================================================================================
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(MARK ONE)
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2002
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: 0-27605
--------------------
VASCULAR SOLUTIONS, INC.
(Exact name of registrant as specified in its charter)
MINNESOTA 41-1859679
(State of Incorporation) (IRS Employer Identification No.)
2495 XENIUM LANE NORTH
MINNEAPOLIS, MINNESOTA 55441
(Address of Principal Executive Offices)
(763) 656-4300
(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 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 whether the registrant is an accelerated filer (as
defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [ X ]
The registrant had 13,151,584 shares of common stock, $.01 par value per share,
outstanding as of October 8, 2002.
================================================================================
VASCULAR SOLUTIONS, INC.
INDEX
PAGE
----
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
Consolidated Balance Sheets 2
Consolidated Statements of Operations 3
Consolidated Statements of Cash Flows 4
Notes to Unaudited Consolidated Financial Statements 5
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations 7
Item 3. Quantitative and Qualitative Disclosure About Market Risks 11
Item 4. Controls and Procedures 11
PART II. OTHER INFORMATION
Item 1. Legal Proceedings 11
Item 2. Changes in Securities and Use of Proceeds 12
Item 3. Defaults upon Senior Securities 13
Item 4. Submission of Matters to a Vote of Security Holders 13
Item 5. Other Information 13
Item 6. Exhibits and Reports on Form 8-K 13
1
VASCULAR SOLUTIONS, INC.
CONSOLIDATED BALANCE SHEETS
SEPTEMBER 30, DECEMBER 31,
2002 2001
-------------- --------------
(Unaudited) (Note)
ASSETS
Current assets:
Cash and cash equivalents ...................................... $ 23,728,786 $ 33,318,115
Accounts receivable, net of allowance for doubtful
accounts of $150,000 in 2002 and $174,526 in 2001 .......... 1,243,825 1,285,011
Inventories .................................................... 2,146,460 1,782,363
Prepaid expenses ............................................... 343,534 289,888
-------------- --------------
Total current assets ............................................... 27,462,605 36,675,377
Property and equipment, net ........................................ 819,617 917,579
Intangible assets .................................................. 971,970 --
-------------- --------------
Total assets ....................................................... $ 29,254,192 $ 37,592,956
============== ==============
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable ............................................... $ 1,655,588 $ 876,891
Accrued compensation ........................................... 854,055 923,705
Accrued expenses ............................................... 97,213 162,476
-------------- --------------
Total current liabilities .......................................... 2,606,856 1,963,072
Commitments and contingencies
Shareholders' equity:
Common Stock, $.01 par value:
Authorized shares - 40,000,000
Issued and outstanding - June 30, 2002 - 13,173,084;
December 31, 2001 - 13,327,002 .......................... 131,731 133,270
Additional paid-in capital ......................................... 70,630,361 70,712,174
Other .............................................................. (71,940) (100,834)
Accumulated deficit ................................................ (44,042,816) (35,114,726)
-------------- --------------
Total shareholders' equity ......................................... 26,647,336 35,629,884
-------------- --------------
Total liabilities and shareholders' equity ......................... $ 29,254,192 $ 37,592,956
============== ==============
SEE ACCOMPANYING NOTES.
Note: The balance sheet at December 31, 2001 has been derived from the audited
financial statements at that date.
