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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(MARK ONE)
[X] QUARTERLY PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2001
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.
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(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
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(Registrant's telephone number, including are 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 past
12 months (or for such shorter period that the registrant was required to file
such reports), and has been subject to such filing requirements for the past 90
days. Yes [X] No [ ]
The registrant had 13,250,267 shares of common stock, $.01 par value per share,
outstanding as of July 31, 2001.
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VASCULAR SOLUTIONS, INC.
INDEX
PAGE
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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 8
Item 3. Quantitative and Qualitative Disclosure About Market Risks 11
PART II. OTHER INFORMATION
Item 1. Legal Proceedings 12
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 14
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VASCULAR SOLUTIONS, INC.
CONSOLIDATED BALANCE SHEETS
JUNE 30, DECEMBER 31,
2001 2000
------------ -------------
(Unaudited) (Note)
ASSETS
Current assets:
Cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . $ 38,592,818 $ 44,097,563
Accounts receivable, net of allowance for doubtful
accounts of $130,000 in 2001 and $80,000 in 2000 . . . . . . . . . . . . 1,915,926 1,971,383
Inventories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,649,446 2,466,445
Prepaid expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 328,061 231,251
------------ ------------
Total current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43,486,251 48,766,642
Property and equipment, net . . . . . . . . . . . . . . . . . . . . . . . . . . 961,096 894,094
------------ ------------
Total assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 44,447,347 $ 49,660,736
============ ============
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 1,049,285 $ 933,059
Accrued compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . 900,821 1,344,995
Accrued expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101,311 188,792
------------ ------------
Total current liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,051,417 2,466,846
Commitments and contingencies
Shareholders' equity:
Common Stock, $.01 par value:
Authorized shares - 16,222,223
Issued and outstanding - June 30,
2001 - 13,207,107; December 31, 2000 - 13,116,008 . . . . . . . . . 132,071 131,160
Additional paid-in capital . . . . . . . . . . . . . . . . . . . . . . . . . . . 70,329,033 69,965,240
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (31,445) (38,182)
Accumulated deficit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (28,033,729) (22,864,328)
------------ ------------
Total shareholders' equity . . . . . . . . . . . . . . . . . . . . . . . . . . . 42,395,930 47,193,890
------------ ------------
Total liabilities and shareholders' equity . . . . . . . . . . . . . . . . . . . $ 44,447,347 $ 49,660,736
============ ============
See accompanying notes.
Note: The balance sheet at December 31, 2000 has been derived from the audited
financial statements at that date.
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VASCULAR SOLUTIONS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30, JUNE 30,
------------------------------- --------------------------------
2001 2000 2001 2000
----------- ----------- ------------ -----------
(unaudited) (unaudited)
Net sales . . . . . . . . . . . . . . . . . . . . . . $ 3,540,103 $ 708,250 $ 6,663,185 $ 1,350,795
Cost of goods sold . . . . . . . . . . . . . . . . . 1,386,509 353,706 2,604,077 702,557
----------- ----------- ------------ -----------
Gross profit . . . . . . . . . . . . . . . . . . . . 2,153,594 354,544 4,059,108 648,238
Operating expenses:
Research and development . . . . . . . . . . . 1,073,863 854,763 2,042,653 1,546,486
Clinical and regulatory . . . . . . . . . . . . 309,645 336,703 646,696 526,607
General and administrative . . . . . . . . . . 911,222 665,107 1,492,423 1,228,679
Sales and marketing . . . . . . . . . . . . . . 3,122,253 1,409,597 6,128,430 2,310,912
----------- ----------- ------------ -----------
Total operating expenses . . . . . . . . . . . . . . 5,416,983 3,266,170 10,310,202 5,612,684
----------- ----------- ------------ -----------
Operating loss . . . . . . . . . . . . . . . . . . . (3,263,389) (2,911,626) (6,251,094) (4,964,446)
Interest income . . . . . . . . . . . . . . . . . . . 439,061 92,648 1,081,693 214,347
----------- ----------- ------------ -----------
Net loss . . . . . . . . . . . . . . . . . . . . . . $(2,824,328) $(2,818,978) $(5,169,401) $(4,750,099)
=========== =========== =========== ===========
Basic and diluted net
loss per share . . . . . . . . . . . . . . . . $ (0.21) $ (0.53) $ (0.39) $ (0.90)
=========== =========== =========== ===========
Shares used in computing
basic and diluted net loss
per share . . . . . . . . . . . . . . . . . . . 13,177,407 5,271,456 13,155,347 5,263,171
=========== =========== =========== ===========
See accompanying notes.
