U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
( X ) QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934.
For the quarterly period ended May 31, 2010
OR
( ) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934.
For the transition period from ________ to ________.
Commission File Number 0-12305
REPRO-MED SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
New York 13-3044880
(State or other jurisdiction of (IRS Employer Identification No.)
incorporation or organization)
24 Carpenter Road, Chester New York 10918
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (845) 469-2042
(Former name, former address and former fiscal year,
if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. [X] Yes [ ] No
Indicate by check mark whether the registrant has submitted electronically and
posted on its corporate Web site, if any, every Interactive Data File required
to be submitted and posted pursuant to Rule 405 of Regulation S-T during the
preceding 12 months (or for such shorter period that the registrant was required
to submit and post such files.) Yes [ ] No [ ]
Indicate by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of "large accelerated filer," "accelerated filer" and "smaller
reporting company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer [ ] Accelerated filer [ ]
Non-accelerated filer [ ] Smaller reporting company [X]
(Do not check if a smaller reporting company)
Indicate by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act). [ ] Yes [X] No
As of May 31, 2010, 35,584,286 shares of common stock, $.01 par value per share,
were outstanding.
REPRO-MED SYSTEMS, INC.
TABLE OF CONTENTS
PAGE
----
PART I FINANCIAL INFORMATION
------------------------------
ITEM 1. Financial Statements
Balance Sheets - May 31, 2010 (Unaudited) and February 28, 2010 . 3
Statements of Operations (Unaudited) - for the Three Months Ended
May 31, 2010 and May 31, 2009 ................................... 4
Statements of Cash Flows (Unaudited) - for the Three Months Ended
May 31, 2010 and May 31, 2009 ................................... 5
Notes to Financial Statements ................................... 6-12
ITEM 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations ........................................... 13-19
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk ...... 19
ITEM 4. Controls and Procedures ......................................... 19
PART II OTHER INFORMATION
--------------------------
ITEM 1. Legal Proceedings ............................................... 20
ITEM 1A. Risk Factors .................................................... 20
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds ..... 20
ITEM 3. Defaults Upon Senior Securities ................................. 20
ITEM 4. Removed and Reserved ............................................ 20
ITEM 5. Other Information ............................................... 20
ITEM 6. Exhibits ........................................................ 20
Page 2
PART 1 - FINANCIAL INFORMATION
REPRO-MED SYSTEMS, INC.
BALANCE SHEETS
MAY 31, FEBRUARY 28,
2010 2010
UNAUDITED
----------- ------------
ASSETS
CURRENT ASSETS:
Cash .......................................................... $ 1,054,416 $ 813,383
Accounts receivable less allowance for doubtful accounts of
$31,873 and $30,823 for May 31, 2010 and February 28, 2010
respectively ................................................. 483,500 654,960
Inventory ..................................................... 627,215 634,584
Prepaid expenses .............................................. 93,239 67,611
Deferred Tax Asset ............................................ 308,250 308,250
----------- -----------
Total Current Assets ............................................ 2,566,620 2,478,788
----------- -----------
PROPERTY & EQUIPMENT, less accumulated depreciation of $1,270,742
and $1,256,617 at May 31, 2010 and February 28, 2010 respectively 218,369 221,043
OTHER ASSETS:
Patents, net of accumulated amortization of $98,155 and
$96,745 at May 31, 2010 and February 28, 2010, respectively 32,938 34,958
Security deposit .............................................. 28,156 28,156
Deferred Tax Asset ............................................ 163,033 224,734
----------- -----------
Total Other Assets .............................................. 224,127 287,848
----------- -----------
TOTAL ASSETS .................................................... $ 3,009,116 $ 2,987,679
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Note payable - current portion ................................ $ 1,824 $ 29,483
Notes payable to related parties - current portion ............ 137,298 36,744
Deferred capital gain - current portion ....................... 22,481 22,481
Accounts payable .............................................. 73,833 80,717
Accrued expenses .............................................. 114,255 118,740
Accrued interest .............................................. 27,758 54,183
Accrued preferred stock dividends ............................. 68,000 68,000
Accrued payroll and related taxes ............................. 28,020 12,655
Warranty liability ............................................ 70,363 72,188
----------- -----------
Total Current Liabilities ....................................... 543,832 495,191
----------- -----------
OTHER LIABILITIES
Note payable - less current portion ........................... 5,011 5,480
Notes payable to related parties - less current portion ....... 508,724 618,259
Deferred capital gain-less current portion .................... 174,235 179,855
----------- -----------
Total Other Liabilities ......................................... 687,970 803,594
----------- -----------
Total Liabilities ............................................... 1,231,802 1,298,785
----------- -----------
STOCKHOLDERS' EQUITY
Preferred Stock, 8% cumulative, liquidation value $100,000,
$0.01 par value, 2,000,000 shares authorized, 10,000 shares
issued and outstanding at May 31, 2010 and February 28, 2010,
respectively ................................................. 100 100
Common Stock, $0.01 par value, 50,000,000 shares authorized,
35,584,286 issued and outstanding at May 31, 2010 and
February 28, 2010, respectively .............................. 355,843 355,843
Additional paid-in Capital .................................... 3,008,162 3,008,162
Accumulated deficit ........................................... (1,444,791) (1,533,211)
----------- -----------
1,919,314 1,830,894
Less: Treasury Stock, 2,275,000 shares at cost at May 31, 2010
and February 28, 2010 ........................................ (142,000) (142,000)
----------- -----------
Total Stockholders' Equity .................................... 1,777,314 1,688,894
----------- -----------
Total Liabilities and Stockholders' Equity ...................... $ 3,009,116 $ 2,987,679
=========== ===========
The accompanying notes are an integral part of these Financial Statements
Page 3
REPRO-MED SYSTEMS, INC.
