<PAGE> 1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K/A
[X] AMENDMENT TO ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended: JUNE 30, 1999
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
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act:
COMMON STOCK, PAR VALUE $.001 PER SHARE
(TITLE OF CLASS)
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 by check mark if disclosure of delinquent filers pursuant to
Item 405 of Regulation S-K is not contained herein, and will not be contained,
to the best of registrant's knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K. [ ]
The aggregate market value of the registrant's voting stock (based upon
the per share closing price of $12.00 on September 17, 1999 and, in making such
calculation, registrant is not making a determination of the affiliate or
non-affiliate status of any holders of shares of Common Stock) was approximately
$89,661,120.
The number of shares outstanding of the registrant's Common Stock, par
value $.001, as of September 17, 1999 was 7,471,760.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the following document are incorporated by reference
into this report:
Definitive Proxy Statement in connection with the 1999 Annual
Meeting of Stockholders
----------------------------------------------
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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
Management's Discussion and Analysis has been amended in this Form
10-K/A to properly conform management's discussion of operations therein to that
description included in the Company's Form S-3 Registration Statement filed on
April 24, 2000 and Amendment Number 1 thereto filed on May 1, 2000.
The following discussion and analysis should be read in conjunction with
"Selected Financial Data" and our financial statements and the related notes.
This discussion contains forward-looking statements that involve risks and
uncertainties. Our actual results could differ materially from those anticipated
in the forward-looking statements as a result of various factors.
OVERVIEW
We were founded in 1984 and our common stock became publicly traded in
December 1995.
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 and 1999 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 by the medical community of
biomaterials and technological advances which have 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 year 1999, we
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 reduction will occur
during the second quarter of fiscal year 2001.
Cost of Products Sold
We have experienced an increase in gross margin 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 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 year 1999, the costs of our patent litigation were
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.
<PAGE> 3
RESULTS OF OPERATIONS
COMPARISON OF FISCAL 1998 AND 1999
Revenues. Revenues increased 44% to $16.2 million in the year ended June
30, 1999, or fiscal 1999, from $11.3 million in the year ended June 30, 1998, or
fiscal 1998. Net sales of products increased 54% to $7.2 million from $4.7
million. Of this, $2.5 million was attributable to increased sales of
biomaterials products comprised of $1.8 million of biomaterials products sold to
multiple customers and $700,000 of increased sales of Angio-Seal components to
St. Jude Medical. The remaining increase was attributable to the sale of 6F
Angio-Seal devices to St. Jude Medical for the international market.
Research and Development Revenue. Research and development revenue
decreased 48% to $1.9 million from $3.6 million. The decrease was due to a
reduction in Angio-Seal research and development activity as the 6F Angio-Seal
transitioned from development to commercialization.
Royalty Income. Royalty income increased 139% to $7.2 million from $3.0
million in fiscal 1999 and fiscal 1998, respectively. Of this increase, $2.7
million was due to increased unit sales of Angio-Seal. Approximately 310,000
Angio-Seal units were sold to end users in fiscal 1999 compared to approximately
178,000 units sold in fiscal 1998. The increase in Angio-Seal unit volume
reflected the launch of the 6F Angio-Seal in Europe in fiscal 1999 as well as
increased demand for the 8F Angio-Seal in both the U.S. and European markets in
fiscal 1999 versus fiscal 1998. In addition, we received a $1.5 million
supplemental royalty payment in fiscal 1999.
Cost of Products Sold. Cost of products sold increased 26% to $5.1 million
in fiscal 1999 from $4.1 million in fiscal 1998. However, the gross margin
increased to 28% from 13%. The increase in gross margin reflects an allocation
of overhead across greater sales volume, which results in a decrease in per unit
costs, as well as increased sales of higher margin biomaterials products.
Research and Development Expense. Research and development expense
increased 3% to $5.7 million in fiscal 1999 from $5.5 million in fiscal 1998.