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VASCULAR SOLUTIONS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30, JUNE 30,
------------------------------ --------------------------------
2001 2000 2001 2000
------------ ------------ ------------ ------------
(unaudited) (unaudited)
OPERATING ACTIVITIES
Net loss for the period . . . . . . . . . . . . . . . . . $ (2,824,328) $ (2,818,978) $ (5,169,401) $ (4,750,099)
Adjustments to reconcile net loss:
Depreciation and amortization . . . . . . . . . . . 105,870 83,336 207,753 164,060
Value of options granted for services . . . . . . . -- -- 10,398 --
Deferred compensation expense . . . . . . . . . . . 9,281 17,829 27,491 36,141
Changes in operating assets and liabilities:
Accounts receivable . . . . . . . . . . . . . 72,671 (151,481) 55,457 (378,572)
Inventories . . . . . . . . . . . . . . . . . 116,750 (289,595) (183,001) (531,328)
Prepaid expenses . . . . . . . . . . . . . . . (82,569) (228,715) (96,810) (231,461)
Accounts payable . . . . . . . . . . . . . . . 27,780 218,442 116,226 107,843
Accrued compensation and expenses . . . . . . 138,200 352,343 (531,655) 438,376
------------ ------------ ------------ ------------
Net cash used in operating activities . . . . . . . . . . (2,436,345) (2,816,819) (5,563,542) (5,145,040)
INVESTING ACTIVITIES
Purchases of property and equipment . . . . . . . . (164,422) (192,132) (274,755) (350,629)
------------ ------------ ------------ ------------
Net cash used in investing activities . . . . . . . . . . (164,422) (192,132) (274,755) (350,629)
FINANCING ACTIVITIES
Proceeds from exercise of stock options . . . . . . 281,938 32,800 354,306 55,000
------------ ------------ ------------ ------------
Net cash provided by financing activities . . . . . . . . 281,938 32,800 354,306 55,000
------------ ------------ ------------ ------------
Effect of exchange rate changes on cash and
cash equivalents . . . . . . . . . . . . . . . . . . . (10,857) -- (20,754) --
Increase (decrease) in cash and cash equivalents . . . . (2,329,686) (2,976,151) (5,504,745) (5,440,669)
Cash and cash equivalents at beginning of period . . . . 40,922,504 8,064,673 44,097,563 10,529,191
------------ ------------ ------------ ------------
Cash and cash equivalents at end of period . . . . . . . $ 38,592,818 $ 5,088,522 $ 38,592,818 $ 5,088,522
============ ============ ============ ============
See accompanying notes.
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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, 2000
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
months and six months ended June 30, 2001 and 2000 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.
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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:
JUNE 30, DECEMBER 31,
2001 2000
----------- ------------
(unaudited)
Raw materials.................................... $ 2,130,009 $1,746,279
Work-in process.................................. 224,613 371,176
Finished goods................................... 294,824 348,990
----------- ----------
$ 2,649,446 $2,446,445
=========== ==========
(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 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.
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 June 30, 2001 and 2000 were 91% and 4% in the United
States, respectively, and 9% and 96% in international markets,
respectively. One customer accounted for 5% of total accounts
receivable as of June 30, 2001. The same customer accounted for 17% of
total accounts receivable as of December 31, 2000. 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 the local currency. 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 June 30, 2001. Sales to significant
customers as a percentage of total net sales are as follows for the
three months ended June 30, 2000:
Customer A................................................................. 30.2%
Customer B................................................................. 25.8%
Customer C................................................................. 16.6%
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VASCULAR SOLUTIONS, INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(6) INITIAL PUBLIC OFFERING
On July 25, 2000, the Company completed the initial public offering of
its common stock. Upon the closing of the initial public offering, the
Company issued 3,500,000 shares of its common stock at an offering
price of $12.00 per share and all of the Company's Series A and Series
B preferred stock automatically converted into 3,777,777 shares of
common stock. 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. Cash proceeds from the sale of the
4,025,000 shares of common stock, net of underwriters' discount and
offering expenses, totaled approximately $44.0 million. Upon closing of
the Company's initial public offering, the authorized capital stock of
the Company consisted of 40,000,000 shares of common stock, par value
$.01 per share, with no shares of preferred stock outstanding or
designated.
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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. Our Duett sealing device is designed to seal the entire puncture
site following catheterization procedures such as angiography, angioplasty and
stenting. 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 our product in the United States through our direct sales
force.
We have a limited history of operations and have experienced significant
operating losses since inception. As of June 30, 2001, we had an accumulated
deficit of $28.0 million. We commenced international sales in February 1998.
From inception through June 2000, we generated substantially all of our revenue
from sales to international distributors who resell the device to medical
clinics.