2
VASCULAR SOLUTIONS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 30, SEPTEMBER 30,
2002 2001 2002 2001
------------ ------------ ------------ ------------
(unaudited) (unaudited)
Net sales ....................................... $ 3,040,758 $ 2,528,994 $ 9,172,707 $ 9,192,179
Cost of goods sold .............................. 1,224,151 1,084,631 3,757,329 3,688,708
------------ ------------ ------------ ------------
Gross profit .................................... 1,816,607 1,444,363 5,415,378 5,503,471
Operating expenses:
Research and development ................... 817,850 1,061,669 2,571,214 3,019,431
Clinical and regulatory .................... 330,865 314,662 1,025,440 961,358
General and administrative ................. 520,616 616,176 1,606,578 2,193,490
Sales and marketing ........................ 2,870,147 3,342,840 9,458,240 9,471,270
Amortization of purchased technology ....... 54,375 -- 90,625 --
------------ ------------ ------------ ------------
Total operating expenses ........................ 4,593,853 5,335,347 14,752,097 15,645,549
------------ ------------ ------------ ------------
Operating loss .................................. (2,777,246) (3,890,984) (9,336,719) (10,142,078)
Interest income ................................. 143,292 369,794 408,629 1,451,487
------------ ------------ ------------ ------------
Net loss ........................................ $ (2,633,954) $ (3,521,190) $ (8,928,090) $ (8,690,591)
============ ============ ============ ============
Basic and diluted net
loss per share ............................. $ (0.20) $ (0.27) $ (0.67) $ (0.66)
============ ============ ============ ============
Shares used in computing
basic and diluted net loss
per share .................................. 13,368,006 13,247,040 13,360,889 13,185,989
============ ============ ============ ============
SEE ACCOMPANYING NOTES.
3
VASCULAR SOLUTIONS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 30, SEPTEMBER 30,
2002 2001 2002 2001
------------ ------------ ------------ ------------
(unaudited) (unaudited)
OPERATING ACTIVITIES
Net loss for the period .......................................... $ (2,633,954) $ (3,521,190) $ (8,928,090) $ (8,690,591)
Adjustments to reconcile net loss:
Depreciation and amortization ............................... 177,569 110,114 455,752 317,867
Value of options granted for services ....................... -- -- -- 10,398
Deferred compensation expense ............................... 17,672 14,457 56,774 41,948
Changes in operating assets and liabilities:
Accounts receivable ...................................... 345,109 600,484 41,186 655,941
Inventories .............................................. 62,354 295,105 99,511 112,104
Prepaid expenses ......................................... (167,614) 70,729 (53,646) (26,081)
Accounts payable ......................................... 385,470 (279,303) 778,697 (163,077)
Accrued compensation and expenses ........................ (169,552) (98,141) (134,913) (629,796)
------------ ------------ ------------ ------------
Net cash used in operating activities ............................ (1,982,946) (2,807,745) (7,684,729) (8,371,287)
INVESTING ACTIVITIES
Purchases of property and equipment ......................... (45,370) (77,402) (243,165) (352,157)
Purchase of Acolysis assets ................................. -- -- (1,550,203) --
------------ ------------ ------------ ------------
Net cash used in investing activities ............................ (45,370) (77,402) (1,793,368) (352,157)
FINANCING ACTIVITIES
Proceeds from exercise of stock options and sale of stock ... -- 138,686 129,200 492,992
Repurchase of common stock .................................. (212,552) -- (212,552) --
------------ ------------ ------------ ------------
Net cash provided by financing activities ........................ (212,552) 138,686 (83,352) 492,992
------------ ------------ ------------ ------------
Effect of exchange rate changes on cash and cash equivalents ..... (17,847) 5,661 (27,880) (15,093)
Increase (decrease) in cash and cash equivalents ................. (2,258,715) (2,740,800) (9,589,329) (8,245,545)
Cash and cash equivalents at beginning of period ................. 25,987,501 38,592,818 33,318,115 44,097,563
------------ ------------ ------------ ------------
Cash and cash equivalents at end of period ....................... $ 23,728,786 $ 35,852,018 $ 23,728,786 $ 35,852,018
============ ============ ============ ============
SEE ACCOMPANYING NOTES.
4
VASCULAR SOLUTIONS, INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
(1) BASIS OF PRESENTATION
The accompanying unaudited financial statements of Vascular Solutions,
Inc. (the "Company") have been prepared in accordance with generally
accepted accounting principles for interim financial information and
with the instructions to Form 10-Q and Regulation S-X. Accordingly,
they do not include all of the information and footnotes required by
generally accepted accounting principles for complete financial
statements. In the opinion of management, all normal, recurring
adjustments considered necessary for a fair presentation have been
included. The financial statements should be read in conjunction with
the audited financial statements for the year ended December 31, 2001
included in the Annual Report on Form 10-K of the Company filed with
the Securities and Exchange Commission. Interim results of operations
are not necessarily indicative of the results to be expected for the
full year or any other interim periods.