This increase was mainly attributable to increased development efforts on the
Aegis Vortex as we applied for and received our investigational device
exemption, or IDE, from the FDA and prepared for the initiation of clinical
trials of the device. We also expanded our development efforts in the area of
resorbable biomaterials. These increases in expense were offset by the ongoing
transition of development of the Angio-Seal product line to St. Jude Medical
along with the 6F product moving to commercialization.
Selling, General and Administrative. Selling, general and administrative
expense increased 47% to $2.6 million in fiscal 1999 from $1.8 million in fiscal
1998. This increase was primarily a result of legal expenses in the amount of
$640,000 related to our ongoing patent infringement suit. We incurred no legal
expenses related to this lawsuit in 1998.
Net Interest Income. Interest expense increased 121% to $332,000 in fiscal
1999 from $150,000 in fiscal 1998. This increase was due to the addition of a
$5.0 million financing agreement in fiscal 1999, of
<PAGE> 4
which $925,000 was used to repay a portion of the existing $2.0 million term
loan. The remainder of the proceeds from the $5.0 million financing agreement
will be used to fund leasehold improvements and for capital expansion. Interest
income increased 20% to $649,000 in fiscal 1999 from $540,000 in fiscal 1998 as
a result of an increase in average total cash and investment balances.
Other Non-Operating Income. Other non-operating income remained constant
at $4,000 for fiscal 1999 and fiscal 1998. Fiscal 1999 other non-operating
income represented primarily a net gain on the sale of fixed assets while fiscal
1998 represented miscellaneous nonrecurring items.
COMPARISON OF FISCAL 1997 AND 1998
Revenues. Revenues increased 43% to $11.3 million in fiscal 1998 from $7.9
million in fiscal 1997. Net sales of products increased 28% to $4.7 million from
$3.6 million. Sales of Angio-Seal components to our partner increased $1.7
million as a result of increased demand for the Angio-Seal in the U.S. and
European markets. This increase was offset by a $900,000 decrease in sales of
complete Angio-Seal devices to our partner as they increased their manufacturing
capacity to meet increased market demands. In addition, biomaterials product
sales increased $200,000, as our business with third-party customers expanded.
Research and Development Revenue. Research and development revenue
increased 28% to $3.7 million in fiscal 1998 from $2.8 million in fiscal 1997.
The increase related to research and development, including clinical trials,
performed for our partner on the Angio-Seal product line.
Milestone Fees. The $1.1 million milestone fee represented the final
milestone under the license agreement with our strategic partner and was earned
by us upon receipt of FDA approval in the first quarter of fiscal 1997.
Royalty Income. Royalty income increased 752% to $3.0 million from
$353,000 in fiscal 1998 and fiscal 1997, respectively. Approximately 178,000
Angio-Seal units were sold by our partner to end users in fiscal year 1998
compared to approximately 26,000 in fiscal 1997. The increase in royalty income
represented a full year of 8F Angio-Seal U.S. unit sales in fiscal 1998 compared
to nine months of U.S. unit sales in fiscal 1997, a significant increase in
demand in the U.S. and European markets and a 3% increase in total royalty per
unit resulting from our acquisition of a third party's patents in November 1997.
Cost of Products Sold. Cost of products sold increased 33% to $4.1 million
in fiscal 1998 from $3.1 million in fiscal 1997 and our gross margin declined to
13% from 16%. The increase in cost of products sold reflected increased unit
sales. The reduction in gross margin was caused by manufacturing inefficiencies
realized in the start-up phase of production for the new sizes of the Angio-Seal
and new biomaterials products during the fiscal year.
Research and Development Expense. Research and development expense
increased 18% to $5.5 million in fiscal 1998 from $4.7 million in fiscal 1997.
We expanded the development of additional Angio-Seal sizes and biomaterials
products, including resorbable polymers and collagen, and increased clinical
trial activity. In addition, we significantly expanded our development on the
Aegis Vortex as we targeted commencement of clinical trials in fiscal year 1999.
