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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 MARCH 31, 2003
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
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VASCULAR SOLUTIONS, INC.
(Exact name of registrant as specified in its charter)
MINNESOTA 41-1859679
(State of Incorporation) (IRS Employer Identification No.)
6464 SYCAMORE COURT
MINNEAPOLIS, MINNESOTA 55369
(Address of Principal Executive Offices)
(763) 656-4300
(Registrant's telephone number, including area code)
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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 12,811,739 shares of common stock, $.01 par value per share,
outstanding as of April 15, 2003.
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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 12
Item 4. Controls and Procedures 12
PART II. OTHER INFORMATION
Item 1. Legal Proceedings 12
Item 2. Changes in Securities and Use of Proceeds 13
Item 3. Defaults upon Senior Securities 13
Item 4. Submission of Matters to a Vote of Security Holders 14
Item 5. Other Information 14
Item 6. Exhibits and Reports on Form 8-K 14
1
VASCULAR SOLUTIONS, INC.
CONSOLIDATED BALANCE SHEETS
MARCH 31, DECEMBER 31,
2003 2002
-------------------------------
(unaudited) (see note)
ASSETS
Current assets:
Cash and cash equivalents ...................................... $ 1,772,947 $ 1,835,059
Available-for-sale securities .................................. 11,625,320 14,914,444
Accounts receivable, net of reserves of $120,000 and $130,000 in
2003 and 2002, respectively .................................. 1,438,314 1,357,946
Inventories .................................................... 3,031,632 2,132,516
Prepaid expenses ............................................... 388,867 326,773
-------------------------------
Total current assets .............................................. 18,257,080 20,566,738
Property and equipment, net ....................................... 683,867 795,885
Intangible assets, net ............................................ 863,220 917,595
-------------------------------
Total assets ...................................................... $ 19,804,167 $ 22,280,218
===============================
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable ............................................... $ 1,103,506 $ 771,078
Accrued compensation ........................................... 724,429 886,130
Accrued expenses ............................................... 326,429 253,777
-------------------------------
Total current liabilities ......................................... 2,154,364 1,910,985
Shareholders' equity:
Common stock, $0.01 par value:
Authorized shares - 40,000,000
Issued and outstanding shares - 12,812,739 - 2003;
12,880,839 - 2002 .......................................... 128,127 128,808
Additional paid-in capital ..................................... 70,292,496 70,355,343
Other .......................................................... (80,158) (21,278)
Accumulated deficit ............................................ (52,690,662) (50,093,640)
-------------------------------
Total shareholders' equity ........................................ 17,649,803 20,369,233
-------------------------------
Total liabilities and shareholders' equity ........................ $ 19,804,167 $ 22,280,218
===============================
SEE ACCOMPANYING NOTES.
Note: The balance sheet at December 31, 2002 has been derived from the audited
financial statements at that date.
2
VASCULAR SOLUTIONS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED
MARCH 31,
2003 2002
-----------------------------
(unaudited)
Net sales ................................ $ 2,968,284 $ 2,803,420
Cost of goods sold ....................... 1,222,591 1,206,918
-----------------------------
Gross profit ............................. 1,745,693 1,596,502
Operating expenses:
Research and development .............. 833,571 897,125
Clinical and regulatory ............... 340,692 315,273
Sales and marketing ................... 2,675,384 3,475,159
General and administrative ............ 500,843 597,767
Amortization of purchased technology .. 54,375 --
-----------------------------
Total operating expenses ................. 4,404,865 5,285,324
-----------------------------
Operating loss ........................... (2,659,172) (3,688,822)
Interest income .......................... 62,150 137,825
-----------------------------
Net loss ................................. $ (2,597,022) $ (3,550,997)
=============================
Basic and diluted net loss per share ..... $ (0.20) $ (0.27)
=============================
Shares used in computing basic and diluted
net loss per share .................... 12,843,865 13,333,113
=============================
SEE ACCOMPANYING NOTES.
