UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
(X) Quarterly Report Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
For the third quarter period ended May 31, 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.
----------------------------------------------------
(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.)
3000 Bernville Road, Reading, Pennsylvania 19605
- ------------------------------------------ ---------
(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 July 12, 1997
----- -----------------------------------
Common Stock, No Par Value 23,226,366
ARROW INTERNATIONAL, INC.
Form 10-Q Index
Page
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Consolidated Balance Sheets at May 31, 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 6. Exhibits and Reports on Form 8-K 17
Signature 18
Exhibit Index 19
-2-
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
ARROW INTERNATIONAL, INC.
CONSOLIDATED BALANCE SHEETS
(All Dollar Amounts in Thousands)
May 31, August 31,
1997 1996
----------- ----------
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 3,288 $ 4,807
Accounts receivable, net 56,576 50,093
Inventories 48,556 43,509
Prepaid expenses and other 9,492 9,575
Deferred income taxes 2,649 2,709
---------- ----------
Total current assets 120,561 110,693
---------- ----------
Property, plant and equipment:
Total property, plant and equipment 168,232 158,551
Less accumulated depreciation 57,809 49,552
---------- ----------
Property, plant and equipment, net 110,423 108,999
---------- ----------
Other assets:
Goodwill, net 49,498 51,754
Intangible and other assets, net 24,591 27,975
Deferred income taxes 467 -
---------- ----------
Total other assets 74,556 79,729
---------- ----------
Total assets $ 305,540 $ 299,421
========== ==========
See accompanying notes to consolidated financial statements.
Continued
-3-
ARROW INTERNATIONAL, INC.
CONSOLIDATED BALANCE SHEETS
(All Dollar Amounts in Thousands)
May 31, August 31,
1997 1996
---------- ----------
(unaudited)
LIABILITIES
Current liabilities:
Current maturities of long-term debt $ 3,552 $ 6,293
Notes payable 22,559 27,708
Accounts payable 4,597 8,078
Accrued liabilities 7,717 6,297
Accrued compensation 5,973 5,493
Accrued income taxes 2,289 1,738
---------- ----------
Total current liabilities 46,687 55,607
---------- ----------
Long-term debt 12,118 15,988
Accrued postretirement benefit obligation 7,909 7,577
Deferred income taxes - 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 207,521 183,502
Less cost of treasury stock:
3,252,447 and 3,249,194 shares
of Common Stock, respectively (8,366) (8,308)
Unearned compensation (293) (469)
Cumulative translation adjustment (3,208) (532)
Unrealized holding loss on
securities, net of tax (2,408) -
---------- ----------
Total shareholders' equity 238,826 219,773
---------- ----------
Total liabilities and
shareholders' equity $ 305,540 $ 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 May 31,
1997 1996
--------- ---------
Net sales $ 62,107 $ 57,548
Cost of goods sold 27,900 27,772
--------- ---------
Gross profit 34,207 29,776
Operating expenses:
Research, development and engineering 4,090 3,631
Selling, general and administrative 14,366 13,660
--------- ---------
Operating income 15,751 12,485
--------- ---------
Other expenses (income):
Interest expense, net
of amounts capitalized 186 418
Interest income (211) (244)
Other, net 338 670
--------- ---------
Other expenses (income), net 313 844
--------- ---------
Income before income taxes 15,438 11,641
Provision for income taxes 5,944 4,307
--------- ---------
Net income $ 9,494 $ 7,334
========= =========
Net income per common share $ .41 $ .32
========= =========
Cash dividends per common share $ .045 $ .04
========= =========
Weighted average shares
outstanding 23,226,428 23,229,437
========== ==========
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 Nine Months
Ended May 31,
1997 1996
--------- ---------
Net sales $ 183,262 $ 170,838
Cost of goods sold 83,283 80,158
--------- ---------
Gross profit 99,979 90,680
Operating expenses:
Research, development and engineering 11,891 10,030
Selling, general and administrative 42,663 39,558
--------- ---------
Operating income 45,425 41,092
--------- ---------
Other expenses (income):
Interest expense, net
of amounts capitalized 780 1,335
Interest income (642) (513)
Other, net 1,324 907
--------- ---------
Other expenses (income), net 1,462 1,729
--------- ---------
Income before income taxes 43,963 39,363
Provision for income taxes 16,926 14,564
--------- ---------
Net income $ 27,037 $ 24,799
========= =========
Net income per common share $ 1.17 $ 1.07
========= =========
Cash dividends per common share $ .13 $ .115
========= =========
Weighted average shares
outstanding 23,227,390 23,230,062
========== ==========
See accompanying notes to consolidated financial statements.