STATEMENTS OF OPERATIONS UNAUDITED
FOR THE THREE MONTHS ENDED
MAY 31,
2010 2009
------------ ------------
NET SALES ................................... $ 982,942 $ 813,129
------------ ------------
COST AND EXPENSES
Cost of goods sold ........................ 363,388 312,535
Selling, general and administrative ....... 460,774 376,689
Research and development .................. 7,206 7,129
Depreciation and amortization ............. 15,535 17,954
------------ ------------
TOTAL COSTS AND EXPENSES .................... 846,903 714,307
------------ ------------
NET OPERATING INCOME ........................ 136,039 98,822
------------ ------------
OTHER INCOME/(EXPENSES)
Gain (Loss) Currency Exchange ............. (3,258) (801)
Interest Expense .......................... (11,013) (12,247)
Forgiveness of Interest ................... 28,425 -
Interest and Other Income ................. 351 238
------------ ------------
TOTAL OTHER INCOME/(EXPENSE) ................ 14,505 (12,810)
------------ ------------
NET INCOME BEFORE TAXES ................... 150,544 86,012
Provision for Income Taxes .............. (62,124) (21,959)
------------ ------------
------------ ------------
NET INCOME ................................ $ 88,420 $ 64,053
PREFERRED STOCK DIVIDENDS ................... $ - $ -
------------ ------------
NET INCOME AVAILABLE TO COMMON STOCKHOLDERS . $ 88,420 $ 64,053
------------ ------------
NET INCOME PER COMMON SHARE AVAILABLE TO
COMMON STOCKHOLDERS ...................... 0.00 0.00
============ ============
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING 35,584,286 34,829,286
The accompanying notes are an integral part of these Financial Statements
Page 4
REPRO-MED SYSTEMS, INC
STATEMENTS OF CASH FLOWS UNAUDITED
FOR THE THREE MONTHS ENDED
--------------------------
MAY 31, MAY 31,
2010 2009
----------- -----------
CASH FLOWS FROM OPERATING ACTIVITIES
Net Income ....................................... $ 88,420 $ 64,053
Adjustments to reconcile net income to net cash
from operating activities:
Depreciation and amortization .................. 15,535 17,954
Deferred capital gain - building lease ......... (5,620) (5,620)
Changes in operating assets and liabilities:
(Increase) decrease in accounts receivable ..... 171,460 134,172
(Increase) decrease in inventory ............... 7,369 (19,101)
(Increase) decrease in prepaid expense ......... (25,628) 11,558
(Increase) decrease in deferred tax asset ...... 61,701 18,245
Increase (decrease) in accounts payable ........ (6,884) (84,414)
Increase (decrease) in accrued payroll and
related taxes ................................. 15,365 9,017
Increase (decrease) in accrued expense ......... (4,485) (44,315)
Increase (decrease) in warranty liability ...... (1,825) (6,205)
Increase (decrease) in accrued interest ........ (26,425) 2,000
----------- -----------
NET CASH PROVIDED BY OPERATING ACTIVITIES .......... 288,983 97,344
----------- -----------
CASH FLOWS FROM INVESTING ACTIVITIES
Payments for property and equipment .............. (11,451) (25,696)
Reduction in patents ............................. 610 -
----------- -----------
NET CASH USED IN INVESTING ACTIVITIES .............. (10,841) (25,696)
----------- -----------
CASH FLOWS FROM FINANCING ACTIVITIES
Payments to note payable to related parties ...... (8,981) (8,459)
Payments on notes payable ........................ (28,128) (1,149)
----------- -----------
NET CASH USED IN FINANCING ACTIVITIES .............. (37,109) (9,608)
----------- -----------
NET INCREASE IN CASH AND CASH EQUIVALENTS .......... 241,033 62,040
CASH BEGINNING OF YEAR ............................. 813,383 519,209
----------- -----------
CASH END OF YEAR ................................... $ 1,054,416 $ 581,249
=========== ===========
Supplemental Information
Cash paid during the year for:
Interest ......................................... $ 9,013 $ 10,247
The accompanying notes are an integral part of these Financial Statements
Page 5
REPRO-MED SYSTEMS, INC.
NOTES TO THE UNAUDITED FINANCIAL STATEMENTS
NOTE 1 NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
THE NATURE OF OPERATIONS
Repro-Med Systems, Inc. (the "Company") was incorporated on March 24, 1980 under
the laws of the State of New York. The Company was organized to engage in
research, development, laboratory and clinical testing, production and marketing
of medical devices used in the treatment of the human condition.
BASIS OF PRESENTATION
The accompanying unaudited financial statements as of May 31, 2010 have been
prepared in accordance with generally accepted accounting principles in
accordance with instructions to regulation S-X. Accordingly, they do not include
all of the information and disclosures required by accounting principles
generally accepted in the United States of America for complete financial
presentation.
In the opinion of the Company's management, the financial statements contain all
adjustments (consisting of normal recurring accruals) necessary to present
fairly the Company's financial position as of May 31, 2010 and the results of
operations and cash flow for the interim periods ended May 31, 2010 and 2009.
The results of operations for the three months ended May 31, 2010 and 2009 are
not necessarily indicative of the results to be expected for the full year.
