DELAWARE
|
94-3076866
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
(IRS
Employer
Identification
No.)
|
Page No. | |||||
Part I | 1 | ||||
Item 1. | Business | 1 | |||
Item 1a. | Risk Factors | 7 | |||
Item 1b. | Unresolved Staff Comments | 10 | |||
Item 2 | Properties | 10 | |||
Item 3. | Legal Proceedings | 10 | |||
Item 4. | Reserved | ||||
Part II | 12 | ||||
Item 5. | Market For Registrant’s Common Equity, Related Stockholder Matters And Issuer Purchases Of Equity Securities | 12 | |||
Item 7. | Management's Discussion And Analysis Of Financial Condition And Results Of Operations | 12 | |||
Item 8. | Financial Statements And Supplementary Data | 17 | |||
Item 9. | Changes In And Disagreements With Accountants On Accounting And Financial Disclosure | 17 | |||
Item 9a. | Controls And Procedures | 17 | |||
Item 9b. | Other Information | 18 | |||
Part III | 18 | ||||
Item 10. | Directors, Executive Officers, And Corporate Governance | 18 | |||
Item 11. | Executive Compensation | 21 | |||
Item 12. | Security Ownership Of Certain Beneficial Owners And Management And Related Stockholder Matters | 22 | |||
Item 13. | Certain Relationships And Related Transactions And Director Independence | 24 | |||
Item 14. | Principal Accountant Fees And Services | 25 | |||
Part IV | 26 | ||||
Item 15. | Exhibits And Financial Statement Schedules | 26 | |||
Signatures | |||||
Index To Financial Statements | F-1 |
·
|
Patented
hypothermic storage and cryopreservation media products for cells,
tissues, and organs
|
·
|
Generic
formulations of blood stem cell freezing media
products
|
·
|
Custom
product formulation and custom packaging
services
|
·
|
Contracted
research and development and consulting services related to optimization
of biopreservation processes and
protocols.
|
·
|
Contract
aseptic manufacturing services
|
|
·
|
Minimize
cell and tissue swelling
|
|
·
|
Remove
free radicals upon formation
|
|
·
|
Maintain
appropriate ion balances
|
|
·
|
Provide
regenerative, high energy substrates to stimulate recovery upon
warming
|
|
·
|
Avoid
the creation of an acidic state
(acidosis)
|
|
·
|
Inhibit
the onset of apoptosis
|
|
·
|
Cell
and tissue banking
|
|
·
|
Cell
suppliers
|
|
·
|
Cord
blood collection and storage
|
|
·
|
Toxicity
testing
|
|
·
|
Hair
transplantation
|
|
·
|
Reproductive
biology
|
|
·
|
Tissue
engineering
|
|
·
|
Organ
transplantation
|
|
·
|
Cellular
therapy
|
|
·
|
Pharmaceutical
drug discovery
|
|
·
|
HypoThermosol
|
|
·
|
GelStor
|
|
·
|
Powering
the Preservation Sciences
|
|
·
|
CryoStor
CS2
|
|
·
|
BioPreservation
Today
|
|
·
|
CP-RXCUE
|
|
·
|
BloodStor
|
|
·
|
CryoStor
|
|
·
|
Shelly
Heimfeld, Ph.D., Director of the Cellular Therapy Laboratory at the Fred
Hutchinson Cancer Research Center in Seattle, and President of the
International Society of Cellular Therapy. Dr. Heimfeld is internationally
recognized for research in hematopoietic-derived stem cells and the
development of cell processing technologies for improved cancer
therapy.
|
|
·
|
Dayong
Gao, Ph.D., Professor of Biomedical Engineering at the University of
Washington in Seattle. Dr. Gao has been actively engaged in
cryopreservation research for more than 20 years, and has authored over
130 peer-reviewed journal articles on
cryopreservation.
|
·
|
Darin
Weber, Ph.D., a leading regulatory expert for cellular and tissue based
products, and former FDA cellular therapy reviewer. Dr. Weber’s knowledge
of the regulatory landscape for cell and gene therapy is extensive and
directly relevant to our business since our biopreservation solutions are
a critical process component in several active clinical trials for new
cellular therapy products.
|
|
·
|
Andrew
Hinson, Vice President for Clinical and Regulatory Affairs for
CardioPolymers, Inc. (formerly Symphony Medical, Inc.) since 2004.
CardioPolymers is a venture capital backed privately-held developer of
therapeutic biopolymer therapies for the treatment of heart failure and
other cardiac abnormalities.
|
|
·
|
Scott
R. Burger, M.D., Principal, Advanced Cell and Gene Therapy, a consulting
firm specializing in cell, gene, and tissue-based therapies. Dr. Burger
works with clients in industry and academic centers worldwide, providing
assistance in process development and validation, GMP/GTP manufacturing,
GMP facility design and operation, regulatory affairs, technology
evaluation, and strategic analysis.
|
|
·
|
Erik
J. Woods, Ph.D., Co-founder, CEO and Laboratory Director of The Genesis
Bank, a private cord blood bank, and also Director of Genome Resources, an
anonymous donor and client depositor sperm bank. Both laboratories are FDA
registered and CLIA compliant.
|
|
·
|
Lizabeth
J. Cardwell, Principal, Compliance Consulting, LLC, a private consulting
business offering quality and regulatory consulting services to cell
therapy, medical device, and pharmaceutical
companies.
