PRESSURE BIOSCIENCES INC - Annual Report: 2007 (Form 10-K)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
10-K
(Mark
One)
|
|
|
|
x
|
Annual
Report Pursuant to Section 13 or 15(d) of the Securities Exchange
Act of
1934
|
|
For
the fiscal year ended December 31, 2007
or
|
o
|
Transition
Report Pursuant to Section 13 or 15(d) of the Securities Exchange
Act of
1934
|
|
For
the transition period from ___________________ to
_______________________
|
PRESSURE
BIOSCIENCES, INC.
(Exact
Name of Registrant as Specified in its Charter)
Massachusetts
|
|
04-2652826
|
(State
or Other Jurisdiction of Incorporation or Organization)
|
|
(I.R.S.
Employer 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)
|
|
|
Securities
registered pursuant to Section 12(b) of the Act:
|
|
Title
of Each Class
|
Name
of Each Exchange on Which Registered
|
Common
Stock, par value $.01 per share
Preferred
Share Purchase Rights
|
The
Nasdaq Stock Market, LLC
|
Securities
registered pursuant to Section 12(g) of the Act:
|
|
|
|
(Title
of Class)
|
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined
in
Rule 405 of the Securities Act. Yes
o No x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or 15(d) of the Exchange Act. Yes o No
x
Indicate
by check mark whether the registrant: (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Exchange Act during the past 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.
Yes
x No
o
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to
this
Form 10-K.
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
(Do not check if smaller reporting
company)
|
Smaller reporting company x |
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No
x
The
aggregate market value of the voting and non-voting common stock held by
non-affiliates of the registrant June 29, 2007 was $8,783,302 based on the
closing price of the common stock as quoted on the NASDAQ Capital Market on
that
date.
As
of
March 21, 2008, there were 2,192,175 shares of the registrant’s common stock
outstanding.
Documents
Incorporated by Reference
TABLE
OF
CONTENTS
Page
|
||
PART
I
|
||
|
|
|
Item
1.
|
Business
|
1
|
|
|
|
Item
1A.
|
Risk
Factors
|
12
|
|
|
|
Item
1B.
|
Unresolved
Staff Comments
|
18
|
Item
2.
|
Properties
|
18
|
Item
3.
|
Legal
Proceedings
|
18
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
18
|
PART
II
|
||
Item
5.
|
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
|
19
|
|
||
Item
6.
|
Selected
Financial Data
|
20
|
|
|
|
Item
7.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operation
|
20
|
Item
7A.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
28
|
Item
8.
|
Financial
Statements and Supplementary Data
|
29
|
Item
9.
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
|
49
|
Item
9A.
|
Controls
and Procedures
|
49
|
Item
9B.
|
Other
Information
|
50
|
PART
III
|
||
Item
10.
|
Directors,
Executive Officers and Corporate Governance
|
51
|
Item
11.
|
Executive
Compensation
|
55
|
Item
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
59
|
Item
13.
|
Certain
Relationships and Related Transactions, and Directors
Independence
|
60
|
Item
14.
|
Principal
Accountant Fees and Services
|
61
|
PART
IV
|
||
Item
15.
|
Exhibits
|
62
|
Introductory
Comment
Throughout
this Annual Report on Form 10-K, the terms “we,” “us,” “our,” “the Company”
and “our company” refer to Pressure BioSciences, Inc., a Massachusetts
corporation, and, unless the context indicates otherwise, also includes our
wholly-owned subsidiaries.
PART
I
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Annual Report on Form 10-K contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended (the
“Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”). 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
plans and expectations with respect to our pressure cycling technology
(PCT) operations;
|
|
-
|
potential
growth in the market for our PCT products;
|
|
-
|
market
acceptance and the potential for commercial success of our PCT
products;
|
|
-
|
our
belief that PCT provides a superior solution for sample
preparation;
|
-
|
the
expected development and success of new product
offerings;
|
|
|
-
|
the
potential applications for PCT;
|
-
|
the
expected benefits and results from our research and development efforts;
|
|
-
|
the
expected benefits and results from our collaboration
program;
|
|
|
-
|
our
belief that we have sufficient liquidity to finance operations into
early
2009;
|
-
|
our
expectation of obtaining additional research grants from the government
in
the future;
|
|
|
-
|
the
amount of cash necessary to operate our business;
|
|
-
|
our
ability to raise additional capital when needed;
|
|
-
|
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 the 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. Factors that could cause or
contribute to differences in our future financial results include those
discussed in the risk factors set forth in Part I, Item 1A of this Report as
well as those discussed elsewhere in this Report. We qualify all of our
forward-looking statements by these cautionary statements.
ITEM 1. |
BUSINESS.
|
Throughout
this document we use the following terms; Barocycler®, PULSE®, and BioSeq®,
which are registered trademarks of the Company. We also use the terms
ProteoSolveTM,
ProteoSolveLRSTM,
the
Power of PCT, all of which are unregistered trademarks of the Company.
Overview
We
are a
life sciences company focused on the development and commercialization of
a
novel, enabling, platform technology called pressure cycling technology (“PCT”).
PCT uses cycles of hydrostatic pressure between ambient and ultra-high levels
(up to 35,000 psi and greater) to control bio-molecular interactions.
Our
pressure cycling technology uses internally developed instrumentation that
is
capable of cycling pressure between ambient and ultra-high levels at controlled
temperatures to rapidly and repeatedly control the interactions of
bio-molecules. Our instrument, the Barocycler®, and our internally developed
consumables product line, which includes PULSE (Pressure Used to Lyse Samples
for Extraction) Tubes as well as the ProteoSolveLRSTM
kit
for
the detergent-free extraction of proteins from lipid-rich samples, together
make
up the PCT Sample Preparation System (“PCT SPS”).
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;
|
|
-
|
pathogen
inactivation;
|
|
-
|
protein
purification;
|
|
-
|
control
of chemical (enzymatic) reactions; and
|
|
-
|
immunodiagnostics.
|
In
2007,
we continued to engage in activities to support the commercialization of our
PCT
product line within genomic and proteomic sample preparation. These activities
included the following:
·
|
Barocycler
NEP2320.
We introduced for sale the Barocycler NEP2320, a smaller, more compact
version of our Barocycler NEP3229. The Barocycler NEP2320 was originally
developed as a demonstration unit for our sales staff. However, we
determined to offer this instrument as a separate product for sale
following market feedback for a smaller instrument with similar
capabilities and features as our larger Barocycler NEP3229.
|
·
|
Expanded
our Consumables Product Line.
We introduced for sale our ProteoSolveLRS
kit to expand our consumables product line. Our ProteoSolveLRS
kit offers researchers a unique method for the safe, rapid, efficient
and
reproducible extraction of proteins from lipid-rich samples, including
adipose and brain tissues, organelles, and membrane preparations,
without
the use of detergents, which can be harmful to the sample extraction
process.
|
·
|
CE
Mark Approval.
Our Barocycler instrumentation received CE Marking, which means that
our
Barocycler instruments meet the essential requirements of the relevant
European health, safety and environmental protection legislation.
The CE
Mark is an important step toward our anticipated full-scale launch
of our
PCT product line in Europe during
2008.
|
·
|
Expanded
Our Sales Force.
We expanded our domestic sales force from one regional sales director
in
the beginning of the year to seven at the end of the year. Additionally,
in February 2008 we re-aligned our senior management team to support
a
full commercialization effort by hiring Matthew B. Potter as our
Vice
President of Sales and allowing Nathan P. Lawrence Ph.D., formerly
responsible for marketing and sales, to focus exclusively on marketing
and
collaboration support, as our Vice President of Marketing.
|
-
1
-
·
|
Expanded
Our International Distribution Network.
We expanded our international distribution network from one long-term
distribution partnership at the beginning of the year to three long-term
partnerships at the end of the year. As of December 31, 2007 our
distribution relationships covered Japan, France, Belgium, Switzerland
and
South Korea.
|
Since
we
began operations as Pressure BioSciences in February 2005, we have installed
33
Barocycler instruments, including 20 instruments in 2007, 8 instruments in
2006,
and 5 instruments in 2005. Our customers include researchers at academic
laboratories, government agencies and biotechnology, pharmaceutical and other
life sciences companies in the United States, and three foreign distribution
partners.
Corporate
Information
We
were
incorporated in the Commonwealth of Massachusetts in August 1978 as Boston
Biomedica, Inc. In September 2004, we completed the sale of the Boston Biomedica
core business units and began to focus exclusively on the development and
commercialization of pressure cycling technology. Following this change in
business strategy, we changed our legal name from Boston Biomedica, Inc. to
Pressure BioSciences, Inc., or PBI, and commenced operations as Pressure
BioSciences in February 2005.
Available
Information
Our
Internet website address is http://www.pressurebiosciences.com. Through our
website, we make available, free of charge, our annual report on Form 10-K,
quarterly reports on Form 10-Q, current reports on Form 8-K and any amendments
to those reports, as soon as reasonably practicable after we electronically
file
such material with, or furnish it to, the Securities and Exchange Commission
(“SEC”). These SEC reports can be accessed through the investor relations
section of our website. The information found on our website is not part of
this
or any other report we file with or furnish to the SEC.
You
may
read and copy any materials we file with the SEC at the SEC’s Public Reference
Room at 100 F Street, NE, Washington, DC 20549. You may obtain information
on
the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.
The SEC also maintains an Internet website that contains reports, proxy and
information statements, and other information regarding Pressure BioSciences
and
other issuers that file electronically with the SEC. The SEC’s Internet website
address is http://www.sec.gov.
Sample
Preparation for Genomic, Proteomic, and Small Molecule
Studies
The
Market
Since
February 2005, we have focused substantially all of our research and development
and commercialization efforts on sample preparation for genomic, proteomic,
and
small molecule studies. This market is comprised of academic and government
research institutions, biotechnology and pharmaceutical companies, and other
public and private laboratories that are engaged in studying genomic, proteomic
and small molecule material within plant and animal cells and tissues.
We
elected to initially focus our resources in the market of genomic, proteomic,
and small molecule sample preparation because we believe it is an area
that:
-
|
is
a rapidly growing market;
|
|
-
|
has
a large and immediate need for better technology;
|
|
-
|
is
comprised mostly of research laboratories, which are subject
to minimal
governmental regulation;
|
|
-
|
is
the least technically challenging application for the development
of our
products;
|
|
-
|
is
compatible with our technical core competency; and
|
|
-
|
is the area in which we currently have strong patent protection. |
We
believe that our existing Barocycler instrumentation fills an important and
growing need in the sample preparation market for the safe, rapid, versatile,
reproducible, and quality extraction of nucleic acids, proteins, and small
molecules from a wide variety of plant and animal cells and tissues. We continue
to invest a significant amount of our engineering resources toward the continued
improvement of our existing instruments and the development of future
instrumentation.
-
2
-
Sample
Extraction Process
The
process of preparing samples for genomic, proteomic, and small molecule studies
includes a crucial step called sample extraction, or sample disruption. This
is
the process of extracting nucleic acid (“DNA” and/or “RNA”), proteins, or small
molecules from the plant or animal cells and tissues that are being studied.
Sample preparation is widely regarded as a significant impediment to research
and discovery, and sample extraction is generally regarded as the key part
of
sample preparation. Our current commercialization efforts are based upon our
belief that pressure cycling technology provides a superior solution to sample
extraction compared to other available technologies or procedures, and can
thus
significantly improve sample preparation.
Collaboration
Program
Our
collaboration program is an important element of our business strategy.
Initiating a collaboration with a researcher usually involves the installation
of a Barocycler instrument for an agreed upon period of time, generally three
to
six months, and the execution of an agreed upon work plan. Our primary
objectives for entering into a collaboration agreement include:
-
|
the
development of a new application for PCT in sample preparation;
|
-
|
the
advancement and validation of our understanding of PCT within an
area of
the life sciences in which we have already have products;
|
-
|
the
demonstration of effectiveness and impact of PCT to specific research
scientists whom we believe can have a positive impact on market acceptance
of PCT; and
|
-
|
the
expectation of peer-reviewed publications and/or presentations at
scientific meetings by a third party on the merits of PCT.
|
Since
we
initiated our collaboration program in June 2005, we have placed Barocycler
instruments in approximately twenty sites, resulting in thirty publications
and
presentations by third party researchers. We believe that this program has
provided, and continues to provide us with independent and objective data about
PCT from well respected laboratories throughout the United States. Below is
a
list of selected publications and presentations that have been made by various
researchers based on their experiences with PCT:
Investigator
|
Institution
|
Title
|
Venue/Journal
|
Venue
Type
|
Date
|
|||||
Nikhil
Patel
|
Bascom
Palmer Eye Institute, University of Miami
|
Strategies
to recover proteins from ocular tissues for proteomics
|
Proteomics
|
Journal
Article
|
March
5, 2008
|
|||||
|
|
|
|
|
|
|||||
Mourad
Ferhat
|
Universite
de Lyon
|
Application
of Pressure Cycling Technology to RNA Extraction from Legionella
Pneumophila Cells
|
Meeting
of the French Association on Legionella
|
Poster
|
October
18-19, 2007
|
|||||
|
|
|
|
|
|
|||||
Patricia
Okubara
|
USDA
ARS
|
Improved
extraction of Rhizoctonia and Pythium DNA from
wheat roots and soil samples using pressure cycling
technology
|
Canadian
Journal of Plant Pathology
|
Journal
Article
|
September
2007
|
|||||
|
|
|
|
|
|
|||||
Paul
Pevsner
|
Department
of Pharmacology, New York University School of Medicine
|
Colon
Cancer: Protein Biomarkers in Tissue and Body Fluids
|
BMSS
29th Annual Meeting, Heriot- Watt University, Edinburgh
|
Poster
|
September
9th – 12th, 2007
|
|||||
|
|
|
|
|
|
|||||
Valerie
S. Calvert
|
George
Mason University
|
A
Systems Biology Approach to the Pathogenesis of Obesity-related
Nonalcoholic Fatty Liver Disease Using Reverse Phase Protein Microarrays
for Multiplexed Cell Signaling Analysis
|
Hepatology
|
Journal
Article
|
June
27, 2007
|
|||||
|
|
|
|
|
|
|||||
Louis
S. Tisa
|
University
of New Hampshire, Department of Microbiology
|
Pressure
Cycling Technology (PCT) Facilitates Analysis of the Frankia
Proteome
|
U.S.
Hupo 2007
|
Poster
|
March
4-8, 2007
|
|||||
|
|
|
|
|
|
|||||
Frank
A. Witzmann
|
Indiana
University Medical School, Department of Cellular and Integrative
Physiology
|
Applications
of Pressure Cycling Technology (PCT) to Tissue Sample Preparation
for
One-and Two-Dimensional Gel Electrophoresis.
|
Electrophoresis
|
Journal
Article
|
February
15, 2007
|
|||||
|
|
|
|
|
|
|||||
Rita
Wong
|
DermTech
International
|
Analysis
of RNA Recovery and Gene Expression in the Epidermis Using Non-invasive
Tape Stripping
|
Journal
of Dermotological Science
|
Journal
Article
|
November
2006
|
|||||
|
|
|
|
|
|
|||||
D.
Alan Kerr
|
University
of Louisville
|
Pressure
Cycling Technology and Its Application in Steroid Receptor
Extraction
|
Journal
of Clinical Ligand Assay
|
Journal
Article
|
Spring
2004
|
Company
Products
Our
PCT
products have been developed to allow researchers to harness the
Power of PCT
to
improve scientific research studies in the life sciences field. All of our
products are developed with the expectation of meeting the needs of scientific
personnel while enhancing the safety, speed, and quality that is available
to
them with existing sample preparation technology.
-
3
-
Barocycler
Instrumentation
Our
Barocycler product line consists of laboratory instrumentation that subjects
a
sample to cycles of pressure from ambient to ultra-high levels and then back
to
ambient, all in a precisely controlled manner. Our instruments, the Barocycler
NEP3229 and Barocycler NEP2320, use cycles of high hydrostatic pressure to
quickly and efficiently break up the cellular structures of a specimen releasing
nucleic acids, proteins and small molecules from the specimen in our consumable
tube, referred to as our PULSE tubes. Our Barocycler instrumentation is designed
to fit on a laboratory bench top, inside a biological safety cabinet, or on
the
shelf of a cold room of a laboratory. Our instruments have an external chiller
hook-up (to control temperature during the PCT process), automatic fill and
dispensing valves, and an integrated micro-processor keypad. The microprocessor
is capable of saving up to 99 specific PCT protocols, so the researcher can
achieve maximum reproducibility for the extraction of genomic, proteomic, or
small molecules from various biological samples. Our Barocycler instruments,
together with our consumable products described below, make up our current
PCT
sample preparation system.
Barocycler
NEP3229 –
The Barocycler NEP3229 contains two units, an upper, user interface and a lower,
power source, comprised primarily of a 1.5 horsepower motor and pump assembly.
Combined, the two components of the NEP3229 weigh approximately 350 pounds.
The
Barocycler NEP3229 is capable of processing up to three samples simultaneously
using our specially designed, single-use PULSE Tubes.
Barocycler
NEP2320 –
The Barocycler NEP2320 is a smaller and more compact version of our NEP3229
unit. It weighs approximately 75 pounds, processes one sample at a time, and
works on compressed air (pneumatic) and not hydraulics like the larger NEP3229
unit. Because this instrument is pneumatic, the NEP2320 can be easily attached
by an air hose to a typical 85 psi air compressor found in most scientific
laboratories, to many consumer-sold portable compressors, or even to bottled
gas. This instrument is currently being used by our sales force as a
demonstration instrument and is being marketed as a second instrument
alternative to our PCT Sample Preparation System.
Consumable
Products
PULSE
Tubes (FT500) –
Our current PULSE Tube, the FT500, is a specially-designed, plastic, single-use,
processing container with two chambers separated by a small disk with about
sixty small holes. This small disk is referred to as a Lysis Disk. PULSE Tubes
transmit the power of PCT from the Barocycler instrument to the sample. In
sample extraction, the specimen is placed on the Lysis Disk, the PULSE Tube
is
placed in the pressure chamber of the Barocycler instrument, pressure chamber
fluid is added, and pressurization begins. As pressure increases, a small
moveable piston (the Ram) pushes the specimen from the top (sample) chamber,
through the Lysis Disk and into the bottom (fluid retention) chamber. When
pressure is released, the sample (now partially homogenized) is pulled back
through the Lysis Disk by the receding Ram. The combination of physical passage
through the Lysis Disk, rapid pressure changes, and other biophysical mechanisms
related to cycled pressure break up the cellular structures of the specimen
to
quickly and efficiently release nucleic acids, proteins, and small
molecules.
ProteoSolveLRS –
(ProteoSolve for Lipid
Rich
Samples)
is a PCT-dependent method for the safe, rapid, efficient, and reproducible
extraction of proteins from lipid-rich samples, including adipose and brain
tissues, organelles, and membrane preparations. Proteomic analysis of these
types of samples is widely used in the study of diabetes, cancer, ALS, heart
disease, and a number of other serious human disorders related to obesity.
We
believe that this PCT-dependent method of protein extraction from lipid-rich
samples offers significant advantages over current extraction techniques,
primarily due to the ability to use certain organic solvents instead of harsh
detergents in the extraction process. Harsh detergents are known to compromise
the integrity of many proteins; therefore the use of these detergents requires
a
very careful and time consuming removal process. The kit includes 12
specially-designed PULSE Tubes, certain organic solvents, other reagents, and
an
instruction sheet on how to utilize this patent-pending process to enhance
the
extraction of proteins from lipid-rich samples.
We
believe our discovery of this PCT-dependent, detergent-free process, and the
subsequent development of the ProteoSolveLRS
kit, is
an example of how our significant investment in research and development can
result in the development of important applications of PCT in a large and
important area of the life sciences.
-
4
-
Government
Grants –
We view federal agency grants to be an important part of our business plan.
These types of grants allow us to bill the federal agency for work that we
are
planning to perform as part of the development of our technology, and we expect
that such work will support our commercialization efforts. Additionally, if
our
work in SBIR Phase I grants is successful, then we expect to apply for larger
NIH SBIR Phase II grants. Such larger grants are typically in excess of $750,000
and can support significant research projects in areas we would expect to
support with internal funds should SBIR Phase II grants not be awarded. To
date
we have been awarded two National Institutes of Health (“NIH”) Small Business
Innovation Research (“SBIR”) Phase I Grants. The first grant was awarded in
September 2006 to fund experiments to demonstrate the feasibility of using
pressure cycling technology in the development of a new method for the
extraction of clinically important protein biomarkers, sub-cellular molecular
complexes, and organelles from cells and tissues. Our second NIH SBIR Phase
I
grant was awarded in March 2007, to fund the investigation of the purification
of nucleic acids using PCT. The amount awarded under each of these grants was
approximately $150,000.
Extended
Service Contracts
- We
offer extended service contracts on our laboratory instrumentation to all of
our
customers. These service contracts allow a customer who purchases a Barocycler
instrument to receive on-site scheduled preventative maintenance, on-site repair
and replacement of all worn or defective component parts, and telephone support,
all at no incremental cost, for the life of the service contract. We have
offered one-year and four-year extended service contracts to customers who
purchase Barocycler instruments.
Fee-for-Service –
We will occasionally perform PCT services on a fee-for-service basis. We may
enter into these types of arrangements if we believe that the customer has
a
high likelihood of purchasing a PCT Sample Preparation System or if we believe
that the customer will publish or present results of the work performed in
scientific journals or in scientific meetings.
Other
Applications of Pressure Cycling Technology
PCT
is an
enabling, platform technology based on a bio-physical process that had not
previously been used to control bio-molecular interactions. During its early
development, under the legacy business of Boston Biomedica, Inc., our scientists
were researching and developing applications of pressure cycling technology
in
many areas of the life sciences, including genomic, proteomic, and small
molecule sample preparation. The data generated during these early years,
combined with the data generated since PBI began significant operations in
February 2005, form the basis of knowledge that we believe will allow us to
successfully commercialize PCT both within and outside of the sample preparation
market.
Our
research and development efforts have shown that, in addition to genomic,
proteomic and small molecule sample preparation, PCT is potentially beneficial
in a number of other areas of the life sciences, including pathogen
inactivation, protein purification, control of chemical (particularly enzymatic)
reactions, and immunodiagnostics. Our pursuit of these markets, however, depends
on a number of factors, including our success in commercializing PCT in the
area
of sample preparation, our judgment regarding the investment required to be
successful in these areas, and the value of these markets to our company. Below
is a brief explanation of each of these additional potential applications and
a
short description of why we believe PCT can be used to improve scientific
studies in these areas.
Pathogen
Inactivation
Biological
products manufactured for human use, such as blood, vaccines, and drugs, are
put
through rigorous processing protocols in an effort to minimize the potential
of
that product to transmit disease. These protocols may include methods to remove
infectious materials (such as pre-processing testing, filtration, or
chromatography), or methods to inactivate infectious materials that are not
captured in the removal steps (such as pasteurization, irradiation, and solvent
detergent inactivation). Notwithstanding current diligence in both the removal
and inactivation steps, significant concern remains that some bacteria and
viruses capable of transmitting infection to recipients may not be removed
or
inactivated with current procedures. In addition, some removal and inactivation
methods may not be useful because of cost, safety, ease-of-use, or other
practical concerns. To that end, we believe that a new inactivation method
is
needed that can safely, rapidly and inexpensively inactivate pathogens in blood,
vaccines, and drugs without the need for chemical or other potentially toxic
additives. We believe we have successfully generated proof-of-concept that
PCT
can satisfy this need. We believe that compared to current procedures, a process
that uses PCT has the potential to increase safety and yield, lower cost, and
decrease the potential side effects of current methods. We have been issued
US,
European, and Japanese patents for this PCT-dependent inactivation
technology.