Selling, General and Administrative. Selling, general and administrative
expense decreased 3%, or $61,000, in fiscal 1998 from fiscal 1997. This decrease
was primarily due to a reduction in certain outside professional fees.
Net Interest Income. Interest expense decreased 22% to $150,000 for fiscal
1998 from $193,000 for fiscal 1997. This decrease resulted from the repayment of
a credit agreement with our partner in October 1996 offset by amounts drawn
under our bank line of credit during the current fiscal year and interest
charges recorded in relation to the obligation under our patent acquisition
agreement. Interest income decreased 14% to $540,000 in fiscal 1998 from
$627,000 in fiscal 1997. The decrease was primarily
<PAGE> 5
attributable to a decrease in cash, cash equivalent and investment balances in
the first quarter of fiscal 1997, representing funds used to repay our credit
agreement.
Insurance Settlement. During fiscal 1997, we received $1.3 million in
final settlement for the business interruption portion of our insurance claim
from our roof collapse in 1996. Of this amount, $969,000 was recorded as other
income.
Other Non-Operating Income. Other non-operating income decreased 47% from
$8,375 in fiscal 1997 to $4,405 in fiscal 1998. Fiscal 1998 represented
miscellaneous nonrecurring items while fiscal 1997 represented primarily a net
gain on the sale of fixed assets.
LIQUIDITY AND CAPITAL RESOURCES
Net cash provided by the Company's operating activities during fiscal 1999
was $2.9 million, and net cash provided by the Company's operating activities
during fiscal 1998 was $6,000. In fiscal 1999, changes in asset and liability
balances resulted in a $1.5 million use of cash, which was offset by a net
income of $3.2 million and non-cash depreciation and amortization of $1.3
million. In fiscal 1998 changes in asset and liability balances resulted in a
$1.4 million use of cash offset by net income of $343,000 and depreciation of $1
million.
Capital expenditures were $1.7 million for fiscal 1999, primarily
representing machinery and equipment and leasehold improvements related to the
continued expansion of the Company's manufacturing capabilities, principally its
collagen and polymer product lines.
The Company's cash, cash equivalents and short-term investments were $9.7
million at June 30, 1999. In addition, the Company has $4.7 million in
restricted investment accounts (not included in the $9.7 million).
The Company has pledged $1.9 million in investments as collateral to secure
bank loans made to employees for the payment of taxes incurred by such employees
as a result of their receipt of Common Stock at the time of the IPO. In exchange
for the Company's pledging this collateral, the employees have pledged their
Common Stock as collateral to the Company. The Company also has $2.8 million in
investments restricted for capital spending through June 30, 2000 under the
terms of a financing arrangement described below. The Company has a $2.8 million
capital spending plan for fiscal year 2000 for the continued expansion and
improvement of its Exton manufacturing facility.
In January 1999, the company entered into a $5 million financing agreement
with a bank (the "Financing Agreement"). Under the terms of the Financing
Agreement, the bank purchased the Company's $5 million tax-exempt bond issue
(the "Bond Issue"), which was issued through the local development
authority. The Company used $925,000 of the proceeds of the Bond Issue to pay
down the balance under its existing $2 million Term Loan. The remaining proceeds
of the Bond Issue were placed into a certificate of deposit (the "CD") from
which withdrawals are restricted for capital expenditure purposes only.
The Company received a $3.0 million royalty advance under the License
Agreement upon receipt of FDA approval of the Angio-Seal in fiscal year 1997.
This royalty advance continues to be reduced as the Company exceeded minimum
royalty stipulations under the Licensing Agreement.
In November 1997, the Company acquired patents under a Patent Acquisition
Agreement 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 any
legal and other related costs incurred to acquire such patents. The present
value of the cash payments ($1.1 million) was recorded on the balance sheet with
a remaining balance at June 30, 1999 of $503,000.