(2) COMPUTATION OF NET LOSS PER SHARE
In accordance with Statement of Financial Accounting Standards No. 128,
EARNINGS PER SHARE, (SFAS 128), basic net loss per share for the three
and nine months ended September 30, 2002 and 2001 is computed by
dividing net loss by the weighted average common shares outstanding
during the periods presented. Diluted net loss per share is computed by
dividing net loss by the weighted average common and dilutive potential
common shares outstanding computed in accordance with the treasury
stock method. For all periods presented, diluted loss per share is the
same as basic loss per share, because the effect of outstanding
options, warrants and convertible preferred stock is antidilutive.
(3) REVENUE RECOGNITION
In the United States and Germany, the Company sells its products
directly to hospitals and clinics. Revenue is recognized upon shipment
of products to customers.
In all other international markets, the Company sells its products to
international distributors which subsequently resell the products to
hospitals and clinics. The Company has agreements with each of its
distributors which provide that title and risk of loss pass to the
distributor upon shipment of the products to the distributor. The
Company warrants that its products are free from manufacturing defects
at the time of shipment to the distributor. Revenue is recognized upon
shipment of products to distributors following the receipt and
acceptance of a distributor's purchase order. Allowances are provided
for estimated warranty costs at the time of shipment. To date, warranty
costs have been insignificant.
5
VASCULAR SOLUTIONS, INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(4) INVENTORIES
Inventories are stated at the lower of cost (first-in, first-out
method) or market and are comprised of the following at:
SEPTEMBER 30, DECEMBER 31,
2002 2001
---- ----
(unaudited)
Raw materials .................... $ 1,646,437 $ 1,294,507
Work-in process .................. 197,135 305,527
Finished goods ................... 302,888 182,329
------------ ------------
$ 2,146,460 $ 1,782,363
============ ============
(5) CONCENTRATIONS OF CREDIT AND OTHER RISKS
Financial instruments that potentially subject the Company to
concentrations of credit risk consist primarily of cash and cash
equivalents and accounts receivables. The Company maintains its
accounts for cash and cash equivalents principally at one major bank
and three investment firms in the United States. The Company has a
formal written investment policy that restricts the placement of
investments to issuers evaluated as creditworthy. The Company has not
experienced any losses on its deposits of its cash and cash
equivalents.
With respect to accounts receivable, the Company performs credit
evaluations of its customers and does not require collateral. Sales by
geographic destination as a percentage of total net sales for the nine
months ended September 30, 2002 and 2001 were 89% and 90% in the United
States, respectively, and 11% and 10% in international markets,
respectively. There have been no material losses on accounts
receivable.
The Company operates in a single industry segment and sells its product
directly to hospitals and clinics in the United States and Germany. In
Germany, the Company sells its product in Euros. In all other
international markets, the Company sells its product in United States
dollars to distributors who, in turn, sell to medical clinics in the
local currency. Loss, termination or ineffectiveness of distributors to
effectively promote the Company's product would have a material adverse
effect on the Company's financial condition and results of operations.
No single customer represented greater than 10% of the total net sales
for the three and nine months ended September 30, 2002 and 2001.
(6) RECLASSIFICATION
Certain 2001 amounts have been reclassified to conform to the 2002
presentation.
6
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
OVERVIEW
We develop, manufacture and market the Vascular Solutions Duett(TM)
sealing device, the Diagnostic Duett(TM) sealing device, the D-Stat(TM) flowable
hemostat and the Acolysis(R) intravascular therapeutic ultrasound system. Our
Duett sealing device is designed to provide a complete seal of the puncture site
following catheterization procedures such as angiography, angioplasty and
stenting. The Diagnostic Duett is a version of the Duett sealing device that is
tailored specifically for treating diagnostic patients. The D-Stat flowable
hemostat is a thick, yet flowable blood clotting material that is used in a wide
variety of interventional medical procedures for the local control of bleeding.
