x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITES EXCHANGE ACT OF
1934
|
¨
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
Pennsylvania
|
23-2328753
|
(State
or other jurisdiction of Incorporation)
|
(IRS
employer identification
number)
|
Large
accelerated filer
|
¨
|
Accelerated
filer
|
¨
|
|||
Non-accelerated
filer
|
¨
|
(Do
not check if a smaller reporting company)
|
Smaller
reporting company
|
x
|
Date:
November 11, 2010
|
Class:
|
Common
Stock, par value $.01 per share
|
Shares
Outstanding: 6,561,826
|
Description
|
Page
|
|
Part
I – Financial Information
|
||
Item
1. Financial Statements
|
||
Condensed
Consolidated Balance Sheets – September 30, 2010 (Unaudited) and December
31, 2009
|
3
|
|
Condensed
Consolidated Statements of Operations – Three months ended September 30,
2010 and September 30, 2009 (Unaudited)
|
4
|
|
Condensed
Consolidated Statements of Operations – Nine months ended September 30,
2010 and September 30, 2009 (Unaudited)
|
5
|
|
Condensed
Consolidated Statements of Cash Flows – Nine months ended September 30,
2010 and September 30, 2009 (Unaudited)
|
6
|
|
Notes
to Condensed Consolidated Financial Statements (Unaudited)
|
7
|
|
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
17
|
|
Item
4. Controls and Procedures
|
30
|
|
Part
II - Other Information
|
||
Item
1A. Risk Factors
|
31
|
|
Item
6. Exhibits
|
32
|
September
30,
2010
(Unaudited)
|
December
31,
2009 |
|||||||
ASSETS
|
||||||||
Current
Assets
|
||||||||
Cash
and cash equivalents
|
$ | 409,505 | $ | 243,524 | ||||
Accounts
receivable, net
|
5,361,264 | 3,372,712 | ||||||
Inventories
|
13,579,298 | 11,489,724 | ||||||
Prepaid
expenses and other current assets
|
456,337 | 456,675 | ||||||
Total
current assets
|
19,806,404 | 15,562,635 | ||||||
Cash
– restricted
|
- | 2,032,164 | ||||||
Equipment
and improvements, net
|
3,412,650 | 3,741,347 | ||||||
Goodwill
|
7,119,726 | 7,119,726 | ||||||
Other
intangible assets, net
|
7,254,725 | 3,994,250 | ||||||
Other
assets, net
|
341,110 | 849,753 | ||||||
Total
Assets
|
$ | 37,934,615 | $ | 33,299,875 | ||||
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
||||||||
Current
Liabilities
|
||||||||
Line
of credit borrowings
|
3,658,625 | 2,306,306 | ||||||
Current
maturities of long-term debt
|
14,503 | 1,759,185 | ||||||
Accounts
payable
|
4,240,277 | 3,363,096 | ||||||
Accrued
expenses and other current liabilities
|
2,305,193 | 1,342,467 | ||||||
Total
current liabilities
|
10,218,598 | 8,771,054 | ||||||
Long-term
debt
|
- | 2,305,851 | ||||||
Other
long-term liabilities
|
69,671 | 96,564 | ||||||
Deferred
tax liability
|
321,323 | 355,349 | ||||||
Total
Liabilities
|
10,609,592 | 11,528,818 | ||||||
Shareholders’
Equity
|
||||||||
Convertible
preferred stock, $.01 par value; 1,468,750 shares authorized;
issued and outstanding: 284,844 shares (liquidation
preference of $4,201,426 at September 30, 2010)
|
2,848 | 2,851 | ||||||
Common
stock, $.01 par value; 18,750,000 authorized; issued and
outstanding: 6,561,826 at September 30, 2010; 5,039,468 at December
31, 2009
|
65,618 | 50,395 | ||||||
Additional
paid-in capital
|
48,620,586 | 41,221,613 | ||||||
Accumulated
