<PAGE>
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 SEPTEMBER 30, 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: 0-21330
AVECOR CARDIOVASCULAR INC.
(Exact name of registrant as specified in its charter)
MINNESOTA 41-1695729
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
7611 NORTHLAND DRIVE, MINNEAPOLIS, MINNESOTA 55428
(Address of principal executive offices) (Zip Code)
(612) 391-9000
(Registrant's telephone number, including area code)
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 such shorter period that the registrant
was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
[ X ] Yes [ ] No
As of November 4, 1997, there were 7,961,548 shares of the registrant's
$.01 par value Common Stock outstanding.
<PAGE>
INDEX
Part I. FINANCIAL INFORMATION Page(s)
Item 1. Financial Statements
Consolidated Balance Sheets as of September 30,
1997 (Unaudited) and December 31, 1996.............. 3
Consolidated Statements of Operations for the
three and nine months ended September 30, 1997 and
1996 (Unaudited)................................... 4
Consolidated Statements of Cash Flows for the
nine months ended September 30, 1997 and 1996
(Unaudited)......................................... 5
Notes to Consolidated Financial Statements
(Unaudited)......................................... 6 - 8
Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations................. 9 - 16
Item 3. Quantitative and Qualitative Disclosures About
Market Risk......................................... 16
Part II. OTHER INFORMATION
Item 1. Legal Proceedings................................... 17
Item 2. Changes in Securities............................... 17
Item 3. Defaults Upon Senior Securities..................... 17
Item 4. Submission of Matters to a Vote of Security
Holders............................................. 17
Item 5. Other Information................................... 17
Item 6. Exhibits and Reports on Form 8-K.................... 17
SIGNATURES......................................................... 18
EXHIBIT INDEX..................................................... 19
2
<PAGE>
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
AVECOR CARDIOVASCULAR INC.
CONSOLIDATED BALANCE SHEETS
<TABLE>
<CAPTION>
ASSETS September 30, December 31,
1997 1996
------------- ------------
(Unaudited)
<S> <C> <C>
Current assets:
Cash and cash equivalents................................ $ 2,187,000 $ 6,114,000
Short-term investments................................... 3,879,000 2,638,000
Accounts receivable, net................................. 8,059,000 7,298,000
Inventories.............................................. 11,596,000 9,476,000
Deferred tax asset....................................... 803,000 1,274,000
Other current assets..................................... 345,000 744,000
------------- ------------
Total current assets.................................. 26,869,000 27,544,000
Restricted cash and investments............................. -- 4,450,000
Property, plant and equipment, net.......................... 15,271,000 4,808,000
Other assets................................................ 608,000 359,000
------------- ------------
Total assets.......................................... $42,748,000 $37,161,000
------------- ------------
------------- ------------
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable......................................... $ 2,771,000 $ 2,790,000
Accrued expenses......................................... 2,865,000 3,091,000
Accrued litigation settlement............................ -- 1,100,000
Current portion of long-term debt........................ 258,000 --
------------- ------------
Total current liabilities............................. 5,894,000 6,981,000
Deferred grant.............................................. 161,000 205,000
Deferred tax liability...................................... 37,000 37,000
Long-term debt.............................................. 4,758,000 --
Shareholders' equity:
Serial preferred stock, par value $.01 per share;
authorized 2,000,000 shares; none issued
Common stock, par value $.01 per share;
authorized 20,000,000 shares; issued and
outstanding 7,961,000 and 7,812,000
shares at September 30, 1997 and
December 31, 1996, respectively...................... 80,000 78,000
Additional paid-in capital............................... 29,992,000 29,024,000
Retained earnings........................................ 1,764,000 609,000
Cumulative translation adjustment........................ 62,000 227,000
------------- ------------
Total shareholders' equity............................ 31,898,000 29,938,000
------------- ------------
Total liabilities and shareholders' equity............ $42,748,000 $37,161,000
------------- ------------
------------- ------------
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements.
