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 second quarter period ended February 28,
1997
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 0-20212
ARROW INTERNATIONAL, INC.
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(Exact name of registrant as specified in its charter)
Pennsylvania 23-1969991
-------------- ------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
2400 Bernville Road, Reading, Pennsylvania 19605
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (610) 378-0131
--------------
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
-- --
Indicate the number of shares outstanding of each of the
issuer's classes of common stock, as of the latest
practicable date.
Class Shares outstanding at April 10, 1997
------- ------------------------------------
Common Stock, No Par Value 23,226,606
ARROW INTERNATIONAL, INC.
Form 10-Q Index
Page
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Consolidated Balance Sheets
at February 28, 1997
and August 31, 1996 3-4
Consolidated Statements of Income 5-6
Consolidated Statements of Cash Flows 7-8
Notes to Consolidated Financial Statements 9-10
Item 2. Management's Discussion and Analysis
of Financial Condition and Results
of Operations 11-16
PART II. OTHER INFORMATION
Item 4. Submission of Matters to a Vote of
Security Holders 17-18
Item 6. Exhibits and Reports on Form 8-K 19
Signature 20
Exhibit Index 21
-2-
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
ARROW INTERNATIONAL, INC.
CONSOLIDATED BALANCE SHEETS
(All Dollar Amounts in Thousands)
February 28, August 31,
1997 1996
------------ ----------
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 9,771 $ 4,807
Accounts receivable, net 56,250 50,093
Inventories 46,877 43,509
Prepaid expenses and other 10,502 9,575
Deferred income taxes 2,784 2,709
--------- ---------
Total current assets 126,184 110,693
--------- ---------
Property, plant and equipment:
Total property, plant and equipment 166,357 158,551
Less accumulated depreciation 55,302 49,552
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Property, plant and equipment, net 111,055 108,999
--------- ---------
Other assets:
Goodwill, net 50,150 51,754
Intangible and other assets, net 26,165 27,975
--------- ---------
Total other assets 76,315 79,729
--------- ---------
Total assets $ 313,554 $ 299,421
--------- ---------
--------- ---------
See accompanying notes to consolidated financial statements
Continued
-3-
ARROW INTERNATIONAL, INC.
CONSOLIDATED BALANCE SHEETS
(All Dollar Amounts in Thousands)
February 28, August 31,
1997 1996
-------------- ----------
(Unaudited)
LIABILITIES
Current liabilities:
Current maturities of long-term debt $ 3,428 $ 6,293
Notes payable 34,687 27,708
Accounts payable 6,747 8,078
Accrued liabilities 8,764 6,297
Accrued compensation 5,138 5,493
Accrued income taxes 1,621 1,738
------------ ----------
Total current liabilities 60,385 55,607
Long-term debt 12,717 15,988
Accrued postretirement benefit obligation 7,815 7,577
Deferred income taxes 205 476
Commitments and contingencies
SHAREHOLDERS' EQUITY
Preferred Stock, no par value;
5,000,000 shares authorized;
none issued - -
Common Stock, no par value;
50,000,000 shares authorized;
issued 26,478,813 shares 45,580 45,580
Retained earnings 199,071 183,502
Less cost of treasury stock:
3,252,207 and 3,249,194 shares
of Common Stock, respectively (8,363) (8,308)
Unearned compensation (343) (469)
Cumulative translation adjustment (2,038) (532)
Unrealized holding loss on
securities, net of tax (1,475) -
---------- ---------
Total shareholders' equity 232,432 219,773
---------- ---------
Total liabilities and
shareholders' equity $ 313,554 $ 299,421
---------- ---------
__________ _________
See accompanying notes to consolidated financial statements
-4-
ARROW INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF INCOME
(Unaudited)
(All Dollar Amounts in Thousands, Except Per Share Data)
For the Three Months
Ended
February 28, February 29,
1997 1996
----------- -----------
Net sales $ 61,965 $ 58,779
Cost of goods sold 27,978 27,556
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Gross profit 33,987 31,223
Operating expenses:
Research, development
and engineering 3,993 3,240
Selling, general and administrative 14,336 12,729
----------- -----------
Operating income 15,658 15,254
----------- -----------
Other expenses (income):
Interest expense, net of
amounts capitalized 133 469
Interest income (232) (136)
Other, net 697 338
----------- -----------
Other expenses (income), net 598 671
----------- -----------
Income before income taxes 15,060 14,583
Provision for income taxes 5,798 5,396
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Net income $ 9,262 $ 9,187
----------- -----------
----------- -----------
Net income per common share $ .40 $ .40
----------- -----------
----------- -----------
Cash dividends per common share $ .045 $ .04
----------- -----------
----------- -----------
Weighted average shares
outstanding 23,226,888 23,229,747
----------- -----------
----------- -----------
See accompanying notes to consolidated financial statements
-5-