other comprehensive income – cumulative
translation adjustments
|
1,413,377 | 1,303,293 | ||||||
Accumulated
deficit
|
(22,777,406 | ) | (20,807,095 | ) | ||||
Total
Shareholders’ Equity
|
27,325,023 | 21,771,057 | ||||||
Total
Liabilities and Shareholders’ Equity
|
$ | 37,934,615 | $ | 33,299,875 |
Three Months ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Net
Sales
|
$ | 15,096,134 | $ | 12,882,425 | ||||
Cost
of sales
|
10,666,204 | 8,838,154 | ||||||
Gross
Profit
|
4,429,930 | 4,044,271 | ||||||
Operating
Expenses
|
||||||||
Selling,
general and administrative
|
4,690,054 | 3,677,182 | ||||||
Research
and development
|
175,380 | 70,412 | ||||||
Total
operating expenses
|
4,865,434 | 3,747,594 | ||||||
Operating
(loss) income
|
(435,504 | ) | 296,677 | |||||
Other
expense, net:
|
||||||||
Interest
expense
|
119,521 | 220,839 | ||||||
Other
income
|
(75,530 | ) | (69,002 | ) | ||||
Total
other expense
|
43,991 | 151,837 | ||||||
(Loss)
income before provision for income taxes
|
(479,495 | ) | 144,840 | |||||
Provision
for income taxes
|
23,057 | 5,237 | ||||||
Net
(Loss) Income
|
$ | (502,552 | ) | $ | 139,603 | |||
Net
(loss) income per common share – basic and diluted
|
$ | (0.08 | ) | $ | 0.03 | |||
Shares
used in computing net (loss) income per common share –
basic
|
6,561,826 | 5,039,468 | ||||||
Shares
used in computing net (loss) income per common share –
diluted
|
6,561,826 | 5,366,413 |
Nine Months ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Net
Sales
|
$ | 41,170,621 | $ | 34,877,658 | ||||
Cost
of sales
|
28,687,388 | 24,051,984 | ||||||
Gross
Profit
|
12,483,233 | 10,825,674 | ||||||
Operating
Expenses
|
||||||||
Selling,
general and administrative
|
13,603,071 | 11,244,347 | ||||||
Research
and development
|
415,232 | 288,338 | ||||||
Total
operating expenses
|
14,018,303 | 11,532,685 | ||||||
Operating
loss
|
(1,535,070 | ) | (707,011 | ) | ||||
Other
expense, net:
|
||||||||
Interest
expense
|
414,120 | 631,909 | ||||||
Loss
on debt extinguishment
|
114,072 | - | ||||||
Other
income
|
(253,661 | ) | (112,791 | ) | ||||
Total
other expense
|
274,531 | 519,118 | ||||||
Loss
before provision (benefit) for income taxes
|
(1,809,601 | ) | (1,226,129 | ) | ||||
Provision
(benefit) for income taxes
|
160,709 | (47,151 | ) | |||||
Net
Loss
|
$ | (1,970,310 | ) | $ | (1,178,978 | ) | ||
Net
loss per common share – basic and diluted
|
$ | (0.31 | ) | $ | (0.23 | ) | ||
Shares
used in computing net loss per common share – basic and
diluted
|
6,259,205 | 5,028,891 |
Nine Months Ended September 30,
|
||||||||
2010
|
2009
|
|||||||
Operating
Activities
|
||||||||
Net
Loss
|
$ | (1,970,310 | ) | $ | (1,178,978 | ) | ||
Adjustments
to reconcile net loss to net cash (used in) provided by operating
activities:
|
||||||||
Depreciation
of equipment and improvements
|
712,622 | 622,171 | ||||||
Amortization
of intangible assets
|
1,248,525 | 987,380 | ||||||
Amortization
of deferred financing costs
|
87,501 | 108,512 | ||||||
Loss
on debt extinguishment
|
114,072 | - | ||||||
Provision
for (recovery of) bad debts
|
22,269 | (87,044 | ) | |||||
Allowance
for sales adjustments
|
54,446 | 630,679 | ||||||
