<PAGE> 1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended: MARCH 31, 2000
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: 0-27120
KENSEY NASH CORPORATION
(Exact name of registrant as specified in its charter)
DELAWARE 36-3316412
(State or other jurisdiction (IRS Employer Identification No.)
of incorporation or organization)
MARSH CREEK CORPORATE CENTER, 55 EAST UWCHLAN AVENUE, EXTON, PENNSYLVANIA 19341
(Address of principal executive offices and zip code)
Registrant's telephone number, including area code: (610) 524-0188
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes X No__
As of April 17, 2000, there were outstanding 7,492,488 shares of Common
Stock, par value $.001, of the registrant.
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KENSEY NASH CORPORATION
QUARTER ENDED MARCH 31, 2000
INDEX
PAGE
----
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
Consolidated Balance Sheets
as of March 31, 2000 (Unaudited) and June 30, 1999.. 3
Consolidated Statements of Operations
for the three and nine months ended March 31,
2000 and 1999 (Unaudited)............................ 4
Consolidated Statements of Stockholders' Equity as of
March 31, 2000 (Unaudited) and June 30, 1999......... 5
Consolidated Statements of Cash Flows
for the nine months ended March 31, 2000 and
1999 (Unaudited)..................................... 6
Notes to Consolidated Financial
Statements (Unaudited)............................... 7
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS................ 9
PART II - OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K............................. 14
SIGNATURES................................................................. 15
2
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PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
<TABLE>
<CAPTION>
KENSEY NASH CORPORATION
CONSOLIDATED BALANCE SHEETS
- - - - - - - - ----------------------------------------------------------------------------------------------------------------
MARCH 31, JUNE 30,
ASSETS 2000 1999
CURRENT ASSETS: (UNAUDITED)
<S> <C> <C>
Cash and cash equivalents $ 1,398,998 $ 1,189,083
Short-term investments 7,633,405 8,479,617
Trade receivables 2,582,339 2,247,050
Royalties receivable (Note 2) 1,736,071 742,143
Officer loans 783,797 264,535
Other receivables (including approximately $112,407 and $62,000 at
March 31, 2000 and June 30, 1999, respectively, due from employees) 339,327 170,181
Inventory (Note 3) 1,137,197 748,698
Prepaid expenses and other 610,279 320,106
----------- -----------
Total current assets 16,221,413 14,161,413
----------- -----------
PROPERTY, PLANT AND EQUIPMENT, AT COST:
Leasehold improvements 5,666,083 4,023,373
Machinery, furniture and equipment 5,997,698 4,840,529
Construction in progress 105,207 676,836
----------- -----------
Total property, plant and equipment 11,768,988 9,540,738
Accumulated depreciation (4,729,838) (3,801,514)
----------- -----------
Net property, plant and equipment 7,039,150 5,739,224
----------- -----------
OTHER ASSETS:
Restricted investments (Note 4) 2,455,725 4,675,725
Property under capital leases, net 12,341 28,368
Acquired patents, net of accumulated amortization of $572,810 and $381,873
at March 31, 2000 and June 30, 1999, respectively 3,419,599 3,610,536
----------- -----------
Total other assets 5,887,665 8,314,629
----------- -----------
TOTAL $29,148,228 $28,215,266
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 974,037 $ 1,446,800
Accrued expenses 523,415 863,458
Current portion of debt, obligation under patent acquisition agreement
and capital lease obligations 196,725 600,398
Deferred revenue - royalties and other (Note 2) 10,250 390,846
----------- -----------
Total current liabilities 1,704,427 3,301,502
DEBT and OBLIGATION UNDER CAPITAL LEASES, long-term portion 5,863,917 6,012,863
----------- -----------
Total liabilities 7,568,344 9,314,365
----------- -----------
COMMITMENTS AND CONTINGENCIES (Note 4):
STOCKHOLDERS' EQUITY:
Preferred stock, $.001 par value, 100,000 shares authorized,
no shares issued or outstanding at March 31, 2000 and June 30, 1999
Common stock, $.001 par value, 25,000,000 shares authorized,
7,492,488 and 7,470,710 shares issued and outstanding at March 31, 2000
and June 30, 1999, respectively 7,492 7,470
Capital in excess of par value 37,850,676 37,697,452
Accumulated deficit (15,730,644) (18,562,619)
Accumulated other comprehensive income (547,640) (241,402)
----------- -----------
Total stockholders' equity 21,579,884 18,900,901
----------- -----------
TOTAL $29,148,228 $28,215,266
=========== ===========
</TABLE>
See notes to consolidated financial statements.