-6-
ARROW INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(All Dollar Amounts in Thousands)
For the Nine Months Ended May 31,
1997 1996
--------- ---------
Cash flows from operating activities:
Net income $ 27,037 $ 24,799
Adjustments to reconcile net income to
net cash provided by operating activities:
Depreciation 8,257 7,324
Amortization of intangible assets 2,910 2,385
Amortization of unearned compensation 151 159
Deferred income taxes (882) 1,112
Other (644) (219)
Changes in operating assets and liabilities:
Accounts receivable (6,592) (4,763)
Inventories (5,047) (7,348)
Prepaid expenses and other 83 (3,587)
Accounts payable and accrued liabilities (2,062) 663
Accrued compensation 480 (1,341)
Accrued income taxes 551 (527)
--------- ---------
Total adjustments (2,795) (6,142)
--------- ---------
Net cash provided by operating activities 24,242 18,657
Cash flows from investing activities:
Capital expenditures (9,681) (18,236)
Purchase of intangible assets (1,269) (14,266)
--------- ---------
Net cash used in investing activities (10,950) (32,502)
Cash flows from financing activities:
(Decrease) increase in notes payable (5,148) 17,533
Principal payments of long-term debt (6,611) (6,999)
Dividends paid (3,020) (2,671)
Purchase of treasury stock (32) (43)
--------- ---------
Net cash (used in)
provided by financing activities (14,811) 7,820
Net change in cash and cash equivalents (1,519) (6,025)
Cash and cash equivalents at
beginning of year 4,807 9,453
--------- ---------
Cash and cash equivalents at end of period $ 3,288 $ 3,428
========= =========
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 Nine Months
Ended May 31,
1997 1996
--------- ----------
Supplemental disclosure of cash flow information:
Cash paid during the year for:
Interest (net of amounts capitalized) $ 780 $ 1,335
Income taxes $ 15,110 $ 14,657
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. All dollar amounts are presented in thousands, except
per share amounts.
Note 2 - Inventories
Inventories are summarized as follows:
May 31, August 31,
1997 1996
--------- ---------
Finished goods $ 17,207 $ 16,878
Semi-finished goods 12,937 10,010
Work-in-process 6,659 7,107
Raw materials 11,753 9,514
--------- ---------
$ 48,556 $ 43,509
========= =========
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 adverse effect on the Company's
financial position or results of operations.
Continued
-9-
ARROW INTERNATIONAL, INC.
Notes to Consolidated Financial Statements
(unaudited)
(All Dollar Amounts in Thousands, Except Per Share Data)
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
$113 and $330 and $375 for the cost of such utilization
during the three months and nine months ended May 31, 1997
and 1996, respectively. The Company made purchases from
Precision amounting to $338 and $255 and $1,029 and $843 for
the three months and nine months ended May 31, 1997 and
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
$162 and $294 and $609 and $739 for the three months and
nine months ended May 31, 1997 and 1996, respectively. At
May 31, 1997 and 1996, the Company had a net receivable from
Precision amounting to $48 and $145, 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 Earnings Per Share ("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 EPS amounts
computed under the present accounting standard.
-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 May 31, 1997 Compared to Three Months
Ended May 31, 1996
Net sales for the three months ended May 31, 1997 increased
by $4.6 million, or 7.9%, to $62.1 million from $57.5
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 10.7% to $52.4 million from $47.4 million in the
comparable prior period. Interventional procedure product
sales decreased to $9.6 million from $10.1 million, a
decrease of 4.5% over the comparable prior period, due
primarily to lower sales of intra-aortic balloon (I.A.B.)
products in Japan where these products have been sold by an
independent distributor and lower U.S. sales of I.A.B.
pumps, which, due to market conditions,
are increasingly placed in hospitals at no charge in return
for commitments to purchase I.A.B. catheters. In July 1997 the
Company will begin to assume direct sales responsibility for these
products in Japan, although sales may be negatively
affected for the balance of 1997 as distributor inventory is
depleted. International sales increased by $0.5 million, or
2.0%, representing 36.5% of net sales, excluding royalty
income, for the three months ended May 31, 1997, compared to
38.6% of net sales 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, which
reduced net sales relative to the comparable prior year period
by $1.9 million, and lower sales of I.A.B. products in Japan.