Provision
for inventory obsolescence
|
399,355 | 257,702 | ||||||
Deferred
rent expense
|
(16,425 | ) | 51,529 | |||||
Compensation
charge for employee stock options
|
618,278 | 668,658 | ||||||
Compensation
charge for restricted stock
|
42,666 | 18,148 | ||||||
Gain
on sale of equipment
|
- | (59,031 | ) | |||||
Deferred
income taxes
|
(41,109 | ) | (21,363 | ) | ||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
(2,065,267 | ) | (394,402 | ) | ||||
Inventories
|
(2,405,249 | ) | 1,630,394 | |||||
Prepaid
expenses and other current assets
|
5,556 | (70,629 | ) | |||||
Other
assets
|
310,505 | (452 | ) | |||||
Accounts
payable
|
814,506 | (802,634 | ) | |||||
Accrued
expenses and other current liabilities
|
882,080 | (763,821 | ) | |||||
Other
long-term liabilities
|
(8,862 | ) | 8,788 | |||||
Net
cash (used in) provided by operating activities
|
(1,194,841 | ) | 1,605,607 | |||||
Investing
Activities
|
||||||||
Purchase
of equipment and improvements
|
(337,011 | ) | (185,222 | ) | ||||
Purchase
of intangible asset
|
(2,250,000 | ) | - | |||||
Proceeds
from sale of equipment
|
- | 61,000 | ||||||
Net
cash used in investing activities
|
(2,587,011 | ) | (124,222 | ) | ||||
Financing
Activities
|
||||||||
Net
change in bank line of credit
|
1,352,319 | (611,016 | ) | |||||
Long-term
debt repayments
|
(4,050,533 | ) | (975,339 | ) | ||||
Net
change in restricted cash
|
2,032,164 | (15,142 | ) | |||||
Proceeds
from issuance of stock, net of costs
|
4,491,279 | (9,290 | ) | |||||
Net
cash provided by (used in) financing activities
|
3,825,229 | (1,610,787 | ) | |||||
Effect
of exchange rate changes on cash
|
122,604 | 138,362 | ||||||
Net
increase in cash and cash equivalents
|
165,981 | 8,960 | ||||||
Cash
and cash equivalents
|
||||||||
Beginning
of period
|
243,524 | 391,038 | ||||||
End
of period
|
$ | 409,505 | $ | 399,998 | ||||
Supplemental
disclosures of cash flow information:
|
||||||||
Issuance
of common stock and warrants for purchase of intangible
asset
|
$ | 2,259,000 | $ | - | ||||
Cash
paid during the period for:
|
||||||||
Interest
|
$ | 346,443 | $ | 494,704 |
1.
|
Organization
and Summary of Significant Accounting
Policies
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Weighted
average common shares outstanding – basic
|
6,561,826 | 5,039,468 | 6,259,205 | 5,028,891 | ||||||||||||
Dilutive
shares attributable to:
|
||||||||||||||||
Convertible
preferred stock
|
– | 285,051 | – | – | ||||||||||||
Warrants
|
– | 1,575 | – | – | ||||||||||||
Stock
options
|
– | 40,319 | – | – | ||||||||||||
Sub-total
dilutive shares
|
– | 326,945 | – | – | ||||||||||||
Weighted average common
shares outstanding – diluted
|
6,561,826 | 5,366,413 | 6,259,205 | 5,028,891 |
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Dilutive
shares:
|
||||||||||||||||
Convertible
preferred stock
|
284,844 | – | 284,844 | 285,051 | ||||||||||||
Restricted
common stock
|
20,000 | – | 20,000 | – | ||||||||||||
Warrants
|
1,734,531 | 1,097,833 | 1,734,531 | 1,099,407 | ||||||||||||
Stock
options
|
1,265,600 | 1,138,821 | 1,265,600 | 1,179,141 | ||||||||||||
Total
dilutive shares
|
3,304,975 | 2,236,654 | 3,304,975 | 2,563,599 |
2.
