1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
/X/ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 1995
----------------------------------------
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 0-9042
MEDEX, INC.
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(Exact name of registrant as specified in its charter)
Ohio 31-4441680
- --------------------------------------------------------------------------------
(State or other jurisdiction (I.R.S. Employer
incorporation or organization) Identification No.)
3637 Lacon Road, Hilliard, Ohio 43026
- --------------------------------------------------------------------------------
(Address of principal executive office) (Zip Code)
Registrant's telephone number, including area code (614) 876-2413
-----------------------------
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.
Yes X No
----- ------
As of March 31, 1995, the latest practicable date, 6,155,470 shares of
the registrant's common shares were issued and outstanding.
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MEDEX, INC.
INDEX TO FORM 10-Q
FOR THE THREE AND NINE MONTHS ENDED MARCH 31, 1995
PAGE NO.
--------
PART I. FINANCIAL INFORMATION
ITEM 1
Title Page 1
Index to Form 10-Q 2
Consolidated Statements of Income -
Three and Nine Months Ended March 31, 1995
and 1994 3
Consolidated Balance Sheets -
March 31, 1995 and June 30, 1994 4-5
Consolidated Statement of Shareholders' Equity -
Nine Months Ended March 31, 1995 6
Consolidated Statements of Cash Flows -
Nine Months Ended March 31, 1995 and 1994 7
Notes To Consolidated Financial Statements 8
ITEM 2
Management's Discussion and Analysis of
Financial Condition and Results of Operations 9-12
PART II OTHER INFORMATION 13
EXHIBIT
11. Computation of Earnings Per Share 15
27. Financial Data Schedule 16
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PART I - FINANCIAL INFORMATION
ITEMS 1 & 2
MEDEX, INC.
CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
THREE MONTHS ENDED NINE MONTHS ENDED
MARCH 31, MARCH 31,
---------------------------- ---------------------------
1995 1994 1995 1994
----------- ----------- ----------- -----------
NET SALES $24,647,101 $24,884,939 $70,105,591 $71,303,903
COST OF GOODS SOLD 12,794,976 12,075,389 37,871,322 35,544,488
----------- ----------- ----------- -----------
GROSS MARGIN 11,852,125 12,809,550 32,234,269 35,759,415
----------- ----------- ----------- -----------
OPERATING EXPENSES:
Sales and marketing 5,662,417 5,608,064 15,947,373 16,164,536
Research and development 800,971 884,101 2,302,428 2,474,094
Administrative 3,505,577 3,394,641 9,541,982 9,802,343
Restructuring costs (Note 3) 381,286 2,055,548
----------- ----------- ----------- -----------
Total 10,350,251 9,886,806 29,847,331 28,440,973
----------- ----------- ----------- -----------
OPERATING INCOME 1,501,874 2,922,744 2,386,938 7,318,442
----------- ----------- ----------- -----------
OTHER INCOME (EXPENSE):
Investment income 19,705 40,996 190,503 169,683
Interest expense (25,273) (29,689) (89,248) (91,632)
Other - net 301,373 63,706 417,730 184,456
----------- ----------- ----------- -----------
Total 295,805 75,013 518,985 262,507
----------- ----------- ----------- -----------
INCOME BEFORE INCOME TAXES 1,797,679 2,997,757 2,905,923 7,580,949
ESTIMATED INCOME TAXES 724,000 1,199,000 1,163,000 3,032,000
----------- ----------- ----------- -----------
INCOME BEFORE
ACCOUNTING CHANGE 1,073,679 1,798,757 1,742,923 4,548,949
----------- ----------- ----------- -----------
CUMULATIVE EFFECT OF CHANGE IN
ACCOUNTING FOR INCOME
TAXES (NOTE 2) 355,827
----------- ----------- ----------- -----------
NET INCOME $ 1,073,679 $ 1,798,757 $ 1,742,923 $ 4,904,776
=========== =========== =========== ===========
NET INCOME PER COMMON SHARE:
INCOME
BEFORE ACCOUNTING CHANGE $ .17 $ .29 $ .28 $ .73
CUMULATIVE EFFECT OF CHANGE IN
ACCOUNTING FOR INCOME
TAXES (NOTE 2) .06
----------- ----------- ----------- -----------
NET INCOME $ .17 $ .29 $ .28 $.79
=========== =========== =========== ===========
WEIGHTED AVERAGE
SHARES OUTSTANDING 6,167,848 6,262,035 6,191,991 6,174,699
=========== =========== =========== ===========
See Notes to Consolidated Financial Statements
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MEDEX, INC.