|
|
·
|
Colleen
Delaney, MSc., M.D., Director of the Cord Blood Research and Transplant
Program at Fred Hutchinson Cancer Research Center (FHCRC) and Seattle
Cancer Care Alliance (SCCA). She is an attending physician at Seattle
Children's Hospital, Assistant Member of the Clinical Research Division of
FHCRC and Assistant Professor at the University of Washington, School of
Medicine.
|
|
·
|
Future
sales of our common stock
|
|
·
|
Announcements
of technological innovations for new commercial products by our present or
potential competitors
|
|
·
|
Developments
concerning proprietary rights
|
|
·
|
Adverse
results in our field or with clinical tests of our products in customer
applications
|
|
·
|
Adverse
litigation
|
|
·
|
Unfavorable
legislation or regulatory decisions
|
|
·
|
Public
concerns regarding our products
|
|
·
|
Variations
in quarterly operating results
|
|
·
|
General
trends in the health care industry
|
|
·
|
Other
factors outside of our control
|
High
|
Low
|
|||||||
Year
ended December 31, 2008
|
||||||||
4th
Quarter
|
$ | 0.04 | $ | 0.03 | ||||
3rd
Quarter
|
0.04 | 0.04 | ||||||
2nd
Quarter
|
0.05 | 0.05 | ||||||
1st
Quarter
|
0.08 | 0.08 | ||||||
Year
ended December 31, 2009
|
||||||||
4th
Quarter
|
$ | 0.11 | $ | 0.10 | ||||
3rd
Quarter
|
0.13 | 0.13 | ||||||
2nd
Quarter
|
0.22 | 0.17 | ||||||
1st
Quarter
|
0.07 | 0.05 |
Years
Ended December 31,
|
||||||||||||||||
2009
|
2008
|
$
Change
|
%
Change
|
|||||||||||||
Revenue
|
||||||||||||||||
Product
sales
|
$ | 1,556,600 | $ | 1,277,497 | $ | 279,103 | 22 | % | ||||||||
Licensing
revenue
|
25,000 | 45,000 | (20,000 | ) | -20 | % | ||||||||||
Total
revenue
|
1,581,600 | 1,322,497 | 259,103 | 20 | % | |||||||||||
Cost
of product sales
|
1,007,022 | 770,646 | 236,376 | 31 | % | |||||||||||
Gross
profit
|
574,578 | 551,851 | 22,727 | 4 | % | |||||||||||
Operating
expenses
|
||||||||||||||||
Research
and development
|
414,465 | 457,640 | (43,175 | ) | -9 | % | ||||||||||
Sales
and marketing
|
558,721 | 372,324 | 186,397 | 50 | % | |||||||||||
General
and administrative
|
1,503,552 | 1,925,654 | (422,102 | ) | -22 | % | ||||||||||
Manufacturing
start-up costs
|
385,205 | 259,687 | 125,518 | 48 | % | |||||||||||
Total operating
expenses
|
2,861,943 | 3,015,305 | (153,362 | ) | -5 | % | ||||||||||
Operating
loss
|
(2,287,365 | ) | (2,463,454 | ) | 176,089 | -7 | % | |||||||||
Other
income (expenses)
|
||||||||||||||||
Interest
income
|
1,069 | 6,354 | (5,285 | ) | -83 | % | ||||||||||
Other
income, net
|
5,957 | 10,495 | (4,538 | ) | -43 | % | ||||||||||
Interest
expense
|
(488,013 | ) | (284,762 | ) | (203,251 | ) | 71 | % | ||||||||
Amortization
of deferred financing costs
|
–– | (43,750 | ) | 43,750 | -100 | % | ||||||||||
Total
other income (expenses)
|
(480,987 | ) | (311,663 | ) | (169,324 | ) | 54 | % | ||||||||
Net
Loss
|
$ | (2,768,352 | ) | $ | (2,775,117 | ) | $ | 6,765 |
Name
|
Age
|
Position
and Offices With the Company
|
|||
Michael
Rice
|
47 |
Chief
Executive Officer,
|
|||
President,
and Director
|
|||||
Howard
S. Breslow
|
70 |
Director,
Secretary
|
|||
Roderick
de Greef
|
49 |
Director
|
|||
Thomas
Girschweiler
|
52 |
Director
|
|||
Raymond
Cohen
|
50 |
Director
|
|||
Andrew
Hinson
|
44 |
Director
|
|
·
|
Three
meetings of the Board of Directors
|
|
·
|
Four
meetings of the Audit Committee
|
|
·
|
Two
meetings of the Compensation
Committee
|
|
·
|
No
meetings of the Nominating and Corporate Governance
Committee
|
Non-Equity
|
Nonqualified
Deferred
|
|||||||||||||||||||||||||||||||||
Name
and Principal
Positions
(a)
|
Year
(b)
|
Salary
($)
(c)
|
Bonus
($)
(d)
|
Stock
Awards
($)
(e)
|
Option
Awards
($)
(f)
(1)
|
Incentive
Plan
Compensation
($)
(g)
|
Compensation
Earnings
($)
(h)
|
All
Other
Compensation
($)
(i)
|
Total
($)
(j)
|
|||||||||||||||||||||||||
Michael
Rice
|
2009
|
287,500
|
––
|
––
|
50,963
|
(2)
|
––
|
––
|
––
|
338,463
|
||||||||||||||||||||||||
President,
Chief
|
2008
|
300,000
|
30,000
|
––
|
––
|
––
|
––
|
––
|
330,000
|
|||||||||||||||||||||||||
Executive
Officer and
|
||||||||||||||||||||||||||||||||||
