x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
¨
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
Delaware
|
13-3419202
|
|
(State or
other jurisdiction of incorporation or organization)
|
(I.R.S.
Employer Identification No.)
|
|
5
Caufield Place, Suite 102, Newtown, PA 18940
|
||
(Address
of principal executive offices) (Zip
Code)
|
Title of each class
Common
Stock, par value $0.33 per share
|
Name of each exchange on which
registered
OTC
Bulletin Board
|
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
(Do not check if smaller reporting company)
|
Smaller
Reporting Company x
|
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
|
1
|
HELPFUL
INFORMATION
|
1
|
PART
I – FINANCIAL INFORMATION
|
2
|
ITEM
1. FINANCIAL STATEMENTS
|
2
|
Condensed
Consolidated Balance Sheets
|
2
|
Condensed
Consolidated Statements of Operations
|
3
|
Condensed
Consolidated Statements of Cash Flows
|
4
|
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
|
17
|
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
26
|
ITEM
4(T). CONTROLS AND PROCEDURES
|
26
|
PART
II – OTHER INFORMATION
|
27
|
ITEM
1. LEGAL PROCEEDINGS
|
27
|
ITEM
1A. RISK FACTORS
|
27
|
ITEM
1A. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
|
27
|
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
|
27
|
ITEM
4. (REMOVED AND RESERVED)
|
28
|
ITEM
5. OTHER INFORMATION
|
28
|
ITEM
6. EXHIBITS
|
28
|
SIGNATURES
|
29
|
·
|
our
need for additional financing to support our
business;
|
·
|
the
early stage of adoption of our Safety-Sponge® System and the need to
expand adoption of our Safety-Sponge®
System;
|
·
|
any
failure of our new management team and Board of Directors to operate
effectively;
|
·
|
our
reliance on third-party manufacturers, some of whom are sole-source
suppliers, and on our exclusive distributor;
and
|
·
|
any
inability to successfully protect our intellectual property
portfolio
|
March
31,
2010
|
December
31,
2009
|
|||||||
Assets
|
(Unaudited)
|
|||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 1,783,029 | $ | 3,446,726 | ||||
Accounts
receivable
|
1,000,533 | 906,136 | ||||||
Inventories,
net
|
606,236 | 565,823 | ||||||
Prepaid
expenses
|
170,766 | 207,598 | ||||||
Total current
assets
|
3,560,564 | 5,126,283 | ||||||
Property
and equipment, net
|
1,045,739 | 744,646 | ||||||
Goodwill
|
1,832,027 | 1,832,027 | ||||||
Patents,
net
|
3,032,789 | 3,114,025 | ||||||
Long-term
investment
|
666,667 | 666,667 | ||||||
Other
assets
|
33,248 | 43,246 | ||||||
Total
assets
|
$ | 10,171,034 | $ | 11,526,894 | ||||
Liabilities
and Stockholders’ Deficit
|
||||||||
Current
liabilities
|
||||||||
Accounts
payable
|
$ | 2,810,120 | $ | 2,043,166 | ||||
Convertible
note
|
1,424,558 | 1,424,558 | ||||||
Capital
lease-current portion
|
18,996 | 19,330 | ||||||
Warrant
derivative liability
|
1,947,598 | 3,666,336 | ||||||
Deferred
revenue
|
7,222,216 | 8,099,144 | ||||||
Accrued
liabilities
|
1,055,104 | 1,242,876 | ||||||
Total
current liabilities
|
14,478,592 | 16,495,410 | ||||||
Capital
lease, less current portion
|
53,183 | 58,274 | ||||||
Deferred
tax liability
|
773,195 | 805,768 | ||||||
Total
liabilities
|
15,304,970 | 17,359,452 | ||||||
Commitments
and contingencies (Note 16)
|
||||||||
Stockholders’
deficit :
|
||||||||
Series
A preferred stock, $1.00 par value, cumulative 7%
dividend:
|
||||||||
1,000,000
shares authorized; 10,950 issued and outstanding at March 31,
2010
|
||||||||
and
December 31, 2009;
|
||||||||
(Liquidation
preference of $1.2 million at March 31, 2010 and December 31,
2009)
|
10,950 | 10,950 | ||||||
Common
stock, $0.33 par value: 100,000,000 shares authorized;
|
||||||||
23,456,063
shares issued and outstanding at March 31, 2010 and December 31,
2009
|
7,740,501 | 7,740,501 | ||||||
Additional
paid-in capital
|
45,158,560 | 44,834,321 | ||||||
Accumulated
deficit
|
(58,043,947 | ) | (58,418,330 | ) | ||||
Total
stockholders’ deficit
|
(5,133,936 | ) | (5,832,558 | ) | ||||
Total
liabilities and stockholders’ deficit
|
$ | 10,171,034 | $ | 11,526,894 | ||||
PATIENT
SAFETY TECHNOLOGIES, INC.