3
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KENSEY NASH CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
- - - - - - - - -------------------------------------------------------------------------------
<TABLE>
<CAPTION>
THREE MONTHS ENDED NINE MONTHS ENDED
MARCH 31, MARCH 31,
--------------------------- ----------------------------
2000 1999 2000 1999
<S> <C> <C> <C> <C>
REVENUES (Notes 1 and 2):
Net sales $ 3,702,541 $ 1,789,974 $ 9,075,453 $ 4,996,010
Research and development 5,447 451,677 48,044 1,611,315
Royalty income (Note 2) 1,693,726 2,126,718 4,639,943 5,026,853
----------- ----------- ----------- -----------
Total revenues 5,401,714 4,368,369 13,763,440 11,634,178
----------- ----------- ----------- -----------
OPERATING COSTS AND EXPENSES:
Cost of products sold 2,022,742 1,274,399 5,088,140 3,713,322
Research and development 1,434,389 1,438,534 4,074,294 4,265,523
Selling, general and administrative 700,299 781,762 2,040,744 1,896,657
----------- ----------- ----------- -----------
Total operating costs and expenses 4,157,430 3,494,695 11,203,178 9,875,502
----------- ----------- ----------- -----------
INCOME FROM OPERATIONS 1,244,284 873,674 2,560,262 1,758,676
----------- ----------- ----------- -----------
OTHER INCOME:
Interest income 186,311 180,605 623,162 443,837
Interest expense (118,211) (95,836) (350,743) (221,731)
Other 300 488 (706) 2,856
----------- ----------- ----------- -----------
Total other income - net 68,400 85,257 271,713 224,962
----------- ----------- ----------- -----------
INCOME BEFORE INCOME TAXES 1,312,684 958,931 2,831,975 1,983,638
----------- ----------- ----------- -----------
Provision for income taxes (Note 5)
NET INCOME $ 1,312,684 $ 958,931 $ 2,831,975 $ 1,983,638
=========== =========== =========== ===========
BASIC and DILUTED EARNINGS PER SHARE $ 0.17 $ 0.13 $ 0.37 $ 0.27
=========== =========== =========== ===========
WEIGHTED AVERAGE COMMON
SHARES OUTSTANDING (Note 1) 7,867,490 7,513,359 7,616,374 7,478,887
=========== =========== =========== ===========
</TABLE>
See notes to consolidated financial statements.