3
VASCULAR SOLUTIONS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
THREE MONTHS ENDED
MARCH 31,
2003 2002
---------------------------
(unaudited)
OPERATING ACTIVITIES
Net loss ............................................ $(2,597,022) $(3,550,997)
Adjustments to reconcile net loss to net cash used in
operating activities:
Depreciation ................................... 131,254 119,458
Amortization ................................... 54,375 --
Deferred compensation expense .................. 17,901 20,601
Changes in operating assets and liabilities:
Accounts receivable .......................... (80,367) 29,878
Inventories .................................. (899,116) (447,768)
Prepaid expenses ............................. (62,094) 50,926
Accounts payable ............................. 332,427 404,789
Accrued compensation and expenses ............ (89,049) (237,956)
---------------------------
Net cash used in operating activities ............... (3,191,691) (3,611,069)
INVESTING ACTIVITIES
Purchase of property and equipment, net ............. (19,236) (157,563)
Purchase of securities .............................. (4,875,876) (7,338,462)
Proceeds from sales of securities ................... 8,165,000 7,367,749
---------------------------
Net cash provided by (used in) investing activities . 3,269,888 (128,276)
FINANCING ACTIVITIES
Proceeds from exercise of stock options ............. -- 20,000
Repurchase of common stock .......................... (63,528) --
Net cash (used in) provided by financing activities . (63,528) 20,000
---------------------------
Effect of exchange rate changes on cash and cash
equivalents ...................................... (76,781) (3,453)
---------------------------
(Decrease) increase in cash and cash equivalents .... (62,112) (3,722,798)
Cash and cash equivalents at beginning of period .... 1,835,059 9,091,640
---------------------------
Cash and cash equivalents at end of period .......... $ 1,772,947 $ 5,368,842
===========================
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, 2002
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) STOCK BASED COMPENSATION
At March 31, 2003, the Company had a stock-based employee compensation
plan. The Company accounts for the plan under the recognition and
measurement principles of Accounting Principles Board (APB) Opinion No.
25, ACCOUNTING FOR STOCK ISSUED TO EMPLOYEES, and related
interpretations. No stock-based employee compensation cost is reflected
in net loss, as all options granted under those plans had an exercise
price equal to the market value of the underlying common stock on the
date of grant. The following table illustrates the effect on net loss
and loss per share if the Company had applied the fair value
recognition provisions of Financial Accounting Standards Board (FASB)
Statement of Financial Accounting Standards (SFAS) No. 123, ACCOUNTING
FOR STOCK-BASED COMPENSATION, to stock-based employer compensation.
QUARTER ENDED MARCH 31
2003 2002
---------------------------
Net loss, as reported ................. $(2,597,022) $(3,550,997)
Deduct: Total stock-based employee
compensation expense determined under
fair-value-based method for all
awards .............................. (208,227) (585,024)
---------------------------
Pro forma net loss .................... $(2,805,249) $(4,136,021)
===========================
Net loss per share:
Basic and diluted - as reported ....... $ (0.20) $ (0.27)
===========================
Basic and diluted - pro forma ......... $ (0.22) $ (0.31)
===========================
(3) 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
months ended March 31, 2003 and 2002 is computed by dividing net loss
by the weighted average common shares outstanding during the periods
presented. For all periods presented, diluted loss per share is the
same as basic loss per
5
VASCULAR SOLUTIONS, INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
share, because the effect of outstanding options, warrants and
convertible preferred stock is antidilutive.
(4) COMPREHENSIVE LOSS
Comprehensive loss for the Company includes net loss and foreign
currency translation. Comprehensive loss for the three months ended
March 31, 2003 and March 31, 2002 was as follows:
MARCH 31, MARCH 31,
2003 2002
(unaudited) (unaudited)
Net Loss ................... $(2,597,022) $(3,550,997)
Foreign currency translation
adjustments ................ (76,781) (3,453)
----------- -----------
Comprehensive loss ......... $(2,673,803) $(3,554,450)
=========== ===========
(5) 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.
(6) INVENTORIES
Inventories are stated at the lower of cost (first-in, first-out
method) or market and are comprised of the following at:
MARCH 31, DECEMBER 31,
2003 2002
---------- ----------
(unaudited)
Raw materials .............. $2,084,902 $1,561,943
Work-in process ............ 99,680 138,134
Finished goods ............. 847,050 432,439
---------- ----------
$3,031,632 $2,132,516
========== ==========
6
VASCULAR SOLUTIONS, INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(7) 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, available-for-sale securities and accounts receivable. The
Company maintains its accounts for cash and cash equivalents and
available-for-sale securities principally at one major bank and two
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 or
available-for-sale securities.
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 three
months ended March 31, 2003 and 2002 were 88% and 91% in the United
States, respectively, and 12% and 9% 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 months ended March 31, 2003 and 2002.
(8) RECLASSIFICATION
Certain 2003 amounts have been reclassified to conform to the 2002
presentation.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
OVERVIEW
We are a medical device company focused on bringing solutions to
interventional cardiologists and interventional radiologists. Our product line
includes the Duett(TM) sealing device, the D-Stat(TM) flowable hemostat and the
Acolysis(R) therapeutic ultrasound system. As a vertically-integrated medical
device company, we generate ideas and create new interventional medical devices,
and then deliver those products directly to the physician through our direct
domestic sales force and international distribution network.