|
Condensed
Consolidated Statements of Operations
(Unaudited)
|
For
the Three Months Ended March 31,
|
||||||||
2010
|
2009
|
|||||||
Revenues
|
$ | 2,364,819 | $ | 935,558 | ||||
Cost
of revenue
|
1,088,887 | 548,244 | ||||||
Gross
profit
|
1,275,932 | 387,314 | ||||||
Operating
expenses:
|
||||||||
Research
and development
|
33,331 | 112,297 | ||||||
Sales
and marketing
|
994,116 | 649,012 | ||||||
General
and administrative
|
1,651,861 | 2,551,444 | ||||||
Total
operating expenses
|
2,679,308 | 3,312,753 | ||||||
Operating
loss
|
(1,403,376 | ) | (2,925,439 | ) | ||||
Other
income (expense)
|
||||||||
Interest
expense
|
(6,333 | ) | (219,729 | ) | ||||
Gain
(loss) on change in fair value of warrant derivative
liability
|
1,718,738 | (414,021 | ) | |||||
Other
income
|
51,944 | 20 | ||||||
Total
other income (expense)
|
1,764,349 | (633,730 | ) | |||||
Income
(loss) before income taxes
|
360,973 | (3,559,169 | ) | |||||
Income
tax benefit
|
32,573 | 32,360 | ||||||
Net
income (loss)
|
393,546 | (3,526,809 | ) | |||||
Preferred
dividends
|
(19,163 | ) | (19,163 | ) | ||||
Net
income (loss) applicable to common shareholders
|
$ | 374,383 | $ | (3,545,972 | ) | |||
Income
(loss) per common share
|
||||||||
Basic
|
$ | 0.02 | $ | (0.21 | ) | |||
Diluted
|
$ | 0.01 | $ | (0.21 | ) | |||
Weighted
average common shares outstanding:
|
||||||||
Basic
|
23,456,063 | 17,197,872 | ||||||
Diluted
|
25,199,632 | 17,197,872 | ||||||
For
the Three Months Ended March 31,
|
||||||||
2010
|
2009
|
|||||||
Operating
activities:
|
||||||||
Net
income (loss)
|
$ | 393,546 | $ | (3,526,809 | ) | |||
Adjustments
to reconcile net income (loss) to net cash used in operating
activities:
|
||||||||
Depreciation
|
136,411 | 84,769 | ||||||
Amortization
of patents
|
81,236 | 81,235 | ||||||
Amortization
of debt discount
|
−− | 118,258 | ||||||
Stock
based compensation
|
324,239 | 225,045 | ||||||
Non-cash
expense related to issuance of additional warrants
|
−− | 1,297,200 | ||||||
(Gain)
loss on change in fair value of warrant derivative
liability
|
(1,718,738 | ) | 414,021 | |||||
Change
in deferred tax liability
|
(32,573 | ) | (33,209 | ) | ||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
(94,397 | ) | 182,848 | |||||
Inventories
|
(40,413 | ) | 165,410 | |||||
Prepaid
expenses
|
36,832 | 10,542 | ||||||
Other
assets
|
9,997 | −− | ||||||
Accounts
payable
|
766,954 | (350,472 | ) | |||||
Accrued
liabilities
|
(187,772 | ) | (8,723 | ) | ||||
Deferred
revenue
|
(876,928 | ) | −− | |||||
Net
cash used in operating activities
|
(1,201,606 | ) | (1,331,885 | ) | ||||
Investing
activities:
|
||||||||
Purchase
of property and equipment
|
(437,504 | ) | (22,051 | ) | ||||
Net
cash used in investing activities
|
(437,504 | ) | (22,051 | ) | ||||
Financing
activities:
|
||||||||
Proceeds
from issuance of notes payable
|
−− | 2,000,000 | ||||||
Capital
lease principle payments
|
(5,424 | ) | −− | |||||
Payments
of preferred dividends
|
(19,163 | ) | (19,163 | ) | ||||
Net
cash (used in) provided by financing activities
|
(24,587 | ) | 1,980,837 | |||||
Net