3
<PAGE>
AVECOR CARDIOVASCULAR INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
<TABLE>
<CAPTION>
Three months ended Nine months ended
September 30, September 30,
-------------------------- --------------------------
1997 1996 1997 1996
----------- ----------- ----------- ------------
<S> <C> <C> <C> <C>
Net sales......................................... $11,273,000 $11,314,000 $35,277,000 $32,753,000
Cost of sales..................................... 6,488,000 6,780,000 20,448,000 19,175,000
----------- ----------- ----------- ------------
Gross profit............................... 4,785,000 4,534,000 14,829,000 13,578,000
Operating expenses:
Selling, general and
administrative............................. 3,371,000 2,807,000 10,203,000 8,657,000
Litigation expense............................. -- -- -- 4,205,000
Research and development....................... 854,000 908,000 2,930,000 2,611,000
----------- ----------- ----------- ------------
Operating income (loss).................... 560,000 819,000 1,696,000 (1,895,000)
Interest income................................ 114,000 167,000 387,000 570,000
Interest expense............................... (104,000) -- (280,000) --
----------- ----------- ----------- ------------
Income (loss) before income taxes................. 570,000 986,000 1,803,000 (1,325,000)
Income tax provision (benefit).................... 205,000 358,000 648,000 (289,000)
----------- ----------- ----------- ------------
Net income (loss)......................... $365,000 $628,000 $1,155,000 ($1,036,000)
----------- ----------- ----------- ------------
----------- ----------- ----------- ------------
Net income (loss) per share....................... $0.05 $0.08 $0.15 ($0.13)
----------- ----------- ----------- ------------
----------- ----------- ----------- ------------
Weighted average common
and common equivalent
shares outstanding.............................. 8,004,000 8,026,000 7,969,000 7,755,000
----------- ----------- ----------- ------------
----------- ----------- ----------- ------------
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements.
4
<PAGE>
AVECOR CARDIOVASCULAR INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
<TABLE>
<CAPTION>
For the nine months ended September 30,
----------------------------------------
1997 1996
------------------- -------------------
<S> <C> <C>
Cash flows from operating activities:
Net income (loss)............................................. $ 1,155,000 ($1,036,000)
Adjustments to reconcile net income (loss) to net cash
used in operating activities:
Depreciation and amortization............................... 1,210,000 988,000
Deferred taxes ............................................. 471,000 --
Accretion of discount on investments........................ (233,000) (412,000)
Changes in operating assets and liabilities:
Accounts receivable....................................... (906,000) (1,650,000)
Inventories............................................... (2,122,000) (3,419,000)
Other current assets...................................... 383,000 (1,001,000)
Accounts payable.......................................... 409,000 (182,000)
Accrued expenses.......................................... (186,000) 882,000
Accrued litigation settlement............................. (1,100,000) 1,100,000
------------- -------------
Net cash used in operating activities................... (919,000) (4,730,000)
------------- -------------
Cash flows from investing activities:
Purchase of property, plant and equipment..................... (11,121,000) (1,775,000)
Purchase of investments....................................... (8,768,000) (8,407,000)
Proceeds upon sale or maturity of short-term
investments................................................. 7,760,000 8,966,000
Cash and investments restricted as to use..................... 3,450,000 --
Increase in other assets...................................... (259,000) (33,000)
------------- -------------
Net cash used in investing activities................... (8,938,000) (1,249,000)
------------- -------------
Cash flows from financing activities:
Net proceeds from sales of common stock....................... 224,000 189,000
Net proceeds from options exercised........................... 718,000 (77,000)
Net proceeds from warrants exercised.......................... 28,000 525,000
Borrowings on long-term debt.................................. 5,167,000 --
Principal payments on long-term debt.......................... (151,000) --
Grant proceeds................................................ -- 101,000
------------- -------------
Net cash provided by financing activities............... 5,986,000 738,000
------------- -------------
Effect of exchange rates on cash................................ (56,000) 7,000
------------- -------------
Net decrease in cash and cash equivalents....................... (3,927,000) (5,234,000)
Cash and cash equivalents at beginning of period................ 6,114,000 9,178,000
------------- -------------
Cash and cash equivalents at end of period...................... $2,187,000 $3,944,000
------------- -------------
------------- -------------
Significant non-cash investing and financing transactions:
Use of restricted funds for purchase of the U.S.
facility...................................................... $1,000,000 --
------------- -------------
------------- -------------
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements.
5
<PAGE>
AVECOR CARDIOVASCULAR INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. BASIS OF PRESENTATION
The consolidated financial statements included in this Form 10-Q have been
prepared by AVECOR Cardiovascular Inc. (the Company), without audit, pursuant
to the rules and regulations of the Securities and Exchange Commission (SEC).
Certain information and footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles
have been condensed, or omitted, pursuant to these rules and regulations. The
year-end balance sheet was derived from audited financial statements, but does
not include all disclosures required by generally accepted accounting
principles. These unaudited consolidated interim financial statements should
be read in conjunction with the financial statements and related notes included
in the Company's 1996 Annual Report on Form 10-K as filed with the SEC.
The consolidated interim financial statements presented herein as of
September 30, 1997 and for the three and nine month periods ended September 30,
1997 and 1996 reflect, in the opinion of management, all adjustments (which
include only normal, recurring adjustments) necessary for a fair presentation
of financial position and the results of operations and cash flows for the
periods presented. The results of operations for any interim period are not
necessarily indicative of results for the full year.