Director
(8/06 –present)
|
OPTION
AWARDS
|
STOCK
AWARDS
|
||||||||||||||||||||||||||||||||
Equity
Incentive
|
Equity
Incentive
Plan
Awards:
|
||||||||||||||||||||||||||||||||
Name
(a)
|
Number
of
Securities
Underlying
Unexercised
Options
(#)
Exercisable
(b)
|
Number
of
Securities
Underlying
Unexercised
Options
(#)
Unexercisable
(c)
|
Equity
Incentive
Plan
Awards:
Number
of
Securities
Underlying
Unexercised
Unearned
Options
(#)
(d)
|
Option
Exercise
Price
($)
(e)
|
Option
Expiration
Date
(f)
|
Number
of
Shares
or
Units
of
Stock
That
Have
Not
Vested
(#)
(g)
|
Market
Value
of
Shares
or
Units
of
Stock
That
Have
Not
Vested
($)
(h)
|
Plan
Awards:
Number
of
Unearned
Shares,
units
or
Other
Rights
That
Have
Not
Vested
(#)
(i)
|
Market
or
Payout
Value
of
Unearned
Shares,
Units
or
Other
Rights
That
Have
Not
Vested
($)
(j)
|
||||||||||||||||||||||||
Michael
Rice
|
1,500,000
|
––
|
––
|
0.07
|
8/7/2016
(1)
|
––
|
––
|
––
|
––
|
||||||||||||||||||||||||
Michael
Rice
|
666,666
|
333,334
|
––
|
0.08
|
2/7/2017
(2)
|
––
|
––
|
––
|
––
|
||||||||||||||||||||||||
Michael
Rice
|
––
|
765,000
|
––
|
0.09
|
2/2/2019
(3)
|
––
|
––
|
––
|
––
|
(1)
|
This
award vests 500,000 shares on each of 8/7/2007, 8/7/2008, and
8/7/2009
|
(2)
|
This
award vests 333,333 shares on each of 2/7/2008, 2/7/2009, and 333,334
shares on 2/7/2010
|
(3)
|
This
award vests 191,250 shares on each of 2/2/2010, 2/2/2011, 2/2/2012 and
2/2/2013
|
Name
(a)
|
Fees
Earned
or
Paid in
Cash
($)
(b)
|
Stock
Awards
($)
(c)
|
Option
Awards
($)
(d)(1)
|
Non-Equity
Incentive
Plan
Compensation
($)
(e)
|
Non-Qualified
Deferred
Compensation
Earnings
($)
(f)
|
All
Other
Compensation
($)
(g)
|
Total
($)
(j)
|
|||||||||||||||||||||
Howard
Breslow (2)
|
8,000
|
––
|
9,197
|
––
|
––
|
––
|
17,197
|
|||||||||||||||||||||
Thomas
Girschweiler (3)
|
11,500
|
––
|
9,197
|
––
|
––
|
––
|
20,697
|
|||||||||||||||||||||
Roderick
de Greef (4)
|
10,500
|
––
|
9,197
|
––
|
––
|
110,000
|
129,697
|
|||||||||||||||||||||
Raymond
Cohen (5)
|
21,500
|
––
|
9,197
|
––
|
––
|
––
|
30,697
|
|||||||||||||||||||||
Andrew
Hinson (6)
|
9,000
|
––
|
9,197
|
––
|
––
|
––
|
18,197
|
(1)
|
See
Note 1 to Notes to Financial Statements for a description on the valuation
methodology of stock option awards.
|
(2)
|
As
of December 31, 2009, Mr. Breslow had received a grant of
150,000 options which vested 100% on 2/2/2010. He owned the
following options and warrants, all of which were exercisable: options to
purchase 500,000 shares of Common Stock and warrants to purchase 500,000
shares of Common Stock.
|
(3)
|
As
of December 31, 2009, Mr. Girschweiler had received a grant of
150,000 options which vested 100% on 2/2/2010. He owned the
following options, all of which were exercisable: options to purchase
250,000 shares of Common Stock.
|
(4)
|
As
of December 31, 2009, Mr. de Greef had received a grant of
150,000 options which vested 100% on 2/2/2010. He owned the
following options and warrants, all of which were exercisable: options to
purchase 500,000 shares of Common Stock and warrants to purchase 1,250,000
shares of Common Stock.
|
(5)
|
As
of December 31, 2009, Mr. Cohen had received a grant of 150,000
options which vested on 2/2/2010. He owned the following
options, all of which were exercisable: options to purchase 750,000 shares
of Common Stock.
|
(6)
|
As
of December 31, 2009, Mr. Hinson had received a grant of 150,000
options which vested on 2/2/2010. He owned the following
options, all of which were exercisable: options to purchase 250,000 shares
of Common Stock.
|
Name
and Address of Beneficial Owner
|
Common
Stock (1)
|
Percentage
of Class (1)
|
||||||
Michael
Rice (Officer and Director)
c/o
BioLife Solutions, Inc.
3303
Monte Villa Pkwy, Suite 310
Bothell,
WA 98021
|
2,691,250 | (2) | 3.7 | % | ||||
John
G. Baust
175
Raish Hill Road
Candor,
NY 13743
|
3,694,722 | 5.3 | % | |||||
Howard
S. Breslow, Esq. (Director)
c/o
Breslow & Walker, LLP
767
Third Avenue
New
York, NY 10017
|
1,203,600 | (3) | 1.7 | % | ||||
Roderick
de Greef (Director)
c/o
BioLife Solutions, Inc.