(decrease) increase in cash and cash equivalents
|
(1,663,697 | ) | 626,901 | |||||
Cash
and cash equivalents at beginning of period
|
3,446,726 | 296,185 | ||||||
Cash
and cash equivalents at end of period
|
$ | 1,783,029 | $ | 923,086 | ||||
Supplemental
disclosures of cash flow information:
|
||||||||
Cash
paid during the period for interest
|
$ | −− | $ | 16,753 | ||||
Cash
paid during the period for taxes
|
$ | 12,570 | $ | −− | ||||
Non
cash investing and financing activities:
|
||||||||
Dividends
accrued
|
$ | 19,163 | $ | 19,163 | ||||
Reclassification
of accrued interest to notes payable
|
$ | −− | $ | 50,000 | ||||
Debt
discount recorded in connection with issuance of notes
payable
|
$ | −− | $ | 1,311,311 | ||||
Reclassification
of warrant equities to derivative liability
|
$ | −− | $ | 3,989,878 |
·
|
Hardware Cost Reimbursement
Revenues: During fiscal year 2009, the Company began a
program in which the scanners and related hardware used in the
Safety-Sponge® System are provided to the hospitals without charge for
their use. Prior to the third quarter of 2009, the Company’s business
model included the sale of its SurgiCounter™ scanners and related software
used in its Safety-Sponge® System to most hospitals that adopted the
Company’s system. Beginning with the third quarter of 2009, the
Company modified its business model and began to provide its SurgiCounter™
scanners and related software to all hospitals at no cost when they adopt
its Safety-Sponge® System. Under the new supply and
distribution agreement with Cardinal Health entered into in November 2009,
the Company is reimbursed an agreed upon percentage of the cost of the
scanners provided by the Company to hospitals that receive their surgical
sponges and towels through Cardinal. Reimbursements received from Cardinal
are initially deferred and are recognized as revenue on a pro-rata basis
over the life of the specific hospital contract. Because the Company
no longer engages in direct SurgiCounter™ scanner sales, it
generally anticipates only recognizing revenues associated with its
SurgiCounter™ scanners in connection with reimbursement arrangements under
its agreement with Cardinal Health.
|
·
|
Surgical Sponge
Revenues: The surgical products (sponges and towels) used in
the Company’s Safety-Sponge® System are sold separately from the hardware
and software described above and those products are not considered to be
part of a multiple-element arrangement. Accordingly, revenues
related to the sale of products used in the Company’s Safety-Sponge®
System are recognized in accordance with ASC 605-25 that addresses revenue
recognition for multiple-element arrangements. Generally revenues from the
sale of surgical products used in the Safety-Sponge® System are recognized
upon shipment as most surgical products used in the Safety-Sponge® System
are sold FOB shipping point. In the event that terms of the sale are
FOB customer, revenue is recognized at the time delivery to the customer
has been completed. Advanced payments are classified as deferred revenue
and recognized as product is shipped to the
customer.