4
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KENSEY NASH CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
- - - - - - - - -------------------------------------------------------------------------------
<TABLE>
<CAPTION>
CAPITAL
IN EXCESS ACCUMULATED
COMMON STOCK OF PAR OTHER COMPREHENSIVE
-------------------- OF PAR ACCUMULATED COMPREHENSIVE INCOME /
SHARES AMOUNT VALUE DEFICIT LOSS (LOSS) TOTAL
<S> <C> <C> <C> <C> <C> <C> <C>
BALANCE, JUNE 30, 1997 7,198,251 $ 7,198 $ 34,203,807 $ (22,084,059) $12,126,946
Exercise of stock options 61,021 61 556,174 556,235
Shares issued under Patent
Acquisition Agreement 200,000 200 2,837,400 2,837,600
Net income 342,682 $ 342,682 342,682
--------- ------- ------------ ------------- =========== -----------
BALANCE, JUNE 30, 1998 7,459,272 7,459 37,597,381 (21,741,377) 15,863,463
--------- ------- ------------ ------------- -----------
Exercise of stock options 11,438 11 100,071 100,082
Net income 3,178,758 3,178,758 3,178,758
Comprehensive loss (Note 1) (241,402) (241,402) (241,402)
-----------
Comprehensive income 2,937,356
--------- ------- ------------ ------------- ---------- =========== -----------
BALANCE, JUNE 30, 1999 7,470,710 7,470 37,697,452 (18,562,619) (241,402) 18,900,901
--------- ------- ------------ ------------- ---------- -----------
Exercise of stock options 21,778 22 153,224 153,246
Net income 2,831,975 2,831,975 2,831,975
Comprehensive loss (Note 1) (306,238) (306,238) (306,238)
----------- -----------
Comprehensive income $ 2,525,737
--------- ------- ------------ ------------- ---------- ===========
BALANCE, MARCH 31, 2000 (Unaudited) 7,492,488 $ 7,492 $ 37,850,676 $ (15,730,644) $ (547,640) $21,579,884
========= ======= ============ ============= ========== ===========
</TABLE>
See notes to the consolidated financial statements.
5
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KENSEY NASH CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
- - - - - - - - ------------------------------------------------------------------------------
<TABLE>
<CAPTION>
NINE MONTHS ENDED
MARCH 31,
------------------------------
2000 1999
<S> <C> <C>
OPERATING ACTIVITIES:
Net income $ 2,831,975 $ 1,983,638
Adjustments to reconcile net income to net cash provided by
(used in) operating activities:
Depreciation and amortization 1,135,288 913,718
Changes in assets and liabilities which provided (used) cash:
Accounts receivable (2,017,625) (1,916,614)
Prepaid expenses and other current assets (290,173) (152,648)
Inventory (388,499) 332,710
Accounts payable and accrued expenses (812,806) 706,767
Deferred revenue (380,596) (932,858)
----------- -----------
Net cash provided by operating activities 77,564 934,713
----------- -----------
INVESTING ACTIVITIES:
Additions to property, plant and equipment (2,228,250) (982,462)
Purchase of restricted investments (3,359,969)
Sale of investments 2,759,974 1,064,502
----------- -----------
Net cash provided by (used in) investing activities 531,724 (3,277,929)
----------- -----------
FINANCING ACTIVITIES:
Principal payments under capital leases (19,688) (28,560)
Repayments of patent acquisition obligation (503,453) (375,776)
Proceeds from long-term debt 5,000,000
Repayments of long-term debt (29,478) (925,000)
Exercise of stock options 153,246 90,398
----------- -----------
Net cash (used in) provided by financing activities (399,373) 3,761,062
----------- -----------
INCREASE IN CASH AND CASH EQUIVALENTS 209,915 1,417,846
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 1,189,083 1,407,684
----------- -----------
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 1,398,998 $ 2,825,530
=========== ===========
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid for interest $ 357,296 $ 204,830
=========== ===========
Cash paid for income taxes $ $
=========== ===========
</TABLE>
See notes to consolidated financial statements.
6
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KENSEY NASH CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 1 -- CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
BASIS OF PRESENTATION
The consolidated balance sheet at March 31, 2000, the
consolidated statements of operations for the three and nine months ended March
31, 2000 and 1999 and the consolidated statements of cash flows for the nine
months ended March 31, 2000 and 1999 have been prepared by Kensey Nash
Corporation (the "Company") and have not been audited by the Company's
Independent Auditors. In the opinion of management, all adjustments (which
include only normal recurring adjustments) necessary to present fairly the
financial position, results of operations and cash flows at March 31, 2000 and
for all periods presented have been made.
Certain information and note disclosures normally included in the Company's
annual financial statements prepared in accordance with generally accepted
accounting principles have been condensed or omitted. These consolidated
financial statements should be read in conjunction with the financial statements
and notes thereto included in the Company's June 30, 1999 consolidated financial
statements filed with the Securities and Exchange Commission on Form 10-K/A. The
results of operations for the period ended March 31, 2000 are not necessarily
indicative of operating results for the full year.