3303
Monte Villa Pkwy, Suite 310
Bothell,
WA 98021
|
5,449,163 | (4) | 7.6 | % | ||||
Walter
Villiger
c/o
BioLife Solutions, Inc.
3303
Monte Villa Pkwy, Suite 310
Bothell,
WA 98021
|
19,240,081 | 27.6 | % | |||||
Thomas
Girschweiler (Director)
c/o
BioLife Solutions, Inc.
3303
Monte Villa Pkwy, Suite 310
Bothell,
WA 98021
|
14,806,552 | (5) | 21.1 | % | ||||
Beskivest
Chart LTD
Goodmans
Bay Center
West
Bay Street & Sea View Drive
Nassau,
Bahamas
|
7,255,026 | 10.4 | % | |||||
Raymond
Cohen (Director)
c/o
BioLife Solutions, Inc.
3303
Monte Villa Pkwy, Suite 310
Bothell,
WA 98021
|
945,000 | (6) | 1.3 | % | ||||
Andrew
Hinson (Director)
c/o
BioLife Solutions, Inc.
3303
Monte Villa Pkwy, Suite 310
Bothell,
WA 98021
|
400,000 | (7) | 0.6 | % | ||||
All
officers and directors as a group
(six
persons)
|
25,495,565 | 33.1 | % |
(1)
|
Shares
of Common Stock subject to options and warrants that are exercisable or
will be exercisable within 60 days are deemed outstanding for computing
the number of shares beneficially owned. The percentage of the
outstanding shares held by a person holding such options or warrants
includes those currently exercisable or exercisable within 60 days, but
such options and warrants are not deemed outstanding for computing
the percentage of any other person. Except as indicated by footnote,
and subject to community property laws where applicable, the Company
believes that the persons named in the table have sole voting and
investment power with respect to all shares shown as beneficially owned by
them.
|
(2)
|
Includes
2,500,000 shares of Common Stock issuable upon the exercise of outstanding
stock options under the Company’s 1998 Stock Option Plan, 191,250 shares
of Common Stock issuable upon the exercise of outstanding stock options
granted subsequent to the expiration of its plan. This does not
include 573,750 and 1,190,878 shares of Common Stock issuable upon the
exercise of non-vested stock options granted on February 2, 2009 and
February 5, 2010, respectively.
|
(3)
|
Includes
500,000 shares of Common Stock issuable upon the exercise of outstanding
stock options under the Company’s 1998 Stock Option Plan, 150,000 shares
of Common Stock issuable upon the exercise of outstanding stock options
granted subsequent to the expiration of its plan, and 500,000 shares of
Common Stock issuable upon the exercise of outstanding warrants, all of
which options and warrants are currently exercisable, and 53,600 common
shares. This does not include 150,000 shares of Common Stock
issuable upon the exercise of non-vested stock options granted on February
5, 2010.
|
(4)
|
Includes
500,000 shares of Common Stock issuable upon the exercise of outstanding
stock options under the Company’s 1998 Stock Option Plan, 150,000 shares
of Common Stock issuable upon the exercise of outstanding stock options
granted subsequent to the expiration of its plan, and 1,250,000 shares of
Common Stock issuable upon the exercise of outstanding warrants, all of
which options and warrants are currently exercisable, and 3,549,163 common
shares. This does not include 150,000 shares of Common Stock
issuable upon the exercise of non-vested stock options granted on February
5, 2010.
|
(5)
|
Includes
250,000 shares of Common Stock issuable upon the exercise of outstanding
stock options under the Company’s 1998 Stock Option Plan, 150,000 shares
of Common Stock issuable upon the exercise of outstanding stock options
granted subsequent to the expiration of its plan, all of which options are
currently exercisable, and 14,406,552 common shares. This does
not include 150,000 shares of Common Stock issuable upon the exercise of
non-vested stock options granted on February 5,
2010.
|
(6)
|
Includes
750,000 shares of Common Stock issuable upon the exercise of outstanding
stock options under the Company’s 1998 Stock Option Plan, 150,000 shares
of Common Stock issuable upon the exercise of outstanding stock options
granted subsequent to the expiration of its plan, all of which options are
currently exercisable, and 45,000 common shares. This does not
include 150,000 shares of Common Stock issuable upon the exercise of
non-vested stock options granted on February 5,
2010.
|
(7)
|
Includes
250,000 shares of Common Stock issuable upon the exercise of outstanding
stock options under the Company’s 1998 Stock Option Plan, 150,000 shares
of Common Stock issuable upon the exercise of outstanding stock options
granted subsequent to the expiration of its plan, all of which options are
currently exercisable. This does not include 150,000 shares of
Common Stock issuable upon the exercise of non-vested stock options
granted on February 5, 2010.
|
Plan
category
|
Number
of
securities
to be
issued
upon
exercise
of
outstanding
options
and
warrants
(in
thousands)
|
Weighted
Average
exercise
price
of
outstanding
options
and
warrants
|
Number
of
securities
remaining
available
for
future
issuance
(in
thousands)
|
|||||||||
Equity
compensation plans approved by security holders
|
6,850
|
$
|
.09
|
––
|
||||||||
Equity
compensation plans not approved by security holders*
|
4,634
|
$
|
.09
|
––
|
||||||||
Total
|
11,484
|
$
|
.09
|
––
|
Years
Ended December 31,
|
||||||||
Description
|
2009
|
2008
|
||||||
Audit
Fees
|
$
|
87,000
|
$
|
73,000
|
||||
Tax
Fees
|
0
|
0
|
||||||
All
Other Fees
|
0
|
0
|
||||||
Totals
|
$
|
87,000
|
$
|
73,000
|
Page
No.