2. ORGANIZATION
The Company was incorporated on December 13, 1990. The Company designs,
develops, manufactures and markets specialty medical devices for heart/lung
bypass surgery and long-term respiratory support.
The consolidated financial statements include the accounts of AVECOR
Cardiovascular Inc. and its wholly-owned subsidiaries, AVECOR Cardiovascular
Ltd. and AVECOR Foreign Sales Corporation after elimination of all significant
intercompany transactions and accounts.
6
<PAGE>
3. INVENTORIES
Inventories consist of the following:
September 30, December 31,
1997 1996
------------- ------------
(Unaudited)
Raw materials $ 4,296,000 $3,424,000
Work-in-process 1,939,000 2,343,000
Finished goods 5,361,000 3,709,000
------------- ------------
$11,596,000 $9,476,000
------------- ------------
------------- ------------
4. INDUSTRY SEGMENT INFORMATION
The Company distributes its products through its direct sales force and
independent sales representatives in the United States, Canada, the United
Kingdom and France. Additionally, the Company distributes its products through
foreign independent distributors who then market the products directly to
medical institutions. During the quarter ended September 30, 1997, the Company
terminated agreements with its last remaining domestic distributor and its only
Canadian distributor. A direct sales force will now serve the markets formerly
assigned to these distributors. No one independent distributor accounted for
10% or more of the Company's net sales for the nine months ended September 30,
1997 and 1996.
Total export sales from the U.S. to unaffiliated entities (primarily to
Europe and payable in U.S. dollars) were $951,000 and $3,514,000, respectively,
for the three and nine month periods ended September 30, 1997. Sales to
customers located outside of the United States were approximately 40% and 41%
of net sales for the three and nine month periods ended September 30, 1997,
respectively, compared to 40% and 39% of net sales for the three and nine month
periods ended September 30, 1996, respectively.
At September 30, 1997, consolidated accounts receivable include $4,160,000
due from customers located outside of the U.S.
5. NEW ACCOUNTING PRONOUNCEMENT
In February 1997, the Financial Accounting Standards Board issued
Statement No. 128, a new standard for computing and presenting earnings per
share. The Company is required to adopt the new standard in the fourth quarter
of 1997; earlier adoption is not permitted. The Company expects that earnings
per share computed under the new standard will approximate earnings per share
currently reported.
6. PATENT MATTERS
In March 1997, the Company filed suit in U.S. District Court for the
District of Minnesota, seeking to invalidate a newly issued U.S. patent held by
a competing manufacturer of blood oxygenators and other medical devices, and
requesting a determination that the Company's
7
<PAGE>
Affinity oxygenator does not infringe the competitor's patent. The Company
filed suit in response to a December 1996 letter from the competitor,
alleging that the Affinity oxygenator infringes certain claims under the
competitor's patent, and requesting discussion regarding a possible license
agreement. The Company reviewed the subject patent and concluded, based on
an opinion from its patent counsel, that none of the claims in the patent are
infringed by the Affinity oxygenator, and that the patent is, in any event,
invalid. However, the expense and effort potentially required to bring this
action, as well as the outcome of any counterclaim successfully brought
against the Company by the competitor, could have a material adverse effect
on the Company's business, financial condition and results of operations.
See Part II, Item 1, "Legal Proceedings".
8
<PAGE>
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
The following is a discussion of the results of operations and financial
condition for the three and nine month periods ended September 30, 1997
compared with the three and nine month periods ended September 30, 1996 and
should be read in conjunction with the Company's Consolidated Financial
Statements and Notes thereto.
OVERVIEW
The Company was incorporated on December 13, 1990 and in June 1991
acquired the business and assets and assumed certain liabilities of the
surgical division of SCIMED Life Systems, Inc. (the Predecessor Business). On
December 1, 1992, the Company exchanged 160,000 shares of its Common Stock for
all of the outstanding shares of AVECOR Cardiovascular Ltd. (formerly Cardio
Med Ltd.) pursuant to which AVECOR Cardiovascular Ltd. became a wholly-owned
subsidiary of the Company. AVECOR Cardiovascular Ltd. had formerly been a
distributor for the Company in the United Kingdom. In October 1995, the
Company opened a sales office in France which is organized as a wholly-owned
subsidiary of AVECOR Cardiovascular Ltd.
The assets acquired by the Company from the Predecessor Business included
the Company's line of solid silicone membrane oxygenators. Since that time,
the Company has been successful in developing and obtaining marketing clearance
for a number of its proprietary products, with the goal of developing and
marketing a more complete line of proprietary products used in the heart/lung
bypass circuit. The Company began marketing its Myotherm cardioplegia delivery
system in October 1991, and began marketing its Signature custom tubing packs
in July 1993 following receipt of marketing clearance from the U.S. Food and
Drug Administration (the FDA). The Company began marketing its Affinity
oxygenator internationally in July 1993 and in the United States in February
1994, following receipt of marketing clearance from the FDA in November 1993.