CONSOLIDATED BALANCE SHEETS
ASSETS
(unaudited)
MARCH 31, JUNE 30,
1995 1994
----------- -----------
CURRENT ASSETS:
Cash and equivalents $ 5,008,264 $ 8,604,455
Investments 1,452,437 1,457,437
Trade Receivables (less allowance for doubtful accounts
March 31 - $704,000; June 30 - $570,000) 18,674,100 16,131,332
Inventories:
Raw materials and supplies 10,917,360 11,093,697
Work-in-process 4,196,356 3,752,113
Finished goods 7,759,001 7,599,961
----------- -----------
Total inventories 22,872,717 22,445,771
Deferred income taxes 1,511,302 1,307,931
Prepaid expenses and other 1,240,894 1,109,754
----------- -----------
Total current assets 50,759,714 51,056,680
----------- -----------
PROPERTY, PLANT AND EQUIPMENT - At cost:
Land and land improvements 1,986,365 1,967,491
Buildings 18,494,312 15,541,850
Machinery and equipment 15,682,712 14,412,533
Dies and molds 8,074,156 7,515,263
Furniture and data processing equipment 7,942,692 7,462,920
Additions in progress 3,787,042 3,984,893
----------- -----------
Total 55,967,279 50,884,950
Less accumulated depreciation 21,967,404 19,362,173
----------- -----------
Property, plant and equipment - net 33,999,875 31,522,777
----------- -----------
COST IN EXCESS OF FAIR VALUE OF NET ASSETS ACQUIRED
(Net of accumulated amortization: March 31, $961,769
June 30 - $855,020) 4,717,642 4,362,651
----------- -----------
OTHER ASSETS:
Deferred income taxes 228,353 244,258
Other 1,681,924 1,925,337
----------- -----------
Total other assets 1,910,277 2,169,595
----------- -----------
TOTAL $91,387,508 $89,111,703
=========== ===========
See Notes to Consolidated Financial Statements
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MEDEX, INC
CONSOLIDATED BALANCE SHEETS
LIABILITIES & SHAREHOLDERS' EQUITY
(unaudited)
MARCH 31, JUNE 30,
1995 1994
------------ ------------
CURRENT LIABILITIES:
Current portion of long-term debt $ 488,409 $ 643,143
Accounts payable (principally trade) 3,829,575 3,138,688
Accrued liabilities:
Compensation and profit sharing 2,478,307 4,244,975
Restructuring costs 1,766,001 240,000
Other 3,376,993 3,021,026
------------ ------------
Total current liabilities 11,939,285 11,287,832
LONG-TERM DEBT - Less current portion 3,905,384 3,975,027
------------ ------------
RESTRUCTURING COST - Less current portion 55,000 165,000
------------ ------------
Total liabilities 15,899,669 15,427,859
------------ ------------
SHAREHOLDERS' EQUITY:
Common stock - $.01 par value
Shares authorized - 20,000,000
Shares outstanding March 31 - 6,155,470
Shares outstanding June 30 - 6,129,866
(net of 150,590 and 156,650,
respectively, treasury shares) 61,554 61,299
Additional paid-in capital 41,958,186 41,702,515
Retained earnings 33,159,175 32,398,479
Foreign currency translation adjustment 308,924 (478,449)
------------ ------------
Total shareholders' equity 75,487,839 73,683,844
------------ ------------
TOTAL $ 91,387,508 $ 89,111,703
============ ============
See Notes to Consolidated Financial Statements
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MEDEX, INC.