CASH AND CASH EQUIVALENTS
Cash and cash equivalents represent cash in banks and short-term investments
having an original maturity of less than three months.
EXPORT SALES
There were no export sales from the Company's U.S. operations to unaffiliated
customers in Europe for the three months ended March 31, 2000. Export sales
totaled $102,878 for the three months ended March 31, 1999 and $206,045 and
$242,893 for the nine months ended March 31, 2000 and 1999, respectively.
EARNINGS PER SHARE
Basic and diluted EPS are computed using the weighted average
number of shares of common stock outstanding, with common equivalent shares from
options included in the diluted computation when their effect is dilutive.
COMPREHENSIVE INCOME
Accumulated other comprehensive loss, shown in the consolidated statements of
shareholders' equity at March 31, 2000 and June 30, 1999, 1998 and 1997, is
solely comprised of unrealized losses on the Company's available-for-sale
securities. There were no unrealized gains or losses in the year ended June 30,
1998. The tax effect of other comprehensive income on fiscal years 2000 and 1999
was not significant.
NOTE 2 -- DEFERRED REVENUE - ROYALTIES
Upon receipt of pre-market approval for the 8 French ("F") size Angio-Seal
device (the "Angio-Seal") from the Food and Drug Administration (the "FDA") on
September 30, 1996, the Company received a $3 million advance on future
royalties under the Company's licensing agreement (the "Licensing Agreement")
with its strategic partner, St. Jude Medical, Inc. ("St. Jude Medical"). Such
advance was recorded as deferred revenue. The Licensing Agreement provides for
certain minimum royalty payments ("Minimum
7
<PAGE> 8
Royalty") during the first five years after receiving FDA approval (each royalty
year begins on October 1 and ends on September 30). As stipulated in the
Licensing Agreement, the $3.0 million advance was reduced in each period by 50%
of royalties earned in excess of the Minimum Royalty in any royalty year. The
remainder of royalties earned was received as cash proceeds by the Company. At
March 31, 2000 the entire $3.0 million royalty advance had been repaid by the
Company through these royalty payment reductions.
NOTE 3 -- INVENTORY
Inventory is stated at the lower of cost (determined by the average cost method,
which approximates first-in, first-out) or market. Inventory primarily includes
the cost of material utilized in the processing of the Company's products and is
as follows:
MARCH 31, 2000 JUNE 30, 1999
-------------- -------------
Raw materials $ 896,169 $ 666,271
Work in process 241,028 82,427
-------------- -------------
Total $ 1,137,197 $ 748,698
============== =============
NOTE 4 -- COMMITMENTS AND CONTINGENCIES
The Company has pledged $1,949,386 in investments as collateral to secure
certain bank loans to employees which were used by such employees for the
payment of taxes incurred by such employees as the result of the receipt of
Common Stock in settlement of the employee stock rights. In exchange for the
Company pledging collateral for such loans, each affected employee has pledged
their Common Stock as collateral to the Company. The balance outstanding on such
employee loans was $1,975,908 at March 31, 2000.
In addition, under the terms of the Company's Financing Agreement, the Company
has placed the remaining proceeds of such agreement into a certificate of
deposit ("CD"). The CD is restricted for capital expenditure purposes only. The
balance of the CD at March 31, 2000 was $506,339 and is included in restricted
investments due to the capital expenditure restriction placed on its use.
NOTE 5 -- INCOME TAXES
As of June 30, 1999, the Company had net operating loss carryforwards for
federal and state tax purposes totaling $14.8 and $3.0 million, respectively. As
such, no provision has been made for income taxes for the three or nine months
ended March 31, 2000 or 1999. A portion of the NOL may be subject to various
statutory limitations as to its usage.