-
5
-
Protein
Purification
Many
vaccines and drugs are comprised of proteins. These proteins need to be purified
from complex mixtures as part of the manufacturing process. Current purification
techniques often result in the loss of a significant amount of the protein,
therefore, any method that could increase the amount of protein being recovered
in the purification step, would subsequently lead to a reduction in cost to
the
manufacturer. We believe we have successfully generated proof-of-concept that
PCT can satisfy this need. We believe that compared to current purification
procedures, a process that uses PCT has the potential to increase protein
recovery, increase the quality of the product, and lower production costs.
We
have been issued US and European patents in this area.
Control
of Chemical (Particularly Enzymatic) Reactions
Chemical
reactions encompass many important interactions in nature. Methods used to
control chemical reactions could have a positive effect on the quality, speed,
and overall result of the reaction. The control and detection of chemical
reactions is particularly useful in the biotechnology field for synthesizing
and
characterizing such molecules as nucleic acids and polypeptides. We believe
that
PCT offers distinct advantages in controlling chemical reactions over current
methods, since PCT can provide precise, automated control over the timing and
synchronization of chemical reactions, particularly enzymatic reactions. We
have
been issued US and European patents in this area.
Immunodiagnostics
Many
tests used in the clinical laboratory today are based on the formation of a
complex between two proteins, such as an antigen and an antibody. Such
“immunodiagnostic” methods are used for the detection of infectious agents (such
as HIV, hepatitis viruses, and West Nile virus), as well as for endocrine,
drug
testing, and cancer diagnostics. We have generated proof-of-concept that PCT
may
be used to control bio-molecular interactions between proteins, such as antigens
and antibodies. We believe this capability may provide a greater degree of
sensitivity and quantitative accuracy in immunodiagnostic testing than that
offered by methods that are available today. We have been issued US and European
patents in this area.
Customers
Our
customers include researchers at academic laboratories, government agencies,
biotechnology, pharmaceutical, and other life science companies in the United
States. Our customers also include three foreign distribution partners that
we
have entered into agreements with over the past 12 months. During 2007, we
sold
limited quantities of PCT products to all of these customer groups. Our goal
in
2008 is to continue our market penetration in these target groups, and to
increase our commercial operations to serve researchers at these types of
institutions on a global basis. We also feel that there is a significant
opportunity to sell additional Barocycler instrumentation to additional
laboratories at current customer institutions.
If
we are
successful in commercializing PCT in applications beyond our current focus
area
of genomic, proteomic, and small molecule sample preparation, our potential
customer base could expand to include hospitals, reference laboratories, blood
banks and transfusion centers, plasma collection centers, pharmaceutical
manufacturing plants, and other sites involved in each specific
application.
Competition
We
compete with companies that have existing technologies for the extraction of
nucleic acids, proteins, and small molecules from “hard-to-lyse” cells and
tissues, including methods such as mortar and pestle grinding, sonication,
rotor-stator homogenization, French Press, bead beating, freezer milling,
enzymatic digestion, and chemical dissolution. We believe that there are a
number of significant issues related to the use of these methods, including:
complexity, sample containment, cross-contamination, shearing of bio-molecules
of interest, limited applicability to different sample types, ease-of-use,
reproducibility, and cost. We believe that the PCT Sample Preparation
System offers a number of significant advantages over these methods, including
labor reduction, temperature control, precision, reproducibility, versatility,
efficiency, simplicity, and safety. To compete, we must be able to clearly
and conclusively demonstrate to potential customers that our products provide
these improved performance capabilities.
-
6
-
We
believe that our PCT Sample Preparation System is a novel and enabling system
for genomic, proteomic and small molecule sample preparation. As such,
many users of current manual techniques will need to be willing to challenge
their existing methods of sample preparation and invest time to evaluate a
method that could change their overall workflow in the sample preparation
process, prior to adopting our technology. We are also aware that the cost
of the PCT Sample Preparation System may be greater than the cost of many of
the
other techniques currently employed. Consequently, we are focusing our
sales efforts on those product attributes that we believe will be most important
and appealing to potential customers, namely versatility, reproducibility,
quality, and safety.
PCT
Compared to Existing Technologies
There
are
several incumbent technologies that offer scientists varying degrees of success
in sample preparation. For several years, PBI scientists have been performing
comparative studies with hundreds of samples to better understand how pressure
cycling technology compares with these competitive technologies. Depending
on
the area of research and the type of material a scientist may be working with,
there is a different level of importance placed on each attribute. Below is
an
illustration of how pressure cycling technology, in our opinion, compares to
several existing technologies across the key attributes that we have assessed
(with a “-“denoting a negative attribute, and a “+” denoting a positive
attribute).
Incumbent Technologies
|
||||||||||||||||||||
Key
Attributes
|
Sonication
|
Bead
Beating |
Tissue
Homogenizer
|
Mortar
Pestle
|
French
Press
|
PCT
|
||||||||||||||
Safety
|
Closed System |
-
|
+
|
-
|
-
|
-
|
+
|
|||||||||||||
Storage, Transport
|
-
|
+
|
-
|
-
|
-
|
+
|
||||||||||||||
Versatility
|
-
|
-
|
-
|
-
|
-
|
+
|
||||||||||||||
Reproducibility
|
-
|
-
|
-
|
-
|
-
|
+
|
||||||||||||||
Efficiency
|
-
|
-/+
|
-
|
-
|
-
|
+
|
||||||||||||||
Shearing
Molecules
|
Yes
|
Yes
|
Yes
|
Min
|
Yes
|
Min
|
Relationship
with Source Scientific, LLC
In
June 2004, we transferred certain assets and liabilities of our PBI Source
Scientific, Inc. subsidiary to a newly formed limited liability company
known as Source Scientific, LLC. At the time of the transfer, we owned 100%
of
the ownership interests of Source Scientific, LLC. We subsequently sold 70%
of
our ownership interests of Source Scientific, LLC to Mr. Richard Henson and
Mr. Bruce A. Sargeant pursuant to a purchase agreement (the “Source
Scientific Agreement”). As a result of the sale of 70% of our ownership
interests, Mr. Henson and Mr. Sargeant each owned 35% and we owned the
remaining 30% of Source Scientific, LLC. Under the Source Scientific Agreement,
we received notes receivable in the aggregate amount of $900,000 (the “Notes”)
payable at the end of three years bearing 8% interest. The Source Scientific
Agreement offered Mr. Henson and Mr. Sargeant the option (“the
Option”) to purchase our 30% ownership interest in Source Scientific, LLC until
May 31, 2007, at an escalating premium (10-50%) over our initial ownership
value, provided that they first paid off the Notes in their
entirety.
On
May
29, 2007, we executed a consent agreement with Mr. Henson and Mr. Sargeant,
Source Scientific LLC, and BIT Analytical Instruments, Inc. (“the Consent
Agreement”) pursuant to which the Notes were repaid in full in the aggregate
amount of $1,201,534 in principal and interest, and Mr. Henson and Mr. Sargeant
exercised their Option through BIT Analytical Instruments, Inc. to purchase
our
remaining 30% ownership interest in Source Scientific, LLC for an aggregate
price of $578,573. As a result of these transactions, we no longer retain any
direct or indirect ownership interest in Source Scientific, LLC.
-
7
-
The
execution of these transactions, and receipt of the funds, triggered our
recognition of a gain on the sale of assets related to discontinued operations
of $1,534,476, net of income taxes of $218,060, during the three months ended
June 30, 2007.
Manufacturing
and Supply
Source
Scientific, LLC, currently provides all of the manufacturing and assembly
services for our instrumentation products. We plan to continue to utilize Source
Scientific, LLC as our primary assembler and contract manufacturer of our
current, and future, Barocycler instruments. During 2007, however, we initiated
several engineering initiatives to position us for greater independence from
any
one supplier, and we are in the process of developing a network of manufacturers
and sub-contractors to reduce our reliance on any single supplier. Until we
develop a broader network of manufacturers and subcontractors, obtaining
alternative sources of supply or manufacturing services could involve
significant delays and other costs and challenges, and may not be available
to
us on reasonable terms, if at all. The failure of a supplier or contract
manufacturer to provide sufficient quantities, acceptable quality and timely
products at an acceptable price, or an interruption of supplies from such a
supplier could harm our business and prospects.
Research
and Development
Our
research and development activities are split into two functional areas,
applications and engineering.
Applications
Research and Development
Our
highly educated, experienced, and trained staff has years of experience in
molecular and cellular biology, virology, and proteomics. This team focuses
on
the development of PCT-dependent genomic, proteomic, and small molecule sample
preparation methods that we believe will result in an immediate commercial
return-on-investment. To help ensure the success of this objective, Dr. Alex
Lazarev our Vice President of Research & Development and his team meet
regularly with our sales, marketing, and engineering departments to discuss
market needs and trends. Our applications research and development staff is
responsible for the technical review of all scientific collaborations, for
the
support of our marketing and sales departments through the generation of
internal data in a number of areas of market interest, and in the development
of
commercially-viable PCT-dependent products. The discovery and subsequent
development of ProteoSolveLRS
is
an
example of how our investment in applications research and development has
expanded the potential commercialization of PCT.
Engineering
Research and Development
Our
engineering research and development team is focused on the design and
development of new and improved instrumentation and consumable products to
support the commercialization of PCT. Our engineering department is led by
Dr.
Edmund Ting, our Senior Vice President of Engineering, and is supported by
a
full-time senior engineer and third parties. Over the past year, the majority
of
this department’s efforts have been directed towards the development of
additional features and benefits for the NEP3229, on the development of the
NEP2320, and on the design of additional consumables for the PCT Sample
Preparation System. Dr. Ting and his team have also begun the design of a
Barocycler that can achieve pressures of approximately 87,000 psi, (useful
for
both sample preparation and inactivation), a Barocycler with minimal features
and benefits that we believe will fill the need for a very basic, low cost,
“mass market” type instrument, as well as a Barocycler that is small, portable,
and robust enough to take out into the field. Future instrumentation could
also
include larger, more sophisticated, high-throughput, fully-automated instruments
that could process several thousand samples per day.
In
addition to instrumentation, we believe there is significant market demand
for
PCT-dependent consumable products that are designed to process samples smaller,
and larger, than the samples that can be processed by our current PULSE Tubes.
Additionally, we are investing research and development resources toward the
development of application specific PULSE Tubes with the intention of offering
added convenience for our customer base, as well as expanding the application
of
PCT into other areas of life sciences.
Our
research and development expenses were approximately $2.0 million and $1.4
million for the years ended December 31, 2007 and 2006, respectively.
-
8
-
Sales
and Marketing
Our
sales
and marketing efforts are centered on using the independent data developed
and
disseminated by our collaboration partners to help drive the installed base
of
PCT Sample Preparation Systems. The development of scientific data by our
partners and our internal researchers provides our sales and marketing staff
with additional tools that are essential in selling a new technology such as
PCT.
Sales
Direct
US Sales Force
Our
domestic sales force is led by our newly hired Vice President of Sales, Matthew
B. Potter. Mr. Potter is responsible for directing the efforts of our seven
full-time sales directors, each of whom is responsible for covering a specific
region of the United States. We hired and trained six of these regional sales
directors during 2007, primarily in the final four months of the year. We
believe that hiring seasoned sales professionals, with at least 10 - 15 years
of
industry experience, will allow us to more effectively penetrate the market
with
a small, focused sales force. Throughout 2008, we plan to monitor this strategy
and may increase the number of sales professionals if our resources permit
and
we believe that doing so will accelerate our commercialization
efforts.
Foreign
Distributor Network
We
have a
distribution agreement with Veritas Corporation (“Veritas”) of Tokyo, Japan
pursuant to which we granted Veritas exclusive distribution rights to all of
our
products in Japan. The term of this agreement expired on December 31, 2007,
however we are currently operating under the terms of the agreement as we
negotiate a three year extension.
In
December 2007, we signed a distribution agreement with Disruptive Technologies
(“DT”) of Villecresnes, France pursuant to which we granted DT exclusive
distribution rights to all of our products in France, Belgium, and Switzerland.
The agreement is effective from January 1, 2008 through December 31, 2010.
In
September 2007, we signed a distribution agreement with CM Corporation (“CM”),
of Seoul, South Korea pursuant to which we granted CM exclusive distribution
rights to all of our products in South Korea. The agreement is effective from
September 1, 2007 through August 31, 2010.
Marketing
Our
marketing team includes our Vice President of Marketing and a marketing
associate. Our marketing department oversees and directs marketing activities
such as trade show attendance and sponsorship, on-line advertising, website
maintenance and improvement, search engine optimization, creation and
dissemination of a PCT newsletter, market research initiatives, and the
arrangement of on-location seminars, lectures, and demonstrations of PCT
capabilities.
Our
marketing team is also responsible for the overall coordination of our
collaboration programs, from initial set-up, research plan design, and training,
service, and data analysis. Some of these responsibilities are shared with
other
PBI departments (such as R&D), but marketing drives the collaborative
process.
Intellectual
Property
We
believe that protection of our patents and other intellectual property is
essential to our business. Our practice is to file patent applications to
protect technology, inventions, and improvements to inventions that are
important to our business development. We also rely on trade secrets,
know-how, and technological innovations to develop and maintain our potential
competitive position. To date, we have been granted thirteen United States
patents, three European patents, one Australian patent, one Japanese patent,
and
one Canadian patent. Our issued patents expire between 2015 and 2027. Our
failure to obtain adequate patent protection may adversely affect our ability
to
enter into, or affect the terms of, any arrangement for the marketing or sale
of
any of our PCT products. It may also allow our competitors to duplicate our
products without our permission and without compensation.
-
9
-
License
Agreements Relating to Pressure Cycling Technology
In
1996,
we acquired our initial equity interest in BioSeq, Inc., which at the time
was
developing our original pressure cycling technology. BioSeq, Inc. acquired
its pressure cycling technology from BioMolecular Assays, Inc. under a
technology transfer and patent assignment agreement. In 1998, we purchased
all of the remaining outstanding capital stock of BioSeq, Inc., and at such
time, the technology transfer and patent assignment agreement was amended to
require us to pay BioMolecular Assays, Inc. a 5% royalty on our sales of
products or services that incorporate or utilize the original pressure cycling
technology that BioSeq, Inc. acquired from BioMolecular Assays, Inc. We
are also required to pay BioMolecular Assays, Inc. 5% of the proceeds from
any
sale, transfer or license of all or any portion of the original pressure cycling
technology. These payment obligations terminate in 2016. During the
fiscal years ended December 31, 2007 and 2006, we paid BioMolecular Assays,
Inc.
$19,596 and $9,809 in royalties.
In
connection with our acquisition of BioSeq, Inc., we licensed certain limited
rights to the original pressure cycling technology back to BioMolecular Assays,
Inc. This license is non-exclusive and limits the use of the
original pressure cycling technology by BioMolecular Assays, Inc. solely for
molecular applications in scientific research and development and in scientific
plant research and development. BioMolecular Assays, Inc. is required to
pay us a royalty equal to 20% of any license or other fees and royalties, but
not including research support and similar payments, it receives in connection
with any sale, assignment, license or other transfer of any rights granted
to
BioMolecular Assays, Inc. under the license. BioMolecular Assays, Inc. must
pay
us these royalties until the expiration of the patents held by BioSeq, Inc.
in
1998, which we anticipate will be 2016. We have not received any royalty
payments from BioMolecular Assays, Inc. under this license.
Regulation
Many
of
our activities are subject to regulation by governmental authorities within
the
United States and similar bodies outside of the United States. The regulatory
authorities may govern the collection, testing, manufacturing, safety, efficacy,
labeling, storage, record keeping, transportation, approval, advertising, and
promotion of our products, as well as the training of our employees.
All
of
our commercialization efforts to date are focused in the area of genomic,
proteomic, and small molecule sample preparation. We do not believe that our
current Barocycler products used in sample preparation are considered “medical
devices” under the United States Food, Drug and Cosmetic Act (the “Act”) and we
do not believe that we are subject to the law’s general control provisions that
include requirements for registration, listing of devices, quality regulations,
labeling, and prohibitions against misbranding and adulteration. Nor do we
believe that we are subject to regulatory inspection and scrutiny. If, however,
we are successful in commercializing PCT in applications beyond our current
focus area of genomic, proteomic, and small molecule sample preparation, such
as
protein purification, pathogen inactivation and immunodiagnostics, our products
may be considered “medical devices” under the Act, at which point we would be
subject to the law’s general control provisions and regulation by the U.S. Food
and Drug Administration (the “FDA”) that include requirements for registration
listing of devices, quality regulations, labeling, and prohibitions against
misbranding and adulteration. The process of obtaining approval to market these
devices in the other potential applications of PCT would be costly and time
consuming and could prohibit us from pursuing such markets.
We
may
also become subject to the European Pressure Equipment Directive, which requires
certain pressure equipment meet certain quality and safety standards. We do
not
believe that we are currently subject to this directive because our Barocycler
instruments are below the threshold documented in the text of the directive.
If
our interpretation were to be challenged, we could incur significant costs
defending the challenge, and we could face production and selling delays, all
of
which could harm our business.
Our
Barocycler instrumentation received CE Marking, which means that our Barocycler
instruments meet the essential requirements of the relevant European health,
safety and environmental protection legislation. The CE Mark is an important
step toward our anticipated full-scale launch of our PCT product line in Europe
during 2008. In order to maintain our CE Marking, a requirement to sell
equipment in many countries of the European Union, we are obligated to uphold
certain safety and quality standards.
Employees
As
of
March 24, 2008 we had 27 full-time employees.
-
10
-
Our
27
employees include 11 employees in the sales and marketing and technical support
functions, four in general and administrative, 10 in applications research
and
development, and two in engineering research and development.
-
11
-
ITEM 1A. |
RISK
FACTORS
|
This
report contains forward-looking statements that involve risks and uncertainties,
such as statements of our objectives, expectations and intentions. The
cautionary statements made in this report should be read as applicable to all
forward-looking statements wherever they appear in this report. Our actual
results could differ materially from those discussed herein. Factors that could
cause or contribute to such differences include those discussed below, as well
as those discussed elsewhere in this report.
We
will require additional capital to further develop our pressure cycling
technology products and services and cannot ensure that additional capital
will
be available on acceptable terms or at all.
We
have
experienced negative cash flows from operations from our pressure cycling
technology business since its inception. As of December 31, 2007, we had
available cash of approximately $5.4 million. Based on our current
projections, we believe our current cash resources are sufficient to fund our
normal operations into early 2009.
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 capital requirements will depend on many factors, including
but not limited to:
·
|
the
problems, delays, expenses, and complications frequently encountered
by
early-stage companies;
|
·
|
market
acceptance of our pressure cycling technology products and services
for
sample preparation;
|
·
|
the
success of our sales and marketing programs;
and
|
·
|
changes
in economic, regulatory or competitive conditions in the markets
we intend
to serve.
|
To
satisfy our potential capital requirements to cover the cost of the development
and commercialization of our pressure cycling technology products and services
relating to sample preparation and other life science applications, we expect
to
raise additional funds in the public or private capital markets. Additional
financing may not be available to us on a timely basis, if at all, or on terms
acceptable to us. If adequate funds are not available or if we fail to obtain
acceptable additional financing, we may be required to:
·
|
obtain
financing with terms that may have the effect of diluting or adversely
affecting the holdings or the rights of the holders of our common
stock;
|
·
|
obtain
funds through arrangements with future collaboration partners or
others
that may require us to relinquish rights to some or all of our
technologies or products; or
|
·
|
otherwise
reduce planned expenditures and forego other business opportunities,
which
could harm our business.
|
We
have a history of operating losses, anticipate future losses and may never
be
profitable.
We
have
experienced significant operating losses in the area of pressure cycling
technology in each period since we began investing resources in pressure cycling
technology in 1998. These losses have resulted principally from research and
development, sales and marketing, and general and administrative expenses
associated with the development of our pressure cycling technology business.
We
expect to continue to incur operating losses until sales of our pressure cycling
technology products increase substantially. We cannot be certain when, if ever,
we will become profitable. Even if we were to become profitable, we might not
be
able to sustain such profitability on a quarterly or annual basis.
Our
financial results depend on revenues from our pressure cycling technology
products and services, which has a limited operating
history.
We
currently rely on revenues from our pressure cycling technology products and
services in the sample preparation area. We only recently commercialized our
pressure cycling technology products and services for sample preparation. Our
limited sales and operating history may not be adequate to enable you to fully
assess our ability to achieve market acceptance of our product offering. If
we
are unable to increase sales of our pressure cycling technology products and
services, our business will fail.
-
12
-
Our
business may be harmed if we encounter problems, delays, expenses, and
complications that affect early-stage companies.
We
are an
early-stage company and our pressure cycling technology business has a limited
operating history. Early-stage companies may encounter problems, delays,
expenses and complications, many of which may be beyond our control or may
harm
our business or prospects. These include:
·
|
unanticipated
problems and costs relating to the development, testing, production,
marketing, and sale of our products;
|
·
|
delays
and costs associated with our ability to attract and retain key personnel;
|
·
|
availability
of adequate financing; and
|
·
|
competition.
|
We
cannot
guarantee that we will successfully complete the transition from an early-stage
company to the commercialization of our pressure cycling technology products
and
services.
We
may be unable to obtain market acceptance of our pressure cycling technology
products and services.
Many
of
our initial sales of our pressure cycling technology products and services
have
been to our collaborators, following their use of our products in studies
undertaken in sample preparation for genomics, proteomics and small molecules
studies. Our technology requires scientists and researchers to adopt a method
of
sample extraction that is different than existing techniques. Our PCT sample
preparation system is also more costly than existing techniques. Our ability
to
obtain market acceptance will depend, in part, on our ability to demonstrate
to
our potential customers that the benefits and advantages of our technology
outweigh the increased cost of our technology compared to existing methods
of
sample extraction. If we are unable to demonstrate the benefits and advantages
of our products and technology as compared to existing technologies, then we
may
not gain market acceptance and our business will fail.
The
sales cycle of our pressure cycling technology products is lengthy. We have
incurred and may continue to incur significant expenses and we may not generate
any significant revenue related to those products.
Many
of
our current and potential customers have required between three and six months,
or more to test and evaluate our pressure cycling technology products. This
increases the possibility that a customer may decide to cancel its order or
otherwise change its plans, which could reduce or eliminate our sales to that
potential customer. As a result of this lengthy sales cycle, we have incurred
and may continue to incur significant research and development, selling and
marketing, and general and administrative expense related to customers from
whom
we have not yet generated any revenue from our products, and from whom we may
never generate the anticipated revenue if a customer cancels or changes its
plans.
Our
business could be harmed if our products contain undetected errors or
defects.
We
are
continuously developing new, and improving our existing, pressure cycling
technology products in sample preparation and we expect to do so in other areas
of life sciences depending upon the availability of our resources. Newly
introduced products can contain undetected errors or defects. In addition,
these
products may not meet their performance specifications under all conditions
or
for all applications. If, despite internal testing and testing by our
collaborators, any of our products contain errors or defects or fail to meet
customer specifications, then we may be required to enhance or improve those
products or technologies. We may not be able to do so on a timely basis, if
at
all, and may only be able to do so at considerable expense. In addition, any
significant reliability problems could result in adverse customer reaction,
negative publicity or legal claims and could harm our business and prospects.
Our
success may depend on our ability to manage growth
effectively.
We
expect
our operations to grow at a rapid pace as we further commercialize our pressure
cycling technology in sample preparation and other areas of life sciences.
Our
failure to manage growth effectively could harm our business and prospects.