|
||||
Index
to Financial Statements
|
F-1 | |||
Report
of Independent Registered Public Accounting Firm
|
F-2 | |||
Audited
Financial Statements:
|
||||
Balance
Sheets
|
F-3 | |||
Statements
of Operations
|
F-4 | |||
Statements
of Shareholders’ Equity (Deficiency)
|
F-5 | |||
Statements
of Cash Flows
|
F-6 | |||
Notes
to Financial Statements
|
F-7 |
Exhibit
|
|||
Number
|
Document
|
||
3.1 |
Certificate
of Incorporation, as amended. (1)
|
||
3.2 |
By-Laws,
and amendment, dated March 19, 1990, thereto. (1)
|
||
4.1 |
Specimen
of Common Stock Certificate. (1)
|
||
10.1 |
Stock
Option Plan, dated July 7, 1988, and amendment, dated July 19,
1989. (1)
|
||
10.2 |
1998
Stock Option Plan (2)
|
||
10.3 |
Employment
Agreement dated July 26, 2006 between the Company and Michael Rice
(3) ^
|
||
10.4 |
Amendment
to Employment Agreement dated February 7, 2007 between the Company
and Michael Rice (4) ^
|
||
10.5 |
Manufacturing
Service Agreement dated October 26, 2007 between the Company and
Bioserv, Inc., a division of NextPharma Technologies, Inc.
(5)
|
||
10.6 |
Quality
Agreement dated October 26, 2007 between the Company and Bioserv,
Inc., a division of NextPharma Technologies, Inc. (5)
|
||
10.7 |
Storage
Services Agreement dated October 26, 2007 between the Company and
Bioserv, Inc., a division of NextPharma Technologies, Inc.
(5)
|
||
10.8 |
Order
Fulfillment Services Agreement dated October 26, 2007 between the
Company and Bioserv, Inc., a division of NextPharma Technologies, Inc.
(5)
|
||
10.9 |
Lease
Agreement dated August 1, 2007 for facility space 3303 Monte Villa
Parkway, Bothell, WA 98021 (6)
|
||
10.10 |
Consulting
Agreement dated August 7, 2007 between the Company and Roderick de
Greef (7)
|
10.11 |
Secured
Convertible Multi-Draw Term Loan Facility Agreement dated January 11,
2008, between the Company and Thomas Girschweiler (8)
|
||
10.12 |
Secured
Convertible Multi-Draw Term Loan Facility Agreement dated January 11,
2008, between the Company and Walter Villiger (8)
|
||
10.13 |
First
Amendment to the Secured Convertible Multi-Draw Term Loan Facility
Agreement dated October 20, 2008, between the Company, Thomas
Girschweiler, and Walter Villiger (9)
|
||
10.14 |
Promissory
Note dated October 20, 2008 issued by the Company to Thomas
Girschweiler (9)
|
||
10.15 |
Promissory
Note dated October 20, 2008 issued by the Company to Walter Villiger
(9)
|
||
10.16 |
First
Amendment to the Lease, dated the November 4, 2008, between the
Company and Monte Villa Farms, LLC (9)
|
||
10.17 |
Second
Amendment to the Secured Convertible Multi-Draw Term Loan Facility
Agreement dated December 16, 2009, between the Company, Thomas
Girschweiler and Walter Villiger *
|
||
10.18 |
Promissory
Note dated December 16, 2009 issued by the Company to Thomas Girschweiler
*
|
||
10.19 |
Promissory
Note dated December 16, 2009 issued by the Company to Walter Villiger
*
|
||
31 |
Certification
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
*
|
||
32 |
Certification
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
*
|
(1)
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB for the
fiscal year ended December 31,
2000.
|
(2)
|
Incorporated
by reference to the Company’s Definitive Proxy Statement for the special
meeting of shareholders held on December 16,
1998.
|
(3)
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB for the
fiscal year ended December 31,
2006.
|
(4)
|
Incorporated
by reference to the Company’s current report on Form 8-K filed
February 12, 2007.
|
(5)
|
Incorporated
by reference to the Company’s current report on Form 8-K filed
October 30, 2007.
|
(6)
|
Incorporated
by reference to the Company’s Annual Report on Form 10-KSB for the
fiscal year ended December 31,
2007.
|
(7)
|
Incorporated
by reference to the Company’s current report on Form 8-K filed
November 19, 2007.
|
(8)
|
Incorporated
by reference to the Company’s current report on Form 8-K filed
January 14, 2008.
|
(9)
|
Incorporated
by reference to the Company’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2008.
|
*
|
Filed
herewith
|
^
|
Compensatory
plan or arrangement
|
|
SIGNATURES
|
Date:
|
March
30, 2010
|
BIOLIFE
SOLUTIONS, INC.