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 JUNE 30, 2001 COMPARED TO THREE MONTHS ENDED JUNE 30, 2000
Net sales increased 400% to $3,540,103 for the three months ended June 30,
2001 from $708,250 for the three months ended June 30, 2000. The increase in net
sales was attributable to the United States market launch of our Duett sealing
device which began in July 2000. As a result, 91% of net sales for the three
months ended June 30, 2001 were to customers in the United States while 9% of
the net sales were to customers in international markets.
Gross profit as a percentage of net sales increased to 61% for the three
months ended June 30, 2001 from 50% for the three months ended June 30, 2000.
This increase as a percentage of net sales resulted from the initiation of
United States sales of the Duett sealing device, increased volume and improved
manufacturing processes.
Research and development expenses increased 26% to $1,073,863 for the
three months ended June 30, 2001 from $854,763 for the three months ended June
30, 2000. This increase was attributable to continued work on product
improvements and exploring new product line extensions. Our first product line
extension under development is the Duett hemostat which is a surgical hemostat
using the procoagulant components of the Duett sealing device. The Duett
hemostat is intended to be used to control active bleeding in open surgical
procedures. Our second product line extension under development is the Duett
pseudoaneurysm closure, which is intended to be a simple delivery system to
close pseudoaneurysms. A pseudoaneurysm is a complication which occurs in
approximately 1-3% of patients following a catheterization procedure and often
requires a surgical procedure to repair. Our third product line extension under
development is a biopsy tract sealing project. The biopsy device is intended to
seal the puncture tract left behind following a solid organ or lung biopsy. We
expect our research and development expenses to increase slightly through the
remainder of 2001 as we continue work on product improvements and product line
extensions.
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10
Clinical and regulatory expenses decreased 8% to $309,645 for the three
months ended June 30, 2001 from $336,703 for the three months ended June 30,
2000. These expenses consist primarily of payments to clinics for participation
in marketing and clinical studies, company personnel related to clinical study
administration and payments to regulatory agencies as part of the product
approval process. The decrease in expense from the previous year is attributed
to the timing of research and development projects and marketing studies in the
current year. We expect clinical and regulatory expenses to increase modestly
during 2001 as we pursue new products and incur expenses for participation in
clinical studies.
General and administrative expenses increased 37% to $911,222 for the
three months ended June 30, 2001 from $665,107 for the three months ended June
30, 2000. This increase is attributable to a $350,000 expense incurred in
connection with the settlement of litigation with St. Jude Medical, and related
to sales of the Duett from inception through the end of the second quarter of
2001 (See "Legal Proceedings" in Item 1 of Part II of this Form 10-Q). Beginning
with the third quarter, we will incur a royalty expense of 2.5% of net sales in
our cost of goods sold until the maximum royalty is attained. We expect general
and administrative expenses to be approximately $500,000 to $550,000 per quarter
for the remainder of 2001.
Sales and marketing expenses increased 122% to $3,122,253 for the three
months June 30, 2001 from $1,409,597 for the three months ended June 30, 2000.
This increase was due primarily to increased personnel costs associated with
hiring, training and deploying a direct United States sales force and costs
associated with travel, marketing and physician training for the domestic and
international distribution of our Duett sealing device. We currently anticipate
that sales and marketing expenses will increase modestly through 2001 as we
continue to hire, train and deploy our direct sales force in the United States.
Interest income increased to $439,061 for the three months ended June 30,
2001 from $92,648 for the three months ended June 30, 2000 primarily as a result
of higher cash balances from the cash proceeds received upon the closing of our
initial public offering in July 2000.
SIX MONTHS ENDED JUNE 30, 2001 COMPARED TO SIX MONTHS ENDED JUNE 30, 2000
Net sales increased 393% to $6,663,185 for the six months ended June 30,
2001 from $1,350,795 for the six months ended June 30, 2000. The increase in net
sales was attributable to the United States market launch of our Duett sealing
device which began in July 2000. As a result, 90% of net sales for the six
months ended June 30, 2001 were to customers in the United States while 10% of
the net sales were to customers in international markets.
Gross profit as a percentage of net sales increased to 61% for the six
months ended June 30, 2001 from 48% for the six months ended June 30, 2000. This
increase as a percentage of net sales resulted from the initiation of United
States sales of the Duett sealing device, increased volume and improved
manufacturing processes.
Research and development expenses increased 32% to $2,042,653 for the six
months ended June 30, 2001 from $1,546,486 for the six months ended June 30,
2000. This increase was attributable to continued work on product improvements
of the Duett sealing device and exploring new product line extensions, including
the Duett hemostat, the Duett pseudoaneurysm closure and the biopsy tract
sealing device.
Clinical and regulatory expenses increased 23% to $646,696 for the six
months ended June 30, 2001 from $526,607 for the six months ended June 30, 2000.
The increase is attributed to additional regulatory approvals for the Duett
Model 2000 and the initial clinical work related to the new product line
extensions.