CONSOLIDATED STATEMENT OF SHAREHOLDERS' EQUITY
FOR THE NINE MONTHS ENDED MARCH 31, 1995
(unaudited)
FOREIGN
COMMON STOCK ADDITIONAL CURRENCY TOTAL
OUTSTANDING PAID-IN RETAINED TRANSLATION SHAREHOLDERS'
SHARES AMOUNT CAPITAL EARNINGS ADJUSTMENT EQUITY
--------------------------------------------------------------------------------------------------------
BALANCE AT
JUNE 30, 1994 6,129,866 $61,299 $41,702,515 $32,398,479 $(478,449) $73,683,844
Net income 1,742,923 1,742,923
Cash Dividends
($.16 per share) (982,227) (982,227)
Foreign currency
translation
adjustment 787,373 787,373
Issuance of stock
under stock option
and purchase plans
(net of exchange of
2,163 treasury shares) 17,381 173 168,276 168,449
Issuance of
treasury stock 8,223 82 87,395 87,477
--------------------------------------------------------------------------------------------------------
BALANCE AT
MARCH 31,
1995 6,155,470 $61,554 $41,958,186 $33,159,175 $ 308,924 $75,487,839
========================================================================================================
See Notes to Consolidated Financial Statements
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MEDEX, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
NINE MONTHS ENDED
MARCH 31, MARCH 31,
1995 1994
----------- -----------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income $ 1,742,923 $ 4,904,776
Adjustment to reconcile net income to net
cash provided by operating activities:
Depreciation and amortization 2,535,336 3,242,440
Cumulative effect of change in accounting for income taxes (355,827)
Change in operating assets and liabilities:
Increase in trade receivables (1,946,326) (1,252,493)
Decrease (increase) in inventories 279,632 (4,030,419)
(Increase) decrease in prepaid expenses and other (13,548) 152,955
Increase (decrease) in accounts payable 265,485 (624,355)
Increase (decrease) in accrued restructuring costs 1,416,001 (738,011)
(Decrease) increase in accrued liabilities (1,735,024) 1,463,384
Other operating items - net 9,109 233,228
----------- -----------
Net cash provided by operating activities 2,553,588 2,995,678
----------- -----------
CASH FLOWS FROM INVESTING ACTIVITIES:
Property additions (4,438,745) (7,521,227)
Proceeds from sale of investments 5,000 240,001
Acquisition of subsidiary, net of cash acquired (368,027)
Decrease in unused proceeds of industrial revenue bond 2,818,659
----------- -----------
Net cash used by investing activities (4,801,772) (4,462,567)
----------- -----------
CASH FLOWS FROM FINANCING ACTIVITIES:
Payment of long-term obligations (395,224) (240,361)
Proceeds from issuance of common shares-net 168,449 760,551
Issuance of treasury shares 87,477
Cash dividends paid (982,227) (913,621)
----------- -----------
Net cash used by financing activities (1,121,525) (393,431)
----------- -----------
EFFECT OF EXCHANGE RATE CHANGES ON CASH (226,482) (165,665)
----------- -----------
NET DECREASE IN CASH AND EQUIVALENTS (3,596,191) (2,025,985)
CASH AND EQUIVALENTS AT BEGINNING OF PERIOD 8,604,455 10,118,673
----------- -----------
CASH AND EQUIVALENTS AT END OF PERIOD $ 5,008,264 $ 8,092,688
=========== ===========
SUPPLEMENTAL DISCLOSURES:
CASH PAID DURING THE PERIOD FOR:
Interest $ 32,682 $ 196,298
=========== ===========
Income taxes $ 797,000 $ 1,879,350
=========== ===========
See Notes to Consolidated Financial Statements
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MEDEX, INC
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 1995
(unaudited)
1. PRESENTATION
The accompanying unaudited financial statements have been prepared in accordance
with the instructions to Form 10-Q and include all of the information and
disclosures required by generally accepted accounting principles for interim
reporting, which are less than those required for annual reporting. In the
opinion of management, the accompanying unaudited financial statements contain
all adjustments (all of which are normal and recurring in nature) necessary to
present fairly the financial position of Medex, Inc. at March 31, 1995, and the
results of operations and cash flows. The notes to the Consolidated Financial
Statements which are contained in the 1994 Annual Report to Shareholders should
be read in conjunction with these Consolidated Financial Statements. Certain
reclassification have been made to prior year's amounts to conform with the
classifications of such amounts for fiscal 1995.