These interim financial statements should be read in conjunction with the
financial statements and notes thereto of the Company and management's
discussion and analysis of financial condition and results of operations
included in the Company's Annual Report for the year ended February 28, 2010, as
filed with the Securities and Exchange Commission on Form 10-K.
CASH AND CASH EQUIVALENTS
For purposes of the statement of cash flows, the Company considers all
short-term investments with an original maturity of three months or less to be
cash equivalents.
INVENTORY
Inventories consist of purchased parts and assembled units and are stated at the
lower of average cost or market value. Average cost is calculated using a
rolling average based upon new purchases and quantities.
PATENTS
Costs incurred in obtaining patents have been capitalized and are being
amortized over seventeen years.
Page 6
INCOME TAXES
Deferred income taxes are provided using the liability method whereby deferred
tax assets are recognized for deductible temporary differences and operating
loss and tax credit carry forwards and deferred tax liabilities are recognized
for taxable temporary differences. Temporary differences are the differences
between the reported amounts of assets and liabilities and their tax bases.
Deferred tax assets are reduced by a valuation allowance when, in the opinion of
management, it is more likely than not that some portion or all of the deferred
tax assets will not be realized. Deferred tax assets and liabilities are
adjusted for the effects of the changes in tax laws and rates of the date of
enactment.
The Company recorded deferred tax assets in the amount of $471,283 and $562,520
for the periods ended May 31, 2010 and February 28, 2010, respectively. The
deferred tax assets have been offset by valuation allowances of $0 at the
periods ended May 31, 2010 and February 28, 2010, respectively. Management based
the valuation allowance calculations on the prospect of future profitability.
The company recorded income tax expense in the amount of $62,124 and $21,959 for
the three months ended May 31,2010 and 2009, respectively.
When tax returns are filed, it is highly certain that some positions taken would
be sustained upon examination by the taxing authorities, while others are
subject to uncertainty about the merits of the position taken or the amount of
the position that would be ultimately sustained. The benefit of a tax position
is recognized in the financial statements in the period during which, based on
all available evidence, management believes it is more likely than not that the
position will be sustained upon examination, including the resolution of appeals
or litigation processes, if any. Tax positions taken are not offset or
aggregated with other positions. Tax positions that meet the
more-likely-than-not recognition threshold are measured as the largest amount of
tax benefit that is more than 50% likely of being realized upon settlement with
the applicable taxing authority. The portion of the benefits associated with tax
positions taken that exceeds the amount measured as described above is reflected
as a liability for unrecognized tax benefits in the balance sheet along with any
associated interest and penalties that would be payable to the taxing
authorities upon examination. The Company does not have any unrecognized tax
benefits at May 31, 2010 and February 28, 2010 or during the periods then ended.
No unrecognized tax benefits are expected to arise within the next twelve
months.
PROPERTY AND EQUIPMENT AND DEPRECIATION
Property and equipment is stated at cost and is depreciated using the
straight-line method over the estimated useful lives of the respective assets.
Routine maintenance, repairs and replacement costs are expensed as incurred and
improvements that extend the useful life of the assets are capitalized. When
property and equipment are sold or otherwise disposed of, the cost and related
accumulated depreciation are eliminated from the accounts and any resulting gain
or loss is recognized in operations.
Page 7
NET INCOME PER COMMON SHARE
Basic earnings per share is computed on the weighted average of common shares
outstanding during each year. Diluted earnings per share includes an increase to
income for the preferred stock dividends and an increase in the weighted average
shares by the common shares issuable upon exercise of employee and director
stock options (Note 6) and convertible preferred stock shares as follows:
INCOME SHARES PER-SHARE
THREE-MONTHS ENDED May 31, 2010 (NUMERATOR) (DENOMINATOR) AMOUNT
------------------------------------ ----------- ------------- ---------
Basic Net Income Per Common Share
Income available ................. $ 88,420 35,584,286 $ -
Preferred stock dividends ........ - - -
Options includable ............... - 2,795,686 -
Convertible preferred stock ...... - 185,185 -
---------- ---------- ---------
Diluted Net Income Per Common Share $ 88,420 38,565,157 $ -
---------- ---------- ---------
USE OF ESTIMATES IN THE FINANCIAL STATEMENTS
The preparation of financial statements in conformity with U.S. generally
accepted accounting principles ("GAAP") requires management to make estimates
and assumptions that affect the amounts reported in the consolidated financial
statements and accompanying notes. Actual results could differ from those
estimates. Important estimates include but are not limited to, asset lives,
valuation allowances, inventory and accruals.
ALLOWANCE FOR DOUBTFUL ACCOUNTS
In determining the allowance for doubtful accounts the Company analyzes the
aging of accounts receivable, historical bad debts, customer creditworthiness
and current economic trends.
REVENUE RECOGNITION
Sales of manufactured products are recorded when shipment occurs and title
passes to a customer, persuasive evidence of an arrangement exists with the
customer, the sales price is fixed and determinable and the collect ability of
the sales price is reasonably assured. The Company's revenue stream is derived
from the sale of an assembled product. Other service revenues are recorded as
the service is performed. Shipping and handling costs are generally billed to
customers and are not included in sales. The Company does not accept return of
goods shipped unless it is a Company error. The Company does not grant sales
allowances other than an occasional 1% discount for payments made within 30
days. The only credits provided to customers are for defective merchandise and
sales incentives are occasional advertising in customer catalogues.