We commenced operations in February 1997, and during 1998 and 1999 we
received regulatory approvals to market our first product, the 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
7
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. In April 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 last quarter of 2002, we commenced active international sales of the
Acolysis product.
We have a limited history of operations and have experienced significant
operating losses since inception. As of March 31, 2003, we had an accumulated
deficit of $52.7 million. Although we have experienced revenue growth in recent
periods, this growth may not be sustainable and, therefore, these recent periods
should not be considered indicative of future performance. We may never achieve
profitability, or if we achieve profitability it may not be sustained in future
periods.
RESULTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2003 COMPARED TO THREE MONTHS ENDED MARCH 31, 2002
Net sales increased 6% to $2,968,284 for the three months ended March 31,
2003 from $2,803,420 for the three months ended March 31, 2002. The increase in
net sales was attributable to the addition of D-Stat and Acolysis products, both
of which were introduced in 2002. Net sales for the three months ended March 31,
2003 for the Duett, D-Stat flowable hemostat, and Acolysis were $2,661,550,
$271,588, and $35,146 respectively.
Gross profit as a percentage of net sales was 59% for the three months
ended March 31, 2003 compared to 57% for the three months ended March 31, 2002.
The increase in the gross margin was attributable to the increase in sales of
our two new higher margin products.
Research and development expenses decreased 7% to $833,571 for the three
months ended March 31, 2003 from $897,125 for the three months ended March 31,
2002. Research and development expenses consist primarily of development of next
generation Duett devices as well as new interventional devices. Additional
interventional medical devices that we incurred research and development
expenses on include the D-Stat Dry hemostatic bandage, the D-Stat Radial
hemostat band, the Pronto extraction catheter and a minimally invasive varicose
vein treatment device.
The Mechanical Duett is a new concept that utilizes an immediate and
complete mechanical seal of the arterial puncture to obtain hemostasis. The
D-Stat Dry bandage consists of a freeze-dried pad of the D-Stat procoagulant
which can be applied to topical bleeding with a custom adhesive bandage. The
D-Stat Radial hemostat band is a customized compression device with the power of
the D-Stat procoagulant for sealing the arterial puncture following
catheterization procedures utilizing the radial artery in the wrist. The Pronto
catheter consists of an extraction catheter with a proprietary atraumatic distal
tip and large extraction lumen for the removal of soft thrombus from arteries.
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 8% to $340,692 for the three
months ended March 31, 2003 from $315,273 for the three months ended March 31,
2002. 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 and perform a clinical
study for an additional indication for our existing D-Stat flowable hemostat
called the D-Stat "Pocket Protector" clinical study.
8
General and administrative expenses decreased 16% to $500,843 for the
three months ended March 31, 2003 from $597,767 for the three months ended March
31, 2002. The three months ended March 31, 2002 included approximately $125,000
for legal expenses relating to our settlement with Datascope Corporation (See
"Legal Proceedings" in Item 1 of Part II of this Form 10-Q). We currently
anticipate that general and administrative expenses will be below $500,000 for
the foreseeable future.
Sales and marketing expenses decreased 23% to $2,675,384 for the three
months ended March 31, 2003 from $3,475,159 for the three months ended March 31,
2002. We increased net sales 6% during the quarter ended March 31, 2003 compared
to the year ago quarter while decreasing sales and marketing expenses 23%. As of
March 31, 2003 our direct sales force consisted of approximately 53 employees,
which we expect to remain relatively stable through the end of 2003. 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 March 31, 2003 and $0 for the three months ended March 31, 2002. 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 $62,150 for the three months ended March 31,
2003 from $137,825 for the three months ended March 31, 2002 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 March 31, 2003, we had approximately $48.6 million of federal net
operating loss carryforwards available to offset future taxable income which
begin to expire in the year 2013. As of March 31, 2003, we also had federal and
state research and development tax credit carryforwards of approximately $1.3
million which begin to expire in the year 2013. Under the Tax Reform Act of
1986, the amounts of and benefits from net operating loss carryforwards may be
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 and, to a lesser extent, sales of our products.
Through March 31, 2003, we have sold common stock and preferred stock generating
aggregate net proceeds of $70.2 million. At March 31, 2003, we had $13.4 million
in cash, cash equivalents and available-for-sale securities on-hand.
