quarter of 2009
was due in part to this increase in the number of Barocycler units sold during
the period and, to a lesser extent, sales of our PCT MicroTube Adapter Kit,
which was released for sale in the second quarter of 2009.
We expect
the number of units installed will continue to increase in future periods as we
continue to commercialize our technology, although we may continue to experience
some delays in customer purchases due to current economic conditions in the
global economy. Furthermore, we may realize some difficulties in
signing up new international distribution partners if we are unable to secure
additional funding through equity or debt financings. We also expect
that some portion of future installations will continue to be for the smaller,
lower priced, Barocycler NEP2320 model and some will be placed under lease or
short-term rental agreements. Therefore, we expect that the average
revenue per installation will continue to fluctuate from period to period as we
continue to drive our installed base and commercialize PCT. As we
continue to expand the installed base of Barocycler instruments in the field we
expect to realize increasing revenues from the sale of consumable products and
extended service contracts. In the short-term, these recurring
revenue streams may continue to fluctuate from period to period.
Grant Revenue. During the
three months ended June 30, 2009 and 2008, we recorded $111,179 and $2,486 of
grant revenue, respectively. Grant revenue recorded during the second
quarter of 2009 was related to the $850,000 SBIR Phase II grant that we were
awarded in June 2008 and to an SBIR Phase I grant of approximately $110,000
awarded in January 2009. We expect grant revenues to increase over
the next several quarters as the amount of time and expense incurred in
connection with these grants continues to increase. The level of
grant revenue that we recognize in any given quarter is dependent upon the level
of resources we devote to grant related work in the period.
Cost
of PCT Products and Services
The cost
of PCT products and services was $90,820 for the three months ended June 30,
2009 compared to $88,434 for the comparable period in 2008. This
increase in cost of PCT products and services was due primarily to the increase
in the number of units installed under sale, lease, or rental arrangements
during the period and, to a lesser extent, costs associated with our June 2009
launch of our PCT MicroTube Adapter Kits. Costs of PCT products and
services as a percentage of revenue decreased to 57% for the three months ended
June 30, 2009, as compared to 75% for the three months ended June 30,
2008. The decrease in the cost of PCT products and services as a
percentage of revenue was due primarily to the sale of two Barocycler units in
the second quarter of 2009 that were collaboration models that had been
previously expensed resulting in a lower cost of PCT products in the current
quarter.
The
relationship between the 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
were $315,046 in the second quarter of 2009 as compared to $461,672 in the same
period in 2008, a decline of 32%. This decline in R&D expenses
was primarily due to the significant restructuring and cost-reduction programs
that we initiated in the third and fourth quarters of 2008, including the
termination of seven R&D employees. The headcount in R&D
during the second quarter of 2009 was three, compared to ten during the same
period in 2008. The
decline in expenses was also due to a significant decrease in the number of
R&D projects we funded during the second quarter of
2009.
Research
and development expense recognized in the second quarters of 2009 and 2008
included $46,885 and $53,633 of non-cash, stock-based compensation expense,
respectively. We expect that the level of stock-based compensation
expense in the near future will be consistent with the amount recorded during
the second quarter of 2009.
Selling
and Marketing
Selling
and marketing expenses decreased to $252,464 for the three months ended June 30,
2009 from $521,606 for the comparable period in 2008, a decline of $269,142 or
52%. This decline in selling and marketing expense was primarily due
to the significant restructuring and cost-reduction programs that we initiated
in the third and fourth quarters of 2008, including the termination of four
sales directors and one marketing assistant. The headcount in selling
and marketing during the second quarter of 2009 was five, compared to ten during
the same period in 2008. A significant decrease in advertising,
exhibit booth rental, and travel cost expense also contributed to the reduction
in overall selling and marketing expense incurred during the second quarter of
2009.
During
the second quarter of 2009 and 2008, selling and marketing expense included
$17,366 and $42,200 of non-cash, stock-based compensation expense,
respectively. We expect the level of stock-based compensation expense
in the near future will be consistent with the amount recorded during the second
quarter of 2009.