STOCK-BASED COMPENSATION
The Company accounts for employee stock based compensation and stock issued for
services using the fair value method. The measurement date of shares issued for
services is the date when the counterparty's performance is complete.
The Company accounts for stock issued for services using the fair value method.
The measurement date of shares issued for service is the date when the
counterparty's performance is complete.
Page 8
SUBSEQUENT EVENTS
-----------------
The Company has evaluated subsequent events through July 15, 2010, the date on
which the financial statements were issued.
RECLASSIFICATIONS
-----------------
Certain amounts in the February 28, 2010 and May 31, 2010, financial statements
have been reclassified to conform to the presentation used in the May 31, 2010,
financial statements.
NOTE 2 INVENTORY
Inventory is valued at the lower of average cost or market and consists of the
following at:
May 31, 2010 February 28, 2010
------------ -----------------
Raw materials ........ $430,463 $451,444
Work in progress ..... 13,353 18,572
Finished goods ....... 183,399 164,568
-------- --------
$627,215 $634,584
-------- --------
NOTE 3 PROPERTY AND EQUIPMENT
Property and equipment consists of the following at:
May 31, February 28, Estimated
2010 2010 Useful Lives
------------ ------------ ------------
Furniture and office equipment .... $ 496,227 $ 489,679 5 years
Manufacturing equipment and
tooling .......................... 992,884 987,981 7-12 years
------------ ------------
1,489,111 1,477,660
Less: accumulated amortization
and depreciation ................. 1,270,742 1,256,617
------------ ------------
Property and Equipment, Net ....... $ 218,369 $ 221,043
------------ ------------
Depreciation expense was $14,125 and $16,704 for the three months ended May 31,
2010 and May 31, 2009, respectively.
Page 9
NOTE 4 RELATED PARTY TRANSACTIONS
NOTES PAYABLE TO RELATED PARTIES
The President of the Company has advanced the Company $100,000 under a demand
loan which bears interest at the rate of 8% (see Note 5 - Long-term debt). This
note has been approved by the Board of Directors. Subsequent to the quarter end
the Company repaid the $100,000 debt to the president, including half of the
associated accrued interest. The other half was forgiven by the president and
recorded as income as an interest rate adjustment for the steady decline in
rates over the past few years.
LEASED AIRCRAFT
The Company leases an aircraft from a Company controlled by the President. The
lease payments aggregated were $5,375 for the three months ended May 31, 2010
and May 31, 2009. The original lease agreement has expired and the Company is
currently on a month-to-month basis for rental payments.
NOTE 5 LONG-TERM DEBT
Long-term debt consists of the following at:
May 31, February 28,
2010 2010
-------- ------------
The President of the Company has loaned the
Company, $100,000 at 8% interest. The loan was
fully paid off in June 2010 ...................... $100,000 $100,000
In January 2008, the Company entered into an
installment loan arrangement to purchase a
vehicle. The loan bears interest at the rate of
6.735% and was payable in 84 monthly installments
of $552. The loan was secured by the vehicle. The
Company paid the loan in full in April 2010 ...... - 27,693
In February 2009, the Company was granted a loan
From a director of the Company in the amount of
$672,663, payable in monthly installments of
$5,754 at a rate of 6.00% interest. The Company
issued the Director 755,000 shares of common stock
at the price of $0.11 per share in June 2009 to
further reduce the debt .......................... 546,022 555,003
In October 2009, the Company entered into an
equipment loan with Key Equipment Finance. The
loan bears interest at a rate of 7.50% and is
payable in 48 monthly installments of $189 ....... 6,835 7,270
-------- --------
652,857 689,966
Less current portion ............................. 139,122 66,227
-------- --------
Long-term portion ................................ $513,735 $623,739
-------- --------
Page 10
Aggregate maturities as required on long-term debt at May 31, 2010 are:
2011 ........ $ 139,122
2012 ........ 41,563
2013 ........ 44,157
2014 ........ 45,564
2015 ........ 47,387
Thereafter .. 335,064
---------
$ 652,857
---------
NOTE 6 STOCK OPTIONS
On June 6, 2007, the Board of Directors approved the issuance of 4,360,000 stock
options to key employees and directors of the Company. The options have an
expiration date of 5 years from the date of grant and an exercise price of $0.06
per share. Of the 4,360,000 stock options granted, 1,690,000 vested immediately
and 890,000 stock options vest each succeeding year for three consecutive years.
The fair value of each option grant was calculated to be $.0272 on the date of
grant using the Black-Schole Option pricing model with the following assumption
used for grants during the applicable period.
Risk free rate .. 2.4%
Volatility ...... 96.16%
Expected life ... 1.5 years
Dividend yield .. 0%
During the three-months ended May 31, 2010, no option expense was recorded
because the Company records the expense semi-annually from the grant date. As of
May 31, 2010, there was approximately $13,000 of total unrecognized compensation
cost related to unvested options. That cost is expected to be recognized within
the next year.