ARROW INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF INCOME
(Unaudited)
(All Dollar Amounts in Thousands, Except Per Share Data)
For the Six Months
Ended
February 28, February 29,
1997 1996
------------ ------------
Net sales $ 121,155 $ 113,290
Cost of goods sold 55,383 52,385
------------ ------------
Gross profit 65,772 60,905
Operating expenses:
Research, development and engineering 7,801 6,400
Selling, general and administrative 28,296 25,898
------------ ------------
Operating income 29,675 28,607
------------ ------------
Other expenses (income):
Interest expense, net of
amounts capitalized 594 917
Interest income (431) (269)
Other, net 987 237
------------ ------------
Other expenses (income), net 1,150 885
------------ ------------
Income before income taxes 28,525 27,722
Provision for income taxes 10,982 10,257
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Net income $ 17,543 $ 17,465
------------ ------------
------------ ------------
Net income per common share $ .76 $ .75
------------ ------------
------------ ------------
Cash dividends per common share $ .085 $ .075
------------ ------------
------------ ------------
Weighted average shares outstanding 23,227,879 23,230,377
------------ ------------
------------ ------------
See accompanying notes to consolidated financial statements
-6-
ARROW INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(All Dollar Amounts in Thousands)
For the Six Months
Ended
February 28, February 29,
1997 1996
------------ ------------
Cash flows from operating activities:
Net income $ 17,543 $ 17,465
Adjustments to reconcile net income to
net cash provided by operating activities:
Depreciation 5,750 4,854
Amortization of intangible assets 2,010 1,504
Amortization of unearned compensation 103 107
Deferred income taxes (344) 712
Other (226) (224)
Changes in operating assets and liabilities:
Accounts receivable (6,225) (6,022)
Inventories (3,368) (4,131)
Prepaid expenses and other (927) (2,760)
Accounts payable and accrued liabilities 1,135 647
Accrued compensation (355) (1,089)
Accrued income taxes (117) (337)
------------- ------------
Total adjustments (2,564) (6,739)
------------- ------------
Net cash provided by operating activities 14,979 10,726
Cash flows from investing activities:
Capital expenditures (7,806) (13,008)
Purchase of intangible assets and other (1,046) (10,926)
------------- ------------
Net cash used in investing activities (8,852) (23,934)
Cash flows from financing activities:
Increase in notes payable 6,979 16,478
Principal payments of long-term debt (6,136) (4,809)
Dividends paid (1,974) (1,742)
Purchase of treasury stock (32) (43)
Net cash (used in) provided by ------------- ------------
financing activities (1,163) 9,884
Net change in cash and cash equivalents 4,964 (3,324)
Cash and cash equivalents at beginning
of year 4,807 9,453
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Cash and cash equivalents at
end of period $ 9,771 $ 6,129
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------------- ------------
See accompanying notes to consolidated financial statements
Continued
-7-
ARROW INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(All Dollar Amounts in Thousands)
For the Six Months
Ended
February 28, February 29,
1997 1996
------------ ------------
Supplemental disclosure of
cash flow information:
Cash paid during the year for:
Interest (net of amounts capitalized) $ 594 $ 992
Income taxes $ 9,504 $ 8,824
See accompanying notes to consolidated financial statements
-8-
ARROW INTERNATIONAL, INC.
Notes to Consolidated Financial Statements
(Unaudited)
(All Dollar Amounts in Thousands, Except Per Share Data)
Note 1 - Basis of Presentation
These unaudited consolidated financial statements include
all adjustments, consisting only of normal recurring
accruals, which management considers necessary for a fair
presentation of the Company's consolidated financial
position, results of operations, and cash flows for the
interim periods presented. Results for the interim period
are not necessarily indicative of results for the entire
year.
Note 2 - Inventories
Inventories are summarized as follows:
February 28, August 31,
1997 1996
----------- ----------
Finished goods $ 16,620 $ 16,878
Semi-finished goods 10,939 10,010
Work-in-process 8,607 7,107
Raw materials 10,711 9,514
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$ 46,877 $ 43,509
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----------- ----------
Note 3 - Commitments and Contingencies
The Company is a party to certain legal actions arising in
the ordinary course of its business. Based upon information
presently available to the Company, the Company believes it
has adequate legal defenses or insurance coverage for these
actions and that the ultimate outcome of these actions would
not have a material effect on the Company's financial
position or results of operations.
Continued
-9-
ARROW INTERNATIONAL, INC.
Notes to Consolidated Financial Statements
(Unaudited)
Note 4 - Related Party Transactions
Certain of the Company's facilities, personnel and services
are being utilized by Arrow Precision Products, Inc.