The Company received marketing clearance from the FDA to market its Affinity
blood reservoirs and Affinity arterial filter in July 1994 and October 1995,
respectively. In connection with the Company's continuing efforts to offer a
more complete line of proprietary heart/lung bypass circuit products, the
Company has developed an improved Myotherm cardioplegia system and a new blood
pump. In July and August 1997, clearances were received from the FDA to market
the improved Myotherm cardioplegia system and the new blood pump, respectively.
Also, in October 1997, the Company filed a 510(k) pre-market notification with
the FDA to market its Affinity oxygenator with Trillium bio-passive surface.
9
<PAGE>
RESULTS OF OPERATIONS
NET SALES
THREE MONTHS ENDED SEPTEMBER 30, 1997 COMPARED TO THE THREE MONTHS ENDED
SEPTEMBER 30, 1996
Net sales decreased .4% to $11,273,000 for the three months ended
September 30, 1997 from $11,314,000 for the three months ended September 30,
1996. This decrease was principally the result of a lower volume of product
shipments of the Company's silicone membrane oxygenator line, as expected, and
the Affinity product line. These decreases were mostly offset by an increase
in product shipments of the Signature custom tubing pack line. Overall,
average prices of product shipments declined slightly when compared to the
corresponding period in 1996.
Sales from the silicone membrane oxygenator and Affinity product lines
decreased approximately $273,000 and $184,000, respectively. Sales increases
of $379,000 associated with the Signature custom pack line offset the majority
of these decreases.
During the quarter ended September 30, 1997, the Company terminated
agreement with its last remaining United States distributor and its only
Canadian distributor. Both distributors have an inventory of the Company's
products which are being sold to medical institutions, however, the Company's
products are not being replenished into the distributors' inventories. Sales
to these distributors decreased approximately $500,000 in the quarter ended
September 30, 1997 as compared to the quarter ended September 30, 1996. These
markets will now be served by the Company's direct sales force. While
management believes these revenue declines are temporary and caused by the
transition to a direct sales force in these territories, this forward-looking
expectation is primarily dependent on the ability of the direct sales personnel
to maintain and develop relations and revenue levels at the medical
institutions previously served by these distributors.
Revenues from distributors in three continental European countries
declined about $750,000 for the three months ended September 30, 1997 when
compared to the corresponding quarter in 1996. During the year ended September
30, 1997, currencies in each of the countries served by these distributors have
weakened about 20% as compared to the U.S. dollar and the U.K. pound sterling.
The Company believes that these types of fluctuations in currency exchange
rates reduce demand for the Company's products by increasing the price of the
Company's products in the currency of the countries in which the product is
sold. The Company cannot predict when, if ever, these exchange rate variances
will reverse.
Sales to the Company's Mexican distributor declined about $160,000 in the
quarter ended September 30, 1997 when compared to the quarter ended September
30, 1996. On October 9, 1997, the Company entered into an agreement with St.
Jude Medical to distribute the Company's products in Mexico and in Central and
South America. Previous sales in these countries have not been significant to
the Company.
10
<PAGE>
The aforementioned factors impacted all of the Company's product lines.
The revenue declines discussed above were virtually offset by revenue growth in
the Company's other domestic and foreign markets.
Sales to customers located outside of the United States were approximately
40% of net sales for the three month periods ended September 30, 1997 and 1996.
The Company has continued to experience decreased sales to contract
perfusion groups controlled by certain of its competitors. Sales to contract
perfusion groups controlled by one of the Company's competitors decreased
$135,000 to $233,000 for the three months ended September 30, 1997 from
$368,000 for the three months ended September 30, 1996. The Company believes
that control of contract perfusion groups by its competitors will continue to
have a negative impact on the Company's ability to market its products to such
groups or to hospitals or other medical providers that contract with competitor-
controlled groups for perfusion services, and could have a material adverse
effect on the Company's business, financial condition and results of operation.
This forward-looking statement is subject to the degree of control exerted by
the Company's competitors with respect to purchasing decisions made by
controlled groups of perfusionists, the extent of future acquisitions of
contract perfusion groups by the Company's competitors, the breadth of the
Company's product offerings relative to those competitors controlling contract
perfusion groups, and the degree to which the Company's research and
development and marketing efforts result in the successful commercialization of
products with enhanced or superior performance characteristics.