General
and Administrative
General
and administrative costs totaled $427,384 for the three months ended June 30,
2009 as compared to $635,672 for the comparable period in 2008, a decrease of
$208,288 or 33%. This decrease in general and administrative expense
was primarily due to the significant restructuring and cost-reduction programs
that we initiated in the third and fourth quarters of 2008. The
decline in expenses was also due to a significant decrease in investor relations
costs, reduced Board of Directors fees, and compensation savings from the
resignation of our Chief Financial Officer in November 2008. At this
time, we are not actively pursuing a replacement for the Chief Financial
Officer.
During
the second quarters of 2009 and 2008, general and administrative expense
included $42,706 and $155,956 of non-cash, stock-based compensation expense,
respectively. The second quarter of 2008 includes a one-time 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. We expect the level of stock-based compensation expense in the
near future will be consistent with the amount recorded during the second
quarter of 2009.
Operating
Loss
Our
operating loss was $815,333 for the three months ended June 30, 2009 as compared
to $1,587,200 for the comparable period in 2008, a decrease of $771,867 or
49%. During the second half of 2008, we initiated a number of cost
reduction measures, including a comprehensive restructuring program to
significantly reduce costs, centralize core operations, and refocus our business
strategy in specific areas where our products had found significant market
acceptance. The restructuring program included: a reduction in
personnel of twelve full-time employees, reduction in travel and meeting
attendance for all personnel, continued reduction in investor relations
activities, reduced Board of Directors fees, decreases in the base salary of
most of our employees and all of our executive officers, a shutdown of our
R&D facility in Rockville, MD, a consolidation of our R&D activities in
Massachusetts, and delay or cancellation of several research and development and
marketing programs.
These
initiatives have significantly decreased our rate of cash utilization, from just
under $1 million per quarter in the second half of 2008 to an average of
approximately $600,000 per quarter during 2009.
Interest
Income
Interest
income totaled $1,284 for the three months ended June 30, 2009 as compared to
interest income of $16,549 in the prior year period. The decrease is
due to lower average cash balances and lower yields on these balances during the
second quarter of 2009, as compared to the second quarter of 2008.
Income
Taxes
During
the second quarters of 2009 and 2008, we did not record a benefit for income
taxes.
Net
Loss
During
the second quarter of 2009, we recorded a net loss to common shareholders
of $847,929 or $(0.39) per share, as compared to $1,570,651 or $(0.72) per share
in the second quarter of 2008. Our net loss in the second quarter of
2009 was lower than the corresponding net loss of the second quarter of 2008 as
the result of increased revenue and lower operating costs, as described
above.
Six
Months Ended June 30, 2009 and 2008
Revenue
We
recognized revenue of $577,143 for the six months ended June 30, 2009, as
compared to $252,560 for the same period in the prior year.
PCT Products, Services,
Other. Revenue from the sale of PCT products and services was $381,344
for the six months ended June 30, 2009 as compared to $199,171 for the same
period in the prior year. During the first half of 2009, we completed
the installation of twenty-two Barocycler instruments, as compared to fourteen
in the same period of 2008. Sixteen of the twenty-two instruments
were domestic installations and six were international sales, compared to nine
domestic installations and five international sales for the same period in
2008. The increase in revenue observed in the first half of 2009 was
due primarily to an increase in the number of Barocycler units sold during the
period.
Grant Revenue. During the six
months ended June 30, 2009 and 2008, we recorded $195,799 and $53,389 of grant
revenue, respectively. Grant revenue recorded during the first half
of 2009 was related to the $850,000 SBIR Phase II grant that we were awarded in
June 2008 and to an SBIR Phase I grant of approximately $110,000 awarded in
January 2009. We expect grant revenues to increase over the next
several quarters as the amount of time and expense incurred in connection with
these grants continues to increase. The level of grant revenue that
we recognize in any given quarter is dependent upon the level of resources we
devote to grant related work in the period.
Cost
of PCT Products and Services
The cost
of PCT products and services was $231,063 for the six months ended June 30, 2009
compared to $136,883 for the comparable period in 2008. This increase
in cost of PCT products and services was due primarily to the increase in the
number of units installed under sale, lease, or rental arrangements during the
period and, to a lesser extent, costs associated with our June 2009 launch of
our PCT MicroTube Adapter Kits. Costs of PCT products and services as
a percentage of revenue decreased to 61% for the six months ended June 30, 2009,
as compared to 69% for the six months ended June 30, 2008. The
decrease in the cost of PCT products and services as a percentage of revenue was
due primarily to the sale of two Barocycler units in the second quarter of 2009
that were collaboration models that had been previously expensed resulting in a
lower cost of PCT products in the six months ended June 30, 2009.