("Precision"). Precision is related to the Company through
common ownership. The Company charged Precision $110 and
$131 and $220 and $262 for the cost of such utilization
during the three months and six months ended February 28,
1997 and February 29, 1996, respectively. The Company made
purchases from Precision amounting to $295 and $283 and $691
and $588 for the three months and six months ended February
28, 1997 and February 29, 1996, respectively. In addition,
the Company made payments on behalf of Precision related to
certain costs incurred by Precision for which the Company
was reimbursed, amounting to $447 and $241 and $613 and $445
for the three months and six months ended February 28, 1997
and February 29, 1996, respectively. At February 28, 1997
and February 29, 1996, the Company had a net receivable from
Precision amounting to $200 and $72, respectively.
Note 5 - Adoption of New Accounting Standards
In February 1997, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standards No. 128, "Earnings Per
Share" (FAS 128). FAS 128 is designed to improve the EPS information
in financial statements by simplifying the existing computational
guidelines (i.e., APB Opinion No. 15, "Earnings Per Share"), revising
the disclosure requirements and increasing the comparability of EPS on
an international basis. FAS 128 is effective for financial statements
issued for periods ending after December 15, 1997. The Company does
not anticipate the effect of adopting this new standard to have a
material effect on the Company's consolidated financial position or
results of operations.
-10-
ARROW INTERNATIONAL, INC.
Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations
The following discussion includes certain forward-looking
statements. Such forward-looking statements are subject to a
number of factors, including material risks, uncertainties and
contingencies, which could cause actual results to differ
materially from the forward-looking statements. For a
discussion of important factors that could cause actual results
to differ materially from the forward-looking statements, see
Exhibit 99.1 to this Report and the Company's periodic reports
and other documents filed with the Securities and Exchange
Commission.
Results of Operations
Three Months Ended February 28, 1997 Compared to Three Months
Ended February 29, 1996
Net sales for the three months ended February 28, 1997
increased by $3.2 million, or 5.4%, to $62.0 million from $58.8
million in the same period last year. Net sales represent
gross sales invoiced to customers, plus royalty income, less
certain related charges, including freight costs, discounts,
returns and other allowances. This increase was due primarily
to an increase in unit volume in the Company's central venous
catheter products, including increased shipments of ARROWg+ard
Blue trademark antiseptic surface treated catheter products. Sales of
critical care products increased 8.2% to $52.6 million from
$48.6 million in the comparable prior period. Interventional
procedure product sales decreased to $9.2 million from $10.1
million, a decrease of 8.1% from the comparable prior period,
due primarily to lower sales of intra-aortic balloon (I.A.B.)
products in Japan where this decrease has led to a decision by
the Company to change its distribution of these products. I.A.B.
sales in Japan will be negatively affected for the balance of
the 1997 fiscal year as distributor inventory is depleted prior
to the Company's assumption of direct sales responsibility.
International sales decreased by $0.7 million, or 3.3%, to
34.0% of net sales, excluding royalty income, for the three
months ended February 28, 1997, compared to 37.1% of net sales
in the comparable period of fiscal 1996, principally as a
result of a stronger U.S. dollar and lower sales of
intra-aortic balloon products.
Gross profit increased 8.9% to $34.0 million in the three
months ended February 28, 1997 compared to $31.2 million in the
same period of fiscal 1996. As a percentage of net sales,
gross profit increased to 54.8% during the three months ended
February 28, 1997 from 53.1% in the comparable period of fiscal
1996, due primarily to the reduction in manufacturing costs
resulting primarily from increased production at the Company's
international manufacturing facilities and increased sales of
higher margin central venous catheter products.
-11-
ARROW INTERNATIONAL, INC.
Research, development and engineering expenses increased by
23.2% to $4.0 million in the three months ended February 28,
1997 from $3.2 million in the comparable prior period,
primarily as a result of increased spending related to
research, product development, process development and clinical
trial activities. As a percentage of net sales, these expenses
increased in the second quarter of fiscal 1997 to 6.4%,
compared to 5.5% in the same period in fiscal 1996. Current
research programs include the development of pullback
atherectomy catheters for treating coronary artery disease,
microwave ablation catheters for the treatment of heart
arrythmias and a fully implantable Left Ventricular Assist
Device.
Selling, general and administrative expenses increased by 12.6%
to $14.3 million in the three months ended February 28, 1997
from $12.7 million in the comparable prior period of fiscal
1996 and increased as a percentage of net sales to 23.1% in the
second quarter of fiscal 1997 from 21.7% in the comparable
period of fiscal 1996. The increase was due primarily
to an increase in expenses related to the amortization of
certain intangible assets and additions to the Company's
domestic direct sales force to replace a distributor in
the New England area in December 1995.