2. INCOME TAXES
The Company adopted Statement of Financial Accounting Standards (SFAS) No. 109,
"Accounting for Income Taxes" effective July 1, 1993. This Statement supersedes
Accounting Principle Board Opinion No. 11 "Accounting for Income Taxes," which
was the previous accounting treatment used by the Company. The cumulative effect
of adopting SFAS No. 109 on the Company's consolidated financial statements was
to increase income by $355,827 ($.06 per share) for the nine months ended March
31, 1994.
3. RESTRUCTURING
On October 20, 1994, the Company announced a plan to close the Medex/Denver
operations and integrate all functions and product lines into other Company
locations.
Management estimates the integration plan will save the Company approximately
$2,500,000 annually, while costing approximately $3,200,000 to implement. Nearly
all of the $3,200,000 will require a cash outlay by the Company from currently
available funds. The physical move was completed during April as planned however
the Company expects to incur the remaining $1,144,000 of costs, primarily
related to the hiring and relocation of personnel, in the fourth quarter of
fiscal 1995 and possibly the first quarter of fiscal 1996.
The savings associated with the plan primarily relate to the elimination of
approximately 25% of the 177 positions currently at the Denver operations and
the avoidance of rent and other facility costs. The Company has the capacity at
its other locations to provide the space necessary to integrate all functions
required as a result of this plan.
Expenses totaling $381,000 ($.04 per share, net of tax) were recorded in the
third quarter primarily consisting of $106,000 for relocating Denver employees
to Columbus or Atlanta, $98,000 for Denver inefficiencies related to the use
of production personnel obtained from temporary agencies and $82,000 of travel
and temporary lodging costs incurred by various employees in relation to the
closing of Denver. The balance of the recorded expense consists of the costs to
ship equipment and other items from Denver to other Company locations and other
miscellaneous items. The remaining $1,144,000 relates to moving, recruiting,
training and other costs which will be expensed as incurred. The Company intends
to use available cash and investments to fund these expenditures.
For the nine months ended March 31, 1995 the total restructuring costs were
$2,056,000 ($.20 per share, net of tax). This amount includes the $381,000
discussed above and $1,675,000 recorded in the second quarter consisting of
$942,000 for the estimated costs of severance and $733,000 for the lease costs
in excess of sub-lease payments, estimated legal expenses and other out of the
pocket costs. On April 28, 1995, substantially all of the 177 Denver employees
were severed at a cost of $876,000. The $66,000 difference between this amount
and cost accrued of $942,000 will be recorded in the fourth quarter.
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MEDEX, INC.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
MARCH 31, 1995
RESULTS OF OPERATIONS
The following table shows Medex, Inc. operating results as a percent of net
sales for the periods indicated for certain items in the consolidated statements
of income. Dollar amounts in the following tables are in thousands.
- --------------------------------------------------------------------------------
PERCENT OF NET SALES
-------------------------------------
THREE MONTHS ENDED NINE MONTHS ENDED
MARCH 31, MARCH 31,
1995 1994 1995 1994
- --------------------------------------------------------------------------------
Net Sales 100.00% 100.00% 100.00% 100.00%
Cost of Goods Sold 51.91 48.52 54.02 49.85
------ ------ ------ ------
Gross Margin 48.09 51.48 45.98 50.15
Operating Expenses 41.99 39.73 42.57 39.89
------ ------ ------ ------
Operating Income 6.10 11.75 3.41 10.26
Other Income 1.20 .30 .74 .37
------ ------ ------ ------
Income Before
Income Taxes 7.30 12.05 4.15 10.63
Estimated Income
Taxes 2.94 4.82 1.66 4.25
------ ------ ------ ------
Income Before
Accounting Change 4.36 7.23 2.49 6.38
Cumulative Effect of Change in
Accounting for Income Taxes .50
------ ------ ------ ------
Net Income 4.36% 7.23% 2.49% 6.88%
====== ====== ====== ======
- -------------------------------------------------------------------------------
THREE MONTHS ENDED NINE MONTHS ENDED
MARCH 31, MARCH 31,
1995 1994 1995 1994
- --------------------------------------------------------------------------------
Net Sales $24,647 $24,885 $70,106 $71,304
- -------------------------------------------------------------------------------
Net sales for the three months ended March 31, 1995 decreased $238,000 or one
percent over the same period of the previous year. Net sales from domestic
operations decreased $2,460,000 or 13 percent to $16,720,000 while sales from
the Company's European operations increased $2,222,000 or 39 percent to
$7,927,000.