The Company plans to continue to expand substantial resources to fund
clinical trials to gain regulatory approvals and to continue to expand research
and development activities particularly for its revascularization technology and
biomaterials products.
The Company believes cash generated from operations as well as funds
available under financing arrangements with its bank will be sufficient to meet
the Company's operating and capital requirements for the next twelve months.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The Company's interest income and expense are most sensitive to changes in
the general level of interest rates. In this regard, changes in interest rates
affect the interest earned on the Company's cash, cash equivalents and
investments as well as interest paid on its debt.
The Company's investment portfolio consists primarily of high quality US
government securities and certificates of deposit with an average maturity of
one year or less. The Company mitigates default risk by investing in what it
believes 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 of interest rates increase. At June 30, 1999, the Company's total
portfolio consisted of approximately $13.2 million of investments, all of which
had maturities within one year. Additionally, the Company generally holds
securities until maturity. Therefore, the Company does not expect its results of
operations or cash flows to be materially impacted due to a sudden change in
interest rates.
The Company has $1,075,000 in fixed rate debt, for which the risk would be
an inability to refinance if rates decreased. The remaining $5 million of the
Company's debt fluctuates with the US treasury rate and is therefore subject to
increases in US interest rates. The estimated potential reduction in earnings
from a one-point increase in the Five Year US treasury rate for the year ended
June 30, 1999 would have been approximately $22,000.
<PAGE> 6
YEAR 2000 COMPLIANCE
The Company is aware of computer program issues associated with existing
computer systems as the year 2000 approaches. The year 2000 problem is pervasive
and complex, as virtually every computer operation will be affected in some way
by the rollover of the two-digit year value from 99 to 00. The issue is whether
computer systems and embedded controls will properly recognize date sensitive
information when the year changes to 2000 ("Year 2000 Compliance Issue").
Systems that do not properly recognize such information could result in system
failures or miscalculations causing disruptions to operations and normal
business activities.
The Company has completed its assessment of potential year 2000 issues and
the associated potential risks. The Company has assessed the impact of the year
2000 issues and believes that its business products and services will not be
significantly impacted. The Company has identified all financial, informational
and operational systems and found that all critical processes incorporating
these systems are 2000 compliant. The Company is verifying the readiness of its
significant customers and suppliers, including its Strategic Alliance Partner,
through the distribution of a questionnaire. This process was substantially
completed as of June 30, 1999. The Company does not warrant, however, that these
companies' year 2000 compliance activities will be completely successful. The
Company continues to monitor the situation and refine its contingency plans as
appropriate.
The Company began work on the computer Year 2000 Compliance Issue in fiscal
year 1998. Software applications, hardware and related information and
non-information technologies have been upgraded or replaced to ensure that all
systems are Year 2000 compliant. Replacing hardware or software in this fashion
is considered a normal cost of doing business and is being expensed or
capitalized as appropriate. Management does not anticipate that the costs of
year 2000 compliance will have a material effect on the Company's results of
operations, cash flows or financial position. The Company does not presently
expect that its operations will be materially affected by problems with its
computer systems or those of third parties with whom it deals.
Statements contained in this Form 10-K 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. The Company cautions
that a number of important factors could cause the Company's actual results for
fiscal year 2000 and beyond to differ materially from those in any
forward-looking statements made by, or on behalf of, the Company. These
important factors include, without limitation, the time, effort and priority
level that the Company's Strategic Alliance Partner attaches to the Angio-Seal
and the Strategic Alliance Partner's ability to successfully manufacture, market
and distribute the Angio-Seal, the Company's ability to manufacture Angio-Seal
components, the results of ongoing clinical trials for the AVS and other
products and timing of additional regulatory approvals in the United States and
in countries outside of Europe including Japan, announcements of technological
innovations or the introduction of new products by the Company, its customers or
its competitors, competition of puncture closure and occluded SVG devices in
general, general business conditions in the healthcare industry and general
economic conditions. 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 the common stock.