Principally due to the above factors, operating income
increased in the second quarter of fiscal 1997 by 2.6% to $15.7
million from $15.3 million in the comparable period of fiscal
1996.
Other expenses (income), net, decreased to $0.6 million in the
second quarter of fiscal 1997 from $0.7 million in the
comparable prior period. Other expenses (income), net, consist
principally of interest expense and foreign exchange gains and
losses associated with the Company's direct sales subsidiaries,
which resulted in a net loss in both periods.
As a result of the factors discussed above, income before
income taxes increased in the second quarter of fiscal 1997 by
3.3% to $15.1 million from $14.6 million in the comparable
prior period. For the second quarter of fiscal 1997, and for
the remainder of fiscal 1997, the Company's effective income
tax rate was, and is expected to be, 38.5%, an increase from
37.0% in fiscal 1996, principally as a result of generating a
larger proportion of earnings in higher-tax jurisdictions.
Net income in the second quarter of fiscal 1997 increased by
0.8% to $9.3 million from $9.2 million in the comparable prior
period. As a percentage of net sales, net income represented
14.9% in the three months ended February 28, 1997, compared to
15.6% in the comparable prior period of fiscal 1996.
Net income per common share was $.40 for both periods.
Weighted average common shares outstanding decreased to
23,226,888 in the second quarter of fiscal 1997 from 23,229,747
in the comparable prior period.
-12-
ARROW INTERNATIONAL, INC.
Six Months Ended February 28, 1997 Compared to Six Months
Ended February 29, 1996
Net sales for the six months ended February 28, 1997
increased by $7.9 million, or 6.9%, to $121.2 million from
$113.3 million in the same period last year. This increase
was due primarily to an increase in unit volume in the
Company's central venous catheter products, including
shipments of ARROWg+ard Blue trademark antiseptic surface treated
catheter products. Sales of critical care products
increased 9.3% to $102.3 million from $93.6 million in the
comparable prior period. Interventional procedure product
sales decreased to $18.8 million from $19.3 million, a
decrease of 2.7% from the comparable prior period, due
primarily to lower sales of intra-aortic balloon (I.A.B.)
products in Japan where this decrease has led to a decision by
the Company to change its distribution of these products. I.A.B.
sales in Japan will be negatively affected for the balance
of the 1997 fiscal year as distributor inventory is depleted
prior to the Company's assumption of direct sales
responsibility. International sales increased by $1.7
million, or 4.0%, to 35.7% of net sales, excluding royalty
income, for the six months ended February 28, 1997, compared
to 36.8% in the comparable period of fiscal 1996,
principally as a result of increased sales of multi-lumen
catheters, offset by the effect of a stronger U.S. dollar
and lower sales of intra-aortic balloon
products.
Gross profit increased 8.0% to $65.8 million in the six
months ended February 28, 1997, compared to $60.9 million in
the same period of fiscal 1996. As a percentage of net
sales, gross profit increased to 54.3% during the six months
ended February 28, 1997 from 53.8% in the comparable period
of fiscal 1996, due primarily to the reduction in
manufacturing costs resulting primarily from increased production at
the Company's international manufacturing facilities and
increased sales of higher margin central venous catheter products.
Research, development and engineering expenses increased by
21.9% to $7.8 million in the six months ended February 28,
1997 from $6.4 million in the comparable prior period. As a
percentage of net sales, these expenses increased in the
first half of fiscal 1997 to 6.4%, compared to 5.6% in the
same period in fiscal 1996, primarily as a result of
increased spending related to research, product development,
process development and clinical trial activities. Current
research programs include the development of pullback
atherectomy catheters for treating coronary artery disease,
microwave ablation catheters for the treatment of heart
arrythmias and a fully implantable Left Ventricular Assist
Device.
-13-
ARROW INTERNATIONAL, INC.
Selling, general and administrative expenses increased by
9.3% to $28.3 million in the six months ended February 28,
1997 from $25.9 million in the comparable prior period and
increased as a percentage of net sales to 23.4% in the first
half of fiscal 1997 from 22.9% in the comparable period of
fiscal 1996. The increase was due primarily to an increase
in expenses related to the amortization of certain intangible
assets and additions to the Company's domestic direct sales
force to replace a distributor in the New England area in
December 1995.
Principally due to the above factors, operating income
increased in the first half of fiscal 1997 by 3.7% to $29.7
million from $28.6 million in the comparable period of
fiscal 1996.
Other expenses (income), net, increased to $1.1 million in
the first half of fiscal 1997 from $0.9 million in the
comparable prior period. Other expenses (income), net,
consist principally of interest expense and foreign exchange
gains and losses associated with the Company's direct sales
subsidiaries, which resulted in a net loss in both periods.