Given our limited resources and personnel, growth of the business could place
significant strain on our management, information technology systems, sources
of
manufacturing capacity and other resources. To properly manage our growth,
we
may need to hire additional employees and identify new sources of manufacturing
capabilities. Failure to effectively manage our growth could make it difficult
to manufacture our products and fill orders, as well as lead to declines in
product quality or increased costs, any of which would adversely impact our
business and results of operations.
-
13
-
Our
success is substantially dependent on the continued service of our senior
management.
Our
success is substantially dependent on the continued service of our senior
management. We do not have long-term employment agreements with our key
employees. The loss of the services of any of these individuals could make
it
more difficult to successfully operate our business and achieve our business
goals. In addition, our failure to retain existing engineering, research and
development and sales personnel could harm our product development capabilities
and customer and employee relationships, delay the growth of sales of our
products and could result in the loss of key information, expertise or
know-how.
We
may not be able to hire or retain the number of qualified personnel,
particularly engineering personnel, required for our business, which would
harm
the development and sales of our products and limit our ability to grow.
Competition
in our industry for senior management, technical, sales, marketing, finance
and
other key personnel is intense. If we are unable to retain our existing
personnel, or attract and train additional qualified personnel, our growth
may
be limited. Our success also depends in particular on our ability to identify,
hire, train and retain qualified engineering personnel with experience in design
and development of laboratory equipment.
Our
reliance on a single third party for all of our manufacturing, and certain
of
our engineering, and other related services could harm our
business.
We
currently rely on Source Scientific, LLC, a third party contract manufacturer,
to manufacture our products, provide engineering expertise, and manage the
majority of our sub-contractor supplier relationships. Because of our dependence
on one manufacturer, our success will depend, in part, on the ability of Source
Scientific to manufacture our products cost effectively, in sufficient
quantities to meet our customer demand, if and when such demand occurs, and
meeting our quality requirements. If Source Scientific experiences manufacturing
problems or delays, or if Source Scientific decides not to continue to provide
us with these services, our business may be harmed. While we believe other
contract manufacturers are available to address our manufacturing and
engineering needs, if we find it necessary to replace Source Scientific, there
will be a disruption in our business and we would incur additional costs and
delays that would harm our business.
Our
failure to manage current or future alliances or joint ventures effectively
may
harm our business.
We
have
entered into business relationships with distribution partners, and we may
enter
into alliances, joint ventures or other business relationships to further
develop our pressure cycling technology product line. We may not be able
to:
·
|
identify
appropriate candidates for alliances, joint ventures or other business
relationships;
|
·
|
assure
that any candidate for an alliance, joint venture or business relationship
will provide us with the support
anticipated;
|
·
|
successfully
negotiate an alliance, joint venture or business relationship on
terms
that are advantageous to us; or
|
·
|
successfully
manage any alliance or joint
venture.
|
Furthermore,
any alliance, joint venture or other business relationship may divert management
time and resources. Entering into a disadvantageous alliance, joint venture
or
business relationship, failing to manage an alliance, joint venture or business
relationship effectively, or failing to comply with any obligations in
connection therewith, could harm our business and prospects.
We
may not be successful in growing our international
sales.
We
cannot
guarantee that we will successfully develop our international sales channels
to
enable us to generate significant revenue from international sales. To date,
we
have entered into three international distribution agreements, one of which
covers Belgium, France, and Switzerland, another covering Japan, and the third
which covers South Korea. We have generated limited sales to date from
international sales and cannot guarantee that we will be able to increase our
sales. As we expand, our international operations may be subject to numerous
risks and challenges, including:
·
|
multiple,
conflicting and changing governmental laws and regulations, including
those that regulate high pressure equipment;
|
·
|
reduced
protection for intellectual property rights in some countries;
|
·
|
protectionist
laws and business practices that favor local companies;
|
-
14
-
·
|
political
and economic changes and
disruptions;
|
·
|
export/import
controls;
|
·
|
tariff
regulations; and
|
·
|
currency
fluctuations.
|
Our
operating results are subject to quarterly variation.
Our
operating results may fluctuate significantly from period to period depending
on
a variety of factors, including the following:
·
|
our
ability to increase our sales of our pressure cycling technology
products
for sample preparation on a consistent quarterly or annual basis;
|
·
|
the
product mix of the Barocycler instruments we install in a given period,
and whether the installations are completed pursuant to sales, rental
or
lease arrangements, and the average selling prices that we are able
to
command for our products;
|
·
|
our
ability to manage our costs and
expenses;
|
·
|
our
ability to continue our research and development activities without
unexpected costs and expenses; and
|
·
|
our
ability to comply with state and federal regulations without incurring
unexpected costs and expenses.
|
Our
instrumentation operates at high pressures and may therefore become subject
to
certain regulation in the European Community. Regulation of high pressure
equipment may limit or hinder our development and sale of future
instrumentation.
Our
Barocycler instruments operate at high pressures. If our Barocycler instruments
exceed certain pressure levels, our products may become subject to the European
Pressure Equipment Directive, which requires certain pressure equipment meet
certain quality and safety standards. We do not believe that we are subject
to
this directive because our Barocycler instruments are currently below the
threshold documented in the text of the directive. If our interpretation were
to
be challenged, we could incur significant costs defending the challenge, and
we
could face production and selling delays, all of which could harm our
business.
We
expect that we will be subject to regulation in the United States, such as
the
FDA, and overseas as we begin to invest more resources in the development and
commercialization of PCT in applications outside of sample preparation.
Our
current pressure cycling technology products in the area of sample preparation
are not regulated by the U.S. Food and Drug Administration, or the FDA.
Applications in which we intend to develop and commercialize pressure cycling
technology, such as protein purification, pathogen inactivation and
immunodiagnostics, are expected to require regulatory approvals or clearances
from regulatory agencies, such as the FDA, prior to commercialization. We expect
that obtaining these approvals or clearances will require a significant
investment of time and capital resources and there can be no assurance that
such
investments will receive approvals or clearances that would allow us to
commercialize the technology for these applications.
If
we are unable to protect our patents and other proprietary technology relating
to our pressure cycling technology products, our business will be
harmed.
Our
ability to further develop and successfully commercialize our products will
depend, in part, on our ability to enforce our patents, preserve our trade
secrets, and operate without infringing the proprietary rights of third parties.
We currently have thirteen United States patents issued and several pending
patent applications for our pressure cycling technology. Several of these have
been followed up with foreign applications, for which three patents have been
issued in Europe and one patent has been issued in Australia, one in Japan,
and
one in Canada. We expect to file additional foreign applications in the future
relating to our pressure cycling technology, and we will file additional United
States applications as we develop new patentable intellectual property.
The patents which have been issued expire between 2015 and 2027.
There
can
be no assurance that:
·
|
any
patent applications filed by us will result in issued
patents;
|
·
|
patent
protection will be secured for any particular
technology;
|
-
15
-
·
|
any
patents that have been or may be issued to us will be valid or
enforceable;
|
·
|
any
patents will provide meaningful protection to
us;
|
·
|
others
will not be able to design around our patents;
or
|
·
|
our
patents will provide a competitive advantage or have commercial
value.
|
The
failure to obtain adequate patent protection would have a material adverse
effect on us and may adversely affect our ability to enter into, or affect
the
terms of, any arrangement for the marketing or sale of any product.
Our
patents may be challenged by others.
We
could
incur substantial costs in patent proceedings, including interference
proceedings before the United States Patent and Trademark Office, and comparable
proceedings before similar agencies in other countries, in connection with
any
claims that may arise in the future. These proceedings could result in adverse
decisions about the patentability of our inventions and products, as well as
about the enforceability, validity, or scope of protection afforded by the
patents.
If
we are unable to maintain the confidentiality of our trade secrets and
proprietary knowledge, others may develop technology and products that could
prevent the successful commercialization of our
products.
We
also
rely on trade secrets and other unpatented proprietary information in our
product development activities. To the extent we rely on trade secrets and
unpatented know-how to maintain our competitive technological position, there
can be no assurance that others may not independently develop the same or
similar technologies. We seek to protect our trade secrets and proprietary
knowledge, in part, through confidentiality agreements with our employees,
consultants, advisors and contractors. Nevertheless, these agreements may not
effectively prevent disclosure of our confidential information and may not
provide us with an adequate remedy in the event of unauthorized disclosure
of
such information. If our employees, consultants, advisors, or contractors
develop inventions or processes independently that may be applicable to our
products, disputes may arise about ownership of proprietary rights to those
inventions and processes. Such inventions and processes will not necessarily
become our property, but may remain the property of those persons or their
employers. Protracted and costly litigation could be necessary to enforce and
determine the scope of our proprietary rights. Failure to obtain or maintain
trade secret protection, for any reason, could harm our business.
If
we infringe on the intellectual property rights of others, our business will
be
harmed.
It
is
possible that the manufacture, use or sale of our pressure cycling technology
products or services may infringe patent or other intellectual property rights
of others. We may be unable to avoid infringement of the patent or other
intellectual property rights of others and may be required to seek a license,
defend an infringement action, or challenge the validity of the patents or
other
intellectual property rights in court. We may be unable to secure a license
on
terms and conditions acceptable to us, if at all. Also, we may not prevail
in
any patent or other intellectual property rights litigation. Patent or other
intellectual property rights litigation is costly and time-consuming, and there
can be no assurance that we will have sufficient resources to bring any possible
litigation related to such infringement to a successful conclusion. If we do
not
obtain a license under such patents or other intellectual property rights,
or if
we are found liable for infringement, or if we are unsuccessful in having such
patents declared invalid, we may be liable for significant monetary damages,
may
encounter significant delays in successfully commercializing and developing
our
pressure cycling technology products, or may be precluded from participating
in
the manufacture, use, or sale of our pressure cycling technology products or
services requiring such licenses.
We
may be unable to adequately respond to rapid changes in technology and the
development of new industry standards.
The
introduction of products and services embodying new technology and the emergence
of new industry standards may render our existing pressure cycling technology
products and related services obsolete and unmarketable if we are unable to
adapt to change. We may be unable to allocate the funds necessary to improve
our
current products or introduce new products to address our customers’ needs and
respond to technological change. In the event that other companies develop
more
technologically advanced products, our competitive position relative to such
companies would be harmed.
-
16
-
We
may not be able to compete successfully with others that are developing or
have
developed competitive technologies and products.
A
number
of companies have developed, or are expected to develop, products that compete
or will compete with our products. We compete with companies that have existing
technologies for the extraction of nucleic acids, proteins and small molecules
from cells and tissues, including methods such as mortar and pestle, sonication,
rotor-stator homogenization, French press, bead beating, freezer milling,
enzymatic digestion, and chemical dissolution. We are aware that there are
additional companies pursuing new technologies with similar goals to the
products developed or being developed by us. Some of the companies with which
we
now compete, or may compete in the future, have or may have more extensive
research, marketing, and manufacturing capabilities, more experience in genomics
and proteomics sample preparation, protein purification, pathogen inactivation,
immunodiagnostics, and DNA sequencing and significantly greater technical,
personnel and financial resources than we do, and may be better positioned
to
continue to improve their technology to compete in an evolving industry. To
compete, we must be able to demonstrate to potential customers that our products
provide improved performance and capabilities. Our failure to compete
successfully could harm our business and prospects.
In
connection with our sale of substantially all of the assets of Boston Biomedica
to SeraCare Life Sciences in September 2004, we continue to be exposed to
possible indemnification claims in amounts up to the purchase price for the
assets, which could prevent us from pursuing our remaining business operations
in the event an indemnification claim is brought against
us.
In
2004
we sold substantially all of the assets of Boston Biomedica, our predecessor
business, to SeraCare Life Sciences. Following the sale, we retained assets
and
liabilities relating to our pressure cycling technology business. In connection
with the sale of assets, we agreed to provide indemnification for breaches
of
representations and warranties contained in the asset purchase agreement. Our
indemnification obligations with respect to most matters have expired, though
our obligations relating to breaches of certain representations and warranties,
such as environmental and tax matters, continue to survive. Our indemnification
obligations are limited by an overall cap equal to the $29 million purchase
price. If we are required to pay any claims for indemnification from SeraCare
Life Sciences, we will have less cash available to fund our operations, our
business will be harmed and it may be difficult to continue our business at
all.
Provisions
in our articles of organization and bylaws and our poison pill may discourage
or
frustrate shareholders’ attempts to remove or replace our current
management.
Our
articles of organization and bylaws contain provisions that may make it more
difficult or discourage changes in our management that our stockholders may
consider to be favorable. These provisions include:
·
|
a
classified board of directors;
|
·
|
advance
notice for stockholder nominations to the board of
directors;
|
·
|
limitations
on the ability of stockholders to remove directors;
and
|
·
|
a
provision that allows a majority of the directors to fill vacancies
on the
board of directors.
|
Our
shareholders rights agreement, or “poison pill”, may also have the effect of
discouraging or preventing a change in control.
These
provisions could prevent or frustrate attempts to make changes in our management
that our stockholders consider to be beneficial and could limit the price that
our stockholders might receive in the future for shares of our common
stock.
The
costs of compliance with the reporting obligations of the Exchange Act, and
with
the requirements of the Sarbanes-Oxley Act of 2002, may place a strain on our
limited resources and our management’s attention may be diverted from other
business concerns.
As
a
result of the regulatory requirements applicable to public companies, we incur
legal, accounting, and other expenses that are significant in relation to the
size of our company. In addition, the Sarbanes-Oxley Act of 2002, as well
as rules subsequently implemented by the SEC and Nasdaq, have required changes
in corporate governance and financial disclosure practices of public companies,
some of which are currently applicable to us and others will or may become
applicable to us in the future. These rules and regulations will increase
our legal and financial compliance costs and may make some activities more
time-consuming. These requirements may place a strain on our systems and
on our management and financial resources.
-
17
-
ITEM 1B. |
UNRESOLVED
STAFF
COMMENTS.
|
Not
Applicable.
ITEM 2. |
PROPERTIES.
|
Our
corporate offices are currently located at 14 Norfolk Avenue, South Easton,
Massachusetts 02375. In November 2007, we signed an 18 month lease
agreement commencing in February 2008 pursuant to which we lease approximately
5,500 square feet of office space, with an option for an additional 18 months.
We pay approximately $6,500 per month for the use of these facilities.
On
June
1, 2006, we entered into a lease agreement with Scheer Partners and the Maryland
Economic Development Corporation, pursuant to which we lease laboratory and
office space in Rockville, MD. In August 2007, we extended the lease agreement
through May 31, 2009. We pay approximately $3,300 per month for the use of
these
facilities.
On
March
1, 2006, we entered into a sub-lease agreement with Proteome Systems, pursuant
to which we lease approximately 650 square feet of laboratory space plus 100
square feet of office space from Proteome Systems in Woburn, Massachusetts.
The
lease period extends through December 31, 2008 and we pay approximately $3,200
per month for the use of these facilities.
ITEM 3. |
LEGAL
PROCEEDINGS.
|
We
are
not currently involved in any legal proceedings.
ITEM 4. |
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY
HOLDERS.
|
-
18
-
PART
II
ITEM 5. |
MARKET
FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER
PURCHASES OF EQUITY
SECURITIES.
|
Our
common stock is traded on the NASDAQ Capital Market under the trading symbol
“PBIO”.
The
following table sets forth, for the periods indicated, the high and low sales
price per share of common stock, as reported by the NASDAQ Capital Market from
January 1, 2006 through December 31, 2007.
Common Stock Price
|
|||||||
Fiscal Year Ended December 31, 2006
|
High
|
Low
|
|||||
First
Quarter
|
$
|
4.80
|
$
|
3.67
|
|||
Second
Quarter
|
4.10
|
3.04
|
|||||
Third
Quarter
|
3.48
|
2.88
|
|||||
Fourth
Quarter
|
5.80
|
3.01
|
Fiscal Year Ended December 31, 2007
|
High
|
Low
|
|||||
First
Quarter
|
$
|
4.35
|
$
|
3.50
|
|||
Second
Quarter
|
5.70
|
4.00
|
|||||
Third
Quarter
|
5.00
|
3.67
|
|||||
Fourth
Quarter
|
7.78
|
3.98
|
As
of
March 19, 2008, there were 20,000,000 shares of common stock authorized of
which
2,192,175 shares were issued and outstanding, and held by 94 stockholders of
record.
Recent
Sales of Unregistered Securities
On
November 21, 2007, we completed a private placement, pursuant to which we sold
an aggregate of 126,750 shares of common stock for a purchase price of $5.00
per
share, resulting in gross proceeds to us of approximately $633,750 (the “Private
Placement”). The shares were issued and sold to a total of 8 accredited
investors pursuant to a Securities Purchase Agreement entered into as of
November 21, 2007 (the “Securities Purchase Agreement”).
The
shares were issued in the Private Placement without registration under the
Securities Act, in reliance upon the exemption from registration set forth
in
Rule 506 of Regulation D (“Regulation D”) promulgated under the Securities Act.
We based our reliance, in part, upon representations made by each purchaser
of
shares, including, but not limited to, representations as to the purchaser’s
status as an “accredited investor” (as defined in Rule 501(a) under Regulation
D) and the purchaser’s investment intent. The shares were not offered or sold by
any form of general solicitation or general advertising; as such terms are
used
in Rule 502 under Regulation D. The shares cannot be offered or sold
in
the United States absent an effective registration statement or an exemption
from the registration requirements under applicable federal and state securities
laws.
Repurchases
by Pressure BioSciences
We
did
not repurchase any of our equity securities during the fourth quarter of 2007.
Equity
Compensation Plan Information
The
information required by this Item 5 with respect to securities authorized for
issuance under equity compensation plans is set forth in Part III, Item 12
of
this Form 10-K.
-
19
-
ITEM 6. |
SELECTED
FINANCIAL
DATA.
|
Not
Applicable.
ITEM
7.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATION.
|
OVERVIEW
We
are a
life sciences company focused on the development and commercialization of
a
novel, enabling, platform technology called pressure cycling technology (“PCT”).
PCT uses cycles of hydrostatic pressure between ambient and ultra-high levels
(up to 35,000 psi and greater) to control bio-molecular interactions.
Our
pressure cycling technology uses internally developed instrumentation that
is
capable of cycling pressure between ambient and ultra-high levels at controlled
temperatures to rapidly and repeatedly control the interactions of
bio-molecules. Our instrument, the Barocycler®, and our internally developed
consumables product line, which includes PULSE (Pressure Used to Lyse Samples
for Extraction) Tubes as well as the ProteoSolveLRSTM
kit
for
the detergent-free extraction of proteins from lipid-rich samples, together
make
up the PCT Sample Preparation System (“PCT SPS”).
Our
pressure cycling technology employs a unique approach that we believe has the
potential for broad applications in a number of established and emerging life
sciences areas, including;
-
|
sample
preparation for genomic, proteomic, and small molecule
studies;
|
-
|
pathogen
inactivation;
|
-
|
protein
purification;
|
-
|
control
of chemical (enzymatic) reactions; and
|
-
|
immunodiagnostics.
|
Since
we
began operations as Pressure BioSciences in February 2005, we have focused
substantially all of our research and development and commercialization efforts
on sample preparation for genomic, proteomic, and small molecule
studies.
Our
business strategy is to commercialize pressure cycling technology in the area
of
sample preparation for genomic, proteomic, and small molecule studies (“sample
preparation”). We also plan to pursue the further development and
commercialization of PCT in other life sciences applications, which could
include working with various strategic partners that have greater scientific,
and regulatory, expertise in the respective applications than we
do.
To
support our current strategy, our primary focus in 2007 was the execution of
our
commercialization plan for PCT in sample preparation. We increased our spending
in important areas of our business during 2007, including increased expenses
associated with additional staff in the areas of sales and research and
development, to support our sales expansion and increased research and
development activities.
If
we are
successful commercializing our technology in the sample preparation market,
we
believe that our financial results will be positively affected by a combination
of the revenue from the sale, lease, and rental of the Barocycler instruments,
and by the recurring revenue streams that we hope to realize from the sale
of
the single-use PULSE Tubes, PCT-dependent kits (such as ProteoSolveLRS),
and extended
service contracts on our instrumentation. We believe the recurring revenue
streams that could be generated from our instruments in the field is a very
important component of our future financial success. Therefore, we believe
that
in the short-term it is more important for us to focus on increasing the number
of installed Barocyclers in the field than it is for us to record revenue in
the
current period. To this end, we have offered our prospective customers the
opportunity to lease or rent the Barocycler instruments. While these
arrangements do not provide us with the immediate revenue of a sale, they do
serve to expand the utilization of PCT and they provide a stream of revenue
from
the monthly rental income and the sale of consumable products. We define sales,
leases, and rentals of Barocycler instruments as revenue-generating
installations.
-
20
-
We
also
derive revenues from Small Business Innovation Research (“SBIR”) grants awarded
to us by the National Institutes of Health. In September 2006, and in March
2007, we received SBIR Phase I grants in the aggregate amount of $300,000.
These
grants have funded experiments to demonstrate the feasibility of using pressure
cycling technology in various applications in the life sciences. If our work
in
SBIR Phase I grants is successful, then we expect to have the opportunity to
apply for larger NIH SBIR Phase II grants. Additionally, if our work with the
SBIR grants is successful, the publication of application notes in specific
areas of research should further support our commercialization
efforts.
Years
Ended December 31, 2007 as compared to 2006
Revenue
We
had
total revenue of $645,870 in the year ended December 31, 2007 as compared to
$210,289 in the prior year.
Revenue
from the sale of PCT products and services was $399,787 in 2007 as compared
to
$210,289 in 2006. This increase in revenue in 2007 was driven primarily by
the
installation of a total of 20 Barocycler instruments during 2007 as compared
to
eight in the prior year. Although the number of instruments that we installed
more than doubled in 2007 as compared to 2006, the increase in revenue was
not
as significant. During 2006, all of the instruments installed were the higher
priced NEP3229 model while during 2007 many of the instruments installed were
the lower priced NEP2320 model. Additionally, in 2007 many of our installations
were completed pursuant to lease or rental agreements rather than outright
sales. When we install instrumentation under lease or rental agreements, we
record the revenue over the life of the agreement, generally 12 months or 36
months.
We
expect
the number of units installed will continue to increase in future periods as
we
continue to commercialize our technology. We also expect that some portion
of
future installations will be for the smaller, lower priced, Barocycler NEP2320
model and some will be placed under lease or short-term rental agreements.
Therefore, the average revenue per installation may fluctuate from period to
period as we continue to drive our installed base and commercialize PCT.
During
2007, we recorded $246,083 of grant revenue. This revenue was earned in
connection with our research and development efforts performed, under the two
SBIR Phase I grants that we were awarded during 2006 and 2007. During 2006,
we
did not record any grant revenue.
Cost
of PCT Products and Services
The
cost
of PCT products and services was $209,050 for the year ended December 31, 2007
compared to $165,233 for the comparable period in 2006. This decrease in overall
cost of goods sold as a percentage of revenue is due to a number of factors.
The
first factor was the third quarter 2007 sale of four prototype Barocycler
NEP2320 instruments. These units were prototypes and therefore the costs
associated with development and assembly of these instruments were recorded
as
research and development expense, as such costs were incurred. The second factor
that contributed to an increase in overall gross margin in 2007 relative to
2006
was a shift in the product mix to include an increasing number of consumables
and the sale of several production Barocycler NEP2320 units, which have a higher
gross margin than the NEP3229.
We
believe that our cost of PCT Products and Services will continue to improve
as a
percentage of revenue as we continue to install more instrumentation, and sell
more consumable products, such as PULSE Tubes and ProteoSolveLRS
kits.
However, we expect our gross margin may fluctuate from period to period as
we
continue to sell, lease, or rent a varying mix of Barocycler instrumentation
and
consumable products.