|
|||
/s/Michael Rice
|
|||||
Michael
Rice
|
|||||
Chief
Executive Officer and Chief
|
|||||
Financial
Officer
|
Date:
|
March
30, 2010
|
/s/Michael Rice
|
|||
Michael
Rice
|
|||||
Director
|
|||||
Date:
|
March
30, 2010
|
/s/Roderick de Greef
|
|||
Roderick
de Greef
|
|||||
Director
|
|||||
Date:
|
March
30, 2010
|
/s/Howard S. Breslow
|
|||
Howard
S. Breslow
|
|||||
Director
|
|||||
Date:
|
March
30, 2010
|
/s/Thomas Girschweiler
|
|||
Thomas
Girschweiler
|
|||||
Director
|
|||||
Date:
|
March
30, 2010
|
/s/Raymond Cohen
|
|||
Raymond
Cohen
|
|||||
Director
|
|||||
Date:
|
March
30, 2010
|
/s/Andrew Hinson
|
|||
Andrew
Hinson
|
|||||
Director
|
INDEX
TO FINANCIAL STATEMENTS
|
Page
No.
|
||||
Report
of Independent Registered Public Accounting Firm
|
F-2 | |||
Balance
Sheets
|
F-3 | |||
Statements
of Operations
|
F-4 | |||
Statements
of Shareholders’ Equity (Deficiency)
|
F-5 | |||
Statements
of Cash Flows
|
F-6 | |||
Notes
to Financial Statements
|
F-7 |
December
31,
|
December
31,
|
|||||||
2009
|
2008
|
|||||||
Assets
|
||||||||
Current
assets
|
||||||||
Cash
and cash equivalents
|
$
|
139,151
|
$
|
98,724
|
||||
Accounts
receivable, trade, net of allowance for doubtful accounts of $550 and
$29,000 at December 31, 2009 and 2008, respectively
|
315,365
|
279,192
|
||||||
Inventories
|
358,219
|
625,291
|
||||||
Prepaid
expenses and other current assets
|
79,635
|
19,483
|
||||||
Total
current assets
|
892,370
|
1,022,690
|
||||||
Property
and equipment
|
||||||||
Leasehold
improvements
|
202,270
|
––
|
||||||
Furniture
and computer equipment
|
164,964
|
109,753
|
||||||
Manufacturing
and other equipment
|
319,224
|
210,558
|
||||||
Subtotal
|
686,458
|
320,311
|
||||||
Less:
Accumulated depreciation and amortization
|
(281,036
|
)
|
(190,214
|
)
|
||||
Net
property and equipment
|
405,422
|
130,097
|
||||||
Long
term deposits
|
36,166
|
17,835
|
||||||
Total
assets
|
$
|
1,333,958
|
$
|
1,170,622
|
||||
Liabilities
and Shareholders’ Equity (Deficiency)
|
||||||||
Current
liabilities
|
||||||||
Accounts
payable
|
$
|
192,834
|
$
|
659,133
|
||||
Accrued
expenses
|
51,251
|
52,722
|
||||||
Accrued
compensation
|
92,588
|
189,459
|
||||||
Deferred
revenue
|
20,000
|
25,833
|
||||||
Total
current liabilities
|
356,673
|
927,147
|
||||||
Long
term liabilities
|
||||||||
Promissory
notes payable, related parties
|
7,888,127
|
5,063,127
|
||||||
Accrued
interest, related parties
|
766,973
|
278,961
|
||||||
Deferred
revenue, long term
|
149,167
|
72,500
|
||||||
Total
liabilities
|
9,160,940
|
6,341,735
|
||||||
Commitments
and Contingencies (Note 8)
|
||||||||
Shareholders'
equity (deficiency)
|
||||||||
Common
stock, $0.001 par value; 100,000,000 shares authorized, 69,679,854 and
69,639,854 shares issued and outstanding at December 31, 2009 and
2008, respectively
|
69,680
|
69,640
|
||||||
Additional
paid-in capital
|
42,314,560
|
42,202,117
|
||||||
Accumulated
deficit
|
(50,211,222
|
)
|
(47,442,870
|
)
|
||||
Total
shareholders' equity (deficiency)
|
(7,826,982
|
)
|
(5,171,113
|
)
|
||||
Total
liabilities and shareholders' equity (deficiency)
|
$
|
1,333,958
|
$
|
1,170,622
|
Years
Ended December 31,
|
||||||||
2009
|
2008
|
|||||||
Revenue
|
||||||||
Product
sales
|
$
|
1,556,600
|
$
|
1,277,497
|
||||
Licensing
revenue
|
25,000
|
45,000
|
||||||
Total
revenue
|
1,581,600
|
1,322,497
|
||||||
Cost
of product sales
|
1,007,022
|
770,646
|
||||||
Gross
profit
|
574,578
|
551,851
|
||||||
Operating
expenses
|
||||||||
Research
and development
|
414,465
|
457,640
|
||||||
Sales
and marketing
|
558,721
|
372,324
|
||||||
General
and administrative
|
1,503,552
|
1,925,654
|
||||||
Manufacturing
start-up costs
|
385,205
|
259,687
|
||||||
Total operating
expenses
|
2,861,943
|
3,015,305
|
||||||
Operating
loss
|
(2,287,365
|
)
|
(2,463,454
|
)
|
||||
Other
income (expenses)
|