As a result of the factors discussed above, income before
income taxes increased in the first half of fiscal 1997 by
2.9% to $28.5 million from $27.7 million in the comparable
prior period. For the first half of fiscal 1997, and for
the remainder of fiscal 1997, the Company's effective income
tax rate was, and is expected to be, 38.5%, an increase from
37.0% in fiscal 1996, principally as a result of its
generating a larger proportion of earnings in higher-tax
jurisdictions.
Net income was $17.5 million in both periods. As a
percentage of net sales, net income represented 14.5% during
the six months ended February 28, 1997 compared to 15.4% in
the comparable period of fiscal 1996.
Net income per common share was $.76 in the six month period
ended February 28, 1997, an increase of 0.5%, or $.01 per
share from $.75 per share in the comparable prior period.
Weighted average common shares outstanding decreased to
23,227,879 from 23,230,377 in the comparable prior periods.
-14-
ARROW INTERNATIONAL, INC.
Liquidity and Capital Resources
For the six months ended February 28, 1997, net cash
provided by operations was $15.0 million, an increase of
$4.3 million from the same period in the prior year.
Accounts receivable increased by $6.2 million in the six
months ended February 28, 1997, compared to a $6.0 million
increase in the same period of fiscal 1996. Accounts
receivable, measured in days sales outstanding during the
period, increased to 78 days at February 28, 1997 from 73
days at February 29, 1996, due principally to an increase in
the collection period for the Company's international sales.
Net cash used in the Company's investing activities
decreased to $8.9 million in the six months ended February
28, 1997 from $23.9 million in the comparable period of
fiscal 1996, principally as a result of a reduction in the
purchase of intangible assets and lower capital
expenditures.
Financing activities used $1.2 million in the six month
period ended February 28, 1997, whereas such activities
provided $9.9 million in the comparable period of fiscal
1996, changing principally as a result of reduced new
borrowings under the Company's revolving credit facilities,
offset by repayments of long-term debt.
During the second quarter of fiscal 1997, the Company
increased the amount of its U.S. revolving line of credit
facilities by $5.0 million to provide for a total of $60.0
million in available revolving credit, of which $30.3
million remained unused as of February 28, 1997. In
addition, certain of the Company's foreign subsidiaries have
revolving credit facilities totaling the U.S. dollar
equivalent of $10.8 million, of which $5.8 remained unused
as of February 28, 1997. Combined borrowings under these
facilities increased $7.0 million during the six month
period ended February 28, 1997.
As a partial hedge against adverse fluctuations in exchange
rates, the Company periodically enters into foreign currency
exchange contracts with certain major financial
institutions. By their nature, all such contracts involve
risk, including the risk of nonperformance by
counterparties. Accordingly, losses relating to these
contracts could have a material adverse effect upon the
Company's business, financial condition and results of
operations. Based upon the Company's knowledge of the
financial condition of the counterparties to its existing
forward contracts, the Company believes that it does not
have any material exposure to any individual counterparty.
The Company's policy prohibits the use of derivative
instruments for trading purposes.
-15-
ARROW INTERNATIONAL, INC.
During the six month periods ended February 28, 1997 and
February 29, 1996, the percentage of the Company's sales
invoiced in currencies other than U.S. dollars was 24.9% and
25.9%, respectively. As of February 28, 1997, outstanding
foreign currency exchange contracts totaling the U.S. dollar
equivalent of $13.3 million mature at various dates through
May 1997. The Company expects to continue to utilize
foreign currency exchange contracts to manage its exposure,
although there can be no assurance that the Company's effort
in this regard will be successful.
Based upon its present plans, the Company believes that
operating cash flow and available credit resources will be
adequate to repay current portions of long-term debt, to
finance currently planned capital expenditures and to meet
the currently foreseeable liquidity needs of the Company.
Overall effects of inflation and seasonality in the
Company's business during the periods discussed above were
not significant.
-16-
ARROW INTERNATIONAL, INC.
PART II. OTHER INFORMATION
Item 4. Submission of matters to a vote of security holders.
(a) The Company held its annual meeting of shareholders on
January 15, 1997.
(b) At the annual meeting, the following matters were voted
upon: (i) the election of four directors (in connection
with which (A) proxies were solicited pursuant to
Regulation 14D under the Securities Exchange Act of
1934, (B) there was no solicitation in opposition to
management's nominees as listed in the proxy statement and
(C) such nominees were elected); and (ii) ratification of
the appointment of Coopers & Lybrand L.L.P. as independent
accountants of the Company for the current fiscal year.
With respect to the election of directors, votes were cast
as follows:
Alan M. Sebulsky
----------------
Votes for 21,821,274
Withheld 61,635
Robert L. McNeil, Jr.