NOTE 6 -- 6F ANGIO-SEAL FDA APPROVAL
In March 2000, the Company announced that the FDA granted approval to St. Jude
Medical for the new 6F Angio-Seal puncture closure device, allowing sale
of the product in the United States. This smaller version of the Angio-Seal is
designed to seal arterial punctures 6F and smaller and specifically address the
largest segment of the puncture closure market.
8
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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
OVERVIEW
We were founded in 1984 and our common stock became publicly traded in
December 1995. We have been profitable in each of our last ten fiscal quarters.
Revenues
Our revenues consist of three components: net sales, research and
development revenue and royalty income.
Net Sales. Net sales is comprised of resorbable biomaterials products and
Angio-Seal devices manufactured by us.
Biomaterials. The biomaterials component of net sales represents
the sale of our biomaterials products to customers for use in the
following markets: orthopedics, cardiology, drug/biologics delivery
and wound care. Historically, our biomaterials sales have represented
primarily the resorbable collagen and polymer components of the
Angio-Seal device supplied to St. Jude Medical. We have experienced
significant sales growth in our biomaterials products in fiscal years
1998, 1999 and 2000 due to sales to new customers, increased sales to
existing customers, new product offerings and the expansion of our
marketing activities. We believe this growth will continue because of
greater acceptance of biomaterials and technological advances by the
medical community. This acceptance has expanded the applications for
our biomaterials products.
Angio-Seal Devices. Historically, we supplied our strategic
partner with partially completed 8F Angio-Seal devices. In fiscal
years 1999 and 2000, we have supplied our partner with 6F Angio-Seal
devices to supplement their production requirements. We anticipate
that St. Jude Medical will transition the manufacturing of these
devices to their facility by June 30, 2000.
Research and Development Revenue. Historically, research and development
revenue has been derived solely from development work performed on the
Angio-Seal. As anticipated, the research and development activities have
transitioned to St. Jude Medical and no additional research and development
revenue is expected.
Royalty Income. We receive a royalty on every Angio-Seal unit sold
worldwide. We anticipate sales of the Angio-Seal device will continue to grow,
particularly due to the recent launches of the 6F Angio-Seal in the U.S. and
Europe. As a result, royalty income will continue to be a significant source of
revenue. The anticipated increase in unit sales will be partially offset in the
fiscal year 2001 by an anticipated reduction in our royalty rate, from 12% to
9%, in accordance with our licensing agreements. We expect this rate reduction
will occur during the second quarter of fiscal year 2001.
Cost of Products Sold
We have experienced an overall increase in gross margin during the fiscal
year 2000 as our net sales have increased and we have been able to spread our
fixed costs of manufacturing over a greater number of units. We anticipate our
gross margin will continue to improve as our sales levels increase and our
product
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mix becomes more favorable, reflecting the shift to higher margin sales of
biomaterials products and a reduction in sales of lower margin Angio-Seal
devices.
Research and Development Expense
Research and development expense consists of expenses incurred for the
development of our proprietary technology such as the Aegis Vortex, resorbable
biomaterials products and technologies and other development programs. While
research and development on the Angio-Seal has become an insignificant portion
of our overall development costs, the progression of the Aegis Vortex into the
clinical trial phase and our continued development of proprietary biomaterials
products and technologies will offset this decrease. We anticipate research and
development expense will continue to increase as we pursue commercialization of
the Aegis Vortex as well as explore opportunities for our other technologies.
Selling, General and Administrative
Selling, general and administrative expenses include general and
administrative costs as well as costs related to the marketing of our products.
During the fiscal years 1999 and 2000, the costs of our patent litigation are
also included within selling, general and administrative expenses. We anticipate
the marketing component of selling, general and administrative expenses, which
has been insignificant in past fiscal years, will increase as we evaluate
opportunities for commercialization of the Aegis Vortex and expand the marketing
efforts for our biomaterials business.