|
Inventories
|
September 30,
2010
|
December 31,
2009 |
|||||||
Finished
goods
|
$ | 9,070,100 | $ | 7,804,339 | ||||
Work
in process
|
965,226 | 466,365 | ||||||
Packaging
materials
|
873,994 | 722,148 | ||||||
Raw
materials
|
2,669,978 | 2,496,872 | ||||||
Total
inventory
|
$ | 13,579,298 | $ | 11,489,724 |
3.
|
Line
of Credit Borrowings
|
4.
|
Long-Term
Debt
|
September
30,
2010
|
December 31,
2009 |
|||||||
U.S.
term loan
|
$ | - | $ | 3,500,000 | ||||
Promissory
note
|
- | 500,000 | ||||||
Capital
lease obligation
|
14,503 | 65,036 | ||||||
Total
debt
|
14,503 | 4,065,036 | ||||||
Less:
current maturities
|
14,503 | 1,759,185 | ||||||
Long-term
debt
|
$ | - | $ | 2,305,851 |
5.
|
Shareholders’
Equity
|
Series
|
Number of Warrants
|
Exercise Price
|
Expiration Date
|
|||||||
H
|
331,915 | $ | 8.00 |
April
30, 2011
|
||||||
I
|
94,351 | $ | 5.76 |
April
30, 2011
|
||||||
J
|
267,858 | $ | 6.16 |
May
31, 2013
|
||||||
K
|
399,064 | $ | 9.60 |
April
1, 2013
|
||||||
L
|
6,250 | $ | 3.12 |
March
31, 2014
|
||||||
N
|
100,000 | $ | 6.25 |
February
22, 2015
|
||||||
O
|
372,600 | $ | 5.50 |
February
22, 2015
|
||||||
P
|
29,160 | $ | 6.25 |
February
16, 2015
|
||||||
Q
|
133,333 | $ | 5.50 |
February
22, 2015
|
||||||
Total
|
1,734,531 |
2010
|
2009
|
|||||||||||||||
Options
|
Weighted
Average Exercise Price |
Options
|
Weighted
Average Exercise Price |
|||||||||||||
Outstanding
– January 1
|
1,066,350 | $ | 5.08 | 1,002,828 | $ | 5.52 | ||||||||||
Granted
|
243,625 | $ | 5.09 | 207,813 | $ | 3.04 | ||||||||||
Forfeited
|
(16,249 | ) | $ | 4.43 | (1,875 | ) | $ | 5.60 | ||||||||
Expired
|
(24,375 | ) | $ | 6.00 | (29,625 | ) | $ | 8.88 | ||||||||
Exercised
|
(3,751 | ) | $ | 3.33 | - | |||||||||||
Outstanding
– September 30
|
1,265,600 | $ | 5.08 | 1,179,141 | $ | 5.04 | ||||||||||
Exercisable
at September 30
|
986,498 | $ | 5.19 | 848,906 | $ | 5.36 |
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Risk-free
interest rate
|
1.78 | % | 2.88 | % | 2.54 | % | 2.31 | % | ||||||||
Volatility
factor
|
107.5 | % | 83.73 | % | 79.97 | % | 92.16 | % | ||||||||
Dividend
yield
|
0 | % | 0 | % | 0 | % | 0 | % | ||||||||
Expected
option life (years)
|
6.25 | 6.25 | 6.25 | 6.25 | ||||||||||||
Contractual
life (years)
|
10 | 10 | 10 | 10 |
Three Months
Ended September 30,
|
Nine Months
Ended September 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Cost
of sales
|
$ | 18,885 | $ | 23,327 | $ | 58,383 | $ | 73,764 | ||||||||
Selling,
general and administrative expenses
|
182,262 | 169,461 | 559,895 | 594,894 | ||||||||||||
Total
stock option compensation expense
|
$ | 201,147 | $ | 192,788 | $ | 618,278 | $ | 668,658 |
Convertible
preferred shares (series A – D)
|
284,844 | |||
Common
stock options available for grant
|
167,026 | |||
Common
stock options outstanding
|
1,265,600 | |||
Common
stock warrants outstanding (series H – Q)
|
1,734,531 | |||
Restricted
common stock available for grant
|
270,625 | |||
Restricted
common stock grants
|
20,000 | |||
Total
common stock shares reserved
|
3,742,626 |
6.