We commenced operations in February 1997, and during 1998 and 1999 we received
regulatory approvals to market our Duett sealing device in several international
markets, principally in Europe. On June 22, 2000, we received approval from the
FDA of our PMA application for the sale of our Duett sealing device in the
United States. As a result, during the third quarter of 2000 we commenced sales
of the Duett in the United States through our direct sales force. We commenced
sales of the Diagnostic Duett in the United States in December 2001, and
commenced sales of the D-Stat in the United States in February 2002. On April 2,
2002, we acquired the assets of the Acolysis system from the secured creditors
of Angiosonics, Inc. The Acolysis controller and probes have been sold in
international markets, principally in Europe and China, for over two years.
During the second quarter of 2002, we commenced international sales of the
Acolysis probes.
We have a limited history of operations and have experienced significant
operating losses since inception. As of September 30, 2002, we had an
accumulated deficit of $44.0 million. We may never achieve profitability, or if
we achieve profitability it may not be sustained in future periods.
RESULTS OF OPERATIONS
THREE MONTHS ENDED SEPTEMBER 30, 2002 COMPARED TO THREE MONTHS ENDED SEPTEMBER
30, 2001
Net sales increased 20% to $3,040,758 for the three months ended September
30, 2002 from $2,528,994 for the three months ended September 30, 2001. The
increase in net sales was attributable to the release of the next generation
"Pro" line of our Duett sealing device during the quarter which resulted in an
8% increase in our Duett product compared to the year ago quarter. The addition
of D-Stat and Acolysis products, both of which were introduced in 2002, also
contributed to the growth. Net sales for the three months ended September 30,
2002 for the Duett, D-Stat flowable hemostat, and Acolysis were $2,756,455,
$244,578, and $39,725 respectively.
Gross profit as a percentage of net sales was 60% for the three months
ended September 30, 2002 compared to 57% for the three months ended September
30, 2001. Beginning July 1, 2001, a royalty expense of 2.5% of net sales is
included in our cost of goods sold related to an agreement that settled all
existing intellectual property litigation with St. Jude Medical, Inc. (See
"Legal Proceedings" in Item 1 of Part II of this Form 10-Q).
7
Research and development expenses decreased 23% to $817,850 for the three
months ended September 30, 2002 from $1,061,669 for the three months ended
September 30, 2001. Research and development expenses consist primarily of
development of next generation Duett devices as well as new interventional
devices. We focused most of our attention on the Mechanical Duett and D-Stat Dry
during the third quarter. The Mechanical Duett is a new concept for femoral
arterial sealing, and the D-Stat Dry is a lyophilized version of the D-Stat that
can be packaged pre-mixed and applied dry in combination with a custom
compression band or bandage. The decrease in research and development spending
is due to more focused spending and efficiencies, not any program cancellations.
We expect our research and development expenses to increase slightly in the
future as we continue work on product improvements and product line extensions.
Clinical and regulatory expenses increased 5% to $330,865 for the three
months ended September 30, 2002 from $314,662 for the three months ended
September 30, 2001. This increase is attributable to a modest increase in the
number of products and product improvements compared to the prior year. We
expect clinical and regulatory expenses to increase modestly in the future as we
pursue new products such as the Mechanical Duett and D-Stat Dry, perform
clinical studies for additional indications for our existing D-Stat flowable
hemostat, and as we incur expenses for additional marketing studies of our Duett
sealing devices.
General and administrative expenses decreased 16% to $520,616 for the
three months ended September 30, 2002 from $616,176 for the three months ended
September 30, 2001. The three months ended September 30, 2001 included
approximately $200,000 for legal expenses relating to our settlement with St.
Jude Medical, Inc. (See "Legal Proceedings" in Item 1 of Part II of this Form
10-Q) compared to approximately $100,000 for legal expenses related to the
patent litigation with Datascope Corp. in the three months ended September 30,
2002. We currently anticipate that general and administrative expenses will
increase by modest amounts for the foreseeable future as we continue to incur
litigation expenses related to the existing Datascope litigation.
Sales and marketing expenses decreased 14% to $2,870,147 for the three
months ended September 30, 2002 from $3,342,840 for the three months ended
September 30, 2001. As of September 30, 2002, our direct sales force consisted
of approximately 53 employees, which we expect to remain relatively stable
through the end of 2002. As a result, we expect our sales and marketing expenses
to continue to remain relatively stable for the foreseeable future.