The following table summarizes the Company's stock options:
WEIGHTED-AVERAGE
WEIGHTED-AVERAGE REMAINING
OPTIONS SHARES EXERCISE PRICE CONTRACTUAL TERM
-------------------------------- --------- ---------------- ----------------
Outstanding at February 28, 2010 3,400,000 $ 0.06
Granted ........................ -
Exercised ...................... -
Forfeited or expired ........... -
--------- ---------------- ----------------
Outstanding at May 31, 2010 .... 3,400,000 $ 0.06 2.0
--------- ---------------- ----------------
Exercisable at May 31, 2010 .... 2,630,000 $ 0.06 2.0
--------- ---------------- ----------------
Page 11
A summary of the status of the Entity's nonvested shares as of May 31, 2010, and
changes during the three-months ended May 31, 2010, is presented below:
WEIGHTED-AVERAGE
NONVESTED SHARES SHARES GRANT-DATE FAIR VALUE
-------------------------------- --------- ---------------------
Nonvested at February 28, 2010 . 770,000 $ 0.06
Granted ........................ - -
Vested ......................... - -
Forfeited ...................... - -
--------- ---------------------
Nonvested at May 31, 2010 ...... 770,000 $ 0.06
--------- ---------------------
NOTE 7 SALE-LEASEBACK TRANSACTION - OPERATING LEASE
On February 25, 1999, the Company entered into a sale-leaseback arrangement
whereby the Company sold its land and building at 24 Carpenter Road in Chester,
New York and leased it back for a period of 20 years. The leaseback is accounted
for as an operating lease. The gain of $449,617 realized in this transaction has
been deferred and is amortized to income in proportion to rental expense over
the term of the related lease.
At May 31, 2010 minimum future rental payments are:
Year Minimum Rental Payments
---- -----------------------
2011 ........ $ 132,504
2012 ........ 132,504
2013 ........ 132,504
2014 ........ 132,504
2015 ........ 132,504
thereafter .. 496,890
----------
$1,159,410
==========
Rent expense aggregated $33,126 for the three months ended May 31, 2010 and
$30,000 for the three months ended May 31, 2009.
NOTE 8 COMMITMENTS AND CONTINGENCIES
Contingencies
The Company is contingently liable to rework and fulfill a contractual
commitment of its product for a customer order. The total additional material
and labor cost to complete this work approximates $10,000. The provision has
been recorded in the Company's financial statements.
Page 12
PART I ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
--------------------------------------------------------------------------------
This Quarterly Report on Form 10-Q contains certain "forward-looking" statements
(as such term is defined in the Private Securities Litigation Reform Act of
1995) and information relating to us that are based on the beliefs of the
management, as well as assumptions made by and information currently available.
Our actual results may vary materially from the forward-looking statements made
in this report due to important factors such as uncertainties associated with
future operating results, unpredictability related to Food and Drug
Administration regulations, introduction of competitive products, limited
liquidity, reimbursement related risks, government regulation of the home health
care industry, success of the research and development effort, market acceptance
of Freedom60(R), availability of sufficient capital to continue operations and
dependence on key personnel. When used in this report, the words "estimate,"
"project," "believe," "anticipate," "intend," "expect" and similar expressions
are intended to identify forward-looking statements. Such statements reflect
current views with respect to future events based on currently available
information and are subject to risks and uncertainties that could cause actual
results to differ materially from those contemplated in such forward-looking
statements. Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. These
statements involve risks and uncertainties with respect to the ability to raise
capital to develop and market new products, acceptance in the market place of
new and existing products, ability to penetrate new markets, our success in
enforcing and obtaining patents, obtaining required Government approvals and
attracting and maintaining key personnel that could cause the actual results to
differ materially. Repro-Med does not undertake any obligation to release
publicly any revision to these forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events.
THREE MONTHS ENDED MAY 31, 2010 VS. 2009
----------------------------------------
Net Operating Profit increased 37.7% from $98,822 to $136,039 for the quarter
ending May 31, 2010 as compared to the same period last year. Net income
increased 38.0% from $64,053 to $88,420, the difference primarily due to higher
sales and gross profit offset by a higher provision for Income Taxes in the
current year for this three month period as compared to last year.
Overall Sales increased 21% from $813,129 to $982,942 quarter over quarter lead
by the increase in sales of the Freedom60 and related accessories which showed a
25% increase going from $609,166 to $760,967 quarter over quarter. RES-Q-VAC
increased 9% from $142,091 to $154,705 with export sales advancing while
domestic sales retreating somewhat due to lower sales in the Emergency Medical
market.
Interest expense decreased by 10% to $11,013 from $12,247 for the comparative
quarter in 2009 as a result of lower interest payments on long term debt and the
elimination of interest on filing New York State tax returns.
Page 13
Selling, General and Administrative increased from $376,689 for May 31, 2009 to
$460,773 for May 31, 2010 or 22.3% resulting from an increases in marketing
expenses including trade shows, advertising, promotions and the short term
hiring of a sales associate to promote the Freedom60 in Europe; salaries,
benefits, and the design of our new subcutaneous infusion sets which are still
in development. Overhead expenses are expected to continue to increase as we add
additional staff including two domestic sales associates and a mechanical
engineer which will occur during our second quarter.
Cost of Goods sold increased $50,853 or 16.3%, from $312,535 to $363,388 due to
an increase in sales and production payroll related benefits.
Research and Development expenses increased $77 or 1.1% from $7,129 in 2009 to
$7,206 in 2010.
Depreciation and amortization expenses decreased by $2,419 from $17,954 in 2009
to $15,535 in 2010 as a result of assets reaching their fully depreciated
values.
LIQUIDITY AND CAPITAL RESOURCES
-------------------------------
Net Cash provided from Operations was $288,983 for the three-months ended May
31, 2010 as compared with net cash provided by operations of $97,344 for the
three months ended May 31, 2009. This is due primarily to an increase in our
receivables collections and a decrease in our tax deferred asset.