-11-
ARROW INTERNATIONAL, INC.
Gross profit increased 14.9% to $34.2 million in the three
months ended May 31, 1997 from $29.8 million in the same
period of fiscal 1996. As a percentage of net sales, gross
profit increased to 55.1% during the three months ended May
31, 1997 from 51.7% in the comparable period of fiscal 1996,
due principally to the reduction in manufacturing costs
resulting 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
12.6% to $4.1 million in the three months ended May 31, 1997
from $3.6 million in the comparable prior period. As a
percentage of net sales, these expenses increased in the
third quarter of fiscal of 1997 to 6.6%, compared to 6.3% 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.
Selling, general and administrative expenses increased by
5.2% to $14.4 million in the three months ended May 31, 1997
from $13.7 million in the comparable prior period of fiscal
1996 due primarily to an increase in expenses related to the
amortization of certain intangible assets. Selling, general
and administrative expenses decreased as a percentage of net
sales to 23.1% in the third quarter of fiscal 1997 from
23.7% in the comparable period of fiscal 1996.
Principally due to the above factors, operating income
increased in the third quarter of fiscal 1997 by 26.2% to
$15.8 million from $12.5 million in the comparable period of
fiscal 1996.
Other expenses (income), net, decreased to $0.3 million
during the third quarter of fiscal 1997 from $0.8 million in
the comparable prior period. Other expenses (income), net,
consist principally of interest expense and gains and losses
on foreign exchange transactions associated with the
Company's direct sales subsidiaries, which resulted in a net
loss in both periods.
-12-
ARROW INTERNATIONAL, INC.
As a result of the factors discussed above, income before
income taxes increased by 32.6% to $15.4 million in the
third quarter of fiscal 1997 from $11.6 million in the
comparable prior period. For the third quarter of fiscal
1997, and for the remainder of fiscal 1997, the Company's
effective 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 in the third quarter of fiscal 1997 increased by
29.5% to $9.5 million from $7.3 million in the comparable
prior period. As a percentage of net sales, net income
represented 15.3% in the three months ended May 31, 1997,
compared to 12.7% in the comparable period of fiscal 1996.
Net income per common share was $.41 in the three month
period ended May 31, 1997, an increase of 29.5%, or $.09 per
share, from $.32 per share in the comparable prior period.
Weighted average common shares outstanding decreased to
23,226,428 in the third quarter of fiscal 1997 from
23,229,437 in the comparable prior period.
Nine Months Ended May 31, 1997 Compared to Nine Months Ended
May 31, 1996
Net sales for the nine months ended May 31, 1997 increased
by $12.4 million, or 7.3%, to $183.3 million from $170.8
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 increased
shipments of ARROWg+ard Blue trademark antiseptic surface treated
catheter products. Sales of critical care products
increased 9.8% to $154.7 million from $141.0 million in the
comparable prior period. Interventional procedure product
sales decreased to $28.4 million from $29.3 million, a
decrease of 3.3% over the comparable prior period, due
primarily to lower sales of intra-aortic balloon (I.A.B.)
products in Japan where these products have been sold by an
independent distributor and lower U.S. sales of I.A.B.
pumps, which, due to market conditions, are
increasingly placed in hospitals at no charge in return
for commitments to purchase I.A.B. catheters.
In July 1997 the Company will begin to assume direct sales
responsibility for these products in Japan, although
sales may be negatively affected for the balance
of 1997 as distributor inventory is depleted. International
sales increased by $2.1 million, or 3.3%, representing
36.0% of net sales, excluding royalty income,
for the nine months ended May 31, 1997, compared to
37.4% of net sales 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,
which reduced net sales relative to the comparable prior
year period by $5.0 million and lower sales of I.A.B.
products in Japan.
-13-
ARROW INTERNATIONAL, INC.
Gross profit increased 10.3% to $100.0 million in the nine
months ended May 31, 1997, compared to $90.7 million in the
same period of fiscal 1996. As a percentage of net sales,
gross profit increased to 54.6% during the nine months ended
May 31, 1997 from 53.1% in the comparable period of fiscal
1996, due principally to the reduction in manufacturing
costs resulting 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
18.5% to $11.9 million in the nine months ended May 31, 1997
from $10.0 million in the comparable prior period. As a
percentage of net sales, these expenses increased in the
first nine months of fiscal 1997 to 6.5%, compared to 5.9%
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.