NINE MONTHS ENDED SEPTEMBER 30, 1997 COMPARED TO THE NINE MONTHS ENDED
SEPTEMBER 30, 1996
Net sales increased 8% to $35,277,000 for the nine months ended September
30, 1997 from $32,753,000 for the nine months ended September 30, 1996. This
increase was principally the result of a higher volume of product shipments of
the Company's Signature custom tubing packs and Affinity product line.
Overall, average prices of product shipments declined slightly when compared to
the corresponding period in 1996.
Sales from Signature custom tubing packs and the Affinity product line
accounted for approximately 76% and 50% of the overall increase in net sales,
respectively. As expected, the silicone membrane oxygenator line net sales
decreased by $637,000 offsetting 25% of the overall increase in net sales for
the nine months ended September 30, 1997 when compared to the corresponding
period in 1996.
Sales to customers located outside of the United States were approximately
41% of net sales for the nine month period ended September 30, 1997 compared to
39% of net sales for the corresponding period in 1996.
Sales to contract perfusion groups controlled by one of the Company's
competitors decreased $535,000 to $949,000 for the nine months ended September
30, 1997 from $1,484,000 for the nine months ended September 30, 1996.
11
<PAGE>
COST OF SALES / GROSS PROFIT
Cost of sales as a percentage of net sales decreased to 57.6% for the
three months ended September 30, 1997 from 59.9% for the three months ended
September 30, 1996. The cost of sales percentage for the nine months ended
September 30, 1997 decreased slightly to 58.0% from 58.5% for the nine months
ended September 30, 1996. The cost of sales percentage for the three and nine
month periods ended September 30, 1997 were favorably impacted by improved raw
material costs and increased manufacturing efficiencies due to greater
production volumes and the Company's move into one facility. These
improvements for the three and nine month periods ended September 30, 1997 were
partially offset by significant increases in sales of the Company's lower-
margin Signature custom tubing pack line, as well as competitive pricing
pressures in the marketplace. The mix of products sold in any period will
influence the cost of sales and gross profit for the period.
Affinity oxygenator product costs continue to improve due to efficiency
and material cost improvements, although these improvements were largely offset
by an ongoing decrease in average selling prices.
The Company's future gross profit margin percentages will be influenced by
the ongoing pressures of the competitive pricing environment, changes in the
sales mix, new product introductions and the extent of further product cost
improvements through increased manufacturing efficiencies and reduced material
costs, if any. Given the uncertainty associated with new product
introductions, the ultimate realization of any such product cost improvements
and the continuing price pressures in the Company's markets, the Company cannot
be certain if its gross profit margin percentage will be maintained, improve or
decline.
SELLING, GENERAL AND ADMINISTRATIVE AND LITIGATION EXPENSE
Selling, general and administrative expenses increased 20% to $3,371,000
for the three months ended September 30, 1997 from $2,807,000 for the three
months ended September 30, 1996. Selling, general and administrative expenses
increased 18% to $10,203,000 for the nine months ended September 30, 1997 from
$8,657,000 for the nine months ended September 30, 1996. These increases are
primarily attributed to costs associated with the continuing development of a
direct sales force in certain of the Company's territories formerly served by
distributors and independent sales representatives and costs incurred for the
introduction of new products, including the new blood pump. As a percent of
sales, selling, general and administrative expenses increased to 29.9% and
28.9% for the three and nine month periods ended September 30, 1997,
respectively, from 24.8% and 26.4% for the three and nine month periods ended
September 30, 1996, respectively.
Management anticipates that selling, general and administrative expenses
for the year ended December 31, 1997 will continue to be about 20% higher than
the year ended December 31, 1996 and will be slightly higher than 1996 as a
percentage of sales. These forward-looking statements will be influenced by
revenue increases achieved by the Company, its ability to attract and retain
qualified sales personnel as the Company continues to develop its direct sales
force, and the timing and extent of promotional activities associated with new
product introductions, if any.
12
<PAGE>
On July 17, 1996, the Company reached an agreement with COBE Laboratories
Inc. (COBE) to settle COBE's patent suit against the Company. The terms of
the settlement with COBE provide for the Company to make net payments totaling
$2,200,000, of which a net $1,100,000 was paid in August 1996. The remaining
$1,100,000 was paid in August 1997. The Company expensed settlement costs and
professional fees, in connection with the COBE suit, of approximately
$4,205,000 for the nine month period ended September 30, 1996. All expenses
related to the COBE matter were recorded during the six months ended June 30,
1996. No related expenses were incurred for the three and nine month periods
ended September 30, 1997.