In January of 2008 we were notified by The Trade Adjustment Assistance Program
of the Trade Department that our application for a grant of $150,000 was
approved for use to assist us with marketing, ISO and regulatory affairs, and
new product development. The grant matches the company on a 50-50 basis thereby
reducing our costs for these new programs by half. The Trade Adjustment
Assistance Program is a United States Government program to help manufacturing
firms adjust to foreign business competition. The program is authorized by the
Trade Act of 1974 and is administered by the U. S. Department of Commerce. The
program operates through Trade Adjustment Assistance Centers located across the
United States. The New York State area is served by the New York State Trade
Adjustment Assistance Center (NYS TAAC). The NYS TAAC is affiliated with the
Research Foundation of the State University of New York at Binghamton. Minimal
funds were used in the previous year. However, we have initiated these programs
now and intend to complete them by the end of our next fiscal year. At the end
of May 31, 2010 there is approximately $55,000 remaining in payment assistance
from this grant.
We believe the Freedom60 continues to find a solid following in the subcutaneous
immune globulin market and with the introduction of a new 20% IgG drug released
early this year, this market is expected to continue to increase both
domestically and internationally. We continue to experience an increase in sales
and cash during three months ended May 31, 2010 and with these increases and the
capital we currently have, we will continue to meet or exceed the company's
financial needs for the next twelve months.
Page 14
FREEDOM60
---------
The Freedom60 Syringe Infusion Pump is designed for ambulatory medication
infusions. Ambulatory infusion pumps are most prevalent in the home care market.
Other potential applications for the Freedom60 are pain control, the infusion of
specialized drugs such as IgG, and chemotherapy. The home infusion therapy
market is comprised of approximately 4,500 sites of service, including local and
national organizations, hospital-affiliated organizations, and national home
infusion organizations, and produces approximately $4.5 Billion in revenue
annually (Ref: www.nhianet.org). With insurance reimbursement in a severe
decline, there is a tremendous need for a low-cost, effective alternative to
electronic and expensive disposable IV administration devices for the home care.
The Freedom60 provides a high-quality delivery to the patient at costs similar
to gravity and is targeted for the home health care industry, patient emergency
transportation, and for any time a low-cost infusion is required.
For the home care patient, Freedom60 is an easy-to-use lightweight mechanical
pump using a 60cc syringe, completely portable, cost effective and maintenance
free, with no batteries to replace and no cumbersome IV pole. For the infusion
professional, Freedom60 delivers precise infusion rates and uniform flow
profiles providing consistent transfer of medication. A Form 510(k) Pre-market
Notification for initial design of the Freedom60 as a Class II device was
approved by the FDA in August 1994.
The Company also designed and manufactured the Freedom60-FM, an enhanced version
of the Freedom60 which contains an electronic flow monitor system that provides
occlusion and end of infusion alarm. This product is directed at nursing homes,
hospitals and pediatric ambulatory applications where alarms are generally
required for nursing acceptance. Nurses also appreciate being able to visualize
the drug volume by reading the scale on the syringe.
We have expanded the use of the Freedom60 to cover most antibiotics including
the widely used and somewhat difficult to administer vancomycin. We have also
found a following for Freedom60 for use in treating thalissemia with the drug
desferal. In Europe we found success in using the Freedom60 for pain control,
specifically post-operative epidural pain administration. Our European market
also uses the Freedom60 for chemotherapy and subcutaneous immune globulin.
The Freedom60 use for Primary Immune Deficiency by injecting immune globulin
(IgG) under the skin as a subcutaneous administration has seen increased usage
especially in Europe over the past year and is expected to continue with the
introduction a new 20% solution of IgG at the beginning of this year. We have
been told by meeting users at trade shows that his method has provided them with
vastly improved quality of life with much fewer unpleasant side effects over the
traditional intravenous route. The Freedom60 is an ideal system for this
administration since the patient is able to self-medicate at home, the pump is
easily configured for this application, and the Freedom60 is the lowest cost
infusion system available in a heavily cost constrained market. We have begun to
advertise one of the main benefits of the Freedom60 for use with IgG which is
that it operates in "dynamic equilibrium", that is, the pump finds and maintains
a balance between the pressure at the patient's sites and the rate that the pump
infuses. This balance is created by a safe, limited and controlled pressure
which adjusts the flow rate automatically to the patient's needs providing
greater convenience and lower cost for these patients.
Page 15
Repro-Med Systems' objective is to build a product franchise with Freedom60 and
the sale of patented disposable tubing sets. Freedom60 uses rate-controlled
tubing with standard slide clamp and luer-lock connector on the patient end. Our
patented syringe disc connector ensures that only the Company's Freedom60 tubing
sets will function with the pump. Non-conforming tubing sets, without the
patented disc connector, are ejected from the pump to prevent the danger of an
overdose or runaway pump from injuring the patient.
THE MARKET FOR INFUSION PUMPS & DISPOSABLES
-------------------------------------------
The ambulatory infusion market has been rapidly changing due to reimbursement
issues. Insurance reimbursement has drastically reduced the market share of
high-end electronic type delivery systems as well as high-cost disposable
non-electric devices, providing an opportunity for the Freedom60. We believe
market pressures have moved to consider alternatives to expensive electronic
systems especially for new subcutaneous administrations which usually cannot be
done with gravity. For cost concerns some patients have been trained to
administer intravenous drugs through IV push where the drug is pushed into the
vein directly from a syringe. This is a low-cost option but has been associated
with complications and considered by many to be a high-risk procedure. Thus, the
overall trend has been towards syringe pumps due to the low-cost of disposables.