|
Three
Months Ended
|
||||||||
March
31,
|
||||||||
2010
|
2009
|
|||||||
Basic
|
||||||||
Income
(loss) available to common stockholders
|
$ | 374,383 | $ | (3,545,972 | ) | |||
Weighted
average common shares outstanding (basic)
|
23,456,063 | 17,197,872 | ||||||
Basic
income (loss) per common share
|
$ | 0.02 | $ | (0.21 | ) | |||
Diluted
|
||||||||
Income
(loss) available to common stockholders
|
$ | 374,383 | $ | (3,545,972 | ) | |||
Weighted
average common shares outstanding
|
23,456,063 | 17,197,872 | ||||||
Assumed
exercise of options
|
|
357,800 | — | |||||
Assumed
exercise of warrants
|
885,769 | — | ||||||
Assumed
conversion of debt
|
500,000 | — | ||||||
Common
and potential common shares
|
25,199,632 | 17,197,872 | ||||||
Diluted
income (loss) per common share
|
$ | 0.01 | $ | (0.21 | ) | |||
Potentially
dilutive securities outstanding at period end
|
||||||||
excluded
from diluted computation as they were anti-dilutive
|
13,005,513 | 19,687,942 |
March
31,
|
December
31,
|
||||||
2010
|
2009
|
||||||
Finished
goods
|
$ | 775,232 | $ | 734,819 | |||
Reserve
for obsolescence
|
(168,996 | ) | (168,996 | ) | |||
Total
inventory, net
|
$ | 606,236 | $ | 565,823 |
March
31,
|
December
31,
|
|||||||
2010
|
2009
|
|||||||
Computer
software and equipment
|
$ | 1,100,003 | $ | 1,097,181 | ||||
Furniture
and equipment
|
298,369 | 298,333 | ||||||
Hardware
for customer use
|
823,686 | 394,861 | ||||||
Property
and equipment, gross
|
2,222,058 | 1,790,375 | ||||||
Less:
accumulated depreciation
|
(1,176,319 | ) | (1,045,729 | ) | ||||
Property
and equipment, net
|
$ | 1,045,739 | $ | 744,646 |
March
31,
2010
|
December
31,
2009
|
|||||||
Patents
|
$ | 4,684,576 | $ | 4,684,576 | ||||
Accumulated amortization
|
(1,651,787 | ) | (1,570,551 | ) | ||||
$ | 3,032,789 | $ | 3,114,025 |
March
31,
2010
|
December
31, 2009
|
|||||||
Alacra
Corporation
|
$ | 666,667 | $ | 666,667 | ||||
Total
|
$ | 666,667 | $ | 666,667 |
March
31,
2010
|
December
31,
2009
|
|||||||
Ault
Glazer Capital Partners, LLC (a) *
|
$ | 1,424,558 | $ | 1,424,558 | ||||
Total
convertible note
|
1,424,558 | 1,424,558 | ||||||
Less: current
portion
|
(1,424,558 | ) | (1,424,558 | ) | ||||
Convertible
note-long term portion
|
$ | — | $ | — |
(a)
|
Effective
June 1, 2007, the Company restructured the entire unpaid
principal and interest under promissory notes issued to Ault Glazer
Capital Partners, LLC (“Ault Glazer”) into a
new Convertible Secured Promissory Note (the "AG Capital Partners
Convertible Note") in the principal amount of $2.5 million. The AG
Capital Partners Convertible Note bears interest at the rate of 7% per
annum and is due on the earlier of December 31, 2010, or the occurrence of
an event of default.