The
relationship between the 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
were $622,270 in the first half of 2009 as compared to $952,603 in the same
period in 2008, a decline of 35%. This decline in R&D expenses
was primarily due to the significant restructuring and cost-reduction programs
that we initiated in the third and fourth quarters of 2008, including the
termination of seven R&D employees. The headcount in R&D
during the first half of 2009 was three, compared to ten during the same period
in 2008. The decline in
expenses was also due to a significant decrease in the number of R&D
projects we funded during the first half of 2009.
Research
and development expense recognized in the first half of 2009 and 2008 included
$99,857 and $96,870 of non-cash, stock-based compensation expense,
respectively. We expect that the level of stock-based compensation
expense in the near future will be consistent with the amount recorded during
the first half of 2009.
Selling
and Marketing
Selling
and marketing expenses decreased to $530,880 for the six months ended June 30,
2009 from $984,767 for the comparable period in 2008, a decline of $453,887 or
46%. This decline in selling and marketing expense was primarily due
to the significant restructuring and cost-reduction programs that we initiated
in the third and fourth quarters of 2008, including the termination of four
sales directors and one marketing assistant. The headcount in selling
and marketing during the first half of 2009 was five, compared to ten during the
same period in 2008. A significant decrease in advertising, exhibit
booth rental, and travel cost expense also contributed to the reduction in
overall selling and marketing expense incurred during the first half of
2009. These reductions in expenses were offset by bad debt expense of
$55,600 recorded in the first quarter of 2009.
During
the first half of 2009 and 2008, selling and marketing expense included $38,574
and $75,232 of non-cash, stock-based compensation expense,
respectively. We expect the level of stock-based compensation expense
in the near future will be consistent with the amount recorded during the first
half of 2009.
General
and Administrative
General
and administrative costs totaled $858,174 for the six months ended June 30, 2009
as compared to $1,136,920 for the comparable period in 2008, a decrease of
$278,746 or 25%. This decrease in general and administrative expense
was primarily due to the significant restructuring and cost-reduction programs
that we initiated in the third and fourth quarters of 2008. The
decline in expenses was also due to a significant decrease in investor relations
costs, reduced Board of Directors fees, and compensation savings from the
resignation of our Chief Financial Officer in November 2008.
During
the first half of 2009 and 2008, general and administrative expense included
$114,429 and $197,892 of non-cash, stock-based compensation expense,
respectively. The first half of 2009 includes a grant of stock
options to purchase 450,000 shares of our common stock to each employee and our
four independent directors. The same period in 2008 includes a
one-time 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. We expect the level of stock-based
compensation expense in the near future will be consistent with the amount
recorded during the first half of 2009.
Operating
Loss
Our
operating loss was $1,665,244 for the six months ended June 30, 2009 as compared
to $2,958,613 for the comparable period in 2008, a decrease of $1,293,369 or
44%. During the second half of 2008, we initiated a number of cost
reduction measures, including a comprehensive restructuring program to
significantly reduce costs, centralize core operations, and refocus our business
strategy in specific areas where our products had found significant market
acceptance. The restructuring program included: a reduction in
personnel of twelve full-time employees, reduction in travel and meeting
attendance for all personnel, continued reduction in investor relations
activities, reduced Board of Directors fees, decreases in the base salary of
most of our employees and all of our executive officers, a shutdown of our
R&D facility in Rockville, MD, a consolidation of our R&D activities in
Massachusetts, and delay or cancellation of several research and development and
marketing programs.
These
initiatives have significantly decreased our rate of cash utilization, from just
under $1 million per quarter in the second half of 2008 to an average of
approximately $600,000 per quarter during 2009.
Interest
Income
Interest
income totaled $3,687 for the six months ended June 30, 2009 as compared to
interest income of $46,857 in the prior year period. The decrease is
due to lower average cash balances and lower yields on these balances during the
first half of 2009, as compared to the same period in 2008.