---------------------
Votes for 21,806,494
Withheld 76,415
John E. Gurski
--------------
Votes for 21,820,374
Withheld 62,535
Marlin Miller, Jr.
------------------
Votes for 21,819,574
Withheld 63,335
-17-
ARROW INTERNATIONAL, INC.
PART II. OTHER INFORMATION (Continued)
Item 4. Submission of matters to a vote of security holders.(Continued)
With respect to other matters, votes were cast as follows:
Ratification of the Appointment
of Independent Accountants
-------------------------------
Votes for 21,876,015
Votes against 3,775
Abstentions 3,119
There were no broker non-votes in respect of these matters.
-18-
ARROW INTERNATIONAL, INC.
Item 6. Exhibits and reports on Form 8-K
(a) Exhibits
The following exhibits will be filed as part of
this Form 10-Q:
Exhibit 27 Financial Data Schedule
Exhibit 99.1 Cautionary Statement for Purposes
of the Safe Harbor Provisions of the
Private Securities Litigation Reform
Act of 1995
(b) Reports on Form 8-K
No reports on Form 8-K were filed during the
quarter ended February 28, 1997.
-19-
ARROW INTERNATIONAL, INC.
SIGNATURE
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 thereunto duly
authorized.
ARROW INTERNATIONAL, INC.
(Registrant)
Date: April 14, 1997 By: /s/ John H. Broadbent, Jr.
---------------------------
(signature)
John H. Broadbent, Jr.
Vice President-Finance
and Treasurer (Principal
Financial Officer and
Chief Accounting Officer)
-20-
EXHIBIT INDEX
Exhibit Description
Number of Exhibit Method of Filing
- ------- ---------- ----------------
27 *Financial Data Schedule EDGAR
99.1 Cautionary Statement for Page 22 of this report
Purposes of the Safe
Harbor Provisions of the
Private Securities
Litigation Reform Act of
1995
*Not deemed filed for purposes of Section 11 of the
Securities Act of 1933, Section 18 of the Securities
Exchange Act of 1934 and Section 323 of the Trust Indenture
Act of 1939, or otherwise subject to the liabilities of such
sections and not deemed part of any registration statement
to which such exhibit relates.
-21-
EXHIBIT 99.1
CAUTIONARY STATEMENT FOR PURPOSES OF THE SAFE HARBOR
PROVISIONS OF THE PRIVATE SECURITIES LITIGATION REFORM ACT
OF 1995
From time to time, in both written reports and in oral
statements by the Company's senior management, expectations
and other statements are expressed regarding future
performance of the Company. These forward-looking
statements are inherently uncertain and investors must
recognize that events could turn out to be different than
such expectations and statements. Key factors impacting
current and future performance are discussed in the
Company's Annual Report on Form 10-K for its fiscal year
ended August 31, 1996 and other filings with the Securities
and Exchange Commission (the "Commission"). In addition to
such information in the Company's Annual Report on Form 10-
K and its other filings with the Commission, the following
risk factors should be considered in evaluating the Company
and its business, as well as in reviewing forward-looking
statements contained in the Company's periodic reports filed
with the Commission and in oral statements made by the
Company's senior management. The Company's actual results
could differ materially from such forward-looking statements
due to material risks, uncertainties and contingencies,
including, without limitation, those set forth below.
STRINGENT GOVERNMENT REGULATION
The Company's products are subject to extensive
regulation by the Food and Drug Administration (the "FDA")
and, in some jurisdictions, by state and foreign
governmental authorities. In particular, the Company must
obtain specific clearance or approval from the FDA before it
can market new products or certain modified products in the
United States. With the exception of one product, the
Company has, to date, obtained FDA marketing clearance only
through the 510(k) premarket notification process. Certain
products under development and future product applications,
however, will require approval through the more rigorous
Premarket Approval application ("PMA") process. The process
of obtaining such clearances or approvals can be time
consuming and expensive, and there can be no assurance that
all clearances or approvals sought by the Company will be
granted or that FDA review will not involve delays adversely
affecting the marketing and sale of the Company's products.
The Company is required to adhere to applicable regulations
setting forth current Good Manufacturing Practices ("GMP")
which require that the Company manufacture its products and
maintain its records in a prescribed manner with respect to
manufacturing, testing and control activities. In addition,
the Company is required to comply with FDA requirements for
labeling and promotion of its products. Failure to comply
with applicable federal, state or foreign laws or
regulations could subject the Company to enforcement action,
including product
-22-
seizures, recalls, withdrawal of clearances or approvals,
and civil and criminal penalties, any one or more of which
could have a material adverse effect on the Company.