In order to receive more favorable Medicare reimbursement for our Freedom60
Syringe Infusion System, we had submitted a formal request for a HCPCS coding
verification with the Statistical Analysis Durable Medical Equipment Regional
Carrier (SADMERC). On May 21, 2007 we received a notification from CMS (Centers
for Medicare & Medicaid Services) that the Freedom60 had been re-reviewed for
Medicare billing. It was the determination that the Medicare HCPCS code(s) to
bill the four Durable Medical Regional Carries (DMERCs) should be: E0779
Ambulatory infusion pump, mechanical, reusable, for infusion 8 hours or greater.
The new coding provides for a substantial increase in reimbursement for
providers using an infusion pump for authorized users under Part B of Medicare.
Current approved uses under Medicare include among others, subcutaneous immune
globulin, antivirals, antifungals, and chemotherapeutics.
COMPETITION FOR THE FREEDOM60
-----------------------------
Competition for the Freedom60 for IgG is currently limited to electrically
powered infusion devices which are more costly and can create high pressures
during delivery which can cause complications for the administration of IgG.
However, there can be no assurance that other companies with greater resources
will not enter the market with competitive products which will have an adverse
effect on our sales.
There is the potential for new drugs to enter the market, such as using
Hyaluronidase which can facilitate absorption of IgG, making multiple site
infusions unnecessary and changing the market conditions for devices such as the
Freedom60. We believe the Freedom60 is ideal for all these new drug combinations
but there can be no assurance that these newer drugs will have the same needs
and requirements as the current drugs being used.
There can be no assurance that Medicare will continue to provide reimbursement
for the Freedom60 or they may allow reimbursement for other infusion pumps that
are currently in the market or new ones that may enter shortly, which could
adversely affect our sales into this market.
Page 16
RES-Q-VAC
---------
The RES-Q-VAC Emergency Airway Suction System is a lightweight, portable,
hand-operated suction device that removes fluids from a patient's airway by
attaching the RES-Q-VAC pump to various proprietary sterile and non-sterile
single-use catheters sized for adult and pediatric suctioning. The one-hand
operation makes it extremely effective and the product is generally found in
emergency vehicles, hospitals and wherever portable aspiration is a necessity,
including backup support for powered suction systems. The disposable features of
the RES-Q-VAC reduce the risk of contaminating the health professional from HIV
or SARS when suctioning a patient or during post treatment cleanup. All of the
parts that connect to the pump are disposable.
We recently introduced a new version of the RES-Q-VAC with the addition of a
portable LED white light, which attaches to the canister assembly. The light is
fully malleable and can direct light during operations when lighting is poor or
at night. We are marketing a hospital version our latest version of the
RES-Q-VAC which contains all of our latest enhancements.
A critical component and advantage of the RES-Q-VAC ULTRA is the Full Stop
Protection, (FSP) a recently patented filtering system that both prevents
leakage and over-flow of the aspirated fluids, even at full capacity, and traps
all air and fluid borne pathogens and potentially infectious materials within
the sealable container. This protects users from potential exposure to disease
and contamination. The Full Stop Protection meets the requirement of the
Occupational Safety and Health Administration. The Company has received a letter
from OSHA confirming that the RES-Q-VAC with the Full Stop Protection falls
under the engineering controls of the Blood Borne Pathogen regulation and that
the product's use would fulfill the regulatory requirements.
We have also added new connectors to our pediatric catheters, which allow them
to connect directly to the adult containers with FSP. These connectors allow
pediatric suctioning with the benefit of the Full Stop Protection device as well
as with sterile catheters. Many infants are born with contagious diseases and
the new system eliminates this concern among paramedics during an emergency
delivery.
A critical advantage of our RES-Q-VAC airway suction system is versatility. With
the addition of Full Stop Protection, we created specific custom RES-Q-VAC kits
for various vertical markets:
Emergency Medicine - we make several special kits for emergency use, which
contain all the catheters necessary to treat adults as well as infants or
children. These first responder kits are generally non-sterile. We also have
special attachments available for the advanced paramedic to treat patients who
are intubated.
Respiratory - in-home care, long term care, situations requiring frequent
suctioning such as cystic fibrosis patients, patients with swallowing disorders,
elderly, patients on ventilators and with tracheostomies all benefit from the
portability, cost and performance of the RES-Q-VAC. In hospitals, the RES-Q-VAC
provides emergency back up due to power loss or breakdown of the wall suction
system.
Page 17
Hospital Use - for crash carts, the emergency room, patients in isolation,
moving patients throughout the hospital (e.g., from ICU to Radiology) and backup
for respiratory, RES-Q-VAC is available sterile with Full Stop Protection for
the ultimate in performance and to meet all the OSHA regulations and CDC
guidelines for use in treating patients in isolation, and in any location.
Hospitals are required under the EMTALA regulations to provide emergency
treatments to patients anywhere in the primary facility and up to 250 yards
away. The RES-Q-VAC insures full compliance with these regulations and helps
minimize unfavorable outcomes and potential lawsuits there from. We provide
special hospital kits, which are fully stocked to meet all hospital applications
for both adult and pediatric.
Nursing Homes, Hospice, Sub-acute - we provide special configurations for dining
areas, portable suctioning for outside events and travel. Chronic suction can be
accommodated with RES-Q-VAC, which can be left by the bedside for rapid use
during critical times.