Amortization of purchased technology was $54,375 for the three months
ended September 30, 2002 and $0 for the three months ended September 30, 2001.
The amortization was the result of our acquisition of the Acolysis assets from
the secured creditors of Angiosonics, Inc. We allocated $870,000 to purchased
technology and are amortizing the amount over four years.
Interest income decreased to $143,292 for the three months ended September
30, 2002 from $369,794 for the three months ended September 30, 2001 primarily
as a result of lower interest rates and lower cash balances compared to the
previous comparable period.
NINE MONTHS ENDED SEPTEMBER 30, 2002 COMPARED TO NINE MONTHS ENDED SEPTEMBER 30,
2001
Net sales were $9,172,707 for the nine months ended September 30, 2002
compared to $9,192,179 for the nine months ended September 30, 2001. Net sales
of the Duett sealing device decreased by approximately $300,000 due to a revised
focus on clinical sales of our Duett devices beginning in the last part of 2001,
which was offset by sales of the D-Stat flowable hemostat and Acolysis.
Beginning in mid-2001, our U.S. distribution strategy for the Duett has focused
on serving our existing accounts to provide better account retention and use per
account. Net sales for the nine months ended September 30, 2002 for the Duett,
D-Stat flowable hemostat and Acolysis were $8,612,704, $515,409, and 44,594
respectively.
8
Gross profit as a percentage of net sales was 59% for the nine months
ended September 30, 2002 compared to 60% for the nine months ended September 30,
2001. Beginning July 1, 2001, a royalty expense of 2.5% of net sales is included
in our cost of goods sold related to an agreement that settled all existing
intellectual property litigation with St. Jude Medical, Inc. (See "Legal
Proceedings" in Item 1 of Part II of this Form 10-Q).
Research and development expenses decreased 15% to $2,571,214 for the nine
months ended September 30, 2002 from $3,019,431 for the nine months ended
September 30, 2001. Research and development expenses consist primarily of
development of next generation Duett devices as well as new interventional
devices. As stated above, the decrease in spending is due to more focused
spending and efficiencies, not any program cancellations. We expect our research
and development expenses to increase slightly in the future as we continue work
on product improvements and product line extensions.
Clinical and regulatory expenses increased 7% to $1,025,440 for the nine
months ended September 30, 2002 from $961,358 for the nine months ended
September 30, 2001. As stated above, the increase is attributable to a modest
increase in the number of products and product improvements.
General and administrative expenses decreased 27% to $1,606,578 for the
nine months ended September 30, 2002 from $2,193,490 for the nine months ended
September 30, 2001. The nine months ended September 30, 2001 included a one-time
charge of $350,000 incurred in connection with the settlement of our patent
litigation with St. Jude Medical, Inc. (See "Legal Proceedings" in Item 1 of
Part II of this Form 10-Q). The remaining decrease is the result of lower
personnel costs from the prior year.
Sales and marketing expenses had no change at $9,458,240 for the nine
months ended September 30, 2002 compared to $9,471,270 for the nine months ended
September 30, 2001. As a result, we expect our sales and marketing expenses to
continue to remain relatively stable for the foreseeable future.
Amortization of purchased technology was $90,625 for the nine months ended
September 30, 2002 and $0 for the nine months ended September 30, 2001. The
amortization was the result of our acquisition of the Acolysis assets from the
secured creditors of Angiosonics, Inc. We allocated $870,000 of the purchase
price to purchased technology and are amortizing the amount over four years.
Interest income decreased to $408,629 for the nine months ended September
30, 2002 from $1,451,487 for the nine months ended September 30, 2001 primarily
as a result of lower interest rates and lower cash balances compared to the
previous comparable period.
INCOME TAXES
We have not generated any pre-tax income to date and therefore have not
paid any federal income taxes since inception in December 1996. No provision or
benefit for federal and state income taxes has been recorded for net operating
losses incurred in any period since our inception.
As of September 30, 2002, we had approximately $41.0 million of federal
net operating loss carryforwards available to offset future taxable income which
begin to expire in the year 2014. As of September 30, 2002, we also had federal
and state research and development tax credit carryforwards of approximately
$1.5 million which begin to expire in the year 2014. Under the Tax Reform Act of
1986, the amounts of and benefits from net operating loss carryforwards may be
9
impaired or limited in certain circumstances, including significant changes in
ownership interests. Future use of our existing net operating loss carryforwards
may be restricted due to changes in ownership or from future tax legislation.