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Approximately 80% of the decrease in domestic sales is due to a decrease in
Bulk/OEM sales caused by certain customers electing to produce various products
in-house versus purchasing them from Medex while the remaining decreases
occurred in the pressure monitoring and cath lab product lines. These decreases
were due to continued pressures in the U.S. healthcare market and the
continuation of the sales force reorganization which began in late fiscal 1994.
The increase in sales from the Company's European operations is primarily due to
increased sales of cath lab and pressure monitoring products and due to the
effect of increased foreign currency translation rates. Cath lab sales increased
primarily due to increased sales of procedure packs which were introduced in
fiscal 1993. The increase in pressure monitoring products is primarily due to
sales efforts being redirected into this product line as a result of the
procedure pack business becoming more established. The increase in the foreign
currency exchange rates accounted for $926,000 of the $2,222,000 increase in the
European sales results.
For the nine months ended March 31, 1995, net sales decreased $1,198,000 or two
percent over the same period in the previous year. Domestic sales decreased
$7,285,000 or thirteen percent to $48,799,000 while European sales increased
$6,087,000 or 40 percent to $21,307,000. The changes in domestic and European
sales for the nine month period were primarily due to the items discussed above
for the three month period.
THREE MONTHS ENDED NINE MONTHS ENDED
MARCH 31, MARCH 31,
1995 1994 1995 1994
- --------------------------------------------------------------------------------
Cost of Goods Sold $12,795 $12,075 $37,872 $35,545
- -------------------------------------------------------------------------------
Gross Margin $11,852 $12,810 $32,234 $35,759
- -------------------------------------------------------------------------------
Cost of goods sold, as a percent of net sales, increased for the period thereby
decreasing gross margin as a percent of net sales. This decrease consists of a
five percentage point decrease in the domestic margin while the European margin
remained the same. Domestic margins have decreased primarily due to significant
unfavorable manufacturing variances attributed to the reduced volumes caused by
lower sales.
European gross margins have remained the same due to the effect of lower per
unit manufacturing costs associated with increased volume from procedure
packing. Europe has also experienced favorable purchase price variances due to
foreign currency fluctuations. The increases associated with volume and price
variances have been partially offset by a change in product mix to include a
larger percentage of procedure packs which generally have a lower gross margin
than the Company's other products.
On a year-to-date basis, the gross margin percentage decreased from 50.2% in
fiscal 1994 to 46.0% in fiscal 1995 primarily due to the reasons noted above.
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THREE MONTHS ENDED NINE MONTHS ENDED
MARCH 31, MARCH 31,
1995 1994 1995 1994
- --------------------------------------------------------------------------------
Operating Expenses $10,350 $9,887 $29,847 $28,441
- -------------------------------------------------------------------------------
Operating expenses increased $463,000 for the three months ended March 31, 1995.
This increase is primarily due to the Company incurring $381,000 of
restructuring expenses representing employee relocations, production
inefficiencies and travel costs incurred by employees to coordinate the move.
See Note 3 of the "Notes to Consolidated Financial Statements" for further
information. The remaining relocation expenses of $1,144,00 are expected to be
incurred in the fourth quarter as the final phases of the restructuring are
completed. Due to timing of relocations and the hiring of replacement personnel,
some costs may be incurred in the first quarter of fiscal 1996.
Excluding the effect of restructuring costs, domestic operating expenses
decreased by $439,000 primarily due to lower selling and administrative
expenses. Selling expenses decreased as a result of the sales reorganization
that left several positions open during a portion of the period and a reduction
of independent sales representatives which lowered commission rates.
Administrative expenses decreased primarily due to salaries as a result of the
elimination of personnel and decreased bonuses resulting from lower domestic
profit levels.
These decreases were partially offset by increases in European selling and
administrative expenses of $521,000 primarily due to the effects of currency
translation which represented $368,000 of the increase. The remaining increase
was primarily in the administrative area due to addition of personnel.
For the nine months ended March 31, 1995, operating expenses excluding the
effects of $2,056,000 in restructuring expenses (see Note 3) decreased $649,000
or two percent over the same period in the previous year. The decrease for the
nine month period was primarily due to the same items discussed above for the
three month period.