-
21
-
Research
and Development
Research
and development expenditures increased to $2,022,730 during 2007 from $1,429,711
in 2006. This increase was primarily due to a significant increase in headcount
from an average of three research and development employees during 2006 to
an
average of 10 in 2007. Consistent with our plans to increase our research and
development capabilities, the growth in our staff has allowed us to perform
more
experiments and provide a higher level of support to our collaboration partners,
and to our newly hired sales team. We believe these efforts are important to
the
continued development and commercialization of PCT. Also contributing to the
increase in research and development expense was the approximate $400,000 that
we incurred in the development of the Barocycler NEP2320. In addition to
developing a new product and a demonstration instrument for our sales force,
this expenditure has resulted in the development of the core technology required
to create future pneumatic (air driven) PCT instrumentation. We believe that
pneumatic pressure technology will allow us to more easily and rapidly develop
the smaller, portable, less expensive instruments that we believe represents
an
additional significant market opportunity.
Research
and development expense included $141,115 and $181,609 of non-cash, stock-based
compensation expense related to Statement of Financial Accounting Standards
(“SFAS”) 123R “ Share-Based
Payment”
(“SFAS
123R”) in 2007 and 2006, respectively.
We
plan
to reduce the level of hiring in 2008, relative to 2007. Therefore, we expect
our spending in this area to increase less significantly than it has in the
prior year. We believe that with our existing staff, we can continue to pursue
research and development programs, and continue to invest in our intellectual
property portfolio, in the sample preparation area.
Selling
and Marketing
Selling
and marketing expenses increased to $1,386,519 in 2007 from $528,265 for the
year ended December 31, 2006. In March 2007 we announced our plans to begin
active commercialization of PCT. As part of this plan, we outlined our intent
to
build a targeted US-based sales force. During 2007, we completed the hiring
of
six additional regional directors (bringing the total to seven) and continued
to
increase our spending in marketing, and sales support. Additionally, we shifted
our technical services department into the sales and marketing function to
reflect a shift in departmental responsibilities.
Selling
and marketing expense included $70,770 and $44,086 of non-cash, stock-based
compensation expense related to SFAS 123R in 2007 and 2006,
respectively.
We
expect
that selling and marketing expense will continue to increase throughout 2008
in
support of our commercialization efforts. We also plan to continue the expansion
of our marketing programs and the further development of our foreign
distribution network.
General
and Administrative
General
and administrative costs totaled $2,174,739 in the year ended December 31,
2007,
as compared to $2,145,196 in 2006. Our general and administrative costs remained
relatively flat despite an increase in spending in the areas of investor
relations, Sarbanes-Oxley compliance, and legal costs associated with our
intellectual property. These increases were almost entirely offset by a decrease
in non-cash, stock-based compensation expense related to SFAS 123R. In 2007,
our
SFAS 123R general and administrative expense was $150,479; in 2006, our general
and administrative SFAS 123R expense was $424,628. The decrease in general
and
administrative SFAS 123R expense was due to the fact that the outside members
of
our Board of Directors did not receive any stock options in 2007. The expense
related to the stock option grants to outside members of our Board of Directors
during 2006 was $313,071.
We
expect
general and administrative spending in 2008 to be approximately the same as
it
was in 2007. We will continue to incur costs in support of our investor
relations programs, Sarbanes-Oxley compliance, and other costs associated with
being a publicly-traded company, and some continued investment in the
development of our infrastructure.
-
22
-
Operating
Loss from Continuing Operations
The
operating loss from continuing operations was $5,147,168 in 2007, as compared
to
$4,058,116 in the year ended December 31, 2006. The $1,089,052 increase relates
primarily to an increase in spending in the research and development and selling
and marketing areas of our business, in support of our development and
commercialization of PCT.
Included
in our operating loss was $367,110 and $660,278 of non-cash, stock-based
compensation expense related to SFAS 123R in 2007 and 2006, respectively.
We
expect
our operating loss in 2008 to be higher than the operating loss incurred in
2007, due primarily to expected increased spending in our sales and marketing
activities and, to a lesser extent, our research and development activities.
We
do, however, expect that the gross profit from increasing revenues will mitigate
the impact of our increased spending on our overall operating loss.
Realized
gain of sale on securities held for sale
During
2007, we recorded a gain on sale of securities of $2,028,720 in connection
with
the sale of our remaining 513,934 shares of Panacos Pharmaceuticals common
stock. In 2006, we realized a gain of $517,938 in connection with the sale
of
57,900 shares of Panacos Pharmaceuticals common stock. As of December 31, 2007,
we no longer held any shares of Panacos Pharmaceuticals common stock.
Interest
Income
Interest
income totaled $286,600 for the year ended December 31, 2007, as compared to
interest income of $381,713 in 2006. The prior year period included
approximately $100,000 of interest income from our chief executive officer
in
connection with his loan payable to us. This Note was paid in full in December
2006.
Income
Tax Benefit from Continuing Operations
For
the
year ended December 31, 2007 we recorded a benefit for income taxes from
continuing operations of $520,214. Despite our history of operating losses,
we
recorded this benefit due to our expected ability under federal income tax
law
to carry back current operating losses to offset taxable income that was
recorded in 2005. During 2006, we recorded a benefit for income taxes from
continuing operations of $745,354.
We
do not
expect to record any income tax benefit for the foreseeable future due to the
fact that we are no longer able to carry back current losses against taxable
income from prior periods and because we expect our operating losses to continue
for several years. If we are successful commercializing PCT and if we are able
to generate operating income, then we may be able to utilize the net operating
loss carry-forwards that we generate.
Gain
on Sale of Net Assets Related to Discontinued Operations
During
2007, we realized a gain on the sale of Source Scientific, LLC of $1,155,973.
This gain is comprised of the $378,503 charge that we recorded in the first
quarter of 2007 under the provisions of Staff Accounting Bulletin (“SAB”) Topic
5E, “Accounting
for Divestiture of a Subsidiary or Other Business Operation
(“SAB
Topic 5E”) and the gain of $1,534,476, net of income taxes of $218,060, that we
recorded during the second quarter of 2007, the period in which we completed
the
sale.
We
recorded this gain in connection with the receipt on May 29, 2007 of $1,780,071
from Mr. Richard W. Henson and Mr. Bruce A. Sargeant, the principals of Source
Scientific, LLC, as full payment for their purchase of our remaining interest
in
that business. During 2006, we accounted for our investment in Source
Scientific, LLC under the provisions of SAB Topic 5E. In accordance with SAB
Topic 5E, we were to record the losses of Source Scientific, LLC, to the extent
they exceeded cumulative income for the year. During 2006, Source Scientific,
LLC, was never in a cumulative loss position therefore we did not record any
loss in connection with our interest in Source Scientific, LLC.
Net
Loss
Our
net
loss in 2007 was $1,155,661 as compared to a net loss of $2,413,111 in 2006.
This decrease in net loss was due to an increase in operating expenses of the
business that was more than offset by the gain in the sale of marketable
securities and the gain in the sale of assets related to discontinued
operations. Without these non-recurring items, our net loss in 2007 would have
exceeded that recorded in 2006.
-
23
-
We
expect
that our net loss in 2008 will be significantly higher than it was in 2007.
Our
expectation of an increase in net loss is based upon plans to increase operating
costs relative to 2007 in our selling and marketing and, to a lesser extent,
our
research and development activities. Additionally, our net loss in 2008 will
not
be mitigated by the gain on sale of marketable securities and the gain on sale
of assets related to discontinued operations, as was the case in 2007. Finally,
during 2008 we do not expect to record a benefit for income taxes as we did
in
2007.
LIQUIDITY
AND FINANCIAL CONDITION
As
of
December 31, 2007, our working capital position was $5,933,822, the primary
components of which were cash and cash equivalents, income tax receivable,
prepaid expenses and deposits on open purchase orders for the production of
Barocycler instruments, partially offset by accounts payable, accrued employee
compensation, other accrued expenses, and accrued income taxes. As of December
31, 2006, our working capital position was $5,770,086, the primary components
of
which were cash and cash equivalents, income tax receivable, prepaid expenses
and other current assets, partially offset by accounts payable, accrued employee
compensation, other accrued expenses, and accrued income taxes. The prior year
working capital balance excluded the $2,060,875 of investment in marketable
securities, and the related deferred tax liability of $669,520, that we had
classified as current.
This
increase in working capital of $163,736 is due primarily to the receipt of
cash
proceeds from the sale of our remaining shares in Panacos Pharmaceuticals common
stock, our receipt of proceeds from the sale of our ownership interest in Source
Scientific, LLC and the sale of 126,750 shares of our common stock in November
2007, partially offset by our utilization of working capital to fund our
operations.
We
expect
our working capital position to decline as we fund our operations from our
cash
and cash equivalents. We believe that we have sufficient liquidity to fund
our
operations at their current level, and with planned increases in selected areas
of our business, into early 2009. The extent to which we increase our
operational costs is dependent upon our judgment of the investment required
to
successfully commercialize PCT and our ability to secure additional funding
through equity or debt financings.
Net
cash
used in continuing operations during 2007 was $3,896,422 as compared to net
cash
used in continuing operations of $2,102,976 during 2006. The cash used in
operations in 2007 included our net loss, an increase in deposits on open
purchase orders, inventory and accounts receivable, partially offset by a
decrease in income tax receivable and an increase in accrued employee
compensation. We expect net cash used in continuing operations to increase
in
2008 as we increase our selling and marketing and research and development
activities.
Net
cash
provided by investing activities during 2007 was $1,852,482 as compared to
$452,854 in the prior year. The cash generated in 2007 was entirely from the
sale of 513,934 shares of Panacos Pharmaceuticals common stock, partially offset
by purchases of fixed assets. The cash generated in the same period in 2006
was
entirely from the sale of 57,900 shares of Panacos Pharmaceuticals common stock,
also partially offset by purchases of fixed assets. We expect that our
investment in fixed assets will increase in 2008 as we continue to increase
our
staff and operating facilities.
Net
cash
generated from financing activities during 2007 was $571,133 and relates to
the
sale of 126,750 shares of our common stock to 8 non-affiliated investors
pursuant to a private placement that we completed in November 2007. Net cash
used in financing activities in 2006 included $323,158 to purchase 110,889
shares of our common stock from unaffiliated shareholders for an average price
of $2.91 per share, partially offset by proceeds generated by the exercise
of
options to purchase 2,000 shares of our common stock by a Director. The stock
purchase from the unaffiliated shareholders was made pursuant to the
authorization of our Board of Directors in September 2006.
Net
cash
provided by discontinued operations during 2007 of $1,562,011 was due to the
completion of the divestiture of Source Scientific, LLC. During the same period
in 2006, we received cash from discontinued operations of $886,390. This amount
was due entirely to the receipt of the final escrow payment in connection with
the 2004 sale of the Boston Biomedica core businesses to SeraCare Life Sciences,
Inc.
-
24
-
CRITICAL
ACCOUNTING POLICIES
Use
of Estimates
To
prepare our consolidated financial statements in conformity with accounting
principles generally accepted in the United States of America, we are required
to make significant estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent assets and liabilities
at
the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. In addition, significant estimates were
made in projecting future cash flows to quantify impairment of assets, deferred
tax assets, the costs associated with fulfilling our warranty obligations for
the instruments that we sell, and the estimates employed in our calculation
of
fair value of stock options awarded. We base our estimates on historical
experience and on various other assumptions that we believe to be reasonable
under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that are not
readily apparent from other sources. Actual results could differ from the
estimates and assumptions used.
Revenue
Recognition
We
recognize revenue in accordance with the Securities and Exchange Commission’s
(“SEC”) Staff Accounting Bulletin (“SAB”) No. 104, Revenue
Recognition
("SAB
104"). Revenue is recognized when realized or earned when all the following
criteria have been met: persuasive evidence of an arrangement exists; delivery
has occurred and risk of loss has passed to the customer; the seller’s price to
the buyer is fixed or determinable; and collectibility is reasonably
assured.
Our
current instruments, the Barocycler NEP3229 and NEP2320, require a basic level
of instrumentation expertise to set-up for initial operation. To support a
favorable first experience for our customers, we send a representative to the
customer site to install every Barocycler that we sell through our domestic
sales force. The installation process includes uncrating and setting up the
instrument and conducting an introductory user training course. Product revenue
related to current Barocycler instrumentation is recognized upon the
installation of our instrumentation at the customer location. Product revenue
related to sales of PCT products to our foreign distributors is recognized
upon
shipment through a common carrier. We provide for the expected costs of warranty
upon the recognition of revenue for the sales of our instrumentation. Our sales
arrangements do not provide a right of return to our customers. Product revenue
related to our consumable products such as PULSE Tubes and
ProteoSolveLRS
kits is
recorded upon shipment through a common carrier. Shipping costs are
included in the costs of sales. Any shipping costs billed to customers are
recognized as revenue.
In
accordance with the Financial Accounting Standards Board (“FASB”) Statement of
Financial Accounting Standards (“SFAS”) No. 13, “Accounting
for Leases”,
we
account for our lease agreements under the operating method. We record revenue
over the life of the lease term and we record depreciation expense on a
straight-line basis over the thirty-six month estimated useful life of the
Barocycler instrument. The depreciation expense associated with assets under
lease agreement is included in the “Cost of PCT products and services” line item
in our Consolidated Statements of Operations. 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.
-
25
-
Intangible
Assets
We
have
classified as intangible assets, costs associated with the fair value of certain
assets of businesses acquired. Intangible assets relate to the remaining
value of acquired patents associated with PCT. The cost of these acquired
patents is amortized on a straight-line basis over sixteen years. We
annually review 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 as of December 31, 2007
concluded they were not impaired.
Long-Lived
Assets and Deferred Costs
In
accordance with 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 related to
the
long-lived assets. 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 analysis at December 31, 2007 and determined that our
long-lived assets were not impaired.
RECENT
ACCOUNTING STANDARDS
In
September 2006, FASB issued SFAS 157, “Fair Value Measurements”. SFAS No. 157
establishes a formal framework for measuring fair value under GAAP and expands
on disclosure of fair value measurements. Although SFAS No. 157 applies to
and
amends the provisions of existing FASB and AICPA pronouncements, it does not,
of
itself, require any new fair value measurements, nor does it establish valuation
standards. SFAS No. 157 applies to all other accounting pronouncements requiring
or permitting fair value measurements, except for; SFAS No. 123R, share based
payment and related pronouncements, the practicability exceptions to fair value
determinations allowed by various other authoritative pronouncements, and AICPA
Statements of Position 97-2 and 98-9 that deal with software revenue
recognition. This statement is effective for financial statements issued for
fiscal years beginning after November 15, 2007, and interim periods within
those
fiscal years.
In
December 2007, the FASB issued SFAS 141 (revised 2007), “Business
Combinations”
(“SFAS
141(R)”) and SFAS No. 160, “Non-controlling
Interests in Consolidated Financial Statements – an amendment of ARB
No. 51”
(“SFAS
160”).
SFAS
141(R) significantly changes the accounting for business combinations. Under
SFAS 141(R), an acquiring entity will be required to recognize all the assets
acquired and liabilities assumed in a transaction at the acquisition-date at
fair value with limited exceptions. SFAS 141(R) further changes the accounting
treatment for certain specific items, including:
-
|
Acquisition
costs will be generally expensed as incurred;
|
-
|
Noncontrolling
interests (formerly known as “minority interests” – see
SFAS
160 discussion below) will be valued at fair value at the acquisition
date;
|
-
|
Acquired
contingent liabilities will be recorded at fair value at the acquisition
date and subsequently measured at either the higher of such amount
or the
amount determined under existing guidance for non-acquired contingencies;
|
-
|
In-process
research and development will be recorded at fair value as an
indefinite-lived intangible asset at the acquisition date;
|
-
|
Restructuring
costs associated with a business combination will be generally expensed
subsequent to the acquisition date; and
|
-
|
Changes
in deferred tax asset valuation allowances and income tax uncertainties
after the acquisition date generally will affect income tax expense.
|
-
|
-
26
-
SFAS
160
establishes new accounting and reporting standards for the non-controlling
interest in a subsidiary and for the deconsolidation of a subsidiary.
Specifically, this statement requires the recognition of non-controlling
interests (minority interests) as equity in the consolidated financial
statements and separate from the parent’s equity. The amount of net income
attributable to non-controlling interests will be included in consolidated
net
income on the face of the income statement. SFAS 160 clarifies that changes
in a
parent’s ownership interest in a subsidiary that does not result in
deconsolidation are treated as equity transactions if the parent retains its
controlling financial interest. In addition, this statement requires that a
parent recognize a gain or loss in net income when a subsidiary is
deconsolidated. Such gain or loss will be measured using the fair value of
the
non-controlling equity investment on the deconsolidation date. SFAS 160 also
includes expanded disclosure requirements regarding the interests of the parent
and its non-controlling interest.
SFAS
160
is effective for fiscal years, and interim periods within such year, beginning
January 1, 2009. Early adoption of both SFAS 141(R) and SFAS 160 is
prohibited. We do not expect that either SFAS 141(R) or SFAS 160 will have
a
material affect on our consolidated results of operations and financial
condition.
-
27
-
ITEM 7A. |
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK.
|
-
28
-
ITEM 8. |
FINANCIAL
STATEMENTS AND SUPPLEMENTARY
DATA.
|
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
DECEMBER
31, 2007 and 2006
2007
|
2006
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
and cash equivalents
|
$
|
5,424,486
|
$
|
5,335,282
|
|||
Accounts
receivable
|
118,471
|
37,495
|
|||||
Inventories
|
172,548
|
19,658
|
|||||
Deposits
|
553,483
|
175,300
|
|||||
Prepaid
income taxes
|
56,863
|
38,687
|
|||||
Income
tax receivable
|
249,541
|
710,013
|
|||||
Prepaid
expenses and other current assets
|
94,783
|
71,476
|
|||||
Investments
in marketable securities
|
-
|
2,060,875
|
|||||
Total
current assets
|
6,670,175
|
8,448,786
|
|||||
PROPERTY
AND EQUIPMENT, NET
|
257,797
|
207,696
|
|||||
OTHER
ASSETS
|
|||||||
Intangible
assets, net
|
328,290
|
376,922
|
|||||
Assets
of discontinued operation
|
-
|
1,420,996
|
|||||
Total
other assets
|
328,290
|
1,797,918
|
|||||
TOTAL
ASSETS
|
$
|
7,256,262
|
$
|
10,454,400
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable
|
$
|
152,729
|
$
|
174,289
|
|||
Accrued
employee compensation
|
377,190
|
242,497
|
|||||
Accrued
professional fees and other expenses
|
186,840
|
150,978
|
|||||
Income
taxes payable
|
4,519
|
45,962
|
|||||
Deferred
taxes
|
-
|
669,520
|
|||||
Deferred
revenue
|
15,075
|
4,099
|
|||||
Total
current liabilities
|
736,353
|
1,287,345
|
|||||
LONG
TERM LIABILITIES
|
|||||||
Deferred
revenue
|
6,767
|
9,126
|
|||||
Liabilities
of discontinued operation
|
-
|
1,042,493
|
|||||
Total
long term liabilities
|
6,767
|
1,051,619
|
|||||
TOTAL
LIABILITIES
|
743,120
|
2,338,964
|
|||||
COMMITMENTS
AND CONTINGENCIES (Note 9)
|
|||||||
STOCKHOLDERS'
EQUITY
|
|||||||
Preferred
stock; 1,000,000 shares authorized; 0 outstanding
|
-
|
-
|
|||||
Common
stock, $.01 par value; 20,000,000 shares authorized; 2,192,175
and
2,065,425 shares issued and outstanding
|
21,922
|
20,654
|
|||||
Additional
paid-in capital
|
6,284,616
|
5,347,641
|
|||||
Accumulated
other comprehensive income
|
-
|
1,384,876
|
|||||
Retained
earnings
|
206,604
|
1,362,265
|
|||||
Total
stockholders' equity
|
6,513,142
|
8,115,436
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
7,256,262
|
$
|
10,454,400
|
The
accompanying notes are an integral part of these consolidated financial
statements
-
29
-
CONSOLIDATED
STATEMENTS OF OPERATIONS
FOR
THE YEARS ENDED DECEMBER 31, 2007 AND 2006
For the Year Ended
|
|||||||
December 31,
|
|||||||
2007
|
2006
|
||||||
REVENUE:
|
|||||||
PCT
Products, services, other
|
$
|
399,787
|
$
|
210,289
|
|||
Grant
revenue
|
246,083
|
-
|
|||||
Total
revenue
|
645,870
|
210,289
|
|||||
COSTS
AND EXPENSES:
|
|||||||
Cost
of PCT products and services
|
209,050
|
165,233
|
|||||
Research
and development
|
2,022,730
|
1,429,711
|
|||||
Selling
and marketing
|
1,386,519
|
528,265
|
|||||
General
and administrative
|
2,174,739
|
2,145,196
|
|||||
Total
operating costs and expenses
|
5,793,038
|
4,268,405
|
|||||
Operating
loss from continuing operations
|
(5,147,168
|
)
|
(4,058,116
|
)
|
|||
OTHER
INCOME:
|
|||||||
Realized
gain on securities available for sale
|
2,028,720
|
517,938
|
|||||
Interest
income
|
286,600
|
381,713
|
|||||
Total
other income
|
2,315,320
|
899,651
|
|||||
Loss
from continuing operations before income taxes
|
(2,831,848
|
)
|
(3,158,465
|
)
|
|||
Income
tax benefit from continuing operations
|
520,214
|
745,354
|
|||||
Loss
from continuing operations
|
(2,311,634
|
)
|
(2,413,111
|
)
|
|||
DISCONTINUED
OPERATIONS:
|
|||||||
Gain
on sale of net assets related to discontinued operations (net of
income
tax of $218,060)
|
1,155,973
|
-
|
|||||
Net
loss
|
$
|
(1,155,661
|
)
|
$
|
(2,413,111
|
)
|
|
Loss
per share from continuing operations - basic and diluted
|
$
|
(1.11
|
)
|
$
|
(1.01
|
)
|
|
Income
per share from discontinued operations - basic and diluted
|
0.55
|
-
|
|||||
Net
loss per share - basic and diluted
|
$
|
(0.56
|
)
|
$
|
(1.01
|
)
|
|
Weighted
average number of shares used to calculate income (loss) per share
- basic
and diluted
|
2,078,657
|
2,396,077
|
The
accompanying notes are an integral part of these consolidated financial
statements
-
30
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
FOR
THE YEARS ENDED DECEMBER 31, 2007 AND 2006
For
the Year Ended
|
|||||||
December
31,
|
|||||||
2007
|
2006
|
||||||
Other
Comprehensive Loss
|
|||||||
Net
loss
|
$
|
(1,155,661
|
)
|
$
|
(2,413,111
|
)
|
|
Holding
gain
|
(27,479
|
)
|
(1,383,417
|
)
|
|||
Reclassification
of unrealized gain to realized gain on securities during the
period
|
(2,028,720
|
)
|
(517,938
|
)
|
|||
Unrealized
loss on marketable securities
|
(2,056,199
|
)
|
(1,901,355
|
)
|
|||
Income
tax benefit related to items of other comprehensive loss
|
671,323
|
748,268
|
|||||
Total
other comprehensive loss, net of taxes
|
(1,384,876
|
)
|
(1,153,087
|
)
|
|||
Comprehensive
loss
|
$
|
(2,540,537
|
)
|
$
|
(3,566,198
|
)
|
The
accompanying notes are an integral part of these consolidated financial
statements
-
31
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
FOR
THE YEARS ENDED DECEMBER 31, 2007 AND 2006
Accumulated
|
|
|||||||||||||||||||||
Common Stock
|
Additional
|
Other
|
Loan Receivable
|
Total
|
||||||||||||||||||
$.01 Par
|
Paid-In
|
Comprehensive
|
from Officer/
|
Retained
|
Stockholders'
|
|||||||||||||||||
Shares
|
Value
|
Capital
|
Income
|
Director
|
Earnings
|
Equity
|
||||||||||||||||
BALANCE,
December 31, 2005
|
2,424,189
|
$
|
24,242
|
$
|
6,027,020
|
$
|
2,537,963
|
$
|
(1,000,000
|
)
|
$
|
3,775,376
|
$
|
11,364,601
|
||||||||
|
||||||||||||||||||||||
Stock
options and other warrants exercised
|
2,000
|
20
|
5,380
|
|
|
5,400
|
||||||||||||||||
Interest
accrued on loan receivable from CEO/Director
|
(25,487
|
)
|
(25,487
|
)
|
||||||||||||||||||
Exchange
of shares for payoff of loan receivable from CEO/Director
|
(249,875
|
)
|
(2,499
|
)
|
(1,022,988
|
)
|
1,025,487
|
-
|
||||||||||||||
Repurchase
shares via stock buy-back program
|
(110,889
|
)
|
(1,109
|
)
|
(322,049
|
)
|
(323,158
|
)
|
||||||||||||||
Stock-based
compensation
|
660,278
|
660,278
|
||||||||||||||||||||
Net
loss
|
|
|
|
|
(2,413,111
|
)
|
(2,413,111
|
)
|
||||||||||||||
Unrealized
loss on investments (net of tax)
|
|
|
|
(1,153,087
|
)
|
|
(1,153,087
|
)
|
||||||||||||||
BALANCE,
December 31, 2006
|
2,065,425
|
$
|
20,654
|
$
|
5,347,641
|
$
|
1,384,876
|
$
|
-
|
$
|
1,362,265
|
$
|
8,115,436
|
|||||||||
|
||||||||||||||||||||||
Issuance
costs relating to private placement
|
|
|
(62,617
|
)
|
|
|
(62,617
|
)
|
||||||||||||||
Stock
issued in private placement
|
126,750
|
1,268
|
632,482
|
633,750
|
||||||||||||||||||
Stock-based
compensation
|
367,110
|
367,110
|
||||||||||||||||||||
Net
loss
|
|
|
|
|
(1,155,661
|
)
|
(1,155,661
|
)
|
||||||||||||||
Unrealized
loss on investments (net of tax)
|
|
|
|
(1,384,876
|
)
|
|
(1,384,876
|
)
|
||||||||||||||
BALANCE,
December 31, 2007
|
2,192,175
|
$
|
21,922
|
$
|
6,284,616
|
$
|
-
|
$
|
-
|
$
|
206,604
|
$
|
6,513,142
|
The
accompanying notes are an integral part of these consolidated financial
statements.