We have established a valuation allowance against the entire amount of our
deferred tax asset because we have not been able to conclude that it is more
likely than not that we will be able to realize the deferred tax asset, due
primarily to our history of operating losses.
LIQUIDITY AND CAPITAL RESOURCES
We have financed all of our operations since inception through the
issuance of equity securities. Through September 30, 2002, we had sold common
stock and preferred stock generating aggregate net proceeds of $70.2 million. At
September 30, 2002, we had $23.7 million in cash and cash equivalents on-hand.
During the three months ended September 30, 2002, we used $2 million of cash and
cash equivalents in operating activities primarily to fund our net loss for the
period of $2.6 million. We also used $212,552 to repurchase 229,800 shares under
our stock repurchase program. In August, the Board of Directors adopted a stock
repurchase program to acquire up to 1 million shares in open market
transactions. The program does not obligate the company to acquire any specific
number of shares and may be discontinued at any time. Our capital expenses to
acquire manufacturing and office equipment totaled $45,370 during the three
months ended September 30, 2002.
We do not have any significant cash commitments related to supply
agreements, nor do we have any commitments for capital expenditures.
We currently anticipate that we will continue to experience a negative
cash flow and our expenses will be a material use of our cash resources. We
anticipate that our operating losses will continue through at least December 31,
2003. We believe that current cash balances along with cash generated from the
future sales of products will be sufficient to meet our operating and capital
requirements for the remainder of 2002, all of 2003 and all of 2004. Our
liquidity and capital requirements beyond 2004 will depend on numerous factors,
including the extent to which our products gain market acceptance and
competitive developments.
If cash generated from operations is insufficient to satisfy our cash
needs, we may be required to raise additional funds. We currently have no
commitments for additional funding and so our ability to meet our long-term
liquidity needs is uncertain. If we raise additional funds through the issuance
of equity securities, our shareholders may experience significant dilution.
Furthermore, additional financing may not be available when needed or, if
available, financing may not be on terms favorable to us or our shareholders. If
financing is not available when required or is not available on acceptable
terms, we may be unable to develop or market our products or take advantage of
business opportunities or respond to competitive pressures.
CAUTIONARY STATEMENT PURSUANT TO THE PRIVATE SECURITIES LITIGATION REFORM ACT OF
1995
The Private Securities Litigation Reform Act of 1995 (the "Act")
provides a "safe harbor" for forward-looking statements to encourage companies
to provide prospective information about their business, so long as those
statements are identified as forward-looking and are accompanied by meaningful
cautionary statements identifying important factors that could cause actual
results to differ materially from those discussed in the statement. Vascular
Solutions, Inc. desires to take advantage of the safe harbor provisions with
respect to any forward-looking statements it may make in this filing, other
filings with the Securities and Exchange Commission and any public oral
statements or written releases. The words or phrases "will likely," "is
10
expected," "will continue," "is anticipated," "estimate," "projected,"
"forecast," or similar expressions are intended to identify forward-looking
statements within the meaning of the Act. Such statements are subject to certain
risks and uncertainties that could cause actual results to differ materially
from those projected. The Company cautions readers not to place undue reliance
on any such forward-looking statements, which speak only as of the date made. In
accordance with the Act, the Company identifies the following important general
factors which if altered from the current status could cause the Company's
actual results to differ from those described in any forward-looking statements:
risks associated with our limited operating history, defense of patent
infringement lawsuits, adoption of our new sealing methodology, reliance on a
sole product, lack of profitability, lack of experience with a direct sales
force, exposure to possible product liability claims, the development of new
products by others, dependence on third party distributors in international
markets, doing business in international markets, limited manufacturing
experience, the availability of third party reimbursement, actions by the FDA
related to the Duett sealing device, the loss of key vendors and those factors
set forth under the heading "Risk Factors" in the Company's Annual Report on
Form 10-K for the year ended December 31, 2001. This list is not exhaustive, and
the Company may supplement this list in any future filing with the Securities
and Exchange Commission or in connection with the making of any specific
forward-looking statement.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISKS
Financial instruments that potentially subject us to concentrations of
credit risk consist primarily of cash and cash equivalents and accounts
receivables. We maintain our accounts for cash and cash equivalents principally
at one major bank and three investment firms in the United States. We have a
formal written investment policy that restricts the placement of investments to
issuers evaluated as creditworthy. We have not experienced any losses on our
deposits of our cash and cash equivalents.