|
Comprehensive
(Loss) Income
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Net
(loss) income as reported
|
$ | (502,552 | ) | $ | 139,603 | $ | (1,970,310 | ) | $ | (1,178,978 | ) | |||||
Other comprehensive income: | ||||||||||||||||
Foreign
currency translation adjustment
|
181,751 | 363,948 | 110,084 | 610,150 | ||||||||||||
Comprehensive
(loss) income
|
$ | (320,801 | ) | $ | 503,551 | $ | (1,860,226 | ) | $ | (568,828 | ) |
7.
|
Operating
Segments
|
Three
Months Ended September 30, 2010
|
||||||||||||||||||||
Wound
Care
|
Wound
Closure-
Specialty
Securement Devices |
Skin
Care
|
Other
|
Total
Company
|
||||||||||||||||
Net
sales
|
$ | 14,511,806 | $ | 428,476 | $ | 155,852 | - | $ | 15,096,134 | |||||||||||
Gross
profit
|
4,165,478 | 228,010 | 36,442 | - | 4,429,930 | |||||||||||||||
Total
expenses
|
- | - | - | $ | (4,932,482 | ) | (4,932,482 | ) | ||||||||||||
Net
loss
|
$ | (502,552 | ) | |||||||||||||||||
Three
Months Ended September 30, 2009
|
||||||||||||||||||||
Net
sales
|
$ | 12,289,311 | $ | 409,565 | $ | 183,549 | - | $ | 12,882,425 | |||||||||||
Gross
profit
|
3,765,137 | 231,070 | 48,064 | - | 4,044,271 | |||||||||||||||
Total
expenses
|
- | - | - | $ | (3,904,668 | ) | (3,904,668 | ) | ||||||||||||
Net
income
|
$ | 139,603 |
Nine Months Ended September 30,
2010
|
||||||||||||||||||||
Wound Care
|
Wound
Closure-
Specialty
Securement Devices |
Skin Care
|
Other
|
Total
Company
|
||||||||||||||||
Net
sales
|
$ | 39,451,842 | $ | 1,303,627 | $ | 415,152 | - | $ | 41,170,621 | |||||||||||
Gross
profit
|
11,675,826 | 705,387 | 102,020 | - | 12,483,233 | |||||||||||||||
Total
expenses
|
- | - | - | $ | (14,453,543 | ) | (14,453,543 | ) | ||||||||||||
Net
loss
|
$ | (1,970,310 | ) | |||||||||||||||||
Nine Months Ended September 30,
2009
|
||||||||||||||||||||
Net
sales
|
$ | 33,023,590 | $ | 1,307,327 | $ | 546,741 | - | $ | 34,877,658 | |||||||||||
Gross
profit
|
9,969,307 | 714,272 | 142,095 | - | 10,825,674 | |||||||||||||||
Total
expenses
|
- | - | - | $ | (12,004,652 | ) | (12,004,652 | ) | ||||||||||||
Net
loss
|
$ | (1,178,978 | ) |
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
United
States
|
72 | % | 72 | % | 69 | % | 72 | % | ||||||||
Canada
|
22 | % | 23 | % | 25 | % | 22 | % | ||||||||
Other
|
6 | % | 5 | % | 6 | % | 6 | % |
8.
|
Income
Taxes
|
9.