Income
Taxes
In the
six months ended June 30, 2009, we recorded a benefit for income taxes of
$623,262 due to provisions in the American Recovery and Reinvestment Act of 2009
relating to net operating loss carry-backs. The cash is expected to
be received during the second half of 2009. There was no provision
for an income tax benefit during the same period in 2008. Aside from
the impact of the passage of this law, we do not expect any additional income
tax benefits relating to carry-backs to prior periods. If we are
successful in commercializing PCT and in generating operating income, then we
may be able to utilize certain net operating losses we may have at the time
against such future operating profits.
Net
Loss
During
the first half of 2009, we recorded a net loss of $1,038,295 or $(0.49) per
share, as compared to $2,911,756 or $(1.33) per share in the first half of
2008. Our net loss in the first half of 2009 was lower than the
corresponding net loss in the same period in 2008 as the result of increased
revenue, the income tax benefit, and lower operating costs, as described
above.
LIQUIDITY AND FINANCIAL
CONDITION
As of
June 30, 2009, our working capital position was $2,407,351, which excludes
$33,880 of accrued preferred stock dividend. As of December 31, 2008,
our working capital position was $1,602,556.
During
the second half of 2008, we took a number of cost reduction measures, including
a comprehensive restructuring program to significantly reduce costs, centralize
core operations, and refocus our business strategy in specific areas where our
products had found significant market acceptance. The restructuring program
included: a reduction in personnel of twelve full-time employees, 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, a shutdown of our R&D facility in Rockville,
MD, a consolidation of our R&D activities in Massachusetts, and the delay or
cancellation of several research and development and marketing
programs. We believe that these initiatives have significantly
decreased our rate of cash utilization, from just under $1 million per quarter
during the second half of 2008 to an expected average of approximately $600,000
per quarter during 2009.
On
December 19, 2008, we received $200,000 from one of our distributors in the
escrow account for the private placement. Prior to February 12, 2009,
the distributor requested that the $200,000 be used as payment for anticipated
future purchases of our PCT instrument and consumable products, and not for an
investment in the private placement. This amount was recorded as
deferred revenue in the first half of 2009. As of June 30, 2009,
$148,304 remained in deferred revenue for future product
purchases. Four Barocycler units have been shipped against this
advance payment.
We
believe that because of the cost restructuring measures we have undertaken,
together with the $1,805,270 we received in connection with our February 2009
private placement of units (consisting of Series A Convertible Preferred Stock
and warrants to purchase Series A Convertible Preferred Stock and Common Stock),
we have sufficient cash resources to fund normal operations into the second
quarter of 2010. We believe we will need substantial additional
capital to fund our operations beyond the second quarter of
2010. If we are able to obtain additional capital or otherwise
increase our revenues, we may increase spending in specific research and
development applications and engineering projects and may hire additional sales
personnel or invest in targeted marketing programs. In the event that
we are unable to obtain financing on acceptable terms, or at all, we may be
required to limit or cease our operations, pursue a plan to sell our operating
assets, or otherwise modify our business strategy, which could materially harm
our future business prospects.
Net cash
used in operations for the six months ended June 30, 2009 was $882,184 as
compared to $2,473,573 for the six months ended June 30, 2008. The
decrease in cash used in operations in 2009 as compared to 2008 is principally
the result of the estimated federal income tax receivable, increased revenues
and lower operating expenses in 2009.
Net cash
used in investing activities for the six months ended June 30, 2009 was $64,932
as compared to cash used of $124,892 for the same period in the prior
year. During the first half of 2009, we received and installed seven
Barocycler instruments under collaboration or lease agreements while selling two
demonstration units. Cash used in the six months of 2008 was for the
purchase of furniture and fixtures associated with our move to new corporate
offices, and for Barocycler instruments that we purchased and installed under
collaboration or lease agreements.