With respect to accounts receivable, we perform credit evaluations of our
customers and do not require collateral. There have been no material losses on
accounts receivables.
In the United States and Germany, we sell our products directly to
hospitals and clinics in the local currency. Revenue is recognized upon shipment
of products to customers.
In all other international markets, we sell our products to independent
distributors who, in turn, sell to medical clinics. We sell our product in these
countries through independent distributors denominated in United States dollars.
Loss, termination or ineffectiveness of distributors to effectively promote our
product would have a material adverse effect on our financial condition and
results of operations.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of disclosure controls and procedures.
Under the supervision and with the participation of our management,
including our Chief Executive Officer and Chief Financial Officer, we evaluated
the effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Rule 13a-14(c) under the Exchange Act) as of a date
(the "Evaluation Date") within 90 days prior to the filing date of this report.
Based upon that evaluation, the Chief Executive Officer and Chief Financial
Officer concluded that, as of the Evaluation Date, our disclosure controls and
procedures were effective in timely alerting them to the material information
relating to us (or our consolidated subsidiaries) required to be included in our
periodic SEC filings.
(b) Changes in internal controls.
There were no significant changes made in our internal controls during
the period covered by this report or, to our knowledge, in other factors that
could significantly affect these controls subsequent to the date of their
evaluation.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
On July 23, 1999, we were named as the defendant in a patent infringement
lawsuit brought by Datascope Corp. in the United States District Court for the
District of Minnesota. The complaint requested a judgment that our Duett sealing
device infringes and, following FDA approval will infringe, a United States
patent held by Datascope and asks for relief in the form of an injunction that
would prevent us from selling our product in the United States as well as an
award of attorneys' fees, costs and disbursements. On August 12, 1999, we filed
our answer to this lawsuit and brought a counterclaim alleging unfair
competition and tortious interference. On August 20, 1999, we moved for summary
11
judgement to dismiss Datascope's claims. On March 15, 2000, the court granted
summary judgment dismissing all of Datascope's claims, subject to the right of
Datascope to recommence the litigation after our receipt of FDA approval of our
Duett sealing device. On July 12, 2000, after our receipt of FDA approval,
Datascope recommenced this litigation, alleging that the Duett sealing device
infringes a United States patent held by Datascope and requesting relief in the
form of an injunction that would prevent us from selling our product in the
United States, damages caused by our alleged infringement, and other costs,
disbursements and attorneys' fees. In 2002 both parties brought motions for
summary judgment, and in August 2002 the Court denied Vascular Solutions' motion
for summary judgment and granted Datascope's partial motion for summary
judgment. The court's decision allows the litigation to proceed to trial on the
issues of damages, if any, with the trial currently in the process of being
scheduled for the fourth quarter of 2002. It is not possible to predict the
timing or outcome of the Datascope litigation, including whether we will be
prohibited from selling our Duett sealing device in the United States, or to
estimate the amount or range of potential loss, if any.
On July 3, 2000, we were named as the defendant in a patent infringement
lawsuit brought by the Daig division of St. Jude Medical in the United States
District Court for the District of Minnesota. The complaint requested a judgment
that our Duett sealing device infringes a series of four patents known as the
Fowler patents held by St. Jude Medical and asks for relief in the form of an
injunction that would prevent us from selling our Duett sealing device in the
United States, damages caused by the manufacture and sale of our product, and
other costs, disbursements and attorneys' fees.
On July 12, 2001, we entered into an agreement that settled all existing
intellectual property litigation with St. Jude Medical. Under the terms of the
settlement agreement, we agreed to pay a royalty of 2.5% of net sales of our
Duett sealing device to St. Jude Medical, up to a maximum amount over the
remaining life of the St. Jude Fowler patents. In exchange, St. Jude Medical
granted to us a non-exclusive license to its Fowler patents and has released us
from any claim of patent infringement based on sales of our Duett sealing
device. We granted a non-exclusive cross-license to our Gershony patents to St.