-
32
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
THE YEARS ENDED DECEMBER 31, 2007 AND 2006
For the Year Ended
|
|||||||
December 31,
|
|||||||
2007
|
2006
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(1,155,661
|
)
|
$
|
(2,413,111
|
)
|
|
Less
gain on sale of discontinued operations
|
(1,155,973
|
)
|
-
|
||||
Loss
from continuing operations
|
$
|
(2,311,634
|
)
|
$
|
(2,413,111
|
)
|
|
Adjustments
to reconcile loss to net cash used in operating
activities:
|
|||||||
Depreciation
and amortization
|
179,446
|
146,256
|
|||||
Non-cash,
stock-based compensation expense
|
367,110
|
660,278
|
|||||
Loss
on disposal of property and equipment
|
-
|
42,781
|
|||||
Interest
received with exchange of stock from Director/CEO
|
-
|
(25,487
|
)
|
||||
Realized
gain on sale of marketable securities
|
(2,028,720
|
)
|
(517,938
|
)
|
|||
Changes
in operating assets and liabilities:
|
|
||||||
Accounts
receivable
|
(80,976
|
)
|
21,303
|
||||
Inventories
|
(152,890
|
)
|
65,549
|
||||
Deposits
|
(378,183
|
)
|
(156,120
|
)
|
|||
Income
tax receivable
|
460,472
|
(178,891
|
)
|
||||
Prepaid
income taxes
|
(18,176
|
)
|
(38,687
|
)
|
|||
Prepaid
expenses and other current assets
|
(23,307
|
)
|
(15,370
|
)
|
|||
Accounts
payable
|
(21,560
|
)
|
117,894
|
||||
Accrued
employee compensation
|
134,693
|
148,143
|
|||||
Other
accrued expenses
|
10,129
|
44,966
|
|||||
Deferred
revenue
|
8,617
|
13,225
|
|||||
Income
taxes payable
|
(41,443
|
)
|
(17,767
|
)
|
|||
Net
cash used in operating activities from continuing
operations
|
(3,896,422
|
)
|
(2,102,976
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Additions
to property and equipment
|
(180,915
|
)
|
(65,609
|
)
|
|||
Proceeds
from sale of marketable securities
|
2,033,397
|
518,463
|
|||||
Net
cash provided by investing activities from continuing
operations
|
1,852,482
|
452,854
|
|||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Repurchase
of common stock
|
-
|
(323,158
|
)
|
||||
Proceeds
from the issuance of common stock
|
571,133
|
5,400
|
|||||
Net
cash provided by (used in) financing activities from continuing
operations
|
571,133
|
(317,758
|
)
|
||||
CASH
FLOWS FROM DISCONTINUED OPERATIONS:
|
|||||||
Operating
cash flows
|
(218,060
|
)
|
(230,915
|
)
|
|||
Cash
flows from investing activities
|
1,780,071
|
1,117,305
|
|||||
Net
cash provided by discontinued operations
|
1,562,011
|
886,390
|
|||||
CHANGE
IN CASH AND CASH EQUIVALENTS:
|
89,204
|
(1,081,490
|
)
|
||||
Cash
and cash equivalents, beginning of year
|
5,335,282
|
6,416,772
|
|||||
Cash
and cash equivalents, end of year
|
$
|
5,424,486
|
$
|
5,335,282
|
|||
SUPPLEMENTAL
INFORMATION:
|
|||||||
Income
taxes paid
|
$
|
20,800
|
$
|
230,863
|
|||
Income
taxes received
|
723,801
|
-
|
The
accompanying notes are an integral part of these consolidated financial
statements
-
33
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
of December 31, 2007
(1) Business
Overview and Management Plans
We
are a
life sciences company focused on the development and commercialization of
a
novel, enabling, platform technology called pressure cycling technology (“PCT”).
PCT uses cycles of hydrostatic pressure between ambient and ultra-high levels
(up to 35,000 psi and greater) to control bio-molecular interactions.
Our
pressure cycling technology uses internally developed instrumentation that
is
capable of cycling pressure between ambient and ultra-high levels at controlled
temperatures to rapidly and repeatedly control the interactions of
bio-molecules. Our instrument, the Barocycler®, and our internally developed
consumables product line, which includes PULSE (Pressure Used to Lyse Samples
for Extraction) Tubes as well as the ProteoSolveLRSTM
kit
for
the detergent-free extraction of proteins from lipid-rich samples, together
make
up the PCT Sample Preparation System (“PCT SPS”).
We
have
experienced negative cash flows from operations with respect to our pressure
cycling technology business since its inception. As of December 31, 2007,
we had
available cash of approximately $5.4 million. We believe that we have sufficient
liquidity to fund our operations at their current level, and with planned
increases in selected areas of our business, into early 2009. The extent
to
which we increase our operational costs is dependent upon our judgment
of the
investment required to successfully commercialize PCT and our ability to
secure
additional funding through equity or debt financing. If we are unable to
increase the number of installations of Barocycler instruments and if we
are
unable to secure additional funding through equity or debt financing we
will be
prepared to reduce our spending. We have developed plans based on these
contingencies and such reductions of spending will include the delay of
certain
research and development projects and the reduction of the cost of our
workforce. We believe that implementing such changes to our business plan
will
allow us to extend our existing cash balances into the middle of 2009,
without
significantly impacting our short-term commercialization efforts.
(2) Summary
of Significant Accounting Policies
(i) Principles
of Consolidation
The
consolidated financial statements include the accounts of Pressure BioSciences,
Inc., and its wholly-owned subsidiary PBI BioSeq, Inc.
(ii) Use
of Estimates
To
prepare our consolidated financial statements in conformity with accounting
principles generally accepted in the United States of America, we are required
to make significant estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent assets and liabilities
at
the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. In addition, significant estimates were
made in projecting future cash flows to quantify impairment of assets, deferred
tax assets, the costs associated with fulfilling our warranty obligations for
the instruments that we sell, and the estimates employed in our calculation
of
fair value of stock options awarded. We base our estimates on historical
experience and on various other assumptions that we believe to be reasonable
under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that are not
readily apparent from other sources. Actual results could differ from the
estimates and assumptions used.
(iii) 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.
-
34
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
of December 31, 2007
Our
current instruments, the Barocycler NEP3229 and NEP2320, require a basic level
of instrumentation expertise to set-up for initial operation. To support a
favorable first experience for our customers, we send a representative to the
customer site to install every Barocycler that we sell through our domestic
sales force. The installation process includes uncrating and setting up the
instrument and conducting an introductory user training course. Product revenue
related to current Barocycler instrumentation is recognized upon the
installation of our instrumentation at the customer location. Product revenue
related to sales of PCT products to our foreign distributors is recognized
upon
shipment through a common carrier. We provide for the expected costs of warranty
upon the recognition of revenue for the sales of our instrumentation. Our sales
arrangements do not provide a right of return to our customers. Product revenue
related to our consumable products such as PULSE Tubes and
ProteoSolveLRS
kits is
recorded upon shipment through a common carrier. Shipping costs are included
in
the costs of sales. Any shipping costs billed to customers are recognized as
revenue.
In
accordance with the Financial Accounting Standards Board (“FASB”) Statement of
Financial Accounting Standards (“SFAS”) No. 13, “Accounting
for Leases”,
we
account for our lease agreements under the operating method. We record revenue
over the life of the lease term and we record depreciation expense on a
straight-line basis over the thirty-six month estimated useful life of the
Barocycler instrument. The depreciation expense associated with assets under
lease agreement is included in the “Cost of PCT products and services” line item
in our Consolidated Statements of Operations. 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.
(iv) 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.
(v) Research
and Development
Research
and development costs, which are comprised of costs incurred in performing
research and development activities including wages and associated employee
benefits, facilities, consumable products and overhead costs that are expensed
as incurred. Our research activities are performed at our laboratories in
Woburn, Massachusetts and Rockville, Maryland and in conjunction with the
collaboration partner sites. In support of our research and development
activities we utilize our Barocycler instruments that are capitalized as fixed
assets and depreciated over their expected useful life.
-
35
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
of December 31, 2007
(vi) Inventories
Inventories
are valued at the lower of cost or market. The composition of inventory as
of December 31, 2007 and 2006 is as follows:
December
31,
|
|||||||
2007
|
2006
|
||||||
Raw
materials
|
$
|
28,115
|
$
|
3,158
|
|||
Finished
goods
|
144,433
|
16,500
|
|||||
Total
|
$
|
172,548
|
$
|
19,658
|
(vii) 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.
(viii) Intangible
Assets
We
have
classified as intangible assets, costs associated with the fair value of
acquired intellectual property. Intangible assets including patents are
being amortized on a straight-line basis over sixteen years. We perform a
quarterly review of our intangible assets for impairment. When impairment
is indicated, any excess of carrying value over fair value is recorded as a
loss. An impairment analysis of intangible assets was performed as of December
31, 2007. Based on this analysis, we have concluded that no impairment of
intangible assets had occurred.
(ix) Long-Lived
Assets and Deferred Costs
In
accordance with the Financial Accounting Standards Board (“FASB”) Statements of
Financial Accounting Standards (“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 at December 31, 2007
and determined that such long-lived assets were not impaired.
(x) Concentrations
Credit
Risk
Our
financial instruments that potentially subject us to concentrations of credit
risk consist primarily of cash, cash equivalents and trade receivables. We
have
cash investment policies which, among other things, limit investments to
investment-grade securities. We perform ongoing credit evaluations of our
customers, and the risk with respect to trade receivables is further mitigated
by the fact that many of our customers are government institutions and
university labs.
During
2007 and 2006 our top five customers accounted for 66.4% and 80.0% of our total
revenues, respectively. During 2007, various agencies of the Federal Government
of the United States in the aggregate accounted for 54.8% of our total
revenues.
As
of
December 31, 2007 and 2006 our top five accounts receivable accounted for 93.8%
and 92.4% of our total receivables balance, respectively. As of December 31,
2007, various agencies of the Federal Government of the United States in the
aggregate accounted for 40.8% of our total accounts receivable.
-
36
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
of December 31, 2007
Product
Supply
Source
Scientific, LLC has been our sole contract manufacturer for all of our PCT
instrumentation. During 2007, however, we initiated several engineering
initiatives to position us for greater independence from any one supplier,
and
we are in the process of developing a network of manufacturers and
sub-contractors to reduce our reliance on any single supplier. Until we develop
a broader network of manufacturers and subcontractors, obtaining alternative
sources of supply or manufacturing services could involve significant delays
and
other costs and challenges, and may not be available to us on reasonable terms,
if at all. The failure of a supplier or contract manufacturer to provide
sufficient quantities, acceptable quality and timely products at an acceptable
price, or an interruption of supplies from such a supplier could harm our
business and prospects.
(xi) Computation
of Loss per Share
Basic
loss per share is computed by dividing loss available to common shareholders
by
the weighted average number of common shares outstanding. Diluted loss per
share
is computed by dividing loss available to common shareholders by the weighted
average number of common shares outstanding plus additional common shares that
would have been outstanding if dilutive potential common shares had been issued.
For purposes of this calculation, stock options are considered common stock
equivalents in periods in which they have a dilutive effect. Stock options
that
are anti-dilutive are excluded from this calculation. The following table
illustrates our computation of loss per share for the years ended December
31,
2007 and 2006.
For the Year Ended
|
|||||||
December 31,
|
|||||||
2007
|
2006
|
||||||
Numerator:
|
|||||||
Loss
from continuing operations - basic and diluted
|
$
|
(2,311,634
|
)
|
$
|
(2,413,111
|
)
|
|
Denominator:
|
|||||||
Weighted
Average Shares Outstanding, basic and diluted
|
2,078,657
|
2,396,077
|
|||||
Loss
per share from continuing operations - basic and diluted
|
$
|
(1.11
|
)
|
$
|
(1.01
|
)
|
|
Shares
excluded from calculations
|
211,796
|
118,751
|
(xii) 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
adopted FIN 48 effective January 1, 2007. FIN 48 requires significant
judgment in determining what constitutes an individual tax position as well
as
assessing the outcome of each tax position. Changes in judgment as to
recognition or measurement of tax positions can materially affect the estimate
of the effective tax rate and consequently, affect our operating results. Prior
to the adoption of FIN 48, we recorded liabilities related to uncertain tax
positions based upon Statement of Financial Accounting Standards No. 5,
“Accounting for Contingencies”.
We
account for income taxes under the asset and liability method, which requires
recognition of deferred tax assets, subject to valuation allowances, and
liabilities for the expected future tax consequences of events that have been
included in the financial statements or tax returns. Deferred income taxes
reflect the net tax effects of temporary differences between the carrying
amounts of asset and liabilities for financial reporting and income tax
purposes. A valuation allowance is established if it is more likely than not
that all or a portion of the net deferred tax assets will not be realized.
-
37
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
of December 31, 2007
(xiii) Accounting
for Stock-Based Compensation
On
January 1, 2006, we adopted SFAS No. 123 (revised 2004), “Share-Based
Payment”
, or
SFAS 123R, and its related implementation guidance as promulgated by both the
FASB, and the SEC SAB 107, associated with the accounting for stock-based
compensation arrangements of our employees and directors. These pronouncements
require that equity-based compensation cost be measured at the grant date (based
upon an estimate of the fair value of the compensation granted) and recorded
to
expense over the requisite service period, which generally is the vesting
period. We adopted SFAS 123R using the modified prospective method in the first
quarter of 2006.
We
estimate the fair value of equity-based compensation utilizing the Black-Scholes
option pricing model. This model requires the input of several factors such
as
the expected option term, expected volatility of our stock price over the
expected term, expected risk-free interest rate over the expected option term,
expected dividend yield rate over the expected option term, and an estimate
of
expected forfeiture rates, and is subject to various assumptions. We believe
this valuation methodology is appropriate for estimating the fair value of
stock
options granted to employees and directors which are subject to SFAS 123R
requirements. These amounts are estimates and thus may not be reflective of
actual future results, nor amounts ultimately realized by recipients of these
grants. These amounts, and the amounts applicable to future quarters, are also
subject to future quarterly adjustments based upon a variety of factors. The
following table summarizes the assumptions we utilized for grants of stock
options to the two sub-groups of our stock option recipients during the twelve
months ended December 31, 2007 and 2006:
Assumptions
|
Outside Board
Members
|
Officers &
Employees |
||
Expected
life
|
5.0
(yrs)
|
6.0
(yrs)
|
||
Expected
volatility
|
55.66%
- 77.86%
|
55.66%
- 92.53%
|
||
Risk-free
interest rate
|
3.69%
- 4.94%
|
3.38%
- 4.94%
|
||
Forfeiture
rate
|
5.00%
|
5.00%
|
||
Expected
dividend yield
|
0.0%
|
0.0%
|
We
developed the above referenced assumptions based on the following rationale.
We
utilized the simplified method provided by SAB No. 107 to develop our estimate
of expected term of the stock options granted. Under this method, stock options
granted to outside board members are estimated to have an expected term of
5
years and stock options granted to our CEO and all other officers and employees
are estimated to have an expected term of 6 years. All stock options granted
have a 10 year contractual life. The stock options granted to outside directors
vest immediately and the stock options granted to the CEO and all other officers
and employees vest ratably over three years. SAB No. 107 provides a simplified
approach to developing the estimate of expected term based on the average of
the
midpoint of the vesting period and the contractual life. The expected volatility
is assumed to approximate the historical volatility that was observed during
the
corresponding expected term for each sub-group of option recipients. The
risk-free interest rate is a weighted average approximation based on the U.S.
Treasury yields in effect at the time of the grants. We used a dividend yield
of
zero for the calculation because we have never paid cash dividends and we have
no intention to begin paying dividends in the foreseeable future. While we
believe these estimates are reasonable, the compensation expense recorded would
increase if the assumed expected term was increased or a higher expected
volatility was used.
We
recognized stock-based compensation expense of $367,110 and $660,278 for the
years ended December 31, 2007 and 2006, respectively. The following table
summarizes the effect of this stock-based compensation expense within each
of
the line items within our Consolidated Statement of Operations:
Year Ended December 31,
|
|||||||
2007
|
2006
|
||||||
Cost
of PCT products and services
|
$
|
4,746
|
$
|
9,955
|
|||
Research
and development
|
141,115
|
181,609
|
|||||
Selling
and marketing
|
70,770
|
44,086
|
|||||
General
and administrative
|
150,479
|
424,628
|
|||||
Total
stock-based compensation expense
|
$
|
367,110
|
$
|
660,278
|
-
38
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
of December 31, 2007
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%, we used this historical rate as our assumption in calculating
future stock-based compensation expense.
During
the years ended December 31, 2007 and 2006, the total fair value of stock
options awarded was $590,912 and $1,089,400, respectively.
As
of
December 31, 2007, the total estimated fair value of unvested stock options
to
be amortized over their remaining vesting period was $688,624. The non-cash,
stock based compensation expense associated with the vesting of these options
will be $411,344 in 2008, $214,101 in 2009 and $63,179 in 2010.
(xiv)
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.
(xv)
Reclassifications
(xvi)
Recent Accounting Standards
In
September 2006, FASB issued SFAS 157, “Fair
Value Measurements”.
SFAS
No. 157 establishes a formal framework for measuring fair value under GAAP
and
expands on disclosure of fair value measurements. Although SFAS No. 157 applies
to and amends the provisions of existing FASB and AICPA pronouncements, it
does
not, of itself, require any new fair value measurements, nor does it establish
valuation standards. SFAS No. 157 applies to all other accounting pronouncements
requiring or permitting fair value measurements, except for: SFAS No. 123R,
“Share-Based
Payment”
and
related pronouncements, the practicability exceptions to fair value
determinations allowed by various other authoritative pronouncements, and AICPA
Statements of Position 97-2 and 98-9 that deal with software revenue
recognition. This statement is effective for financial statements issued for
fiscal years beginning after November 15, 2007, and interim periods within
those
fiscal years. We do not expect the adoption of SFAS 157 to have a material
impact on our consolidated 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:
- |
Acquisition
costs will be generally expensed as incurred;
|
- |
Noncontrolling
interests (formerly known as “minority interests” – see SFAS 160
discussion below) will be valued at fair value at the acquisition
date;
|
- |
Acquired
contingent liabilities will be recorded at fair value at the acquisition
date and subsequently measured at either the higher of such amount
or the
amount determined under existing guidance for non-acquired contingencies;
|
- |
In-process
research and development will be recorded at fair value as an
indefinite-lived intangible asset at the acquisition date;
|
-
39
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
of December 31, 2007
- |
Restructuring
costs associated with a business combination will be generally expensed
subsequent to the acquisition date; and
|
-
|
Changes
in deferred tax asset valuation allowances and income tax uncertainties
after the acquisition date generally will affect income tax expense.
|
SFAS
141(R) includes a substantial number of new disclosure requirements. FAS 141(R)
applies prospectively to business combinations for which the acquisition date
is
on or after January 1, 2009.
SFAS
160
establishes new accounting and reporting standards for the non-controlling
interest in a subsidiary and for the deconsolidation of a subsidiary.
Specifically, this statement requires the recognition of non-controlling
interests (minority interests) as equity in the consolidated financial
statements and separate from the parent’s equity. The amount of net income
attributable to non-controlling interests will be included in consolidated
net
income on the face of the income statement. SFAS 160 clarifies that changes
in a
parent’s ownership interest in a subsidiary that does not result in
deconsolidation are treated as equity transactions if the parent retains its
controlling financial interest. In addition, this statement requires that a
parent recognize a gain or loss in net income when a subsidiary is
deconsolidated. Such gain or loss will be measured using the fair value of
the
non-controlling equity investment on the deconsolidation date. SFAS 160 also
includes expanded disclosure requirements regarding the interests of the parent
and its non-controlling interest.
SFAS
160
is effective for fiscal years, and interim periods within such year, beginning
January 1, 2009. Early adoption of both SFAS 141(R) and SFAS 160 is
prohibited. We do not expect that either SFAS 141(R) or SFAS 160 will have
a
material affect on our consolidated results of operations and financial
condition.
(xvii)
Investment in Marketable Securities
As
of
December 31, 2007 and 2006, we held 0 and 513,934 shares of common stock of
Panacos Pharmaceuticals, Inc., respectively. During 2007 and 2006 we accounted
for this investment in accordance with the provisions of SFAS 115 “Accounting
for Certain Investments in Debt and Equity Securities”
as
securities available for sale. On December 31, 2006, our balance sheet reflected
the fair value of our investment in Panacos Pharmaceuticals to be approximately
$2.1 million, based on the closing price of Panacos Pharmaceutical shares of
$4.01 per share on that day. During 2007 and 2006 the carrying value of our
investment in Panacos Pharmaceuticals common stock changed from period to period
based on changes in the closing price of the common stock on the NASDAQ Global
Market. We recorded these changes in market value on a quarterly basis as
unrealized gains and losses in Comprehensive Income or Loss.
(xviii)
Advertising
Advertising
costs are expensed as incurred. During 2007 and 2006 we incurred $30,572 and
$0,
respectively in advertising expense.