|
March
31,
2010
|
December
31,
2009
|
|||||||
Accrued
lease liability
|
$ | 7,547 | $ | 7,547 | ||||
Accrued
dividends on preferred stock
|
114,976 | 114,976 | ||||||
Accrued
salaries
|
47,449 | 47,449 | ||||||
Accrued
director’s fees
|
162,500 | 162,500 | ||||||
Contingent
tax liability
|
671,600 | 740,726 | ||||||
Accrued
commissions
|
— | 13,200 | ||||||
Other
|
51,032 | 156,478 | ||||||
Total
accrued liabilities
|
$ | 1,055,104 | $ | 1,242,876 |
March
31,
2010
|
December
31,
2009
|
|||||||
Cardinal
Health advance payment on purchase order
|
$ | 6,925,491 | $ | 8,000,000 | ||||
Scanner
reimbursement revenue
|
292,142 | 99,144 | ||||||
Maintenance
agreements
|
4,583 | — | ||||||
Total
|
$ | 7,222,216 | $ | 8,099,144 |
Preferred Stock
|
Common Stock Issued
|
Paid
– In
|
Accumulated
|
Total
Stockholders’
|
||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Equity
(Deficit)
|
||||||||||||||||||||||
BALANCES,
December 31, 2009
|
10,950 | 10,950 | 23,456,063 | 7,740,501 | 44,834,321 | (58,418,330 | ) | (5,832,558 | ) | |||||||||||||||||||
Preferred
dividend
|
−− | −− | −− | −− | −− | (19,163 | ) | (19,163 | ) | |||||||||||||||||||
Stock-based
compensation
|
−− | −− | −− | −− | 324,239 | 324,239 | ||||||||||||||||||||||
Net
income
|
−− | −− | −− | −− | −− | 393,546 | 393,546 | |||||||||||||||||||||
BALANCES,
March 31, 2010
|
10,950 | $ | 10,950 | 23,456,063 | $ | 7,740,501 | $ | 45,158,560 | $ | (58,043,947 | ) | $ | (5,133,936 | ) |
Amount
|
Range
of Exercise
Price
|
|||||||
Warrants
outstanding December 31, 2009
|
8,064,978 | $ | 0.75 − 6.05 | |||||
Issued
|
— | − | ||||||
Cancelled/Expired
|
(295,125 | ) | $ | 2.00 – 5.27 | ||||
Warrants
outstanding March 31, 2010
|
7,769,853 | $ | 0.75 − 6.05 |
#
of Warrants
|
Range
of Exercise Price
|
|||||||
2010
|
120,000 | $ | 2.00 − 6.05 | |||||
2011
|
2,301,419 | $ | 0.75 − 4.50 | * | ||||
2012
|
818,000 | $ | 2.00 | |||||
2013
|
1,786,267 | $ | 0.75 − 1.40 | * | ||||
2014
|
1,890,000 | $ | 1.82 − 4.00 | |||||
2015
|
854,167 | $ | 1.25 | |||||
Total
|
7,769,853 | $ | 0.75 − 6.05 |
January
1, 2010
|
Gain
on change in fair value included in earnings
|
March
31, 2010
|
||||||||||
Warrant
Derivative
Liability
|
$ | (3,666,336 | ) | $ | 1,718,738 | $ | (1,947,598 | ) |
Three
Months Ended
March
31,
|
||||||
2010
|
2009
|
|||||
Weighted
average risk free interest rate
|
2.76%
|
1.67%
|
||||
Weighted
average life (in years)
|
6.0
years
|
2.42-4.38 years
|
||||
Volatility
|
123%
|
105%
|
||||
Expected
dividend yield
|
0%
|
0%
|
||||
Weighted
average grant-date fair value per share of options granted
|
$1.39
|
$0.76
|
Outstanding
Options
|
||||||||||||||||
Number
of Shares |
Weighted AverageExercise Price |
Weighted Average (years)
|
Aggregate Intrinsic
Value |
|||||||||||||
Balance
at December 31, 2009(2)
|
5,821,000 | $ | 1.41 | 8.96 | $ | 4,301,385 | ||||||||||
Options
Granted
|
680,000 | $ | 1.39 | 9.83 | ||||||||||||
Exercised
|
— | — | — | |||||||||||||
Forfeited
|
(21,771 | ) | $ | 1.70 | ||||||||||||
Cancelled
|
— | — | ||||||||||||||
Balance
at March 31, 2010
|
6,479,229 | $ | 1.37 | 8.83 | ||||||||||||
Vested
and exercisable as of
March
31, 2010
|
2,506,832 | $ | 1.72 | 8.11 | $ | 388,723 | ||||||||||
Unvested
as of March 31, 2010
|
3,972,397 | $ | 1.16 | 9.27 | $ | 938,562 |
1)
|
The
aggregate intrinsic value is calculated as the difference between the
exercise price of the underlying awards and the closing stock price of
$1.20 of the Company’s common stock at March 31,
2010.