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General and administrative expenses increased 22% to $1,492,423 for the
six months ended June 30, 2001 from $1,228,679 for the six months ended June 30,
2000. This increase was attributable to the patent litigation settlement payment
to St. Jude Medical, Inc. (See "Legal Proceedings" in Item 1 of Part II of this
Form 10-Q) but was partially offset by slightly lower personnel costs from the
prior year.
Sales and marketing expenses increased 165% to $6,128,430 for the six
months ended June 30, 2001 from $2,310,912 for the six months ended June 30,
2000. This increase was due to in increased personnel costs and associated with
travel, marketing and physician training for the United States market launch of
the Duett sealing device.
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 June 30, 2001, we had approximately $24.8 million of federal net
operating loss carryforwards available to offset future taxable income which
begin to expire in the year 2013. As of June 30, 2001, we also had federal and
state research and development tax credit carryforwards of approximately $1.4
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. Through June 30, 2001, we had sold common stock
and preferred stock generating aggregate net proceeds of $69.8 million. At June
30, 2001, we had $38.6 million in cash and cash equivalents on-hand. During the
three months ended June 30, 2001, we used $2.4 million of cash and cash
equivalents in operating activities. The cash used in operating activities was
primarily used to fund our net loss for the period of $2.8 million and increase
inventories to support our increased operations. Our capital expenses to acquire
manufacturing and office equipment totaled $164,000 during the three months
ended June 30, 2001.
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 significant
growth in our expenses 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 the third quarter of 2002, as we plan to spend
substantial amounts hiring and training a direct United States sales force,
funding sales and marketing activities and creating and expanding research and
development initiatives. 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 through at least the end of 2003. Our
liquidity and capital
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requirements beyond 2003 will depend on numerous factors, including the extent
to which our Duett sealing device gains market acceptance and competitive
developments.
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 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, 2000. 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 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.
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PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
In July 1999, we were named as the defendant in a patent infringement
lawsuit brought by Datascope Corp., a competitor, in the United States District
Court of 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. In August 1999,
we filed our answer to this lawsuit and moved for summary judgment 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. It is not possible to predict the timing or outcome of this
lawsuit, including whether we will be prohibited from selling our Duett sealing
device in the United States or internationally, 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, Inc., a
competitor, in the United States District Court of the District of Minnesota.
The complaint requested a judgment that our Duett sealing device infringed a
series of four patents held by St. Jude Medical and asked for relief in the form
of an injunction that would prevent us from selling our product 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, Inc. (See "Exhibits and Reports on Form 8-K" in Item 6 of Part II
of this Form 10-Q). Under the terms of the settlement agreement, we agreed to
pay a royalty of 2.5% of net sales of our Duet sealing device to St. Jude
Medical, up to a maximum amount over the remaining life of the St. Jude Medical
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 the 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. Starting July 1, 2001, we will include a royalty expense
of 2.5% of net sales in our cost of goods sold until the maximum royalty is
attained.
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
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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 $10.5 million of the net proceeds to hire, train
and deploy a direct sales force in the United States, and $7.3 million
for general corporate purposes.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The annual meeting of Shareholders of the Company was held on April 19,
2001 at which time (i) six nominees were elected to the Board of Directors for
one-year terms, (ii) the Vascular Solutions, Inc. Employee Stock Purchase Plan
was adopted and (iii) the appointment of Ernst & Young LLP as the independent
auditors of the Company was approved. Proxies for the Company were solicited
pursuant to Section 14(a) of the Securities Exchange Act of 1934, as amended,
and there was no solicitation in opposition to management's solicitations. All
nominees for directors as listed in the proxy statement were elected.
The voting results were as follows:
Broker
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For Against Withheld Non-Votes
---------- ------- -------- ---------
Election of Directors:
Gary Gershony, M.D. 11,824,221 0 420,805 0
James Jacoby, Jr. 11,810,321 0 434,705 0
Michael Kopp 12,166,291 0 78,735 0
Gerard Langeler 12,165,216 0 79,810 0
Richard Nigon 12,165,711 0 79,315 0
Howard Root 11,588,616 0 656,410 0
Adoption of Vascular Solutions, Inc.
Employee Stock Purchase Plan 10,943,022 1,293,072 8,932 0
Approval of Independent Auditors 11,136,807 1,100,497 7,722 0
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits:
None.
(b) Reports on Form 8-K:
We filed a Form 8-K on July 12, 2001 to report the settlement
of patent litigation with St. Jude Medical (see "Legal
Proceedings" in Item 1 of Part II of this Form 10-Q). There
were no financial statements required to be filed with the
Form 8-K.
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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: August 14, 2001 By: /s/ Richard J. Buchholz
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Richard J. Buchholz
Chief Financial Officer
Duly authorized officer and principal
financial and accounting officer)
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