(xvix)
Rent Expense
Rental
costs are expensed as incurred. During 2007 and 2006 we incurred $85,555 and
$86,864, respectively in rent expense for the use of our corporate office and
research and development facilities.
(3) Discontinued
Operations
Source
Scientific, LLC
In
June 2004, we transferred certain assets and liabilities of our PBI Source
Scientific, Inc. subsidiary to a newly formed limited liability company
known as Source Scientific, LLC. At the time of the transfer, we owned 100%
of
the ownership interests of Source Scientific, LLC. We subsequently sold 70%
of
our ownership interests of Source Scientific, LLC to Mr. Richard Henson and
Mr. Bruce A. Sargeant pursuant to a purchase agreement (the “Source
Scientific Agreement”). As a result of the sale of 70% of our ownership
interests, Mr. Henson and Mr. Sargeant each owned 35% and we owned the
remaining 30% of Source Scientific, LLC. Under the Source Scientific Agreement,
we received notes receivable in the aggregate amount of $900,000 (the “Notes”)
payable at the end of three years bearing 8% interest. The Source Scientific
Agreement offered Mr. Henson and Mr. Sargeant the option (“the
Option”) to purchase our 30% ownership interest in Source Scientific, LLC until
May 31, 2007, at an escalating premium (10-50%) over our initial ownership
value, provided that they first paid off the Notes in their
entirety.
-
40
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
of December 31, 2007
On
May
29, 2007, we executed a consent agreement with Mr. Henson and Mr. Sargeant,
Source Scientific LLC, and BIT Analytical Instruments, Inc. (“the Consent
Agreement”) pursuant to which the Notes were repaid in full in the aggregate
amount of $1,201,534 in principal and interest, and Mr. Henson and Mr. Sargeant
exercised their Option through BIT Analytical Instruments, Inc. to purchase
our
remaining 30% ownership interest in Source Scientific, LLC for an aggregate
price of $578,573. As a result of these transactions, we no longer retain any
direct or indirect ownership interest in Source Scientific, LLC.
The
execution of these transactions, and receipt of the funds, triggered our
recognition of a gain on the sale of assets related to discontinued operations
of $1,534,476, net of income taxes of $218,060, during the twelve months ended
December 31, 2007.
Boston
Biomedica, Inc
On
September 14, 2004, we completed the sale of substantially all of the assets
and
selected liabilities of the BBI Diagnostics and BBI Biotech divisions of our
legacy company Boston Biomedica, Inc. to SeraCare Life Sciences, Inc. Pursuant
to the Asset Purchase Agreement, the businesses were sold for $30 million in
cash of which $27.5 million was paid at the closing and the remaining $2.5
million was deposited in escrow pursuant to an escrow agreement expiring in
March 2006. In December 2004, and again in February 2005, we settled
disagreements with SeraCare Life Sciences, Inc., regarding the value of the
inventory and accounts receivable in the closing balance sheets by releasing
approximately $1.4 million from the escrow account. On March 15, 2006, we
received approximately $1.1 million in remaining escrow funds.
(5) Property
and Equipment
Property
and equipment as of December 31, 2007 and 2006 consisted of the following
components:
2007
|
2006
|
||||||
Laboratory
and manufacturing equipment
|
$
|
59,361
|
$
|
43,986
|
|||
Office
equipment
|
105,906
|
64,496
|
|||||
PCT
collaboration, demonstration and leased systems
|
351,838
|
227,708
|
|||||
517,105
|
336,190
|
||||||
Less
accumulated depreciation
|
(259,308
|
)
|
(128,494
|
)
|
|||
Net
book value
|
$
|
257,797
|
$
|
207,696
|
Depreciation
expense for the years ended December 31, 2007 and 2006 was $130,814 and $97,621,
respectively.
(6) Intangible
Assets
Intangible
assets as of December 31, 2007 reflect an estimate of purchase price
attributable to patents in connection with the 1998 acquisition of BioSeq,
Inc.
and the PCT business. Acquired PCT patents are being amortized to expense on
a
straight line basis at the rate of $48,632 per year over their estimated
remaining useful life of approximately 7 years. Intangible assets at December
31, 2007 and 2006 consisted of the following:
-
41
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
of December 31, 2007
2007
|
2006
|
||||||
PCT
Patents
|
$
|
778,156
|
$
|
778,156
|
|||
Less
accumulated amortization
|
(449,866
|
)
|
(401,234
|
)
|
|||
Net
book value
|
$
|
328,290
|
$
|
376,922
|
Amortization
expense for each of the years ended December 31, 2007 and 2006 was
$48,632.
(7) Retirement
Plan
We
provide all of our employees with the opportunity to participate in our
retirement savings plan. Our retirement savings plan has been qualified under
Section 401(k) of the Internal Revenue Code. Eligible employees are permitted
to
contribute to the plan through payroll deductions within statutory limitations
and subject to any limitations included in the plan. During 2007 and 2006 we
contributed $15,708 and $9,565, respectively, in the form of discretionary
company matching contributions.
(8) Income
Taxes
For the Year Ended
December 31, |
|||||||
2007
|
2006
|
||||||
Current
benefit: federal
|
$
|
481,394
|
$
|
929,961
|
|||
Current
benefit (provision): state
|
38,820
|
(184,607
|
)
|
||||
Total
current benefit
|
520,214
|
745,354
|
|||||
Deferred
provision: federal
|
-
|
-
|
|||||
Deferred
provision: state
|
-
|
-
|
|||||
Total
deferred provision
|
-
|
-
|
|||||
Total
benefit for income taxes from continuing operations
|
$
|
520,214
|
$
|
745,354
|
Significant
items making up the deferred tax assets and deferred tax liabilities as of
December 31, 2007 and 2006 are as follows:
December
31,
|
|||||||
|
2007
|
2006
|
|||||
Current
deferred taxes:
|
|||||||
Inventories
|
$
|
-
|
$
|
24,512
|
|||
Other
accruals
|
82,748
|
31,536
|
|||||
Unrealized
gain on marketable securities
|
-
|
(669,520
|
)
|
||||
Less:
valuation allowance
|
(82,748
|
)
|
(56,048
|
)
|
|||
Total
current deferred tax liabilities
|
$
|
-
|
$
|
(669,520
|
)
|
||
Long
term deferred taxes:
|
|||||||
Accelerated
tax depreciation
|
$
|
373
|
$
|
(721
|
)
|
||
Source
Scientific Note, OID
|
-
|
57,989
|
|||||
Non-cash,
stock-based compensation, NQ
|
194,300
|
156,035
|
|||||
Goodwill
and intangibles
|
(132,203
|
)
|
(151,787
|
)
|
|||
Operating
loss carryforwards
|
1,648,542
|
1,359,572
|
|||||
Less:
valuation allowance
|
(1,711,012
|
)
|
(1,421,088
|
)
|
|||
Total
long term deferred tax assets (liabilities), net
|
-
|
-
|
|||||
Total
net deferred tax liabilities
|
$
|
-
|
$
|
(669,520
|
)
|
A
valuation allowance is established if it is more likely than not that all or
a
portion of the deferred tax asset will not be realized. Accordingly, a
valuation allowance was established in 2007 and 2006 for the full amount of
our
deferred tax assets due to the uncertainty of realization. During 2006 our
valuation allowance increased by $245,081. We believe based on our projection
of
future taxable operating income for the foreseeable future, it is more likely
than not that we will not be able to realize the benefit of the deferred tax
asset at December 31, 2007 and 2006.
-
42
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
of December 31, 2007
We
had
net operating loss carry-forwards for federal income tax purposes of
approximately $2,476,000 and $577,000 as of December 31, 2007 and 2006,
respectively. Included in these numbers are loss carry-forwards that were
obtained through the acquisition of BioSeq, Inc. and are subject to Section
382
NOL limitations. These net operating loss carry-forwards expire at various
dates from 2013 through 2025. We had net operating loss carry-forwards for
state income tax purposes of approximately $16,165,000 and $13,507,000 as of
December 31, 2007 and 2006, respectively. These net operating loss
carry-forwards expire at various dates from 2008 through 2025.
Our
effective income tax benefit rate for continuing operations was different than
the statutory federal income tax benefit rate as follows:
For the Year Ended
December 31, |
|||||||
2007
|
2006
|
||||||
Federal
tax benefit (provision) rate
|
34
|
%
|
34
|
%
|
|||
Permanent
differences
|
5
|
%
|
-2
|
%
|
|||
State
tax expense
|
3
|
%
|
-4
|
%
|
|||
Valuation
allowance
|
-21
|
%
|
-4
|
%
|
|||
Effective
income tax benefit rate from continuing operations
|
21
|
%
|
24
|
%
|
(9) Commitments
and Contingencies
Operating
Leases
Our
corporate offices are currently located at 14 Norfolk Avenue, South Easton,
Massachusetts 02375. In November 2007, we signed an 18 month lease
agreement commencing in February 2008, pursuant to which we lease approximately
5,500 square feet of office space, with an option for an additional 18 months.
We pay approximately $6,500 per month for the use of these facilities.
On
June
1, 2006, we entered into a lease agreement with Scheer Partners and the Maryland
Economic Development Corporation, pursuant to which we lease laboratory and
office space in Rockville, MD. In August 2007, we extended the lease agreement
through May 31, 2009. We pay approximately $3,300 per month for the use of
these
facilities.
On
March
1, 2006, we entered into a sub-lease agreement with Proteome Systems, pursuant
to which we lease approximately 650 square feet of laboratory space plus 100
square feet of office space from Proteome Systems in Woburn, Massachusetts.
The
lease period extends through December 31, 2008 and we pay approximately $3,200
per month for the use of these facilities.
Royalty
Commitments
In
1996,
we acquired our initial equity interest in BioSeq, Inc., which at the time
was
developing our original pressure cycling technology. BioSeq, Inc. acquired
its pressure cycling technology from BioMolecular Assays, Inc. under a
technology transfer and patent assignment agreement. In 1998, we purchased
all of the remaining outstanding capital stock of BioSeq, Inc., and at such
time, the technology transfer and patent assignment agreement was amended to
require us to pay BioMolecular Assays, Inc. a 5% royalty on our sales of
products or services that incorporate or utilize the original pressure cycling
technology that BioSeq, Inc. acquired from BioMolecular Assays, Inc. We
are also required to pay BioMolecular Assays, Inc. 5% of the proceeds from
any
sale, transfer or license of all or any portion of the original pressure cycling
technology. These payment obligations terminate in 2016. During the
fiscal years ended December 31, 2007 and 2006, we paid BioMolecular Assays,
Inc.
$19,596 and $9,809 in royalties.
In
connection with our acquisition of BioSeq, Inc., we licensed certain limited
rights to the original pressure cycling technology back to BioMolecular Assays,
Inc. This license is non-exclusive and limits the use of the
original pressure cycling technology by BioMolecular Assays, Inc. solely for
molecular applications in scientific research and development and in scientific
plant research and development. BioMolecular Assays, Inc. is required to
pay us a royalty equal to 20% of any license or other fees and royalties, but
not including research support and similar payments, it receives in connection
with any sale, assignment, license or other transfer of any rights granted
to
BioMolecular Assays, Inc. under the license. BioMolecular Assays, Inc. must
pay
us these royalties until the expiration of the patents held by BioSeq, Inc.
in
1998, which we anticipate will be 2016. We have not received any royalty
payments from BioMolecular Assays, Inc. under this license.
-
43
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
of December 31, 2007
Purchase
Commitments
In
March
2007, we executed a purchase order with Source Scientific, LLC under which
we
agreed to purchase 20 Barocycler NEP3229 units and nine demonstration (NEP2320)
units to be used by our sales force. In connection with this purchase order,
we
placed deposits with Source Scientific, LLC in the amount of $260,000. The
nine
demonstration (NEP2320) instruments were prototype units and were therefore
billable on a time and materials basis. As of December 31, 2007 we have taken
possession of all of these completed units and the cost was expensed as incurred
in research and development expense within our consolidated statement of
operations. The order for 20 NEP3229 units is based on a fixed bill of materials
and we are billed for the complete cost of each unit as it is completed, net
of
the deposit we placed for each instrument. As of December 31, 2007, none of
the
NEP3229’s had been completed. We expect all of these units to be completed and
available for sale, lease or collaboration in early 2008.
In
June
2007, we executed a purchase order with Source Scientific, LLC under which
we
agreed to purchase 40 Barocycler NEP2320 units. In connection with this purchase
order we placed a deposit with Source Scientific, LLC in the amount of $140,000.
In accordance with the terms of this purchase order, we are billed based on
a
fixed bill of materials, for the complete cost of each unit as it is completed,
net of the deposit we placed for each instrument.
As
of
December 31, 2007 we had $379,000 on deposit with Source for 54 remaining units
pursuant to these purchase orders. As of December 31, 2006 we had $168,000
on
deposit with Source for 21 remaining units pursuant to open purchase orders.
Indemnification
In
connection with our sale of substantially all of the assets of Boston Biomedica,
Inc., (“BBI Core Businesses”) to SeraCare Life Sciences, Inc. in September 2004,
we continue to be exposed to possible indemnification claims in amounts up
to
the purchase price of approximately $29 million. Our indemnification obligations
for breaches of some representations and warranties relating to compliance
with
environmental laws extend until September 14, 2009, representations and
warranties relating to tax matters extend for the applicable statute of
limitations period (which varies depending on the nature of claim), and
representations and warranties relating to our due organization, subsidiaries,
authorization to enter into and perform the transactions contemplated by the
Asset Purchase Agreement and brokers fees, extend indefinitely.
Severance
and Change of Control Agreements
Each
of
our executive officers; Mr. Schumacher, Mr. Myles, Dr. Ting, Dr. Lazarev, Dr.
Lawrence and Mr. Potter is entitled to receive a severance payment if terminated
by us without cause. The severance benefits would include a payment in an amount
equal to one year of such executive officer’s annualized base salary
compensation plus accrued paid time off. Additionally, the officer will be
entitled to receive medical and dental insurance coverage for one year following
the date of termination. The total commitment related to these agreements in
the
aggregate is approximately $1.2 million.
Each
of
our executive officers, other than Mr. Schumacher, is entitled to receive a
change of control payment in an amount equal to one year of such executive
officer’s annualized base salary compensation, accrued paid time off, and
medical and dental coverage, in the event of a change of control of the Company.
In the case of Mr. Schumacher this payment would be equal to two years of
annualized base salary compensation, accrued paid time off, and two years of
medical and dental coverage. The total commitment related to these agreements
in
the aggregate is approximately $1.5 million.
-
44
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
of December 31, 2007
(10) 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 December 31, 2007 none of these shares
have been issued.
Shareholders
Purchase Rights Plan
On
March
3, 2003, our Board of Directors adopted a shareholder purchase rights plan
(“the
Rights Plan”) and declared a distribution of one Right for each outstanding
share of our Common Stock to shareholders of record at the close of business
on
March 21, 2003 (the “Rights”). Initially, the Rights will trade automatically
with the common stock and separate Right Certificates will not be issued.
The Rights Plan is designed to deter coercive or unfair takeover tactics and
to
ensure that all of our shareholders receive fair and equal treatment in the
event of an unsolicited attempt to acquire the Company. The Rights Plan was
not
adopted in response to any effort to acquire the Company and the Board is not
aware of any such effort. The Rights will expire on February 27, 2013 unless
earlier redeemed or exchanged. Each Right entitles the registered holder,
subject to the terms of a Rights Agreement, to purchase from the Company one
one-thousandth of a share of the Company’s Series A Junior Participating
Preferred Stock at a purchase price of $45.00 per one one-thousandth of a share,
subject to adjustment. In general, the Rights will not be exercisable until
a
subsequent distribution date which will only occur if a person or group acquires
beneficial ownership of 15% or more of our common stock or announces a tender
or
exchange offer that would result in such person or group owning 15% or more
of
the common stock. With respect to any person or group who currently beneficially
owns 15% or more of our common stock, the Rights will not become exercisable
unless and until such person or group acquires beneficial ownership of
additional shares of common stock.
Subject
to certain limited exceptions, if a person or group acquires beneficial
ownership of 15% or more of our outstanding common stock or if a current 15%
beneficial owner acquires additional shares of common stock, each holder of
a
Right (other than the 15% holder whose Rights become void once such holder
reaches the 15% threshold) will thereafter have a right to purchase, upon
payment of the purchase price of the Right, that number of shares of our common
stock which at the time of such transaction will have a market value equal
to
two times the purchase price of the Right In the event that, at any time
after a person or group acquires 15% or more of our common stock, we are
acquired in a merger or other business combination transaction or 50% or more
of
its 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 was
reserved for issuance upon exercise of stock options or other equity awards
made
under the Plan. Under the Plan, we may award stock options, stock
issuances, 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 December 31, 2007, options to acquire 867,000
shares are outstanding under the Plan.
We
also
have 244,000 stock options outstanding under our 1999 Non-qualified Plan and
9,500 stock options outstanding under our 1994 Incentive Stock Option Plan.
As
of December 31, 2007, there were 4,800 shares available for future grant under
the 1999 Non-qualified Plan. The 1994 Incentive Stock Option Plan expired;
therefore, there are no shares available for future grants under this
plan.
-
45
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
of December 31, 2007
The
following tables summarize information concerning options outstanding and
exercisable:
Stock Options
|
|||||||||||||
Weighted
|
Weighted
|
||||||||||||
Average price
|
Average price
|
||||||||||||
Shares
|
per share
|
Exercisable
|
per share
|
||||||||||
Balance
outstanding, 12/31/2005
|
585,000
|
$
|
2.96
|
385,000
|
$
|
2.97
|
|||||||
Granted
|
382,000
|
3.91
|
|||||||||||
Exercised
|
(2,000
|
)
|
2.70
|
||||||||||
Expired
|
(19,500
|
)
|
4.11
|
||||||||||
Forfeited
|
|||||||||||||
Balance
outstanding, 12/31/2006
|
945,500
|
$
|
3.32
|
524,000
|
$
|
3.17
|
|||||||
Granted
|
200,000
|
4.09
|
|||||||||||
Exercised
|
-
|
||||||||||||
Expired
|
-
|
||||||||||||
Forfeited
|
(25,000
|
)
|
3.58
|
||||||||||
Balance
outstanding, 12/31/2007
|
1,120,500
|
$
|
3.45
|
691,166
|
$
|
3.23
|
Options Outstanding
|
Options Exercisable
|
||||||||||||||||||
Weighted Average
|
Weighted Average
|
||||||||||||||||||
Range of Exercise
Prices
|
Number of
Options
|
Remaining
Contractual
Life
|
Exercise
Price
|
Number of
Options
|
Remaining
Contractual
Life
|
Exercise
Price
|
|||||||||||||
$2.50
- $2.70
|
159,000
|
4.7
|
$
|
2.64
|
159,000
|
4.7
|
$
|
2.64
|
|||||||||||
2.71
- 3.08
|
343,000
|
6.7
|
2.96
|
276,333
|
6.5
|
2.97
|
|||||||||||||
3.09
- 3.95
|
389,500
|
8.3
|
3.71
|
128,833
|
7.9
|
3.70
|
|||||||||||||
3.96
- 5.93
|
229,000
|
8.7
|
4.31
|
127,000
|
7.9
|
4.05
|
|||||||||||||
$2.50
- $5.93
|
1,120,500
|
7.4
|
$
|
3.45
|
691,166
|
6.6
|
$
|
3.23
|
The
aggregate intrinsic value of options outstanding as of December 31, 2007 was
$2,162,565. The aggregate intrinsic value of options exercisable as of December
31, 2007 was $1,486,007. The aggregate intrinsic value of options outstanding
as
of December 31, 2006 was $347,410. The aggregate intrinsic value of options
exercisable as of December 31, 2006 was $274,355.
Stock
Buy-back Program
During
the quarter ended September 30, 2006 our board of directors approved a stock
buy-back program pursuant to which we are authorized to use up to $500,000
of
our cash resources to purchase shares of the Company’s common stock in the open
market or in privately negotiated transactions. As of December 31, 2006, we
had
purchased 110,889 shares of our common stock from unaffiliated shareholders
for
approximately $2.91 per share. We did not acquire any shares through our stock
buy-back program during 2007.
Sale
of Common Stock
On
November 21, 2007, we completed a private placement, pursuant to which we sold
an aggregate of 126,750 shares of common stock, $0.01 par value (the “Shares”),
for a purchase price of $5.00 per share, resulting in gross proceeds to us
of
approximately $633,750 (the “Private Placement”). The Shares were issued and
sold to a total of 8 accredited investors pursuant to a Securities Purchase
Agreement entered into as of November 21, 2007 (the “Securities Purchase
Agreement”).
The
Shares were issued in the Private Placement without registration under the
Securities Act of 1933, as amended (the “Securities Act”), in reliance upon the
exemption from registration set forth in Rule 506 of Regulation D (“Regulation
D”) promulgated under the Securities Act. We based such reliance upon
representations made by each purchaser of Shares, including, but not limited
to,
representations as to the purchaser’s status as an “accredited investor” (as
defined in Rule 501(a) under Regulation D) and the purchaser’s investment
intent. The Shares were not offered or sold by any form of general solicitation
or general advertising, as such terms are used in Rule 502 under Regulation
D.
The Shares may not be offered or sold in the United States absent an effective
registration statement or an exemption from the registration requirements under
applicable federal and state securities laws.
-
46
-
PRESSURE
BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
As
of December 31, 2007
In
connection with the Private Placement, we agreed to prepare and file a
Registration Statement on Form S-3 (the “Registration Statement”) covering the
resale of the Shares purchased in the Private Placement, and to use its
commercially reasonable efforts to cause such Registration Statement to be
declared effective as promptly as possible after the filing thereof and to
keep
the Registration Statement continuously effective under the Securities Act
until
all shares covered by such Registration Statement have been sold, or may be
sold
without volume restrictions pursuant to Rule 144 (or any successor Rule under
the Securities Act). The Registration Statement was declared effective by the
SEC on January 22, 2008.
(11) Related
Party Transaction
On
December 29, 2006, Richard T. Schumacher, President and Chief Executive Officer,
delivered to us 249,875 shares of his common stock of the Company in full and
complete satisfaction and payment of all outstanding amounts, including all
principal and accrued interest, of Mr. Schumacher’s loan receivable to us. The
loan amount consisted of $1,000,000 in principal and $25,487 in interest accrued
in the fourth quarter of 2006. The number of shares was determined based upon
a
value of $4.10 per share, the volume weighted average trading price of the
shares of our common stock on the NASDAQ Capital Market during the 60 trading
days ending on December 29, 2006. In connection with the payment of the loan,
we
terminated our security interest in Mr. Schumacher’s shares of common stock, and
released to Mr. Schumacher the remaining 229,782 shares of common stock
previously held as collateral.
-
47
-
Report
of Independent Registered Public Accounting Firm
To
the
Board of Directors of
Pressure
BioSciences, Inc. and Subsidiaries:
We
have
audited the consolidated balance sheets of Pressure BioSciences, Inc., and
Subsidiaries (the “Company”) as of December 31, 2007 and 2006, and the related
consolidated statements of operations, comprehensive income (loss), changes
in
stockholders’ equity, and cash flows for the years then ended. These financial
statements are the responsibility of the Company’s management. Our
responsibility is to express an opinion on these financial statements based
on
our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and perform the audit to obtain reasonable assurance about whether the
consolidated financial statements are free of material misstatement. The Company
is not required to have, nor were we engaged to perform, an audit of its
internal control over financial reporting. Our audits included consideration
of
internal control over financial reporting as a basis for designing audit
procedures that are appropriate in the circumstances, but not for the purpose
of
expressing an opinion on the effectiveness of the Company’s internal control
over financial reporting. Accordingly, we express no such opinion. An audit
also
includes examining, on a test basis, evidence supporting the amounts and
disclosures in the consolidated financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our
opinion.