|
2)
|
Includes
3,150,000 non-qualified options that were issued outside the 2005 and 2009
stock option plans.
|
March
31,
2010
|
December
31,
2009
|
|||||||
Convertible Note:
|
||||||||
Ault
Glazer Capital Partners, LLC
|
$ | 1,424,558 | $ | 1,424,558 |
Three Months Ended March
31,
|
2010
|
2009
|
||||||
Revenues:
|
||||||||
United
States
|
$ | 2,364,819 | $ | 935,558 | ||||
Other
|
— | — | ||||||
Total
revenues
|
$ | 2,364,819 | $ | 935,558 |
Three Months Ended March
31,
|
2010
|
2009
|
||||||
Revenues:
|
||||||||
Surgical
sponges and towels
|
$ | 2,339,487 | $ | 732,082 | ||||
Scanners
and related products
|
25,332 | 203,476 | ||||||
Total
revenues
|
$ | 2,364,819 | $ | 935,558 |
·
|
Ineffective
control environment due to the following identified
weaknesses:
|
o
|
Failure
to retain individuals competent in the application of generally accepted
accounting principles (“GAAP”) to complex accounting
transactions.
|
o
|
Failure
to establish sufficiently detailed accounting policies and procedures and
to properly train accounting department
staff.
|
·
|
Ineffective
internal control policies and procedures relating to the period end close
process including lack of controls relating to journal entries, post
closing adjustments and management review of conclusions regarding
accounting and financial reporting
matters.
|
·
|
Ineffective
internal control policies and procedures designed to provide reasonable
assurance regarding the accuracy and integrity of spreadsheets used in the
financial reporting system.
|
·
|
Ineffective
control environment due to the following identified
weaknesses:
|
o
|
Failure
to retain individuals competent in the application of generally accepted
accounting principles (“GAAP”) to complex accounting
transactions.
|
o
|
Failure
to establish sufficiently detailed accounting policies and procedures and
to properly train accounting department
staff.
|
·
|
Ineffective
internal control policies and procedures relating to the period end close
process including lack of controls relating to journal entries, post
closing adjustments and management review of conclusions regarding
accounting and financial reporting
matters.
|
·
|
Ineffective
internal control policies and procedures designed to provide reasonable
assurance regarding the accuracy and integrity of spreadsheets used in the
financial reporting system.
|
Exhibit
Number
|
Description
|
|
31.1*
|
Certification
of Chief Executive Officer required by Rule 13a-14(a) or Rule
15d-14(a)*
|
|
31.2*
|
Certification
of Chief Financial Officer required by Rule 13a-14(a) or Rule
15d-14(a)*
|
|
32.1*
|
Certification
of Chief Executive Officer and Chief Financial Officer required by Rule
13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of
the United States Code*
|
PATIENT SAFETY TECHNOLOGIES, INC.
|
|||
Date:
May 14, 2010
|
|
By: /s/ Steven H. Kane | |
Steven H. Kane, President and Chief | |||
Executive Officer | |||