||||||||
Interest
income
|
1,069
|
6,354
|
||||||
Other
income
|
9,692
|
10,495
|
||||||
Interest
expense
|
(488,013
|
)
|
(284,762
|
)
|
||||
Loss
on disposal of property and equipment
|
(3,735)
|
––
|
||||||
Amortization
of deferred financing costs
|
––
|
(43,750
|
)
|
|||||
Total
other income (expenses)
|
(480,987
|
)
|
(311,663
|
)
|
||||
Net
Loss
|
$
|
(2,768,352
|
)
|
$
|
(2,775,117
|
)
|
||
Basic
and diluted net loss per common share
|
$
|
(0.04
|
)
|
$
|
(0.04
|
)
|
||
Basic
and diluted weighted average common shares used to calculate net loss per
common share
|
69,647,635
|
69,631,566
|
Common
Stock
|
Additional
Paid-in
|
Accumulated
|
Total
Shareholders'
Equity
|
|||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
(Deficiency)
|
||||||||||||||||
Balance,
January 1, 2008
|
69,606,520
|
$
|
69,607
|
$
|
42,128,356
|
$
|
(44,667,753
|
)
|
$
|
(2,469,790)
|
||||||||||
Exercise
of options to purchase common stock
|
33,334
|
33
|
2,300
|
––
|
2,333
|
|||||||||||||||
Stock-based
compensation
|
––
|
––
|
71,461
|
––
|
71,461
|
|||||||||||||||
Net
loss
|
––
|
––
|
––
|
(2,775,117
|
)
|
(2,775,117
|
)
|
|||||||||||||
Balance,
December 31, 2008
|
69,639,854
|
$
|
69,640
|
$
|
42,202,117
|
$
|
(47,442,870
|
)
|
$
|
(5,171,113
|
)
|
|||||||||
Exercise
of options to purchase common stock
|
40,000
|
40
|
2,560
|
––
|
2,600
|
|||||||||||||||
Stock-based
compensation
|
––
|
––
|
109,883
|
––
|
109,883
|
|||||||||||||||
Net
loss
|
––
|
––
|
––
|
(2,768,352
|
)
|
(2,768,352
|
)
|
|||||||||||||
Balance,
December 31, 2009
|
69,679,854
|
$
|
69,680
|
$
|
42,314,560
|
$
|
(50,211,222
|
)
|
$
|
(7,826,982
|
)
|
Years
Ended December 31,
|
||||||||
2009
|
2008
|
|||||||
Cash
flows from operating activities
|
||||||||
Net
loss
|
$
|
(2,768,352
|
)
|
$
|
(2,775,117
|
)
|
||
Adjustments
to reconcile net loss to net cash used in operating
activities
|
||||||||
Depreciation
|
93,690
|
29,281
|
||||||
Loss
on disposal of property and equipment
|
3,735
|
––
|
||||||
Amortization
of deferred financing costs
|
––
|
43,750
|
||||||
Stock-based
compensation expense
|
109,883
|
71,461
|
||||||
Other
|
782
|
––
|
||||||
Change
in operating assets and liabilities
|
||||||||
(Increase)
Decrease in
|
||||||||
Accounts
receivable, trade
|
(36,173)
|
21,313
|
||||||
Inventories
|
267,072
|
(526,229
|
)
|
|||||
Prepaid
expenses and other current assets and long-term deposits
|
(78,483)
|
76,196
|
||||||
Increase
(Decrease) in
|
||||||||
Accounts
payable
|
(466,301)
|
561,995
|
||||||
Accrued
compensation and other expenses
|
(98,342)
|
9,169
|
||||||
Accrued
interest, related parties
|
488,012
|
284,763
|
||||||
Deferred
revenue
|
70,835
|
90,000
|
||||||
Net
cash used in operating activities
|
(2,413,642
|
)
|
(2,113,418
|
)
|
||||
Cash
flows from investing activity
|
||||||||
Purchase
of property and equipment
|
(373,531
|
)
|
(46,688
|
)
|
||||
Cash
flows from financing activities
|
||||||||
Proceeds
from notes payable
|
2,825,000
|
2,200,000
|
||||||
Proceeds
from exercise of options
|
2,600
|
2,333
|
||||||
Net
cash provided by financing activities
|
2,827,600
|
2,202,333
|
||||||
Net
increase in cash and cash equivalents
|
40,427
|
42,227
|
||||||
Cash
and cash equivalents - beginning of year
|
98,724
|
56,497
|
||||||
Cash
and cash equivalents - end of year
|
$
|
139,151
|
$
|
98,724
|
2009
|
2008
|
||||
Basic
and diluted weighted average common stock shares
outstanding
|
69,647,635
|
69,631,566
|
|||
Potentially
dilutive securities excluded from loss per share
computations:
|
|||||
Common
stock options
|
9,265,000
|
8,000,000
|
|||
Common
stock purchase warrants
|
2,218,750
|
2,218,750
|
|||
Assumptions
|
2009
|
2008
|
||||||
Risk-free
rate
|
1.78
|
%
|
2.55
|
%
|
||||
Annual
rate of dividends
|
––
|
––
|
||||||
Historical
volatility
|
82.27
|
%
|
69.38
|
%
|
||||
Expected
life
|
6.4
years
|
7
years