RESULTS OF OPERATIONS
COMPARISON OF THREE MONTHS ENDED MARCH 31, 1999 AND 2000
Revenues. Revenues increased 24%, to $5.4 million in the three months ended
March 31, 2000 from $4.4 million in the three months ended March 31, 1999. Net
sales of products increased 107%, to $3.7 million from $1.8 million for the
three months ended March 31, 2000 and 1999, respectively. Of this increase, $1.2
million was attributable to an increase in sales of 6F Angio-Seal devices to St.
Jude Medical. The remaining $700,000 was attributable to increased sales of
biomaterials products. We have been providing St. Jude Medical with 6F
Angio-Seal devices for the U.S. and international markets. We expect to continue
to supplement St. Jude Medical's manufacturing of these devices for the
remainder of fiscal year 2000.
Research and Development Revenues. Research and development revenues
decreased 99%, to $5,000 from $452,000, for the three months ended March 31,
2000 and 1999, respectively. St. Jude Medical has transitioned substantially all
of the Angio-Seal research and development in-house. We do not expect research
and development revenues to be significant in the future.
Royalty Income. Royalty income increased 23%, net of a $750,000
supplemental payment from our previous partner in the three months ended March
31, 1999, to $1.7 million from $1.4 million in the three months ended March 31,
2000 and 1999, respectively. Royalty units increased as approximately 93,000
Angio-Seal units were sold to end-users during the three months ended March 31,
2000 compared to approximately 73,000 units sold during the three months ended
March 31, 1999. This unit increase was due to St. Jude Medical's increased sales
and marketing efforts primarily in the U.S. and sales of the new 6F device in
the international markets. The 6F device was introduced in the international
markets in April 1999 and in the U.S. in late March 2000.
10
<PAGE> 11
Cost of Products Sold. Cost of products sold increased 59% to $2.0 million
in the three months ended March 31, 2000 from $1.3 million in the three months
ended March 31, 1999. However, gross margin increased to 45% from 29%. This
increase reflects an allocation of overhead across a greater sales volume
resulting in a decrease in per unit costs.
Research and Development Expense. Research and development expense was $1.4
million in both the three months ended March 31, 2000 and March 31, 1999. While
development of the Angio-Seal product line has transitioned to St. Jude Medical,
our development efforts on the Aegis Vortex, including clinical trials, have
significantly increased. We also continued to expand our development efforts on
our biomaterials products. We expect research and development expense to
increase as we investigate and develop new products, conduct clinical trials and
seek regulatory approvals for our proprietary products.
Selling, General and Administrative. Selling, general and administrative
expense decreased 10% to $700,000 in the three months ended March 31, 2000 from
$782,000 in the three months ended March 31, 1999. This decrease was the result
of a reduction in legal expenses related to our patent infringement suit offset
by an increase in our sales and marketing efforts for the Aegis Vortex and our
biomaterials products.
Net Interest Income. Interest expense increased 23% to $118,000 in the
three months ended March 31, 2000 from $96,000 in the three months ended March
31, 1999. This was due to the addition of a $5.0 million financing agreement in
January 1999, of which $925,000 was used to repay a portion of the $2.0 million
term loan. The remainder of the proceeds from the $5.0 million financing
agreement are being used to fund leasehold improvements and capital expansion.
Interest income increased 3% to $186,000 in the three months ended March 31,
2000 from $181,000 in the three months ended March 31, 1999 as a result of a
slight increase in average cash and investment balances.
COMPARISON OF NINE MONTHS ENDED MARCH 31, 1999 AND 2000
Revenues. Revenues increased 18%, to $13.8 million in the nine months ended
March 31, 2000 from $11.6 million in the nine months ended March 31, 1999. Net
sales of products increased 82% to $9.1 million from $5.0 million for the nine
months ended March 31, 2000 and 1999, respectively. Of this increase, $2.5
million was attributable to an increase in sales of 6F Angio-Seal devices to St.
Jude Medical. The remaining $1.6 million was attributable to increased sales of
biomaterials products. We have been providing St. Jude Medical with 6F
Angio-Seal devices for the international and U.S. markets. We expect to continue
to supplement St. Jude Medical's manufacturing of these devices for the
remainder of fiscal year 2000.