Jude Medical, subject to a similar royalty payment if St. Jude Medical utilizes
our Gershony patents in any future device. Beginning on July 1, 2001, a royalty
expense of 2.5% of net sales is included in our cost of goods sold until the
maximum royalty is attained.
From time to time we are involved in legal proceedings arising in the
normal course of our business. Other than as described above, as of the date of
this report we are not a party to any legal proceeding in which an adverse
outcome would reasonably be expected to have a material adverse effect on our
results of operations or financial condition.
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS
(a) Not applicable
(b) Not applicable
(c) Not applicable
(d) On July 25, 2000, we sold 3,500,000 shares of our common stock, at
an initial public offering price of $12.00 per share, pursuant to a
Registration Statement on Form S-1 (Registration No. 333-84089),
which was declared effective by the Securities and Exchange
Commission on July 19, 2000. The managing underwriters of our
initial public offering were Salomon Smith Barney Inc., Stephens
Inc. and William Blair & Company, L.L.C. On August 15, 2000, the
12
underwriters exercised in full their over-allotment option to
purchase an additional 525,000 shares of common stock at $12.00 per
share. Our net proceeds from the offering were approximately $44.0
million. To date, we have spent approximately $18.0 million of the
net proceeds to hire, train and deploy a direct sales force in the
United States, $3.5 million for general corporate purposes, and
$1.6 million for the purchase of the Acolysis assets from
Angiosonics.
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:
10.1 Lease Agreement dated August 30, 2002 by and between
First Industrial, L.P. as Landlord and Vascular
Solutions, Inc. as Tenant.
99.1 Certification of Chief Executive Officer and Acting
Chief Financial Officer pursuant to Section 906 of
Sarbanes-Oxley Act of 2002.
(b) Reports on Form 8-K:
We did not file any Current Report on Form 8-K during the
quarter ended September 30, 2002.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
VASCULAR SOLUTIONS, INC.
Date: October 18, 2002 By: /s/ Howard Root
-------------------------
Howard Root
CHIEF EXECUTIVE OFFICER
(Duly authorized officer)
13
CERTIFICATIONS
I, Howard Root, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Vascular
Solutions, Inc.;
2. Based on my knowledge, this quarterly report does not contain any
untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period covered by this
quarterly report;
3. Based on my knowledge, the financial statements, and other financial
information included in this quarterly report, fairly present in all material
respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this quarterly report;
4. The registrant's other certifying officers and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
(a) designed such disclosure controls and procedures to ensure
that material information relating to the registrant,
including its consolidated subsidiaries, is made known to us
by others within those entities, particularly during the
period in which this quarterly report is being prepared;
(b) evaluated the effectiveness of the registrant's disclosure
controls and procedures as of a date within 90 days prior to
the filing date of this quarterly report (the "Evaluation
Date"); and
(c) presented in this quarterly report our conclusions about the
effectiveness of the disclosure controls and procedures based
on our evaluation as of the Evaluation Date;
5. The registrant's other certifying officers and I have disclosed,
based on our most recent evaluation, to the registrant's auditors and the audit
committee of registrant's board of directors (or persons performing the
equivalent function):
(a) all significant deficiencies in the design or operation of
internal controls which could adversely affect the
registrant's ability to record, process, summarize and report
financial data and have identified for the registrant's
auditors any material weaknesses in internal controls; and
(b) any fraud, whether or not material, that involves management
or other employees who have a significant role in the
registrant's internal controls; and
6. The registrant's other certifying officers and I have indicated in
this quarterly report whether or not there were significant changes in internal
controls or in other factors that could significantly affect internal controls
subsequent to the date of our most recent evaluation, including any corrective
actions with regard to significant deficiencies and material weaknesses.
Date: October 18, 2002
/s/ Howard Root
-------------------------
Howard Root
Chief Executive Officer and
Acting Chief Financial
Officer (Principal executive
officer and principal
financial officer)
14