Medical device laws and regulations with similar substantive
and enforcement provisions are also in effect in many of the
foreign countries where the Company does business. Federal,
state and foreign laws and regulations regarding the
manufacture and sale of medical devices are subject to
future changes. No assurance can be given that such changes
will not have a material adverse effect on the Company.
SIGNIFICANT COMPETITION AND CONTINUAL TECHNOLOGICAL CHANGE
The markets for medical devices are highly competitive.
The Company currently competes with many companies in the
development and marketing of catheters and related medical
devices. Some of the Company's competitors have access to
greater financial and other resources than the Company.
Furthermore, the markets for medical devices are
characterized by rapid product development and technological
change. The present or future products of the Company could
be rendered obsolete or uneconomical by technological
advances by one or more of the Company's current or future
competitors. The Company's future success will depend upon
its ability to develop new products and technology to remain
competitive with other developers of catheters and related
medical devices. The Company's business strategy emphasizes
the continued development and commercialization of new
products and the enhancement of existing products for the
critical care and interventional procedure markets. There
can be no assurance that the Company will be able to
continue to successfully develop new products and to enhance
existing products, to manufacture these products in a
commercially viable manner, to obtain required regulatory
approvals or to gain satisfactory market acceptance for such
products.
COST PRESSURES ON MEDICAL TECHNOLOGY AND PROPOSED HEALTH CARE REFORM
The Company's products are purchased principally by
hospitals, hospital networks and hospital buying groups.
Although the Company's products are used primarily for non-
optional medical procedures, the Company believes that the
overall escalating cost of medical products and services has
led and will continue to lead to increased pressures upon
the health care industry to reduce the cost or usage of
certain products and services, which has included and will
continue to include those of the Company. In the United
States, these cost pressures are leading to increased
emphasis on the price and cost-effectiveness of any
treatment regimen and medical device. In addition, third
party payors, such as governmental programs, private
insurance plans and managed care plans, which are billed by
hospitals for such health care services, are increasingly
negotiating the prices charged for medical products and
services and may deny reimbursement if they determine that a
device was not used in
-23-
accordance with cost-effective treatment methods as
determined by the payor, was experimental, unnecessary or
used for an unapproved indication. In international
markets, reimbursement systems vary significantly by
country. Many international markets have government managed
health care systems that control reimbursement for certain
medical devices and procedures and, in most such markets,
there also are private insurance systems which impose
similar cost restraints. There can be no assurance that
hospital purchasing decisions or government or private third
party reimbursement policies in the United States or in
international markets will not adversely affect the
profitability of the Company's products.
In recent years, several comprehensive health care
reform proposals have been introduced in the U.S. Congress.
While none of these proposals have to date been adopted, the
intent of these proposals was, generally, to expand health
care coverage for the uninsured and reduce the rate of
growth of total health care expenditures. In addition,
certain states have made significant changes to their
Medicaid programs and have adopted various measures to limit
costs. Implementation of government health care reform and
other private sector efforts to control costs may limit the
price of, or the level at which reimbursement is provided
for, the Company's products. Similar initiatives to limit
the growth of health care costs, including price regulation,
are also under way in several other countries in which the
Company does business. The Company anticipates that
Congress, state legislatures, foreign governments and the
private sector will continue to review and assess
alternative health care delivery and payment systems. The
Company cannot predict what additional legislation or
regulation, if any, relating to the health care industry may
be enacted in the future or what impact the adoption of any
federal, state or foreign health care reform, private sector
reform or market forces may have on its business. No
assurance can be given that any such reforms will not have a
material adverse effect on the medical device industry in
general, or the Company in particular.
DEPENDENCE ON PATENTS AND PROPRIETARY RIGHTS
The Company owns numerous U.S. and foreign patents and
has several U.S. and foreign patent applications pending.
The Company also has exclusive license rights to certain
patents held by third parties. These patents relate to
aspects of the technology used in certain of the Company's
products. From time to time, the Company is subject to
legal actions involving patent and other intellectual
property claims. Successful litigation against the Company
regarding its patents or infringement by the Company of the
patent rights of others could have a material adverse effect
on the Company. In addition, there can be no assurance that
pending patent applications will result in issued patents or
that patents issued to or licensed-in by the Company will
not be challenged or circumvented by competitors or found to
be valid or sufficiently broad to protect
-24-
the Company's technology or to provide it with any
competitive advantage. The Company also relies on trade
secrets and proprietary technology that it seeks to protect,
in part, through confidentiality agreements with employees,
consultants and other parties. There can be no assurance
that these agreements will not be breached, that the Company
will have adequate remedies for any breach, that others will
not independently develop substantially equivalent
proprietary information or that third parties will not
otherwise gain access to the Company's trade secrets.