|
Comvita
Licensing, Manufacturing and Sales
Agreement
|
Quarter
Ended September 30,
|
Variance
|
|||||||||||||||
|
2010
|
2009
|
||||||||||||||
Gross
Sales
|
$ | 17,653,812 | $ | 15,356,917 | $ | 2,296,895 | 15.0 | % | ||||||||
Sales
adjustments
|
(2,557,678 | ) | (2,474,492 | ) | (83,186 | ) | 3.4 | % | ||||||||
Net
sales
|
15,096,134 | 12,882,425 | 2,213,709 | 17.2 | % | |||||||||||
Cost
of sales
|
10,666,204 | 8,838,154 | 1,828,050 | 20.7 | % | |||||||||||
Gross
profit
|
4,429,930 | 4,044,271 | 385,659 | 9.5 | % | |||||||||||
Selling,
general and administrative expense
|
4,690,054 | 3,677,182 | 1,012,872 | 27.5 | % | |||||||||||
Research
and development expense
|
175,380 | 70,412 | 104,968 | 149.1 | % | |||||||||||
Interest
expense
|
119,521 | 220,839 | (101,318 | ) | (45.9 | )% | ||||||||||
Other
income, net
|
(75,530 | ) | (69,002 | ) | (6,528 | ) | 9.5 | % | ||||||||
Total
expenses
|
4,909,425 | 3,899,431 | 1,009,994 | 25.9 | % | |||||||||||
(Loss)
income before income taxes
|
(479,495 | ) | 144,840 | (624,335 | ) | 431.1 | % | |||||||||
Provision
for income taxes
|
23,057 | 5,237 | 17,820 | |||||||||||||
Net
(loss) income
|
$ | (502,552 | ) | $ | 139,603 | $ | (642,155 | ) |
Quarter Ended September 30,
|
||||||||
|
2010
|
2009
|
||||||
Gross
Sales
|
$
|
17,653,812
|
$
|
15,356,917
|
||||
Trade
rebates
|
(1,868,953
|
)
|
(1,820,697
|
)
|
||||
Distributor
fees
|
(301,711
|
)
|
(266,783
|
)
|
||||
Sales
incentives
|
(185,638
|
)
|
(164,711
|
)
|
||||
Returns
and allowances
|
(79,910
|
)
|
(118,355
|
)
|
||||
Cash
discounts
|
(121,466
|
)
|
(103,946
|
)
|
||||
Total
adjustments
|
(2,557,678
|
)
|
(2,474,492
|
)
|
||||
Net
sales
|
$
|
15,096,134
|
$
|
12,882,425
|
Quarter Ended September 30,
|
||||||||
|
2010
|
2009
|
||||||
Beginning
balance – June 30
|
$ | 2,385,569 | $ | 2,309,304 | ||||
Rebates
paid
|
(1,874,922 | ) | (1,759,195 | ) | ||||
Rebates
accrued
|
1,868,953 | 1,820,697 | ||||||
Ending
balance – September 30
|
$ | 2,379,600 | $ | 2,370,806 |
Quarter Ended September 30,
|
Variance
|
|||||||||||||||
|
2010
|
2009
|
||||||||||||||
Net
Sales
|
$ | 15,096,134 | $ | 12,882,425 | $ | 2,213,709 | 17.2 | % | ||||||||
Cost
of sales
|
10,666,204 | 8,838,154 | 1,828,050 | 20.7 | % | |||||||||||
Gross
Profit
|
$ | 4,429,930 | $ | 4,044,271 | $ | 385,659 | 9.5 | % | ||||||||
Gross
Profit %
|
29.3 | % | 31.4 | % |
Quarter Ended September 30,
|
Variance
|
|||||||||||||||
|
2010
|
2009
|
||||||||||||||
Distribution
|
$ | 436,772 | $ | 443,592 | $ | (6,820 | ) | (1.5 | )% | |||||||
Marketing
|
405,516 | 371,624 | 33,892 | 9.1 | % | |||||||||||
Sales
|
1,819,067 | 1,306,140 | 512,927 | 39.3 | % | |||||||||||
General
and administrative
|
2,028,699 | 1,555,826 | 472,873 | 30.4 | % | |||||||||||
Total
|
$ | 4,690,054 | $ | 3,677,182 | $ | 1,012,872 | 27.5 | % |
Nine Months Ended September
30,
|
Variance
|