|
2009
|
2008
|
|||||||
Raw
materials
|
$
|
123,421
|
$
|
9,820
|
||||
Work
in progress
|
49,350
|
113,382
|
||||||
Finished
goods
|
185,448
|
502,089
|
||||||
Total
|
$
|
358,219
|
$
|
625,291
|
2009
|
2008
|
|||||||
Notes
payable to Thomas Girschweiler and Walter Villiger, secured by all assets
of the Company, principal balances of all notes payable outstanding due in
full in January 2011, including interest of 7% (see Note
2)
|
$
|
7,888,127
|
$
|
5,063,127
|
||||
Total
notes payable, long-term
|
$
|
7,888,127
|
$
|
5,063,127
|
2009
|
2008
|
|||||||
Federal
tax (benefit) at statutory rate
|
$
|
(941,240
|
)
|
$
|
(943,540
|
)
|
||
Expiration
of net operating loss carryforwards
|
486,462
|
2,003,596
|
||||||
Expiration
of tax credits
|
114,000
|
150,000
|
||||||
Change
in valuation allowance
|
339,840
|
(1,210,920
|
)
|
|||||
Other
|
938
|
864
|
||||||
Provision
for income taxes, net
|
$
|
––
|
$
|
––
|
2009
|
2008
|
|||||||
Deferred
tax assets (liabilities)
|
||||||||
Net
operating loss carryforwards
|
$
|
9,766,585
|
$
|
9,506,573
|
||||
Tax
credits
|
178,000
|
292,000
|
||||||
Accrued
compensation
|
31,480
|
41,296
|
||||||
Depreciation
|
1,204
|
(7,112
|
)
|
|||||
Stock-based
compensation
|
140,820
|
103,460
|
||||||
Accrued
related party interest
|
260,771
|
94,847
|
||||||
Other
|
2,361
|
10,317
|
||||||
Total
|
10,381,221
|
10,041,381
|
||||||
Less: Valuation
allowance
|
(10,381,221
|
)
|
(10,041,381
|
)
|
||||
Net
deferred tax asset
|
$
|
––
|
$
|
––
|
Year
of
|
Net
Operating
|
R&D
Tax
|
||||||
Expiration
|
Losses
|
Credits
|
||||||
2010
|
$
|
1,562,000
|
$
|
145,000
|
||||
2011
|
5,277,000
|
33,000
|
||||||
2012
|
1,570,000
|
––
|
||||||
2013
|
1,425,000
|
––
|
||||||
2014
|
1,234,000
|
––
|
||||||
2020
|
2,849,000
|
––
|
||||||
2021
|
4,168,000
|
––
|
||||||
2023
|
1,217,000
|
––
|
||||||
2024
|
646,000
|
––
|
||||||
2025
|
589,000
|
––
|
||||||
2026
|
873,000
|
––
|
||||||
2027
|
2,607,000
|
––
|
||||||
2028
|
2,512,000
|
––
|
||||||
2029
|
2,196,000
|
––
|
||||||
Total
|
$
|
28,725,000
|
$
|
178,000
|
Year
Ended
|
Year
Ended
|
|||||||||||||||
December
31, 2009
|
December
31, 2008
|
|||||||||||||||
Wgtd.
Avg.
|
Wgtd.
Avg.
|
|||||||||||||||
Exercise
|
Exercise
|
|||||||||||||||
Shares
|
Price
|
Shares
|
Price
|
|||||||||||||
Outstanding
at beginning of year
|
2,218,750
|
$
|
0.12
|
4,239,075
|
$
|
0.46
|
||||||||||
Exercised
|
––
|
––
|
––
|
––
|
||||||||||||
Forfeited
|
––
|
––
|
(2,020,325
|
)
|
0.83
|
|||||||||||
Outstanding
at end of year
|
2,218,750
|
$
|
0.12
|
2,218,750
|
$
|
0.12
|
||||||||||
Warrants
exercisable at year end
|
2,218,750
|
$
|
0.12
|
2,218,750
|
$
|
0.12
|
Year
Ended
|
Year
Ended
|
|||||||||||||||
December
31, 2009
|
December
31, 2008
|
|||||||||||||||
Wgtd.
Avg.
|
Wgtd.
Avg.
|
|||||||||||||||
Exercise
|
Exercise
|
|||||||||||||||
Shares
|
Price
|
Shares
|
Price
|
|||||||||||||
Outstanding
at beginning of year
|
8,000,000
|
$
|
0.09
|
6,844,000
|
$
|
0.12
|
||||||||||
Granted
|
1,765,000
|
0.09
|
1,400,000
|
0.04
|
||||||||||||
Exercised
|
(40,000
|
)
|
(0.07
|
)
|
(33,334)
|
(0.07)
|
||||||||||
Forfeited
|
(460,000
|
)
|
(0.17
|
)
|
(210,666
|
)
|
(0.88
|
)
|
||||||||
Outstanding
at end of year
|
9,265,000
|
$
|
0.09
|
8,000,000
|
$
|
0.09
|
||||||||||
Stock
options exercisable at year end
|
5,846,667
|
$
|
0.09
|
4,258,333
|
$
|
0.10
|
Number
|
||||||
Outstanding
at
|
Weighted
Average
|
|||||
Range
of
|
December
31,
|
Remaining
|
Weighted
Average
|
|||
Exercise
Prices
|
2009
|
Contractual
Life
|
Exercise
Price
|
|||
$0.04-$0.07
|
2,800,000
|
7.48
|
$0.06
|
|||
$0.08-$0.09
|
5,650,000
|
7.42
|
$0.08
|
|||
$0.10-$1.25
|
815,000
|
6.42
|
$0.16
|
|||
9,265,000
|
7.35
|
$0.09
|
Year
Ending
|
||||
December
31
|
||||
2010
|
$
|
263,540
|
||
2011
|
274,082
|
|||
2012
|
285,045
|
|||
2013
|
296,447
|
|||
2014
|
77,076
|
|||
Total
|
$
|
1,196,190
|