Net cash
provided by financing activities for the six months ended June 30, 2009 was
$1,567,924. On February 12, 2009, we completed a private placement,
pursuant to which we sold an aggregate of 156,980 units for a purchase price of
$11.50 per unit (the “Purchase Price”),
resulting in gross proceeds to us of $1,805,270 (the “Private
Placement”). Each unit consists of (i) one share of
a newly created series of preferred stock, designated “Series A Convertible
Preferred Stock,” par value $0.01 per share (the “Series A Convertible
Preferred Stock”) convertible into 10 shares of our common stock, (ii) a
warrant to purchase, at the purchaser’s election to be made within 7 days of the
closing, either 10 shares of our common stock, at an exercise price equal to
$1.25 per share, with a term expiring 15 months after the date of closing
(“15 Month Common
Stock Warrant”), or one share of Series A Convertible Preferred Stock at
an exercise price equal to $12.50 per share, with a term expiring 15 months
after the date of closing (“15 Month Preferred Stock
Warrant”) (all of the purchasers elected the 15 Month Preferred Stock
Warrants); and (iii) a warrant to purchase 10 shares of common stock at an
exercise price equal to $2.00 per share, with a term expiring 30 months after
the date of closing (the “30 Month Common Stock
Warrants”). The expenses related to the offering totaled
approximately $233,000.
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.
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 leased approximately
5,500 square feet of office space, with an option for an additional 12
months. We exercised the renewal option to extend the lease term
until July 14, 2010. We pay approximately $6,500 per month for the
use of these facilities.
In
connection with the reduction of staff levels and consolidation of operations in
Rockville, MD and Woburn, MA, the Company moved its research and development
activities within Massachusetts.
Royalty
Commitments
In 1996,
we acquired our initial equity interest in BioSeq, Inc., which at the time was
developing our original pressure cycling technology. BioSeq, Inc. acquired
its pressure cycling technology from BioMolecular Assays, Inc. (“BMA”) under a
technology transfer and patent assignment agreement. In 1998, we purchased
all of the remaining outstanding capital stock of BioSeq, Inc., and at such
time, the technology transfer and patent assignment agreement was amended to
require us to pay BMA a 5% royalty on sales of products or services that
incorporate or utilize the original pressure cycling technology that BioSeq,
Inc. acquired from BMA. We are also required to pay BMA 5% of the proceeds
from any sale, transfer, or license of all or any portion of the original
pressure cycling technology. These payment obligations terminate in
2016. During the three months ended June 30, 2009 and 2008, we
incurred $6,176 and $5,451, respectively in royalty expense associated with our
obligation to BMA. During the six months ended June 30, 2009 and
2008, we incurred $15,002 and $8,451, respectively in royalty expense associated
with our obligation to BMA.
In
connection with our acquisition of BioSeq, Inc., we licensed certain limited
rights to the original pressure cycling technology back to BMA. This
license is non-exclusive and limits the use of the original pressure cycling
technology by BMA solely for molecular applications in scientific research and
development and in scientific plant research and development. BMA is
required to pay us a royalty equal to 20% of any license or other fees and
royalties, but not including research support and similar payments, it receives
in connection with any sale, assignment, license or other transfer of any rights
granted to BMA under the license. BMA must pay us these royalties
until the expiration of the patents held by BioSeq, Inc. in 1998, which we
anticipate will be in 2016. We have not received any royalty payments from
BMA under this license.
Battelle
Memorial Institute
In
December 2008, we entered into an exclusive patent license agreement with the
Battelle Memorial Institute ("Battelle"). The licensed technology is described
in the patent application filed by Battelle on July 31, 2008 (US serial number
12/183,219). This application includes subject matter related to a method and a
system for improving the analysis of protein samples, including through an
automated system utilizing pressure and a pre-selected agent to obtain a
digested sample in a significantly shorter period of time than current methods,
while maintaining the integrity of the sample throughout the preparatory
process. Pursuant to the terms of the agreement, we paid Battelle a
non-refundable initial fee. In addition to royalty payments on net
sales on “licensed products”, we are obligated to make minimum royalty payments
for each year that we retain the rights outlined in the patent license
agreement. and we are required to have our first commercial sale of the licensed
products within one year following the issuance of the patent covered by the
licensed technology.
Severance
and Change of Control Agreements
Each of
our executive officers is entitled to receive a severance payment if terminated
by the Company without cause. The severance benefits would include a payment in
an amount equal to one year of each executive officer’s annualized base salary
compensation plus accrued paid time off. Additionally, each executive officer
will be entitled to receive medical and dental insurance coverage for one year
following the date of termination. The total commitment related to these
agreements in the aggregate is approximately $1.0 million.
Each of
our executive officers, other than Mr. Richard T. Schumacher, our President and
Chief Executive Officer, is entitled to receive a change of control payment in
an amount equal to one year of such executive officer’s annualized base salary
compensation, accrued paid time off, and medical and dental coverage, in the
event of a change of control of the Company. In the case of Mr.