|||||||||||||||
|
2010
|
2009
|
||||||||||||||
Gross
Sales
|
$ | 48,918,341 | $ | 41,668,350 | $ | 7,249,991 | 17.4 | % | ||||||||
Sales
adjustments
|
(7,747,720 | ) | (6,790,692 | ) | (957,028 | ) | 14.1 | % | ||||||||
Net
sales
|
41,170,621 | 34,877,658 | 6,292,963 | 18.0 | % | |||||||||||
Cost
of sales
|
28,687,388 | 24,051,984 | 4,635,404 | 19.3 | % | |||||||||||
Gross
profit
|
12,483,233 | 10,825,674 | 1,657,559 | 15.3 | % | |||||||||||
Selling,
general and administrative expense
|
13,603,071 | 11,244,347 | 2,358,724 | 21.0 | % | |||||||||||
Research
and development expense
|
415,232 | 288,338 | 126,894 | 44.0 | % | |||||||||||
Interest
expense
|
414,120 | 631,909 | (217,789 | ) | (34.5 | )% | ||||||||||
Loss
on debt extinguishment
|
114,072 | - | 114,072 | |||||||||||||
Other
income, net
|
(253,661 | ) | (112,791 | ) | (140,870 | ) | 124.9 | % | ||||||||
Total
expenses
|
14,292,834 | 12,051,803 | 2,241,031 | 18.6 | % | |||||||||||
Loss
before income taxes
|
(1,809,601 | ) | (1,226,129 | ) | (583,472 | ) | 47.6 | % | ||||||||
Provision
(benefit) for income taxes
|
160,709 | (47,151 | ) | 207,860 | ||||||||||||
Net
loss
|
$ | (1,970,310 | ) | $ | (1,178,978 | ) | $ | (791,332 | ) | 67.1 | % |
Nine Months Ended September 30,
|
||||||||
|
2010
|
2009
|
||||||
Gross
Sales
|
$ | 48,918,341 | $ | 41,668,350 | ||||
Trade
rebates
|
(5,772,856 | ) | (4,934,121 | ) | ||||
Distributor
fees
|
(970,664 | ) | (711,980 | ) | ||||
Sales
incentives
|
(422,610 | ) | (453,411 | ) | ||||
Returns
and allowances
|
(253,372 | ) | (384,403 | ) | ||||
Cash
discounts
|
(328,218 | ) | (306,777 | ) | ||||
Total
adjustments
|
(7,747,720 | ) | (6,790,692 | ) | ||||
Net
sales
|
$ | 41,170,621 | $ | 34,877,658 |
Nine Months Ended September 30,
|
||||||||
|
2010
|
2009
|
||||||
Beginning
balance – January 1
|
$ | 2,493,232 | $ | 2,660,086 | ||||
Rebates
paid
|
(5,886,488 | ) | (5,223,401 | ) | ||||
Rebates
accrued
|
5,772,856 | 4,934,121 | ||||||
Ending
balance – September 30
|
$ | 2,379,600 | $ | 2,370,806 |
Nine Months Ended September
30,
|
Variance
|
|||||||||||||||
|
2010
|
2009
|
||||||||||||||
Net
Sales
|
$ | 41,170,621 | $ | 34,877,658 | $ | 6,292,963 | 18.0 | % | ||||||||
Cost
of sales
|
28,687,388 | 24,051,984 | 4,635,404 | 19.3 | % | |||||||||||
Gross
Profit
|
$ | 12,483,233 | $ | 10,825,674 | $ | 1,657,559 | 15.3 | % | ||||||||
Gross
Profit %
|
30.3 | % | 31.0 | % |
Nine Months Ended September 30,
|
Variance
|
|||||||||||||||
|
2010
|
2009
|
||||||||||||||
Distribution
|
$ | 1,342,207 | $ | 1,331,067 | $ | 11,140 | 0.1 | % | ||||||||
Marketing
|
1,258,378 | 1,201,411 | 56,967 | 4.7 | % | |||||||||||
Sales
|
4,947,452 | 3,743,003 | 1,204,449 | 32.2 | % | |||||||||||
General
and administrative
|
6,055,034 | 4,968,866 | 1,086,168 | 21.9 | % | |||||||||||
Total
|
$ | 13,603,071 | $ | 11,244,347 | $ | 2,358,724 | 21.0 | % |
|
1.