In
our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the financial position of Pressure BioSciences, Inc.,
and Subsidiaries as of December 31, 2007 and 2006, and the results of their
operations and their cash flows for the years then ended in conformity with
accounting principles generally accepted in the United States of
America.
As
discussed in Note 2 to the consolidated financial statements, effective January
1, 2007, the Company adopted FASB Interpretation No. 48, “Accounting for
Uncertainty in Income Taxes - an Interpretation of FASB Statement No. 109”.
As discussed in Note 2 to the consolidated financial statements, effective
January 1, 2006, the Company adopted Financial Accounting Standards Board
Statement No. 123 (Revised 2004) - "Share-Based Payments."
/s/
UHY
LLP
Boston,
Massachusetts
March
27, 2008
-
48
-
ITEM 9. |
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE.
|
None
ITEM 9A. |
CONTROLS
AND
PROCEDURES.
|
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that
information required to be disclosed in the reports we file under the Exchange
Act is recorded, processed, summarized and reported, within the time periods
specified in the SEC’s rules and forms, and that such information is accumulated
and communicated to our management, including our President (Principal Executive
Officer) and our Senior Vice President and Chief Financial Officer (Principal
Financial Officer), as appropriate, to allow timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and procedures,
management recognized that any controls and procedures, no matter how well
designed and operated, can provide only reasonable assurance of achieving the
desired control objectives, as ours are designed to do, and management
necessarily was required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures.
As
of
December 31, 2007, we carried out an evaluation, under the supervision and
with
the participation of our management, including our President (Principal
Executive Officer) and our Senior Vice President of Finance and Chief Financial
Officer (Principal Financial Officer) of the effectiveness of the design and
operation of our disclosure controls and procedures, as defined in
Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based upon that
evaluation, our President (Principal Executive Officer) and our Senior Vice
President of Finance and Chief Financial Officer (Principal Financial Officer)
concluded that our disclosure controls and procedures are effective in enabling
us to record, process, summarize, and report information required to be included
in our periodic SEC filings within the required time period.
We
are
responsible for establishing and maintaining adequate internal control over
financial reporting. Internal control over financial reporting is defined in
Rule 13a-15(f) and 15d-15(f) under the Exchange Act, as a process designed
by,
or under the supervision of our principal executive and principal financial
officers and effected by our board of directors, management and other personnel
to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles and includes those policies and
procedures that:
-
|
pertain
to the maintenance of records that in reasonable detail accurately
and
fairly reflect the transactions and disposition of our
assets;
|
-
|
provide
reasonable assurance that transactions are recorded as necessary
to permit
preparation of financial statements in accordance with generally
accepted
accounting principles, and that our receipts and expenditures are
being
made only in accordance with authorization of our management and
directors; and
|
-
|
provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of our assets that could
have
a material effect on the financial
statements.
|
Our
internal control system is designed to provide reasonable assurance to our
management and board of directors regarding the preparation and fair
presentation of published financial statements. Because of its inherent
limitations, internal control over financial reporting may not prevent or detect
misstatements. Projections of any evaluation of effectiveness to future periods
are subject to the risks that controls may become inadequate because of changes
in conditions, or that the degree of compliance with the policies or procedures
may deteriorate.
-
49
-
We
have
assessed the effectiveness of our internal control over financial reporting
as
of December 31, 2007. In making this assessment, we used the criteria set forth
by the Committee of Sponsoring Organizations of the Treadway Commission (COSO)
in Internal Control-Integrated Framework.
Based
on
our assessment, we believe that, as of December 31, 2007, our internal control
over financial reporting is effective at a reasonable assurance level based
on
these criteria.
This
annual report does not include an attestation report of our registered public
accounting firm regarding internal control over financial reporting.
Management's report was not subject to attestation by our registered public
accounting firm pursuant to temporary rules of the SEC that permit us to provide
only management's report in this annual report.
Changes
in Internal Control Over Financial Reporting
There
have been no changes in our internal control over financial reporting that
occurred during the fourth quarter of 2007 that have materially affected, or
are
reasonably likely to materially affect, our internal control over financial
reporting.
ITEM 9B. |
OTHER
INFORMATION.
|
None.
-
50
-
ITEM 10. |
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE
GOVERNANCE.
|
Our
Directors
The
names
of our directors, their ages as of March 24, 2008, their committee membership
and certain biographical information are set forth below:
Name
|
Age
|
Position
|
Director
Since
|
Year
Term
Expires
and
Class
|
||||
R.
Wayne Fritzsche(1)
|
59
|
Chairman
of the Board
|
2003
|
2009,
Class I
|
||||
Calvin
A. Saravis, Ph.D (2)
|
78
|
Director
|
1987
|
2009,
Class I
|
||||
J.
Donald Payne (1)
|
52
|
Director
|
2003
|
2010,
Class II
|
||||
P.
Thomas Vogel(1)
|
68
|
Director
|
2004
|
2010,
Class II
|
||||
Richard
T. Schumacher
|
57
|
Director,
President, Chief Executive Officer and Clerk
|
1978
|
2008,
Class III
|
(1) Member
of
the Audit Committee, Compensation Committee, and Nominating
Committee
(2) Member
of
the Compensation Committee, Nominating Committee, and Chairman of the Scientific
Advisory Board
Mr.
R. Wayne Fritzsche
has
served as a director and Chairman of our Board of Directors since October 2,
2003. Mr. Fritzsche has served as a member of our Scientific Advisory Board
since 1999. Mr. Fritzsche is the founder of Fritzsche & Associates, Inc., a
consulting firm which provides strategic, financial, and scientific consulting
to medical companies in the life sciences and healthcare industries, and has
served as its President since 1991. Since 2003, Mr. Fritzsche has also served
as
interim President of Chemokine Pharmaceutical Company, Inc. (formerly PGBP
Pharmaceuticals), a small molecule discovery company. Since 2001, Mr. Fritzsche
has served as a board member of Opexa Pharmaceuticals, a multiple sclerosis
and
cell immunology therapy company, and Vascular Sciences, Inc., an extracorporeal,
macular degeneration company. He also previously served as a board member of
Intelligent Medical Imaging, an automated microscopic imaging company, from
1994
to 1997, Clarion Pharmaceuticals, a drug development company, from 1994 to
1996,
Nobex Pharmaceuticals, a drug delivery firm, from 1996 to 2001, Cardio Command,
Inc., a transesophageal cardiac monitoring and pacing firm, from 1999 to 2001,
and Hesed BioMed, an antisense oligonucleotide and catalytic antibody company,
from 2000 to 2002. Mr. Fritzsche holds a BA from Rowan University, and an MBA
from the University of San Diego.
Dr.
Calvin A. Saravis
has
served as one of our directors since 1986. Dr. Saravis has also served as
Chairman of our Scientific Advisory Board since 2003. From 1984 to 1998 he
was
an Associate Professor of Surgery (Biochemistry) at Harvard Medical School
(presently emeritus) and from 1983 to 1999, he was an Associate Research
Professor of Pathology at Boston University School of Medicine (presently
emeritus). From 1971 to 1997, Dr. Saravis was a Senior Research Associate at
the
Mallory Institute of Pathology and from 1979 to 1997 he was a Senior Research
Associate at the Cancer Research Institute-New England Deaconess Hospital.
Dr.
Saravis received his Ph.D. in immunology and serology from Rutgers
University.
Mr.
J. Donald Payne
has
served as one of our directors since December 30, 2003. Since September 2001,
Mr. Payne has served as President and a Director of Nanospectra Biosciences,
Inc., a privately-held medical device company developing products for cancer.
Prior to that, Mr. Payne held various executive positions in finance and
administration of public and private life science companies since 1992, served
as a financial executive in the energy industry from 1980 through 1990, and
was
in public accounting from 1976 to 1980. Mr. Payne received an MBA from Rice
University in 1992 and a BBA from Texas A&M University in 1976. He is a
Certified Public Accountant in Texas, and a member of the AICPA and Financial
Executives Institute.
-
51
-
Mr.
P. Thomas Vogel
has
served as one of our directors since January 9, 2004. Since 2006 Mr. Vogel
is
the President of Vogel Associates, a consulting company, and a Principal of
Franchise Finders, LLC, a franchise consulting company. From April 2002 until
December 2005, Mr. Vogel served as the President and Chief Executive Officer
of
AdipoGenix, Inc, an early-stage drug discovery company focused on obesity and
metabolic diseases. From 2000 to 2002, Mr. Vogel served as President and Chief
Executive Officer of Arradial, Inc., an early stage biopharmaceutical company.
From 1996 to 2000, Mr. Vogel was Chief Executive Officer and Director of Mosaic
Technologies, Inc., an early-stage molecular biology company. From 1992 to
1995,
Mr. Vogel was President of Fisher Scientific Company, a $1 billion laboratory
supply distribution business. Mr. Vogel served as President of PB Diagnostics
from 1991 to 1992, as President of Instrumentation Laboratory from 1990 to
1991,
and as President of Serono Diagnostics from 1988 to 1990. Mr. Vogel was in
the
venture capital arena from 1982 to 1987. Prior to that, from 1974 to 1982,
Mr.
Vogel worked in the Diagnostics Division of Abbott Laboratories, Inc., where
he
served as Divisional Vice President and General Manager of Diagnostic Products.
Mr. Vogel graduated from the Georgia Institute of Technology with a Bachelor's
Degree in Electrical Engineering and from The Wharton Business School with
a
Master's Degree in Business Administration.
Mr.
Richard T. Schumacher,
the
founder of our company, has served as one of our directors since 1978. He has
served as our Chief Executive Officer since April 16, 2004 and President since
September 14, 2004. He previously served as Chief Executive Officer and Chairman
of the Board of our company from 1992 to February 2003. From July 9, 2003 until
April 14, 2004 he served as a consultant to our company pursuant to a consulting
agreement. He served as President of our company from 1986 to August 1999.
Mr.
Schumacher served as the Director of Infectious Disease Services for Clinical
Sciences Laboratory, a New England-based medical reference laboratory, from
1986
to 1988. From 1972 to 1985, Mr. Schumacher was employed by the Center for Blood
Research, a nonprofit medical research institute associated with Harvard Medical
School. Mr. Schumacher received a B.S. in Zoology from the University of New
Hampshire.
Our
Executive Officers
The
following table sets forth the names, ages and positions of our current
executive officers:
Name
|
|
Age
|
|
Position
|
Richard
T. Schumacher
|
|
57
|
|
President,
Chief Executive Officer and Director
|
Edward
H. Myles
|
|
36
|
|
Senior
Vice President of Finance, Chief Financial Officer, Treasurer and
Assistant Clerk
|
Edmund
Ting, Ph.D.
|
|
53
|
|
Senior
Vice President of Engineering
|
Nathan
P. Lawrence, Ph.D.
|
|
53
|
|
Vice
President of Marketing
|
Alexander
Lazarev, Ph.D.
|
|
43
|
|
Vice
President of Research and Development
|
Matthew
B. Potter
|
44
|
Vice
President of Sales
|
Set
forth
below is biographical information for each of our executive officers, other
than
Mr. Schumacher whose biographical information is set forth above under the
heading “Our Directors”.
Mr.
Edward H. Myles
was
appointed to serve as Vice President of Finance and Chief Financial Officer
on
April 3, 2006 and was promoted to the position of Senior Vice President of
Finance and Chief Financial Officer on February 12, 2007. Prior to joining
Pressure BioSciences, Inc., Mr. Myles served as the controller for EMD
Pharmaceuticals, a wholly-owned affiliate of Merck KGaA, from 2003 to 2006.
At
EMD, Mr. Myles had a wide variety of responsibilities in the areas of accounting
and business development. Prior to EMD Pharmaceuticals, Mr. Myles worked in
the
health care investment banking group of SG Cowen Securities Corporation from
2002 to 2003. From 2000 to 2002, Mr. Myles was enrolled in the full-time MBA
program at Washington University in St. Louis, where he co-founded Luminomics,
an early-stage biotechnology company. Prior to enrolling in graduate
school, Mr. Myles was the Corporate Controller of Boston Biomedica, Inc. Prior
to joining Boston Biomedica, Inc., in 1997 he worked at the accounting firms
Price Waterhouse LLP and Coopers & Lybrand LLP where he held positions of
increasing responsibility between 1993 and 1997. Mr. Myles became a CPA in
1996,
and earned a BSBA, with honors, in accounting and finance from the University
of
Hartford, and an MBA from Washington University in St. Louis.
-
52
-
Dr.
Edmund Ting
joined
as Senior Vice President of Engineering on April 24, 2006. Prior to joining,
Dr.
Ting served as the Chief Research Officer of Avure Technologies, a leading
worldwide manufacturer of high pressure hydrostatic processing equipment for
the
food and materials processing industry, where he worked from 2001 to 2006.
From
1990 to 2001, Dr. Ting was employed by Flow International Corporation, a world
leader in the ultrahigh pressure waterjet cutting technology market, and the
parent company of Avure Technologies until November 2005. Dr. Ting last held
the
position of VP of Engineering Research and Development at Flow International
Corporation. From 1984 to 1990, Dr. Ting was a research scientist, then a group
leader at Grumman Aerospace Corporation. Dr. Ting earned a Bachelor of Science
degree in mechanical engineering from Northeastern University and a Science
Doctorate in materials science and engineering from the Massachusetts Institute
of Technology.
Dr.
Nathan P. Lawrence
was
appointed Vice President of Marketing and Sales on April 1, 2006. Dr.
Lawrence joined Pressure BioSciences Inc. in 2005, serving as Director of
Research and Development until his promotion to Vice President of Marketing
and
Business Development in 2006. Dr. Lawrence was responsible for the
development of protocols based on Pressure Cycling Technology (PCT). From
2004 through 2005, Dr. Lawrence worked for 454 Life Sciences in product
development. Prior to 454 Life Sciences, Dr. Lawrence was Director of
Research and Development for Boston Biomedica, Inc. from 1998-2004. He was
responsible for the development of PCT, as well as the development of nucleic
acid-based diagnostic assays. Prior to joining Boston Biomedica, Inc., Dr.
Lawrence held several positions with increasing responsibility in Research
and
Development and manufacturing at Becton Dickinson and Gene Trak Systems.
Dr. Lawrence holds a BA from the University of Miami, an M.S. from Southern
Connecticut State University, and a Ph.D. from Yale University.
Dr.
Alexander Lazarev
was
promoted to the position of Vice President of Research and Development,
effective March 20, 2007. Prior to his promotion he served as our Director
of
Research and Development, since joining us on April 3, 2006. Prior to joining
Pressure BioSciences, Inc., Dr. Lazarev worked as a Visiting Scientist at the
Barnett Institute of Chemical and Biological Analysis at Northeastern University
in 2005, and served as a Director of New Technology Development at Proteome
Systems, Inc., where he was involved in research and development of innovative
proteomic analysis applications from 2001 until early 2006. From 1998 to 2001,
Dr. Lazarev was employed as Senior Scientist at the Proteomics Division of
Genomic Solutions, Inc. Prior to his employment at Genomic Solutions, Inc.,
Dr.
Lazarev was employed in an analytical contract service startup company,
PhytoChem Technologies, Inc., which was founded as a spin-off from ESA, Inc.
in
1997. Previously, Dr. Lazarev held various scientific positions at the Ohio
State University School of Medicine and the Uniformed Services University of
Health Sciences. Most of his scientific career has been dedicated to development
of methods and applications for biochemical analysis. Since 2005, Dr. Lazarev
has been elected as an Executive Board member of the MASSEP.org, a non-profit
scientific discussion forum dedicated to the promotion and improvement of
chromatography and other analytical technologies. Dr. Lazarev earned his
undergraduate and graduate degrees at the University of Kazan, Russian
Federation.
Mr.
Matthew B. Potter
joined
PBI as our Vice President of Sales on February 25, 2008 and was appointed an
executive officer on March 6, 2008. Mr. Potter has worked in many
different disciplines that include molecular biology, chromatography,
personalized medicine, diagnostics, & biophysics. Prior to joining PBI Mr.
Potter was the Vice President of Sales & Marketing at Abcam, Inc. from July
2007 to January 2008. Prior to Abcam, Mr. Potter was the National Sales Manager:
Key Accounts Pharmaceutical at Qiagen, Inc. from July 2005 to May 2007. Prior
to
Qiagen, Mr. Potter was Director, Sales and Marketing at MicroCal, LLC from
January 2000 to July 2005. Mr. Potter is also a former Treasurer of the New
England Scientific Manufacturers Association and has been cited as a co-author
and contributor on assorted scientific publications during his tenure working
at
the Worcester Foundation for Experimental Biology. Mr. Potter holds a BA in
Biology from Clark University and an MBA from Assumption College, both located
in Worcester, MA.
Section
16(a) Beneficial Ownership Reporting Compliance
Section
16(a) of the Exchange Act requires our executive officers and directors, and
persons who own more than 10% of our common stock, to file reports of ownership
and changes in ownership on Forms 3, 4 and 5 with the SEC.
Based
solely on our review of the copies of such filings we have received and written
representations from certain reporting persons, we believe that all of our
executive officers, directors, and greater than 10% stockholders complied with
all Section 16(a) filing requirements applicable to them during our fiscal
year
ended December 31, 2007.
-
53
-
Code
of Ethics
Pursuant
to Section 406 of the Sarbanes-Oxley Act of 2002, we have adopted a Code of
Ethics for Senior Financial Officers that applies to our principal executive
officer, principal financial officer, principal accounting officer, controller,
and other persons performing similar functions. A
copy of
the code of ethics is posted on, and may be obtained free of charged from our
Internet website at http://www.pressurebiosciences.com.
If
we
make any amendments to this Code of Ethics or grant any waiver, including any
implicit waiver, from a provision of this Code of Ethics to our principal
executive officer, principal financial officer, principal accounting officer,
controller, or other persons performing similar functions, we will disclose
the
nature of such amendment or waiver, the name of the person to whom the waiver
was granted and the date of waiver in a Current Report on Form 8-K.
Our
Board
of Directors has appointed an Audit Committee of the Board of Directors,
comprised of Messrs.
Wayne Fritzsche, J. Donald Payne, and P. Thomas Vogel. The Board of Directors
has determined that Mr. Payne qualifies as an “audit committee financial expert”
as defined in Item 407(d)(5) of Regulation S-K.
-
54
-
Compensation
Committee
General.
Messrs.
Fritzsche, Payne, and Vogel and Dr. Saravis are currently the members of the
Compensation Committee. The Compensation Committee operates pursuant to a
written charter, a copy of which is publicly available on the investor relations
portion of our website at www.pressurebiosciences.com.
The
primary functions of the Compensation Committee include (i) reviewing and
approving our executive compensation, (ii) reviewing the recommendations of
the
President and Chief Executive Officer regarding the compensation of our
executive officers, (iii) evaluating the performance of the Chief Executive
Officer, (iv) overseeing the administration and approval of grants of stock
options and other equity awards under our equity incentive plans, and (v)
recommending compensation for our Board of Directors and each committee thereof
for review and approval by the Board of Directors. The Compensation Committee
held one (1) meeting during calendar 2007.
Compensation
Objectives
In
light
of the early stage of commercialization of our products, we recognize the
importance of attracting and retaining key employees with sufficient experience,
skills, and qualifications in areas vital to our success, such as operations,
finance, sales and marketing, research and development and engineering, and
individuals who are committed to our short- and long-term goals. The
Compensation Committee has designed our executive compensation programs with
the
intent of attracting, motivating, and retaining experienced executives and
rewarding them for their contributions by offering them a competitive base
salary, annual cash incentive bonuses, and long-term equity-based incentives,
typically in the form of stock options. The Compensation Committee strives
to
balance the need to retain key employees with financial prudence given our
history of operating losses and the early stage of our commercialization.
Executive
Officers and Director Compensation Process
The
Compensation Committee considers and determines executive compensation according
to an annual and semi-annual objective setting and measurement cycle.
Specifically, corporate goals for the year are initially developed by our
executive officers and are then presented to the Board of Directors and
Compensation Committee for review and approval. Individual goals are intended
to
focus on contributions that facilitate the achievement of the corporate goals.
Individual goals are first proposed by each executive officer, other than the
President and Chief Executive Officer, then discussed by the entire senior
executive management team and ultimately compiled and prepared for submission
to
the Board of Directors and the Compensation Committee, by the President and
Chief Executive Officer. The Compensation Committee sets and approves the goals
for the President and Chief Executive Officer. Generally, corporate and
individual goals are set during the first quarter of each calendar year. The
objective setting process is coordinated with our annual financial planning
and
budgeting process so our Board of Directors and Compensation Committee can
consider overall corporate and individual objectives in the context of budget
constraints and cost control considerations. Annual salary increases, bonuses,
and equity awards, such as stock option grants, if any, are tied to the
achievement of these corporate and individual performance goals as well as
our
financial position and prospects.
Under
the
annual performance review program, the Compensation Committee evaluates
individual performance against the goals for the recently completed year. The
Compensation Committee’s evaluation generally occurs in the first quarter of the
following year. The evaluation of each executive (other than the President
and
Chief Executive Officer) begins with a written self-assessment submitted by
the
executive to the President and Chief Executive Officer. The President and Chief
Executive Officer then prepares a written evaluation based on the executive’s
self-assessment, the President and Chief Executive Officer’s evaluation, and
input from others within our company. This process leads to a recommendation
by
the President and Chief Executive Officer for a salary increase, bonus, and
equity award, if any, which is then considered by the Compensation Committee.
In
the case of the President and Chief Executive Officer, the Compensation
Committee conducts his performance evaluation and determines his compensation,
including salary increase, bonus, and equity awards, if any. We generally
expect, but are not required, to implement salary increases, bonuses, and equity
awards, for all executive officers, if and to the extent granted, by April
1st.
-
55
-
Non-employee
director compensation is set by our Board of Directors upon the recommendation
of the Compensation Committee. In developing its recommendations, the
Compensation Committee is guided by the following goals: compensation should
be
fair relative to the required services for a director of comparable companies
in
our industry and at our company’s stage of development; compensation should
align directors’ interests with the long-term interest of stockholders; the
structure of the compensation should be simple, transparent, and easy for
stockholders to understand; and compensation should be consistent with the
financial resources, prospects, and competitive outlook for our
company.
In
evaluating executive officer and director compensation, the Compensation
Committee considers the practices of companies of similar size, geographic
location, and market focus. In order to develop reasonable benchmark data the
Compensation Committee has referred to publicly available sources such as
Salary.com and the BioWorld Survey. While the Compensation Committee does not
believe benchmarking is appropriate as a stand-alone tool for setting
compensation due to the unique aspects of our business objectives and current
stage of development, the Compensation Committee generally believes that
gathering this compensation information is an important part of its
compensation-related decision making process.
The
Compensation Committee has the authority to hire and fire advisors and
compensation consultants as needed and approve their fees. No advisors or
compensation consultants were hired or fired in fiscal 2007.
The
Compensation Committee is also authorized to delegate any of its
responsibilities to subcommittees or individuals as it deems appropriate. The
Compensation Committee did not delegate any of its responsibilities in fiscal
2007.
In
February 2008, our Board of Directors met with senior management and discussed
the 2007 business and financial results and reviewed the proposed objectives
for
2008. The Board of Directors and the Compensation Committee also reviewed the
proposed 2008 budget and operating plan and determined that discussions of
salaries, bonuses and equity awards should be deferred until the middle of
the
year. Considering this, the Compensation Committee recommended, and the Board
of
Directors approved the following actions to be taken:
·
|
Implement
a 4% cost of living increase for all employees hired prior to December
31,
2007, except for Mr. Schumacher, and for our regional sales directors,
effective immediately.
|
·
|
Grant
each non-employee member of the Board of Directors non-qualified
stock
options to purchase 10,000 shares of our common stock, effective
on April
15, 2008.
|
-
56
-
EXECUTIVE
COMPENSATION
Summary
Compensation Table
The
Summary Compensation Table below sets forth the total compensation paid or
earned for the fiscal years ended December 31, 2007 and 2006 for: (i) each
individual serving as our Chief Executive Officer (“CEO”) or acting in a similar
capacity during any part of fiscal 2007 and 2006; and (ii) the other two most
highly paid executive officers (collectively, the "Named Executive
Officers").