RESEARCH AND DEVELOPMENT
Research and development expenses decreased 6% to $854,000 for the three
month period ended September 30, 1997 and increased 12% to $2,930,000 for the
nine month period ended September 30, 1997 from $908,000 and $2,611,000 for the
three and nine month periods ended September 30, 1996, respectively. The
decreased spending associated with the three month comparison is a result of
the completion or near completion of major projects including the blood pump
and improved Myotherm cardioplegia system (Myotherm XP) which received
marketing clearances from the FDA in July and August 1997, respectively, and
the Affinity oxygenator with Trillium bio-passive surface for which a 510(k)
pre-market notification was filed with the FDA in October 1997. The increased
research and development spending for the nine month comparison is a result of
the Company's ongoing efforts to pursue a number of potential product
opportunities including the blood pump, Myotherm XP and Affinity oxygenator
with Trillium bio-passive surface. There can be no assurance that the improved
Myotherm cardioplegia system or the blood pump will become commercially
successful. Additionally, there can be no assurance that the Affinity
oxygenator with Trillium bio-passive surface will receive the appropriate
marketing clearance from the FDA on a timely basis, if at all, or, if received,
that this device will become commercially successful.
The Company anticipates that research and development expenses will finish
1997 approximately 10% over 1996 levels, as the Company continues to expand and
improve its proprietary line of disposable medical devices. This forward-
looking projection is dependent upon the extent and timing of new product
development and the impact of the regulatory process in obtaining marketing
clearance for new products. The need or desire to modify the Company's
existing products could also influence the level of research and development
expenses. In addition to the aforementioned improved Myotherm cardioplegia
system, blood pump and proprietary systems coatings, the Company is developing
a new oxygen saturation/hematocrit technology that is expected to be submitted
to the FDA in the first quarter of 1998. There can be no assurance, however,
that the Company's research and development efforts will result in additional
regulatory submissions to the FDA as set forth above, if at all, or will result
in any commercially successful products. The forward-looking statements
regarding anticipated regulatory submissions contained in this paragraph will
be impacted by the results of the Company's development efforts, the
availability of any required clinical data, any changes in the regulatory
scheme for such products, and the Company's assessment of the cost and
anticipated benefit of such submissions.
13
<PAGE>
INTEREST INCOME AND EXPENSE
Interest income decreased to $114,000 for the three months ended September
30, 1997 from $167,000 for the three months ended September 30, 1996.
Similarly, interest income decreased to $387,000 for the nine months ended
September 30, 1997 from $570,000 for the nine months ended September 30, 1996.
The decrease in interest income for the three and nine month periods ended
September 30, 1997 when compared to the three and nine month periods ended
September 30, 1996 is primarily due to the use of cash and cash equivalents and
investments for the Company's new facility, additional inventories needed to
support the Company's new product lines and revenue growth and the costs
associated with the COBE matter. Interest income during the three and nine
month periods ended September 30, 1997 was earned primarily from the investment
of the remaining net proceeds from the Company's June 1995 stock offering. At
September 30, 1997, the majority of these proceeds were invested with two
investment portfolio managers who invested in U.S. government securities,
agency paper, money markets, commercial paper and corporate obligations.
Interest expense for the three and nine month periods ended September 30,
1997 was $104,000 and $280,000, respectively, and exclusively due to the
mortgage on the new facility. The closing on the facility purchase occurred in
late January 1997.
INCOME TAX PROVISION
For the three and nine month periods ended September 30, 1997, tax
provisions of $205,000 and $648,000 were recorded compared to a tax provision
of $358,000 for the three month period ended September 30, 1996 and a tax
benefit of $289,000 for the nine month period ended September 30, 1996. The
tax provisions and benefits recorded correspond to the pretax income and losses
for those respective periods, and vary in 1996 from the statutory U.S.
corporate rates due to international taxation matters.
NET INCOME
Net income was $365,000 or $.05 per share and $1,155,000 or $.15 per share
for the three and nine month periods ended September 30, 1997, respectively,
compared to net income of $628,000 or $.08 per share for the three month period
ended September 30, 1996 and a net loss of $1,036,000 or $.13 per share nine
month period ended September 30, 1996.
LIQUIDITY AND CAPITAL RESOURCES
For the nine months ended September 30, 1997, the Company used $919,000 in
operating activities compared to $4,730,000 used in operating activities for
the same period in 1996. The net change of approximately $3,811,000 is
primarily the result of $3,100,000 expended during the corresponding period in
1996 related to the COBE litigation compared to $1,100,000 expended during
1997, smaller increases in levels of inventories, a decrease to other current
assets, slower accounts receivable growth and increased accounts payable
balances. These were partially offset by a use of cash in 1997, when compared
to 1996, for reduced accrued expenses. The Company's inventories have
continued to increase as a result of inventories needed to support the
Company's new product lines, revenue growth and in part as a result of lower
than anticipated shipments of the Affinity product line in the third quarter of
1997.