Selling, general and administrative expenses increased by
7.8% to $42.7 million in the nine months ended May 31, 1997
from $39.6 million in the comparable prior period and
increased as a percentage of net sales to 23.3% in the first
nine months of fiscal 1997 from 23.1% in the comparable
period of fiscal 1996. This percentage increase was due
primarily to an increase in expenses related to the
amortization of certain intangible assets and additions to
the domestic direct sales force to replace in December 1995 a
distributor in the New England area.
Principally due to the above factors, operating income
increased in the first nine months of fiscal 1997 by 10.5%
to $45.4 million from $41.1 million in the comparable period
of fiscal 1996.
Other expenses (income), net, decreased to $1.5 million in
the first nine months of fiscal 1997 from $1.7 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 first nine months of fiscal
1997 by 11.7% to $44.0 million from $39.4 million in the
comparable prior period. 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.
-14-
ARROW INTERNATIONAL, INC.
Net income in the first nine months of fiscal 1997 increased
by 9.0% to $27.0 million from $24.8 million in the
comparable prior period. As a percentage of net sales, net
income represented 14.8% during the nine months ended May
31, 1997 compared to 14.5% in the comparable period of
fiscal 1996.
Net income per common share was $1.17 in the nine month
period ended May 31, 1997, an increase of 9.0%, or $.10 per
share, from $1.07 per share in the comparable prior period.
Weighted average common shares outstanding decreased to
23,227,390 from 23,230,062 in the comparable prior period.
Liquidity and Capital Resources
For the nine months ended May 31, 1997, net cash provided by
operations was $24.2 million, an increase of $5.6 million
from the same period in the prior year. Accounts receivable
increased by $6.6 million in the nine months ended May 31,
1997, compared to a $4.8 million increase in the same period
of fiscal 1996. Accounts receivable, measured in day sales
outstanding during the period, increased to 84 days at May
31, 1997 from 78 days at May 31, 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 $10.9 million in the nine months ended May 31,
1997 from $32.5 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 $14.8 million in the nine month
period ended May 31, 1997, whereas such activities provided
$7.8 million in the comparable period of fiscal 1996,
changing principally as a result of repayments of borrowings
under the Company's revolving credit facilities and of long-
term debt.
As of May 31, 1997, the Company had U.S. bank credit
facilities providing a total of $60.0 million in revolving
credit for general business purposes, of which $41.5 million
remained unused. In addition, certain of the Company's
foreign subsidiaries have revolving credit facilities
totaling the U.S. dollar equivalent of $13.4 million, of
which $9.3 million remained unused as of May 31, 1997.
Combined borrowings under these facilities decreased $5.1
million during the nine month period ended May 31, 1997.
-15-
ARROW INTERNATIONAL, INC.
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.
During the nine month periods ended May 31, 1997 and 1996,
the percentage of the Company's sales invoiced in currencies
other than U.S. dollars was 24.7% and 26.7%, respectively.
As of May 31, 1997, outstanding foreign currency exchange
contracts totaling the U.S. dollar equivalent of $22.1
million mature at various dates through December 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.
During the periods discussed above, the overall effects of
inflation and seasonality on the Company's business were not
significant.
-16-
ARROW INTERNATIONAL, INC.
PART II. OTHER INFORMATION
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 10.11.1 Modification Agreement, dated
October 25, 1995, to License
Agreement between Daltex Medical
Sciences, Inc. and the Company
Exhibit 10.11.2 Second Modification Agreement,
dated May 30, 1997, to License
Agreement between Daltex Medical
Sciences, Inc. and the Company
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 May 31, 1997.
-17-
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: July 15, 1997 By: /s/ John H. Broadbent, Jr.
---------------------------
(signature)
John H. Broadbent, Jr.
Vice President-Finance
and Treasurer (Principal
Financial Officer and
Chief Accounting Officer)
-18-
EXHIBIT INDEX
EXHIBIT DESCRIPTION
NUMBER OF EXHIBIT METHOD OF FILING
- ------- ---------- ----------------
10.11.1 Modification Agreement, Filed with this Report
dated October 25, 1995,
to License Agreement
between Daltex Medical
Sciences, Inc. and the
Company
10.11.2 Second Modification Filed with this Report
Agreement, dated May 30,
1997, to License
Agreement between Daltex
Medical Sciences, Inc.
and the Company
27 *Financial Data Schedule EDGAR
99.1 Cautionary Statement for Page 20 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.
-19-
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
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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
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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
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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.
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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.
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