THREE MONTHS ENDED NINE MONTHS ENDED
MARCH 31, MARCH 31,
1995 1994 1995 1994
- --------------------------------------------------------------------------------
Other Income $ 296 $ 75 $ 519 $ 263
- -------------------------------------------------------------------------------
The increase in other income for the three month period ended March 31, 1995, as
compared to the same period for the prior year is primarily due to foreign
currency exchange gains of $172,000.
For the nine months ended March 31, 1995, the increase in other income is
primarily due to an increase in foreign currency exchange gains of $205,000.
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THREE MONTHS ENDED NINE MONTHS ENDED
MARCH 31, MARCH 31,
1995 1994 1995 1994
- --------------------------------------------------------------------------------
Estimated Income
Taxes/(benefit) $724 $1,199 $1,163 $3,032
- -------------------------------------------------------------------------------
Income taxes for both the current and previous fiscal year are estimated to be
40 percent of pre-tax income.
Effective July 1, 1993, the Company adopted Statement of Financial Accounting
Standards (SFAS) No. 109, "Accounting for Income Taxes". The cumulative effect
of adopting SFAS No. 109 on the Company's consolidated financial statements was
to increase income by $356,000 which has been reported separately as the
cumulative effect of an accounting change. See Note 2 of the "Notes to
Consolidated Financial Statements" for further information.
LIQUIDITY AND CAPITAL RESOURCES
Net working capital decreased approximately $948,000 over the working capital at
June 30, 1994. The current ratio was 4.25 to 1.00 at March 31, 1995 as compared
to 4.52 to 1.00 at June 30, 1994.
Property additions of approximately $4,439,000 primarily relate to the
renovation of the 71,000 square foot facility acquired in Hilliard, Ohio, in
fiscal 1994 and the acquisition of machinery and equipment.
Management believes that currently available cash and investments, cash provided
from future operations and debt financing options will be sufficient to finance
future capital expenditures.
MANAGEMENT'S OUTLOOK
Management anticipates that the Company's European operations will continue to
contribute an increasing share of the Company's revenues and profits during the
remainder of the fiscal year.
The domestic results are expected to continue to be soft due to the continued
weakness in the United States healthcare market, additional training and start
up costs related to the sales reorganization, and lower bulk/OEM sales. However,
the Company has replaced a portion of the bulk/OEM business and management
believes the Company will begin to see positive results from the sales
reorganization in the fourth quarter. The continued integration of the
Medex/Denver operations with the Company's other locations will also have a
negative impact on the fourth quarter's results as indicated in Note 3 of the
"Notes to the Consolidated Financial Statements".
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PART II - OTHER INFORMATION
ITEM 1.
LEGAL PROCEEDINGS
The Company is not presently a party to any material pending legal
proceedings.
ITEM 2.
CHANGES IN SECURITIES
None
ITEM 3.
DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4.
SUBMISSION OF MATTERS TO VOTE OF SECURITY HOLDERS
None
ITEM 5.
OTHER INFORMATION
On April 17, 1995, Medex, Inc., (the Company), received a Warning Letter,
dated April 11, 1995, from the United States Food and Drug Administration (FDA)
resulting from a previous FDA inspection of the Company's manufacturing facility
in Hilliard, Ohio.
The letter cited deviations from Good Manufacturing Practice (GMP)
Regulations and Medical Device Reporting requirements. The Company has taken
action to correct these deviations and has communicated these corrective actions
to the FDA.
The Company has devoted substantial efforts to correct the deviations cited
in the Warning Letter. Management believes that said Warning Letter will not
have a material adverse effect on the Company and with the completed corrective
actions at the Hilliard facility, the Company and its subsidiaries are in
compliance with the Federal Food, Drug and Cosmetic Act and the regulations
issued thereunder.
ITEM 6.
EXHIBITS AND REPORTS ON FORM 8-K
A. Exhibits
11. Computation of earnings per share
27. Financial Data Schedule
B. Reports on Form 8-K
None
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereto duly authorized.
MEDEX, INC.
Date: May 11 , 1995 By: /s/ Phillip D. Messinger
------------------ -----------------------
Phillip D. Messinger
President
Chief Executive Officer
And: /s/ Donald H. Barry
-----------------------
Donald H. Barry
Treasurer
Chief Financial Officer
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