Research and Development Revenues. Research and development revenues
decreased 97% to $48,000 from $1.6 million for the nine months ended March 31,
2000 and 1999, respectively. St. Jude Medical has transitioned substantially all
of the Angio-Seal research and development in-house. We do not expect research
and development revenues to be significant in the future.
Royalty Income. Royalty income increased 8%, net of a $750,000 supplemental
payment from our previous strategic partner in the nine months ended March 31,
1999, to $4.6 million from $4.3 million in the nine months ended March 31, 2000
and 1999, respectively. Royalty units increased as approximately 255,000
Angio-Seal units were sold to end-users during the nine months ended March 31,
2000 compared to approximately 227,000 units sold during the nine months ended
March 31, 1999. This unit increase was due to St. Jude Medical's increased sales
and marketing efforts primarily in the U.S. and sales of the new
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6F device in the international markets. The 6F device was introduced in the
international markets in April 1999 and in the U.S. in late March 2000.
Cost of Products Sold. Cost of products sold increased 37% to $5.1 million
in the nine months ended March 31, 2000 from $3.7 million in the nine months
ended March 31, 1999. However, gross margin increased to 44% from 26%. This
increase reflected an allocation of overhead across a greater sales volume,
which resulted in a decrease in per unit costs.
Research and Development Expense. Research and development expense
decreased 4% to $4.1 million in the nine months ended March 31, 2000 compared to
$4.3 million in the nine months ended March 31, 1999. This decrease was mainly
attributable to the transition of substantially all of the development for the
Angio-Seal product line to St. Jude Medical. This decrease was offset by our
continued development efforts on the Aegis Vortex, including clinical trial
expenses. We also continued to expand our development efforts on our
biomaterials products. We expect research and development expense to increase as
we investigate and develop new products, conduct clinical trials and seek
regulatory approvals for our proprietary products.
Selling, General and Administrative. Selling, general and administrative
expense increased 8% to $2.0 million in the nine months ended March 31, 2000
from $1.9 million in the nine months ended March 31, 1999. This increase was
primarily the result of increased sales and marketing efforts for the Aegis
Vortex and our biomaterials products.
Net Interest Income. Interest expense increased 58% to $351,000 in the nine
months ended March 31, 2000 from $222,000 in the nine months ended March 31,
1999. This was due to the addition of a $5.0 million financing agreement in
January 1999, of which $925,000 was used to repay a portion of the $2.0 million
term loan. The remainder of the proceeds from the $5.0 million financing
agreement are being used to fund leasehold improvements and capital expansion.
Interest income increased 40% to $623,000 in the nine months ended March 31,
2000 from $444,000 in the nine months ended March 31, 1999 as a result of an
increase in average total cash and investment balances.
LIQUIDITY AND CAPITAL RESOURCES
Net cash provided by our operating activities was $78,000 and $935,000
during the nine months ended March 31, 2000 and 1999, respectively. In the nine
months ending March 31, 2000, changes in asset and liability balances resulted
in a net $3.9 million use of cash, offset by net income of $2.8 million and
non-cash depreciation and amortization of $1.1 million. Changes in asset and
liability balances resulted in a net $2.0 million use of cash, offset by net
income of $2.0 million and non-cash depreciation and amortization of $914,000,
in the nine months ending March 31, 1999.
Our cash, cash equivalents and short-term investments were $9.0 million at
March 31, 2000. In addition, we have $2.5 million in restricted investment
accounts. We have pledged $1.9 million in investments as collateral to secure
bank loans made to employees to pay taxes incurred by these employees when they
received common stock at the time of our initial public offering. In exchange
for our pledging this collateral, the employees have pledged their common stock
to us as collateral. We also have $507,000 in investments restricted for capital
spending through June 30, 2000 under the terms of an agreement which provided a
total of $5.0 million. Related to this financing agreement, we have a capital
spending plan for fiscal year 2000 of which, for the nine months ended March 31,
2000, $2.2 million was expended primarily on machinery, equipment and leasehold
improvements. These expenditures were related to the continued expansion of our
manufacturing capabilities, principally our for biomaterials product lines.