|
Assuming the existing resources
in place are generating the expected return, we will continue to expand
our investment in sales and marketing resources in support of our advanced
wound care products in the U.S. Starting with ten sales representatives at
the beginning of the year, we presently have twenty direct sales
representatives in place.
|
|
2.
|
The first aid products business
represents a growth opportunity. In addition to its core business
opportunities, the first aid products business will serve as a platform
for introducing our existing advanced and traditional wound care products
to new customers and markets, especially the retail market. We continue to
work on completion of a cost effective supply chain for first aid
products. The supply chain is expected to be fully operational within the
next three months, at which time we expect to be able to begin to improve
liquidity by reducing the level of inventory required to support the
business.
|
|
3.
|
In February 2010, we licensed the
worldwide rights to Medihoney. This will serve as the catalyst for the
expansion of our international business. We have establish a direct
presence in Europe and, ultimately, in other areas of the world employing
a direct presence or distributor model as the basis for conducting
business, as circumstances
dictate.
|
|
4.
|
We made a significant investment
in DSC 127 beginning in December 2007. While the launch of DSC 127 is
several years away, we believe the market potential for this product is
considerable. The product began Phase II trials in early 2008 to achieve
proof of principle in a human model. The projected cost to complete the
Phase II trial is approximately $1,870,000 (excluding any grant funding
received), including $1,468,116 spent through September 2010. We plan to
continue with this investment and anticipate spending approximately
$401,884 to complete the Phase II trial. Enrollment in the trial was
closed at the end of September. We expect to announce top-line
efficiency data by the end of the year or early next year and complete the
study and file our report with the FDA by the end of September 2011. In
November 2010, we received a $244,479 grant from the federal government
under the Patient Protection and Affordable Care Act to assist in the
financing of the trial.
|
Year
|
Low
|
High
|
||||||
2005
|
$ | 3.36 | $ | 6.24 | ||||
2006
|
$ | 3.60 | $ | 7.20 | ||||
2007
|
$ | 4.64 | $ | 11.20 | ||||
2008
|
$ | 1.60 | $ | 10.80 | ||||
2009
|
$ | 1.92 | $ | 6.80 | ||||
2010
*
|
$ | 4.40 | $ | 9.00 |
|
•
|
Quarter to quarter variations in
our operating results;
|
|
•
|
Changes in earnings estimates by
securities analysts;
|
|
•
|
Changes in interest rates or
other general economic
conditions;
|
|
•
|
Changes in market conditions in
the wound care industry;
|
|
•
|
Fluctuations in stock market
prices and trading volumes of similar
companies;
|
|
•
|
Discussion
of us or our stock price by the financial and scientific press and in
online investor communities;
|
|
•
|
Additions or departures of key
personnel;
|
|
•
|
Changes in third party
reimbursement policies;
|
|
•
|
The
introduction of new products either by us or by our competitors;
and
|
•
|
The loss of a major
customer.
|
Exhibit
|
Description
|
|
31.1
|
Certification
of the Principal Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
31.2
|
Certification
of the Principal Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
32.1
|
Certification
of the Principal Executive Officer pursuant to U.S.C. Section 1350 as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
|
32.2
|
Certification
of the Principal Financial Officer pursuant to U.S.C. Section 1350 as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
DERMA
SCIENCES, INC.
|
|||
Dated: November
11, 2010
|
By:
|
/s/ John E. Yetter
|
|
John
E. Yetter, CPA
|
|||
Chief
Financial Officer
|