14
<PAGE>
The Company believes that its existing cash and cash equivalents and
investments as well as anticipated cash generated from operations will be
sufficient to satisfy the Company's cash requirements for the foreseeable
future.
Cash expenditures for capital additions, other than the purchase of the
new facility and related furniture, fixtures and equipment, totaled $3,121,000
for the nine months ended September 30, 1997 compared to $1,775,000 for the
nine months ended September 30, 1996. These expenditures were primarily
related to equipment, molds and tooling necessary to begin the production of
the Affinity blood pump and improved Myotherm cardioplegia system, and to
increase production efficiencies and reduce raw material costs of the Affinity
oxygenator and related blood reservoirs. During the nine months ended
September 30, 1997, the expenditures for furniture, fixtures and equipment
additions related to the Company's new U.S. manufacturing, research and
development and administrative facility were approximately $760,000.
Leases for the Company's U.S. manufacturing, research and development and
administrative facilities expired on December 31, 1996. In January 1997, the
Company consolidated its four separate facilities into a newly constructed
facility, which the Company has purchased. The cost of this facility was
approximately $8,600,000, plus an additional $1,050,000 for the purchase of
furniture, fixtures and manufacturing equipment for the facility. To finance
the $9,650,000 total cost of the project, the Company entered into a $5,167,000
bank note payable agreement in January 1997 and, in addition, funded $4,483,000
out of corporate funds. Closing occurred on January 30, 1997.
The note payable agreement bears interest at 8.11% and requires monthly
principal payments of $21,531, plus interest, through January 2002 with the
remaining principal and interest due February 2002. The note payable is
collateralized by the new corporate headquarters and manufacturing facility
and, among other things, requires the Company to meet certain ratios related to
leverage, debt service and cash flow. As of September 30, 1997, the Company
was in compliance with the ratios required by the note payable. Additionally,
the bank note payable agreement prohibits the Company from distributing
dividends to its shareholders.
At September 30, 1997, the Company had no restricted cash or investments.
Of the $4,450,000 which was restricted at December 31, 1996 for payment of the
U.S. facility, $1,000,000 was used for the purchase of the facility and
$3,450,000 became unrestricted, was reinvested and is being used for general
corporate purposes, research and development and working capital.
The Company's capital expenditures for 1997 are expected to be
approximately $4,000,000, excluding any capital expenditures which were
required in connection with the new facility, as discussed above. This
estimate includes additional equipment, molds and tooling for the new blood
pump, the improved Myotherm cardioplegia system, new oxygen
saturation/hematocrit technology and for furthering production of the Affinity
oxygenator line.
The foregoing forward-looking statements relating to the amount of capital
expenditures and ultimate cash usage are dependent on the progress of the
Company's product development efforts, the timing of the receipt of FDA
marketing clearances for any future products and the
15
<PAGE>
investment in opportunities to further existing products' production related
to improved production efficiencies and quality, and reduced cost.
FOREIGN CURRENCY TRANSACTIONS
Transactions by the Company's international subsidiaries are negotiated,
invoiced and paid in various foreign currencies, primarily pounds sterling, and
U.S. dollars. Accordingly, the Company is currently subject to risks
associated with fluctuations in exchange rates between the various currencies.
Substantially all of the Company's other international transactions are
denominated in U.S. dollars. Fluctuations in currency exchange rates in other
countries may therefore reduce the demand for the Company's products by
increasing the price of the Company's products in the currency of the countries
in which the products are sold.
NEW ACCOUNTING PRONOUNCEMENT
In February 1997, the Financial Accounting Standards Board issued
Statement No. 128, a new standard for computing and presenting earnings per
share. The Company is required to adopt the new standard in the fourth quarter
of 1997; earlier adoption is not permitted. The Company expects that earnings
per share computed under the new standard will approximate earnings per share
currently reported.
CERTAIN IMPORTANT FACTORS
Except for the historical financial information contained herein, this
Form 10-Q contains certain forward-looking statements. For this purpose, any
statements contained in this Form 10-Q that are not statements of historical
fact may be deemed to be forward-looking statements. Without limiting the
foregoing, words such as "may", "will", "expect", "believe", "anticipate",
"estimate", or "continue," the negative or other variations thereof, or
comparable terminology, are intended forward-looking statements. These
statements by their nature involve substantial risks and uncertainties, and
actual results may differ materially depending on a variety of factors,
including the progress of product development and clinical studies, the timing
of and ability to attain regulatory approvals, the availability of third party
reimbursement, the extent to which the Company's products gain market
acceptance, litigation regarding patent and other intellectual property rights,
the introduction of competitive products by others, and other factors.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
16
<PAGE>
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
During the quarter ended September 30, 1997, there were no material
developments in the Company's suit seeking to invalidate a newly
issued U.S. patent held by a competing manufacturer of blood
oxygenators and other medical devices, and requesting a determination
that the Company's Affinity oxygenator does not infringe the
competitor's patent. However, on October 6, 1997, the Magistrate
Judge of the United States District Court vacated a previous order
and granted a stay in the proceedings, including suspension of
discovery, pending the outcome of the competitor's request for re-
issuance of the aforementioned patent. Further information regarding
the suit was previously reported in the Company's Quarterly Reports
on Form 10-Q for the quarters ended March 31, 1997 and June 30, 1997.