Schumacher, this payment would be equal to two years of annualized base salary
compensation, accrued paid time off, and two years of medical and dental
coverage. The total commitment related to these agreements in the aggregate is
approximately $1.3 million. The severance payment is
meant to induce the executive to become an employee of the Company and to remain
in the employ of the Company, in general, and particularly in the occurrence of
a change in control.
RECENT ACCOUNTING
STANDARDS
On
January 1, 2008, the Company adopted 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, we adopted
SFAS 157 as of January 1, 2008 for financial assets and liabilities only. There
was no significant effect on our financial statements. We do not
believe that the adoption of SFAS 157 to non-financial assets and liabilities
will significantly effect our financial statements.
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:
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Acquisition
costs will be generally expensed as
incurred;
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Non-controlling
interests (formerly known as “minority interests” – see SFAS 160
discussion below) will be valued at fair value at the acquisition
date;
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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;
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In-process
research and development will be recorded at fair value as an
indefinite-lived intangible asset at the acquisition
date;
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Restructuring
costs associated with a business combination will be generally expensed
subsequent to the acquisition date;
and
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Changes
in deferred tax asset valuation allowances and income tax uncertainties
after the acquisition date generally will affect income tax
expense.
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In April
2008, the FASB issued FASB Staff Position (“FSP”) No. FAS 142-3, Determination
of the Useful Life of Intangible Assets (“FSP 142-3”). FSP 142-3 removes the
requirement under Statement of Financial Accounting Standards (SFAS) No. 142,
Goodwill and Other Intangible Assets, to consider whether an intangible asset
can be renewed without substantial cost or material modifications to the
existing terms and conditions, and replaces it with a requirement that an entity
consider its own historical experience in renewing similar arrangements, or a
consideration of market participant assumptions in the absence of historical
experience. FSP 142-3 also requires entities to disclose information that
enables users of financial statements to assess the extent to which the expected
future cash flows associated with the asset are affected by the entity’s intent
and/or ability to renew or extend the arrangement. We have adopted FSP 142-3.
The adoption of this statement does not have any impact to our financial
statements.
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.
We have
adopted SFAS 160 and the statement does not have a material affect on our
consolidated results of operations and financial condition.
In March
2008, the FASB issued Statement of Financial Accounting Standards No. 161,
“Disclosures about Derivative Instruments and Hedging Activities (“SFAS 161”), –
an amendment of FASB Statement No. 133”, which requires additional disclosures
about the objectives of derivative instruments and hedging activities, the
method of accounting for such instruments under SFAS No. 133 and its related
interpretations, and a tabular disclosure of the effects of such instruments and
related hedged items on our financial position, financial performance, and cash
flows. We adopted SFAS No. 161 and our adoption of SFAS No. 161 did not have a
material impact on our financial statements.
On June
30, 2009, the Company adopted Statement of Financial Accounting Standards No.
165, “Subsequent Events (“SFAS 165”), which requires disclosure of the period
after the balance sheet date during which management of a reporting entity
should evaluate events or transactions that may occur for potential recognition
or disclosure in the financial statements. The adoption of SFAS 165
did not have a material impact on our financial statements.
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
filings are 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 was
necessarily required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures.
As of
June 30, 2009, we carried out an evaluation, under the supervision and with the
participation of our management, including our Principal Executive Officer and
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 Principal Executive Officer and 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 Principal Executive Officer and Principal Financial
Officer, to allow timely decisions regarding required disclosure.
There
have been no changes in our internal controls 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 controls over
financial reporting.
PART II. OTHER
INFORMATION
ITEM 6. EXHIBITS
Exhibits
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Reference
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31.1
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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
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Filed
herewith
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31.2
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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
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Filed
herewith
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32.1
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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
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Filed
herewith
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32.2
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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
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Filed
herewith
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SIGNATURES
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.
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PRESSURE
BIOSCIENCES, INC.
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Date: August
10, 2009
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By:
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/s/ Richard T.
Schumacher
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Richard
T. Schumacher
President
& Chief Executive Officer
(Principal Executive Officer, Principal Financial Officer and
Principal Accounting
Officer)
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