There has been substantial litigation regarding patent
and other intellectual property rights in the medical
devices industry. Historically, litigation has been
necessary to enforce certain patent and trademark rights
held by the Company. Future litigation may be necessary to
enforce patent and other intellectual property rights
belonging to the Company, to protect trade secrets or know-
how owned by the Company or to defend the Company against
claimed infringement of the rights of others and to
determine the scope and validity of the proprietary rights
of the Company and others. Any such litigation could result
in substantial cost to and diversion of effort by the
Company. Adverse determinations in any such litigation
could subject the Company to significant liabilities to
third parties, could require the Company to seek licenses
from third parties and could prevent the Company from
manufacturing, selling or using certain of its products, any
of which could have a material adverse effect on the
Company's business, financial condition and results of
operations.
RISKS ASSOCIATED WITH INTERNATIONAL OPERATIONS
The Company generates significant sales outside the
United States and is subject to risks generally associated
with international operations, such as unexpected changes in
regulatory requirements, tariffs, customs, duties and other
trade barriers, difficulties in staffing and managing
foreign operations, longer payment cycles, problems in
collecting accounts receivable, political risks,
fluctuations in currency exchange rates, foreign exchange
controls which restrict or prohibit repatriation of funds,
technology export and import restrictions or prohibitions,
delays from customs brokers or government agencies and
potentially adverse tax consequences resulting from
operating in multiple jurisdictions with different tax laws,
which could materially adversely impact the success of the
Company's international operations. As its revenues from
its international operations increase, an increasing portion
of the Company's revenues and expenses are denominated in
currencies other than U.S. dollars, and changes in exchange
rates could have a greater effect on the Company's results
of operations. There can be no assurance that such factors
will not have a material adverse effect on the Company's
future operations and, consequently, on the Company's
business, results of operations and financial condition. In
addition, there can be no assurance that laws or
administrative practices relating to regulation of medical
devices, taxation, foreign exchange or other matters of
countries within which the Company operates will not change.
Any such change could have a material adverse effect on the
Company's business, financial condition and results of
operations.
-25-
POTENTIAL PRODUCT LIABILITY
The Company's business exposes it to potential product
liability risks which are inherent in the testing and
marketing of catheters and related medical devices. The
Company's products are often used in intensive care settings
with seriously ill patients. In addition, many of the
medical devices manufactured and sold by the Company are
designed to be implanted in the human body for long periods
of time and component failures, manufacturing flaws, design
defects or inadequate disclosure of product-related risks
with respect to these or other products manufactured or sold
by the Company could result in an unsafe condition or injury
to, or death of, the patient. The occurrence of such a
problem could result in product liability claims and/or a
recall of, or safety alert relating to, one or more of the
Company's products. There can be no assurance that the
product liability insurance maintained by the Company will
be available or sufficient to satisfy all claims made
against it or that the Company will be able to obtain
insurance in the future at satisfactory rates or in adequate
amounts. Product liability claims or product recalls in the
future, regardless of their ultimate outcome, could result
in costly litigation and could have a material adverse
effect on the Company's business or reputation or on its
ability to attract and retain customers for its products.
RISKS ASSOCIATED WITH DERIVATIVE FINANCIAL INSTRUMENTS
As a partial hedge against adverse fluctuations in
exchange rates, the Company periodically enters into foreign
currency exchange contracts with certain major financial
institutions. By their nature, all such contracts involve
risk, including the risk of nonperformance by
counterparties. Accordingly, losses relating to these
contracts could have a material adverse effect upon the
Company's business, financial condition and results of
operations. The Company's policy prohibits the use of
derivative instruments for speculative purposes.
DEPENDENCE ON KEY MANAGEMENT
The Company's success depends upon the continued
contributions of key members of its senior management team,
certain of whom have been with the Company since its
inception in 1975. Accordingly, loss of the services of one
or more of these key members of management could have a
material adverse effect on the business of the Company.
None of these individuals has an employment agreement with
the Company.
-26-
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<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
FINANCIAL STATEMENTS OF ARROW INTERNATIONAL, INC. FOR THE SIX MONTHS ENDED
FEBRUARY 28, 1997 AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH
FINANACIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000
<S> <C>
<PERIOD-TYPE> 6-MOS
<FISCAL-YEAR-END> AUG-31-1997
<PERIOD-END> FEB-28-1997
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<RECEIVABLES> 57,092
<ALLOWANCES> 842
<INVENTORY> 46,877
<CURRENT-ASSETS> 126,184
<PP&E> 166,357
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<SALES> 121,155
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<CGS> 55,383
<TOTAL-COSTS> 91,480
<OTHER-EXPENSES> 987
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<INTEREST-EXPENSE> 163
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<INCOME-TAX> 10,982
<INCOME-CONTINUING> 17,543
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