Option
|
All other
|
||||||||||||||||||
Name
and Principal Position
|
Fiscal Year
|
Salary
(1)
|
Bonus
(2)
|
Awards (3)
|
Compensation (4)
|
Total
|
|||||||||||||
Richard
T. Schumacher
|
2007
|
$
|
288,697
|
$
|
-
|
$
|
102,297
|
$
|
12,069
|
$
|
403,063
|
||||||||
President & Chief Executive Officer
|
2006
|
267,981
|
55,000
|
67,987
|
15,628
|
406,596
|
|||||||||||||
|
|||||||||||||||||||
Edward
H. Myles
|
2007
|
178,538
|
-
|
45,993
|
3,306
|
227,837
|
|||||||||||||
Senior
Vice President of Finance
|
2006
|
120,962
|
17,000
|
40,018
|
50,349
|
228,329
|
|||||||||||||
&
Chief Financial Officer
|
|
|
|||||||||||||||||
|
|||||||||||||||||||
Edmund
Ting, Ph.D
|
2007
|
185,673
|
-
|
50,304
|
3,163
|
239,140
|
|||||||||||||
Senior Vice President of Engineering
|
2006
|
114,423
|
17,500
|
40,340
|
3,234
|
175,497
|
(1)
Salary refers to base salary compensation paid through the Company’s normal
payroll process.
(2)
A
cash bonus is paid to executive officers based on a combination of factors
including the performance of the company relative to specific objectives, the
financial condition of the company, and the performance of the individual
executive relative to specific objectives. Amounts for 2006 reflect bonuses
earned in 2006 and paid in February 2007. The Compensation Committee has
deferred the discussion of executive bonuses for 2007, to be paid in 2008,
until
the middle of 2008.
(3)
Amounts shown do not reflect compensation received by the Named Executive
Officers. Instead, the amounts shown are the compensation costs recognized
by
the Company in each of the fiscal years presented for option awards as
determined pursuant to SFAS 123R. Please refer to Note 2, xiii, “Accounting
for Stock-Based Compensation”
in
the
Notes to our Consolidated Financial Statements included in this Annual Report
on
Form 10-K for the year ended December 31, 2007, for the relevant assumptions
used to determine the valuation of our stock option grants. Based on the
assumptions outlined in the Notes to the Company’s Consolidated Financial
Statements the value of our stock options awarded to executives and other
employees during 2006 and 2007 was between $2.55 and $3.00 per
option.
(4)
“All
Other Compensation” includes the company’s match to the executives’ 401(k)
contribution and premiums paid on life insurance for the executive. Both of
these benefits are available to all employees of the company. In the case of
Mr.
Schumacher, “All Other Compensation” also includes $7,980 in premiums paid by
the company for a life insurance policy to which Mr. Schumacher’s wife is the
beneficiary.
Outstanding
Equity Awards at Fiscal-Year End
The
following table sets forth certain information regarding outstanding stock
options awards for each of the Named Executive Officers as of December 31,
2007.
|
|||||||||||||
Name
|
Number
of
Securities
Underlying
Unexercised
Options
#
Exercisable
|
Number of Securities
Underlying
Unexercised Options
# Unexercisable
(1)
|
Option
Exercise
Price
($)
|
Option
Expiration
Date
|
|||||||||
Richard
T. Schumacher
|
40,000
|
0
|
|
$2.60
|
5/2/2011
|
||||||||
President & Chief Executive Officer
|
60,000
|
0
|
|
$3.08
|
2/11/2012
|
||||||||
30,000
|
0
|
|
$2.70
|
12/2/2012
|
|||||||||
50,000
|
25,000
|
(2) |
|
$2.92
|
6/17/2015
|
||||||||
10,000
|
20,000
|
(2)
|
|
$3.86
|
3/30/2016
|
||||||||
0
|
70,000
|
(2)
|
|
$3.51
|
2/12/2017
|
||||||||
|
|
||||||||||||
Edward
H. Myles
|
18,334
|
36,666
|
(3)
|
|
$3.86
|
4/3/2016
|
|||||||
Senior
Vice President of Finance
|
|
||||||||||||
&
Chief Financial Officer
|
|
||||||||||||
|
|||||||||||||
Edmund
Y. Ting, Ph.D
|
20,000
|
40,000
|
(4)
|
|
$3.87
|
4/24/2016
|
|||||||
Senior
Vice President of Engineering
|
-
57
-
(1)
All
unvested stock options listed in this column were granted to the Named Executive
Officer pursuant to the Company’s 2005 Equity Incentive Plan. All of such stock
options vest ratably over three years and expire ten years after the date
of
grant. Unvested stock options become fully vested and exercisable upon a
change
of control of the Company.
(2)
Options to purchase 75,000 shares of common stock were granted to Mr. Schumacher
on June 17, 2005, of which options to purchase 25,000 shares became vested
on
June 17, 2006, and an additional 25,000 became vested on June 17,
2007. Options to purchase 30,000 shares of common stock were granted to Mr.
Schumacher on March 30, 2006 of which 10,000 became vested on March 30,
2007. Options to purchase 70,000 shares of common stock were granted to Mr.
Schumacher on February 12, 2007.
(3)
Options to purchase 55,000 shares of common stock were granted to Mr. Myles
on
April 3, 2006, 18,334 became vested on April 3, 2007.
(4)
Options to purchase 60,000 shares of common stock were granted to Dr. Ting
on
April 24, 2006, 20,000 became vested on April 24, 2007.
Retirement
Plan
All
employees, including the Named Executive Officers, may participate in our 401(k)
Plan. Under the 401(k) Plan, employees may elect to make before tax
contributions of up to 60% of their base salary, subject to current Internal
Revenue Service limits. The 401(k) Plan does not permit an investment in our
common stock. We match employee contributions up to 50% of the first 2% of
the
employee’s contribution. Our contribution is 100% vested
immediately.
Severance
Arrangements
Each
of
our executive officers; Mr. Schumacher, Mr. Myles, Dr. Ting, Dr. Lazarev, Dr.
Lawrence and Mr. Potter is entitled to receive a severance payment if terminated
by us without cause. The severance benefits would include a payment in an amount
equal to one year of such executive officer’s annualized base salary
compensation plus accrued paid time off. Additionally, the officer will be
entitled to receive medical and dental insurance coverage for one year following
the date of termination.
Change-in-Control
Arrangements
Each
of
our executive officers, other than Mr. Schumacher, is entitled to receive a
change of control payment in an amount equal to one year of such executive
officer’s annualized base salary compensation, accrued paid time off, and
medical and dental coverage, in the event of a change of control of the Company.
In the case of Mr. Schumacher this payment would be equal to two years of
annualized base salary compensation, accrued paid time off, and two years of
medical and dental coverage.
Pursuant
to the Company’s 2005 Equity Incentive Plan (the “Plan”), any unvested stock
options held by a Named Executive Officer will become fully vested upon a change
in control (as defined in the Plan) of the Company.
Director
Compensation
The
following table sets forth certain information regarding compensation earned
or
paid to the Company’s directors during fiscal 2007.
Name
|
Fees Earned or
Paid in Cash (1)
|
Option
Awards (2) |
Total
|
|||||||
R.
Wayne Fritzsche
|
$
|
32,000
|
$
|
-
|
$
|
32,000
|
||||
Calvin
A. Saravis, Ph.D
|
32,000
|
-
|
32,000
|
|||||||
J.
Donald Payne
|
32,000
|
-
|
32,000
|
|||||||
P.
Thomas Vogel
|
32,000
|
-
|
32,000
|
The
Company’s non-employee directors receive the following compensation for service
as a director of the Company:
(1)
A
quarterly stipend of $8,000, of which $4,000 is compensation for attending
meetings of the full Board of Directors (whether telephonic or in-person) and
$4,000 is compensation for attending committee meetings. There is no limit
to
the number of meetings of the Board of Directors or committees that may be
called. Cash compensation is paid on or immediately prior to the last day of
each fiscal quarter.
(2)
During 2007 the Board of Directors decided not to award fully vested,
non-qualified stock options to its non-employee members.
-
58
-
ITEM 12. |
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER
MATTERS.
|
Beneficial
Ownership Information
The
following table sets forth certain information as of March 24, 2008, as to
shares of our common stock beneficially owned by: (i) each person
(including any “group” as that term is used in Section 13(d)(3) of the
Exchange Act) known by us to be the beneficial owner of 5% or more of our common
stock, (ii) each of our executive officers listed in the Summary
Compensation Table under Item 11 of this report, (iii) each of our
directors and (iv) all of our directors and executive officers as a
group.
We
have
determined beneficial ownership in accordance with the rules of the SEC.
Except as indicated by the footnotes below, we believe, based on the information
furnished to us, that the persons and entities named in the table below have
sole voting and investment power with respect to all shares of common stock
that
they beneficially own.
Name
|
Number
of
Shares
of
Common Stock
Beneficially
Owned
(1)
|
Percent of
Class
|
|||||
Lloyd
I. Miller, III (2)*
|
157,686
|
5.5
|
%
|
||||
4550
Gordon Drive
|
|||||||
Naples,
FL 34102
|
|||||||
Richard
T, Schumacher (3)(4)*
|
449,154
|
15.8
|
%
|
||||
130
Lake Ridge Drive
|
|||||||
Taunton,
MA 02780
|
|||||||
Edward
H. Myles
|
38,667
|
1.4
|
%
|
||||
Edmund
Y. Ting, Ph.D
|
42,000
|
1.5
|
%
|
||||
All
other executive officers
|
80,116
|
2.8
|
%
|
||||
R.
Wayne Fritzsche
|
63,000
|
2.2
|
%
|
||||
Calvin
A. Saravis, Ph.D
|
100,000
|
3.5
|
%
|
||||
J.
Donald Payne
|
62,000
|
2.2
|
%
|
||||
P.
Thomas Vogel
|
60,000
|
2.1
|
%
|
||||
All
Executive Officers and Directors as a Group (4)
|
894,937
|
31.4
|
%
|
*
Address
provided for beneficial owners of more than 5% of the common stock.
(1)
Includes the following shares of common stock issuable upon exercise of options
exercisable within 60 days after March 24, 2008: Mr. Schumacher – 223,334; Dr.
Saravis - 110,000; Mr. Fritzsche - 73,000; Mr. Payne - 68,000; Mr. Vogel -
70,000; Mr. Myles – 36,667; Dr. Ting – 40,000.
(2)
Based
on information contained in a Schedule 13 G/A filed with the SEC on February
11,
2008, Mr. Miller reports shared voting and shared dispositive power as to
150,646 shares of common stock and sole voting power and sole dispositive power
to 7,040 shares.
(3)
Does
not include 15,162 shares of common stock held by Mr. Schumacher’s minor son as
his wife exercises all voting and investment control over such
shares.
(4)
Includes an aggregate of 694,334 shares of common stock that the current
directors and executive officers have the right to acquire upon exercise of
outstanding stock options exercisable within sixty (60) days after March 24,
2008.
-
59
-
Equity
Compensation Plan Information
We
maintain a number of equity compensation plans for employees, officers,
directors and other entities and individuals whose efforts contribute to our
success. The table below sets forth certain information as of our fiscal year
ended December 31, 2007 regarding the shares of our common stock available
for
grant or granted under our equity compensation plans.
Plan Category
|
Number of
securities to be
issued upon
exercise of
outstanding options
|
Weighted-average
exercise price of
outstanding
options
|
Number of securities
remaining available
for future issuance
under equity
compensation plans
|
|||||||
Equity
compensation plans approved by security holders
|
1,120,500
|
$
|
3.45
|
137,800
|
Includes
the following plans: 1994 ISO Stock Option Plan, 1999 Non-Qualified Stock
Option
Plan, and 2005 Equity Incentive Plan.
ITEM 13. |
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS; AND DIRECTOR
INDEPENDENCE.
|
Related
Persons Transactions
On
December 29, 2006, Richard T. Schumacher, our President and Chief Executive
Officer, delivered to us
249,875
shares of his common stock of the company in full and complete satisfaction
and
payment of all outstanding amounts, including all principal and accrued
interest, of Mr. Schumacher’s loan payable to us. The loan amount consisted of
$1,000,000 in principal and $25,487 in interest accrued in the quarter ended
December 31, 2006. The number of shares was determined based upon a value of
$4.10 per share, the volume weighted average trading price of the shares of
our
common stock on the NASDAQ Capital Market during the 60 trading days ending
on
December 29, 2006. In connection with the payment of the loan, we terminated
our
security interest in Mr. Schumacher’s shares of common stock, and released to
Mr. Schumacher the remaining 229,782 shares of common stock previously held
as
collateral.
Director
Independence
The
Board
of Directors has reviewed the qualifications of each of Messrs. Fritzsche,
Payne, Vogel and Dr. Saravis, constituting more than a majority of our
directors, and has affirmatively determined that each individual is“independent”
as such term is defined under the current listing standards of the NASDAQ Stock
Market. The Board of Directors has determined that none of these directors
has a
material relationship with us that would interfere with the exercise of
independent judgment. In addition, each member of the Audit Committee is
independent as required under Section 10A(m)(3) of the Securities Exchange
Act
of 1934, as amended.
-
60
-
ITEM 14. |
PRINCIPAL
ACCOUNTANT FEES AND
SERVICES
|
Independent
Registered Public Accounting Fees
The
following is a summary of the fees billed to the Company by UHY LLP (“UHY”), our
principal accountant, for the fiscal years ended December 31, 2007 and December
31, 2006, respectively:
Fiscal 2007 Fees
|
Fiscal 2006 Fees
|
||||||
($)
|
($)
|
||||||
Audit
Fees
|
$
|
105,691
|
$
|
155,162
|
|||
Audit-Related
Fees
|
24,791
|
-
|
|||||
$
|
130,482
|
$
|
155,162
|
Audit
Fees.
Consists of aggregate fees billed for professional services rendered for the
audit of our consolidated financial statements and review of the interim
consolidated financial statements included in quarterly reports, as well as
services that are normally provided by the independent registered public
accounting firm in connection with statutory and regulatory filings or
engagements.
Audit-Related
Fees.
Consists of aggregate fees billed for assurance and related services that are
reasonably related to the performance of the audit or review of our consolidated
financial statements and are not reported under “Audit Fees.” Fees billed by UHY
for 2007 were fees associated with consents delivered in connection with the
Company’s Registration Statement on Form S-3 and certain agreed upon procedures
with respect to Source Scientific, LLC.
There
were no other fees for services rendered by UHY other than those described
above.
Audit
Committee Policy on Pre-Approval of Services
The
Audit
Committee’s policy is to pre-approve all audit and permissible non-audit
services provided by the independent registered public accounting firm. These
services may include audit services, audit-related services, tax services,
and
other services. Pre-approval is generally provided for up to one year. The
Audit
Committee may also pre-approve particular services on a case-by-case
basi
-
61
-
ITEM 15. |
EXHIBITS.
|
Exhibit
No.
|
Reference
|
||
3.1
|
Amended
and Restated Articles of Organization of the Company
|
A-3.1**
|
|
3.2
|
Articles
of Amendment to Amended and Restated Articles of Organization of
the
Company
|
B-3.1**
|
|
3.3
|
Amended
and Restated Bylaws of the Company
|
A-3.2**
|
|
3.4
|
Amendment
to Amended and Restated Bylaws of the Company
|
C-3.3**
|
|
4.1
|
Specimen
Certificate for Shares of the Company’s Common Stock
|
D-4.1**
|
|
4.2
|
Description
of Capital Stock (contained in the Amended and Restated Articles
of
Organization, as amended, of the Company filed as Exhibits 3.1 and
3.2)
|
A-3.1
& 3.2**
|
|
4.3
|
Rights
Agreement dated as of February 27, 2003 between the Company and
Computershare Trust Company, Inc.
|
E-4**
|
|
4.4
|
Amendment
No. 1 to Rights Agreement dated April 16, 2004 between the Company
and
Computershare Trust Company, Inc.
|
F-4**
|
|
4.5
|
Securities
Purchase Agreement dated November 21, 2007 between the Company and
the
purchasers named therein
|
G-4.9**
|
|
4.6
|
Registration
Rights Agreement dated November 21, 2007 between the Company and
the
purchasers named therein
|
G-4.10**
|
|
10.1
|
1994
Employee Stock Option Plan*
|
A-10.16**
|
|
10.2
|
1999
Non-Qualified Stock Option Plan*
|
H**
|
|
10.3
|
1999
Employee Stock Purchase Plan*
|
H**
|
|
10.4
|
2005
Equity Incentive Plan.*
|
I-99.1**
|
|
10.5
|
Description
of Compensation for Certain Directors*
|
Filed
herewith
|
|
10.6
|
Severance
Agreement between the registrant and Richard T.
Schumacher*
|
Filed
herewith
|
|
10.7
|
Form
of Severance Agreement including list of officers to whom
provided*
|
Filed
herewith
|
|
10.8
|
LLC
Membership Interest Purchase Agreement dated June 8, 2004 by and
between
BBI Source Scientific Inc., Boston Biomedica, Inc., and Source Scientific,
LLC.
|
J-2.1**
|
|
10.9
|
Consent
Agreement, dated May 29, 2007, by and among the registrant, PBI Source
Scientific, Inc., Source Scientific, LLC, BIT Analytical Instruments,
Inc., Richard W. Henson and Bruce A. Sargeant.
|
K-10.1**
|
|
10.10
|
Asset
Purchase Agreement dated April 16, 2004 between the Company, BBI
Biotech
Research Laboratories, Inc. and SeraCare Life Sciences,
Inc.
|
F-1**
|
|
10.11
|
Technology
Transfer and Patent Assignment Agreement dated October 7, 1996, between
Bioseq, Inc. and BioMolecular Assays, Inc.
|
Filed
herewith
|
|
10.12
|
Amendment
to Technology Transfer and Patent Assignment Agreement dated October
8,
1998 between Bioseq, Inc. and BioMolecular Assays, Inc.
|
Filed
herewith
|
|
10.13
|
Nonexclusive
License Agreement dated September 30, 1998 between Bioseq, Inc. and
BioMolecular Assays, Inc.
|
Filed
herewith
|
|
10.14
|
Flex
Space Office Lease dated May 5, 2005 by and between Saul Holding
Limited Partnership and the registrant
|
L-10.1**
|
|
10.15
|
Agreement
for Research Services dated February 1, 2006 by and between the registrant
and the University of New Hampshire
|
M-10.1**
|
|
10.17
|
Loan
Repayment Agreement with Richard T. Schumacher dated December 29,
2006
|
N-10.1**
|
|
23.1
|
Consent
of Independent Registered Public Accounting Firm
|
Filed
herewith
|
|
31.1
|
Principal
Executive Officer Certification Pursuant to Item 601(b)(31) of Regulation
S-K, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act
of
2002
|
Filed
herewith
|
|
31.2
|
Principal
Financial and Accounting Officer Certification Pursuant to Item 601(b)(31)
of Regulation S-K, as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
Filed
herewith
|
|
32.1
|
Principal
Executive Officer Certification Pursuant to Item 601(b)(32) of Regulation
S-K, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of
2002
|
Filed
herewith
|
|
32.2
|
Principal
Financial and Accounting Officer Certification Pursuant to Item 601(b)(32)
of Regulation S-K, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
Filed
herewith
|
-
62
-
A
|
We
previously filed this exhibit with the referenced exhibit number
as an
exhibit to the registrant’s Registration Statement on Form S-1
(Registration No. 333-10759) filed with the Commission on August
23,
1996.
|
B
|
We
previously filed this exhibit with the referenced exhibit number
as an
exhibit to the registrant’s Quarterly Report on Form 10-Q for the fiscal
quarter ended September 30, 2004.
|
C
|
We
previously filed this exhibit with the referenced exhibit number
as an
exhibit to the registrant’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2002.
|
D
|
We
previously filed this exhibit with the referenced exhibit number
as an
exhibit to the registrant’s Annual Report on Form 10-KSB for the fiscal
year ended December 31, 2004.
|
E
|
We
previously filed this exhibit with the referenced exhibit number
as an
exhibit to the registrant’s Current Report on Form 8-K filed with the
Commission March 12, 2003.
|
F
|
We
previously filed this exhibit with the referenced exhibit number
as an
exhibit to the registrant’s Current Report on Form 8-K filed with the
Commission April 16, 2004.
|
G
|
We
previously filed this exhibit with the referenced exhibit number
as an
exhibit to the registrant’s Registration Statement on Form S-3
(Registration No. 333-148227) filed with the Commission on December
20,
2007.
|
H
|
We
previously filed this exhibit as an appendix to the registrant’s proxy
statement filed June 14, 1999.
|
I
|
We
previously filed this exhibit with the referenced exhibit number
as an
exhibit to the registrant’s Registration Statement on Form S-8 (Reg. No.
333-128594) filed with the Commission on September 26,
2005.
|
J
|
We
previously filed this exhibit with the referenced exhibit number
as an
exhibit to the registrant’s Current Report on Form 8-K filed with the
Commission June 16, 2004.
|
K
|
We
previously filed this exhibit with the referenced exhibit number
as an
exhibit to the registrant’s Current Report on Form 8-K filed with the
Commission on June 1, 2007.
|
L
|
We
previously filed this exhibit with the referenced exhibit number
as an
exhibit to the registrant’s Current Report on Form 8-K filed with the
Commission on May 11, 2005.
|
M
|
We
previously filed this exhibit with the referenced exhibit number
as an
exhibit to the registrant’s Current Report on Form 8-K filed with the
Commission on February 7, 2006.
|
N
|
We
previously filed this exhibit with the referenced exhibit number
as an
exhibit to the registrant’s Current Report on Form 8-K filed with the
Commission on December 29, 2006.
|
-
63
-
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf
by
the undersigned, thereunto duly authorized.
Date:
March 27, 2008
|
Pressure
BioSciences, Inc.
|
|
|
By:
|
/s/
Richard T. Schumacher
|
|
Richard
T. Schumacher
|
|
|
President
and Chief Executive Officer
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has
been
signed below by the following persons on behalf of the registrant and in the
capacity and on the dates indicated.
SIGNATURES
|
|
TITLES
|
|
DATE
|
|
|
|
|
|
/s/
Richard
T. Schumacher
|
|
President,
Chief Executive Officer (Principal Executive Officer )
|
March
27, 2008
|
|
Richard
T. Schumacher
|
|
|
|
|
/s/
Edward
H. Myles
|
|
Senior
Vice President and Chief Financial Officer (Principal Financial and
Principal Accounting Officer) and Treasurer
|
March
27, 2008
|
|
Edward
H. Myles
|
|
|
|
|
/s/
R. Wayne Fritzsche
|
|
Director
and Chairman of the Board
|
March
27, 2008
|
|
R.
Wayne Fritzsche
|
|
|
|
|
/s/
J.
Donald Payne
|
|
Director
|
March
27, 2008
|
|
J.
Donald Payne
|
||||
|
|
|
|
|
/s/
Calvin A. Saravis, Ph.D.
|
|
Director
|
March
27, 2008
|
|
Calvin
A. Saravis, Ph. D.
|
||||
|
|
|
|
|
/s/
P. Thomas Vogel
|
|
Director
|
March
27, 2008
|
|
P.
Thomas Vogel
|