ITEM 2. CHANGES IN SECURITIES.
None
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
None
ITEM 5. OTHER INFORMATION.
None
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.
(a) Exhibits:
The exhibits to this Quarterly Report on Form 10-Q are
listed in the Exhibit Index beginning on page 19 of this
Report.
(b) Reports on Form 8-K:
None
17
<PAGE>
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 thereunto duly authorized.
AVECOR CARDIOVASCULAR INC.
November 11, 1997 By /s/ Anthony Badolato
- ----------------------------- -----------------------------
Date Anthony Badolato
Chief Executive Officer
November 11, 1997 By /s/ Gregory J. Melsen
- ----------------------------- -----------------------------
Date Gregory J. Melsen
Vice President-Finance, Treasurer and
Chief Financial Officer
(Principal Financial and Accounting
Officer)
18
<PAGE>
AVECOR CARDIOVASCULAR INC.
EXHIBIT INDEX TO QUARTERLY REPORT
ON FORM 10-Q
For the Quarter Ended September 30, 1997
Item No. Description Method of Filing
11.1 Statement regarding computation of
earnings per share Filed herewith electronically
27.1 Financial Data Schedule Filed herewith electronically
19
<PAGE>
EXHIBIT 11.1 - STATEMENT RE COMPUTATION OF EARNINGS PER SHARE
(Unaudited)
<TABLE>
<CAPTION>
Three Months Three Months Nine Months Nine Months
Ended Ended Ended Ended
September 30, September 30, September 30, September 30,
1997 1996 1997 1996
------------- ------------- ------------- -------------
(In thousands, except per share data)
<S> <C> <C> <C> <C>
NET INCOME $365 $628 $1,155 ($1,036)
------------- ------------- ------------- -------------
------------- ------------- ------------- -------------
PER SHARE DATA:
Net income per common equivalent share,
primary $0.05 $0.08 $0.15 ($0.13)
------------- ------------- ------------- -------------
------------- ------------- ------------- -------------
Net income per common equivalent share,
fully diluted $0.05 $0.08 $0.15 ($0.13)
------------- ------------- ------------- -------------
------------- ------------- ------------- -------------
WEIGHTED AVERAGE NUMBER OF
COMMON AND COMMON EQUIVALENT
SHARES:
Primary:
Weighted average number of common
shares outstanding 7,944 7,791 7,901 7,755
Common equivalent shares:
Warrants 0 3 0 0
Options 61 232 68 0
------------- ------------- ------------- -------------
8,004 8,026 7,969 7,755
------------- ------------- ------------- -------------
------------- ------------- ------------- -------------
Fully diluted:
Weighted average number of common
shares outstanding 7,944 7,791 7,901 7,755
Common equivalent shares:
Warrants 0 3 0 0
Options 61 244 68 0
------------- ------------- ------------- -------------
8,004 8,038 7,969 7,755
------------- ------------- ------------- -------------
------------- ------------- ------------- -------------
</TABLE>
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<CIK> 0000883982
<NAME> AVECOR CARDIOVASCULAR INC.
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> DEC-31-1997
<PERIOD-START> JAN-01-1997
<PERIOD-END> SEP-30-1997
<CASH> 2,187,000
<SECURITIES> 3,879,000
<RECEIVABLES> 8,299,000
<ALLOWANCES> 240,000
<INVENTORY> 11,596,000
<CURRENT-ASSETS> 26,869,000
<PP&E> 20,923,000
<DEPRECIATION> 5,652,000
<TOTAL-ASSETS> 42,748,000
<CURRENT-LIABILITIES> 5,894,000
<BONDS> 161,000
0
0
<COMMON> 79,000
<OTHER-SE> 31,819,000
<TOTAL-LIABILITY-AND-EQUITY> 42,748,000
<SALES> 35,277,000
<TOTAL-REVENUES> 35,277,000
<CGS> 20,448,000
<TOTAL-COSTS> 33,581,000
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> (107,000)
<INCOME-PRETAX> 1,803,000
<INCOME-TAX> 648,000
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 1,155,000
<EPS-PRIMARY> .15
<EPS-DILUTED> .15
</TABLE>