<PAGE> 7
14(A) 2. FINANCIAL STATEMENT SCHEDULES
All schedules have been omitted because they are not applicable or not
required.
14(A) 3. EXHIBITS
Exhibit # Description
--------- -----------
3.1* Form of Amended and Restated Certificate of
Incorporation of the Company.
3.2* Form of Amended and Restated Bylaws of the Company.
4.1* Specimen stock certificate representing Common Stock.
10.1* Kensey Nash Corporation Employee Stock Incentive Plan
and form of Stock Option Agreement.
10.2* Kensey Nash Corporation Nonemployee Directors' Stock
Option Plan and form of Stock Option Agreement.
10.3* Form of Directors' Indemnification Agreement.
10.4* Employment Agreement dated March 24, 1995, by and
between the Company and Joseph W. Kaufmann.
10.5* Employment Agreement dated July 1, 1993, by and
between the Company and Kenneth R. Kensey, M.D.
10.6* Employment Agreement dated July 1, 1993, by and
between the Company and John E. Nash, P.E.
10.7* Employment Agreement dated March 24, 1995, by and
between the Company and Douglas G. Evans, P.E. and
First Amendment to Employment Agreement dated October
1, 1995.
10.8* Collagen Component Supply Agreement dated May 31,
1995, by and between the Company and Quinton
Instrument Company.
10.9* Credit Agreement dated as of May 3, 1993, by and
between the Company and American Home Products
Corporation, as amended.
10.10* License Agreement (United States) dated September 4,
1991, by and between the Company and American Home
Products Corporation.
10.11* License Agreement (Foreign) dated September 4, 1991,
by and between the Company and American Home Products
Corporation.
10.12* Research and Development Agreement dated November 19,
1995, by and between the Company and American Home
Products Corporation.
10.13* Amendment No. 1 to Credit Agreement dated November
30, 1993, by and between the Company and American
Home Products Corporation.
10.14* Amendment No. 2 to Credit Agreement dated as of
August 1, 1995, by and between the Company and
American Home Products Corporation.
27.1** Financial Data Schedule
--------------------------
* This exhibit is incorporated by reference to the exhibit with the same
Exhibit Number in the Company's Registration Statement on Form S-1,
Registration Statement No. 33-98722.
** This exhibit has been previously filed on Form 10-K dated September
28, 1999.
<PAGE> 8
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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, on the 16th day of
May, 2000.
KENSEY NASH CORPORATION
By: /s/ WENDY F. DICICCO
-------------------------------
Wendy F. DiCicco
Chief Financial Officer
Pursuant to the requirements of the Securities Exchange Act of 1934,
this Report has been signed below by the following persons on behalf of the
Registrant and in the capacities indicated on the 16th day of May, 2000.
<TABLE>
<CAPTION>
SIGNATURE TITLES
--------- ------
<S> <C>
/s/ JOSEPH W. KAUFMANN Chief Executive Officer (Principal Executive Officer),
- --------------------------------------- President, Secretary and Director
Joseph W. Kaufmann
/s/ JOHN E. NASH, P.E. Vice President of New Technologies and Director
- ---------------------------------------
John E. Nash, P.E.
/s/ KENNETH R. KENSEY, M.D. Director
- ---------------------------------------
Kenneth R. Kensey, M.D.
/s/ DOUGLAS G. EVANS, P.E. Chief Operating Officer, Assistant Secretary and Director
- ---------------------------------------
Douglas G. Evans, P.E.
/s/ WENDY F. DICICCO, CPA Chief Financial Officer (Principal Accounting and Financial Officer)
- ---------------------------------------
Wendy F. DiCicco, CPA
/s/ ROBERT J. BOBB Director
- ---------------------------------------
Robert J. Bobb
/s/ HAROLD N. CHEFITZ Director
- ---------------------------------------
Harold N. Chefitz
/s/ WALTER R. MAUPAY, JR. Director
- ---------------------------------------
Walter R. Maupay, Jr.
</TABLE>