Dental Applications - we offer a version of the RES-Q-VAC, called DENTAL-EVAC
which addresses the needs of oral surgeons for emergency back up suction during
a procedure. DENTAL-EVAC is supplied with the dental suction attachments such as
saliva ejector and high volume evacuator.
Military Applications - due to its lightweight, portability, and rapid
deployment, we believe that the RES-Q-VAC is ideal for any military situation.
In addition, rapid, aggressive, and repeated suctioning best treats exposure to
chemical weapons of mass destruction such as Sarin. We believe that the
RES-Q-VAC's compact size, powerful pump, and full protection of the user from
any contamination, gives us a competitive edge in this market.
RES-Q-VAC is sold domestically and internationally by emergency medical device
distributors. These distributors generally sell to the end user and advertise
these products in relevant publications and in their catalogs.
COMPETITION FOR THE RES-Q-VAC
-----------------------------
We believe that the RES-Q-VAC(R) is currently the performance leader for manual,
portable suction instruments. In the emergency market, the primary competition
is the V-Vac from Laerdal. The V-Vac is more difficult to use, cannot suction
infants, and cannot be used while wearing heavy gloves such as in chemical
warfare or in the extreme cold. Laerdal had more resources than Repro-Med
Systems and had begun marketing the V-Vac before RES-Q-VAC(R) entered the
market. Another competitor is Ambu, with the Res-Cue brand pump, a product
similar to our design, made in China. We believe that the product is not as well
made or as versatile, and may not be purchased by the military segment of the
market due to lines of supply concerns. We believe we will continue to maintain
and build market share and gain a significant portion of the electric suction
pump market. We believe that the addition of Full Stop Protection(R)
substantially separates the RES-Q-VAC(R) from competitive units, which tend to
leak fluid when becoming full or could pass airborne pathogens during use. There
is a heightened concern from health care professionals concerning exposure to
disease and we believe the RES-Q-VAC(R) provides improved protection for these
users.
Page 18
TRADE SHOWS
-----------
We continue to support both of our main product lines at both National and
International tradeshows. In March we exhibited at the EMS Today show in
Baltimore, MD. There we promoted RES-Q-VAC to the EMS market, demonstrating its
power hands-on against electric suction. We also took part in the Annual Meeting
and Company Banquet of one of our major RES-Q-VAC distributors to further
support their efforts in the promotion, education and sale of this device. In
both April and May we promoted Freedom60 for the infusion of IgG and
antibiotics. In April we exhibited at the NHIA: National Home Infusion
Association's Annual Conference and Exposition in Dallas, TX. NHIA represents
the interests of organizations that provide alternate-site infusion and
specialized pharmacy products and services to the home care market. In May, we
traveled to Ft. Lauderdale, FL for the INS: Infusion Nurses Society Annual
Meeting and Industrial Exhibition; the largest meeting for infusion nursing
professionals in the United States. To support our products internationally, we
have reserved our space for the Medica 2010 trade show held each November in
Dusseldorf, Germany, as well as, ESID which will be held in Istanbul Turkey.
These two trade shows are among the largest meetings of medical professionals
and distributors in the world.
PART I ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
--------------------------------------------------------------------------------
Not Applicable
PART I ITEM 4. CONTROLS AND PROCEDURES
--------------------------------------
The Company's management, including the Company's chief executive officer/
Principal financial officer, has evaluated the effectiveness of the company's
"disclosure controls and procedures "as such is defined in Rule 13a-15(e)
promulgated under the Securities Exchange Act of 1934, as amended (the "Exchange
Act"). Based upon his evaluation, the chief executive officer / Principal
financial officer concluded that, as of the end of the period covered by this
report, the Company's disclosure controls and procedures were effective for the
purpose of ensuring that the information required to be disclosed in the reports
that the Company files or submits under the Exchange Act with the Securities and
Exchange Commission (the "SEC") (1) is recorded, processed, summarized and
reported within the time periods specified in the SEC's rules and forms and (2)
is accumulated and communicated to the Company's management, including its chief
executives and chief financial officers, as appropriate to allow timely
decisions regarding required disclosure.
There have been no changes in the Company's internal control over financial
reporting during the quarter ended May 31, 2010 that have materially affected,
or are reasonably likely to materially affect, the Company's internal control
over financial reporting.
Page 19
PART II - OTHER INFORMATION
---------------------------
ITEM 1. LEGAL PROCEEDINGS
-------------------------
We are, from time to time, subject to claims and suits arising in the ordinary
course of business, including claims for damages for personal injuries, breach
of management contracts and employment related claims.
ITEM 1A. RISK FACTORS
---------------------
Not required for Smaller reporting companies
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
--------------------------------------------------
None
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
----------------------------------------
None
ITEM 4. REMOVED AND RESERVED
----------------------------
ITEM 5. OTHER INFORMATION
-------------------------
None
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
-----------------------------------------
(a) EXHIBITS
31.1 Certification of Chief Executive Officer and Principal Financial
Officer Pursuant to Section 302 of Sarbanes-Oxley Act 2002
32.1 Certification of Chief Executive Officer and Principal Financial
Officer Pursuant to Section 906 of the Sarbanes-Oxley Act 2002
Page 20
SIGNATURES
----------
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.
REPRO-MED SYSTEMS, INC.
/s/ Andrew I. Sealfon July 15, 2010
---------------------
Andrew I. Sealfon, President, Treasurer, Chairman of the Board, Director,
Chief Executive Officer and Principal Financial Officer
Page 21