12
<PAGE> 13
We received a $3.0 million royalty advance under our licensing agreement
upon receipt of FDA approval for the Angio-Seal in fiscal year 1997. This
royalty advance has been reduced in each period by 50% of the excess of royalty
income over minimum royalties stipulated within the licensing agreement. During
the nine months ended March 31, 2000, the liability was retired.
In November 1997, we acquired patents in exchange for 200,000 shares of
common stock and a series of eight quarterly cash payments, which began on March
31, 1998, totaling $1.2 million. The patents were recorded on the balance sheet
at the value of the shares on the date of the agreement plus the present value
of the $1.2 million cash and the legal and other related costs incurred to
acquire such patents. The present value of the cash payments was $1.1 million
and was recorded on the balance sheet as an obligation. The obligation was fully
repaid during the nine months ended March 31, 2000.
We plan to continue to spend substantial amounts to fund clinical trials,
to gain regulatory approvals and to continue to expand research and development
activities, particularly for the Aegis Vortex and our biomaterials products. We
believe cash generated from operations will be sufficient to meet our operating
and capital requirements for the next twelve months.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our interest income and expense are sensitive to changes in the general
level of interest rates. In this regard, changes in interest rates affect the
interest earned on our cash, cash equivalents and investments as well as
interest paid on our debt.
Our investment portfolio consists primarily of high quality U.S.
government securities and certificates of deposit with an average maturity of
one year or less. We mitigate default risk by investing in what we believe are
the safest and highest credit quality securities and by monitoring the credit
rating of investment issuers. The portfolio includes only marketable securities
with active secondary or resale markets to ensure portfolio liquidity and there
are limitations regarding duration of investments. These available-for-sale
securities are subject to interest rate risk and decrease in market value if
interest rates increase. At March 31, 2000, our total portfolio consisted of
approximately $11.5 million of investments, all of which had maturities within
one year. Additionally, we generally hold securities until maturity. Therefore,
we do not expect our results of operations or cash flows to be materially
impacted due to a sudden change in interest rates. We have $1.1 million in fixed
rate debt, for which the risk would be an inability to refinance if rates
decreased. The remaining $5.0 million of our debt fluctuates with the U.S.
treasury rate and is therefore subject to increases in U.S. interest rates. The
estimated potential reduction in earnings from a one-point increase in the Five
Year U.S. treasury rate for the nine months ended March 31, 2000 would have been
approximately $37,500.
Statements contained in this Form 10-Q that are not historical facts are
forward-looking statements that are made pursuant to the Safe Harbor provisions
of the Private Securities Litigation Reform Act of 1995. We caution that a
number of important factors could cause our actual results for fiscal year 2000
and beyond to differ materially from those in any forward-looking statements
made by us or on our behalf. These important factors include, without
limitation, the success of our biomaterials products, our ability to obtain the
necessary regulatory approvals for, fund and commercialize the Aegis Vortex, the
success of St. Jude Medical in manufacturing, marketing and distributing the
Angio-Seal, the ability of our customers to market and obtain regulatory
approvals for their biomaterials products, the acceptance of our products by the
medical community, our ability to maintain key vendors and personnel,
competition in our markets, general business conditions in the healthcare
industry and general economic conditions. Our results of operations in any past
period should not be considered indicative of the results to be expected for
future periods. Fluctuations in operating results may also result in
fluctuations in the price of our common stock.
13
<PAGE> 14
PART II - OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.
A. Exhibits.
None
B. Reports on Form 8-K.
None
C. Financial Data Schedule
14
<PAGE> 15
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.
KENSEY NASH CORPORATION
Date: April 24, 2000 By: /s/ Wendy F. DiCicco
-----------------------
Wendy F. DiCicco
Chief Financial Officer
15
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