During the three months ended March 31, 2003, we used $3.2 million in
operating activities. The cash used in operating activities was primarily used
to fund our net loss for the period of $2.6 million,
9
which was offset by depreciation and amortization of $185,629. We generated
proceeds of $3,269,888 in investing activities, primarily from the net sales of
investment securities of $3,289,124. We used $63,528 in financing activities for
the repurchase of 68,100 shares of our common stock, we have now purchased a
total of 677,000 shares under our stock repurchase program. In August of 2002,
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.
We do not have any significant cash commitments related to supply
agreements, nor do we have any significant commitments for capital expenditures.
We currently anticipate that we will continue to experience a negative
cash flow for the foreseeable future and our expenses will be a material use of
our cash resources. We anticipate that our operating losses will continue
through at least mid-2004. 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 at least the next 24 months. Our
liquidity and capital requirements beyond the next 24 months will depend on
numerous factors, including the extent to which our current and future 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.
CRITICAL ACCOUNTING POLICIES:
The critical accounting policies of the Company are set forth below. We
believe the policies set forth below are the most critical to an investor's
understanding of our financial results and condition, and require complex
management judgment.
INVENTORY
We state our inventory at the lower of cost or market. We record reserves
for inventory shrinkage and for potentially excess, obsolete and slow moving
inventory based upon historical experience and forecasted demand. Our reserve
requirements could be materially different if demand for our products decreased
because of competitive conditions or market acceptance, or if products become
obsolete because of advancements in the industry.
REVENUE RECOGNITION
We recognize revenue upon shipment of products to customers, net of
estimated returns. We analyze the rate of historical returns when evaluating the
adequacy of the allowance for sales returns, which is included with the
allowance for doubtful accounts on our balance sheet. If the historical data we
use to calculate these estimates does not properly reflect future returns,
revenue could be overstated.
10
ALLOWANCE FOR DOUBTFUL ACCOUNTS
We maintain allowances for doubtful accounts for estimated losses
resulting from the inability of our customers to make required payments. This
allowance is regularly evaluated by us for adequacy by taking into consideration
factors such as past experience, credit quality of the customer base, age of the
receivable balances, both individually and in the aggregate, and current
economic conditions that may affect a customer's ability to pay. If the
financial condition of our customers were to deteriorate, resulting in an
impairment of their ability to make payments, additional allowances may be
required.
VALUATION OF LONG-LIVED ASSETS AND GOODWILL
In fiscal 2002, we adopted Statement of Financial Accounting Standards
(SFAS) 142, "Goodwill and Other Intangible Assets." Goodwill is tested for
impairment annually or more frequently if changes in circumstance or the
occurrence of events suggests an impairment exists. The test for impairment
requires us to make several estimates about fair value, most of which are based
on projected future cash flows.
We regularly review the carrying value of certain long-lived assets and
identifiable intangible assets with respect to any events or circumstances that
indicate an impairment or an adjustment to the amortization period is necessary.
If circumstances suggest the recorded amounts cannot be recovered, calculated
based upon estimated future undiscounted cash flows, the carrying values of
these assets are reduced to fair value.
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
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
primarily on one 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, 2002. 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.
11
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, available-for-sale
securities and accounts receivables. We maintain our accounts for cash and cash
equivalents and available-for-sale securities principally at one major bank and
two 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,
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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 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. On November 26, 2002, we entered into an
agreement that settled all existing intellectual property litigation with
Datascope Corporation. Under the terms of the Settlement Agreement, Datascope
granted us a non-exclusive license to its Janzen patents as they apply to all
current versions of the Duett sealing sevice, and to certain permitted future
product improvements. Datascope also has released us from any claim of patent
infringement based on past or future sales of the Duett sealing device. In
exchange, we paid Datascope a single lump sum of $3,750,000 in the fourth
quarter of 2002.
From time to time we are involved in legal proceedings arising in the
normal course of our business. 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
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 $20.0 million of the
net proceeds to hire, train and deploy a direct sales force in the
United States, $1.6 million for the purchase of the Acolysis assets
from Angiosonics, $4.1 million to settle the St. Jude and Datascope
litigation, $3.0 million for research and development of new
products and $4.9 million for general corporate purposes.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
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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:
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 filed a Form 8-K on April 21, 2003 to report our press release dated
April 14, 2003 on our first quarter results.
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: April 30, 2003 By: /s/ Howard Root
-------------------------
Howard Root
CHIEF EXECUTIVE OFFICER
(Duly authorized officer)
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;
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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: April 30, 2003 By: /s/ Howard Root
----------------------------------
Howard Root
CHIEF EXECUTIVE OFFICER AND ACTING
CHIEF FINANCIAL OFFICER
15