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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 JUNE 30, 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)
---------------
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 12,822,363 shares of common stock, $.01 par value per share,
outstanding as of July 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 8
Item 3. Quantitative and Qualitative Disclosure About Market
Risks 13
Item 4. Controls and Procedures 13
PART II. OTHER INFORMATION
Item 1. Legal Proceedings 14
Item 2. Changes in Securities and Use of Proceeds 14
Item 3. Defaults upon Senior Securities 15
Item 4. Submission of Matters to a Vote of Security Holders 15
Item 5. Other Information 15
Item 6. Exhibits and Reports on Form 8-K 15
1
VASCULAR SOLUTIONS, INC.
CONSOLIDATED BALANCE SHEETS
JUNE 30, DECEMBER 31,
2003 2002
-------------------------------
(unaudited) (see note)
ASSETS
Current assets:
Cash and cash equivalents ...................................... $ 2,568,772 $ 1,835,059
Available-for-sale securities .................................. 8,013,223 14,914,444
Accounts receivable, net of reserves of $150,000 and $130,000 in
2003 and 2002, respectively .................................. 1,339,008 1,357,946
Inventories .................................................... 3,251,908 2,132,516
Prepaid expenses ............................................... 206,413 326,773
-------------------------------
Total current assets .............................................. 15,379,324 20,566,738
Property and equipment, net ....................................... 721,085 795,885
Intangible assets, net ............................................ 808,845 917,595
-------------------------------
Total assets ...................................................... $ 16,909,254 $ 22,280,218
===============================
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable ............................................... $ 701,534 $ 771,078
Accrued compensation ........................................... 849,271 886,130
Accrued expenses ............................................... 293,127 253,777
-------------------------------
Total current liabilities ......................................... 1,843,932 1,910,985
Shareholders' equity:
Common stock, $0.01 par value:
Authorized shares - 40,000,000
Issued and outstanding shares - 12,816,463 - 2003;
12,880,839 - 2002 .......................................... 128,165 128,808
Additional paid-in capital ..................................... 70,273,616 70,355,343
Other .......................................................... 37,203 (21,278)
Accumulated deficit ............................................ (55,373,662) (50,093,640)
-------------------------------
Total shareholders' equity ........................................ 15,065,322 20,369,233
-------------------------------
Total liabilities and shareholders' equity ........................ $ 16,909,254 $ 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 SIX MONTHS ENDED
JUNE 30, JUNE 30,
2003 2002 2003 2002
---------------------------------------------------------------------
(unaudited) (unaudited)
Net sales ................................ $ 2,724,721 $ 3,328,529 $ 5,693,005 $ 6,131,948
Cost of goods sold ....................... 1,085,592 1,326,260 2,308,183 2,533,178
---------------------------------------------------------------------
Gross profit ............................. 1,639,129 2,002,269 3,384,822 3,598,770
Operating expenses:
Research and development .............. 1,070,536 762,501 1,904,107 1,659,626
Clinical and regulatory ............... 408,465 379,302 749,157 694,575
Sales and marketing ................... 2,381,941 3,112,935 5,057,324 6,588,094
General and administrative ............ 447,327 581,932 948,170 1,179,699
Amortization of purchased technology .. 54,375 36,250 108,750 36,250
---------------------------------------------------------------------
Total operating expenses ................. 4,362,644 4,872,920 8,767,508 10,158,244
---------------------------------------------------------------------
Operating loss ........................... (2,723,515) (2,870,651) (5,382,686) (6,559,474)
Interest income .......................... 40,514 127,513 102,664 265,338
---------------------------------------------------------------------
Net loss ................................. $ (2,683,001) $ (2,743,138) $ (5,280,022) $ (6,294,136)
=====================================================================
Basic and diluted net loss per share ..... $ (0.21) $ (0.20) $ (0.41) $ (0.47)
=====================================================================
Shares used in computing basic and diluted
net loss per share .................... 12,816,316 13,381,165 12,830,014 13,357,272
=====================================================================
SEE ACCOMPANYING NOTES.
3
VASCULAR SOLUTIONS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30, JUNE 30,
2003 2002 2003 2002
---------------------------------------------------------------------
(unaudited) (unaudited)
OPERATING ACTIVITIES
Net loss .......................................... $ (2,683,001) $ (2,743,138) $ (5,280,022) $ (6,294,136)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation ................................. 89,238 122,475 220,493 241,933
Amortization ................................. 54,375 36,250 108,750 36,250
Deferred compensation expense ................ 14,106 18,501 32,007 39,102
Changes in operating assets and liabilities:
Accounts receivable ........................ 99,306 (333,802) 18,938 (303,924)
Inventories ................................ (220,276) 484,924 (1,119,392) 37,157
Prepaid expenses ........................... 182,454 63,042 120,360 113,968
Accounts payable ........................... (401,971) (11,559) (69,544) 393,228
Accrued compensation and expenses .......... 91,540 272,595 2,491 34,639
---------------------------------------------------------------------
Net cash used in operating activities ............. (2,774,229) (2,090,712) (5,965,919) (5,701,783)
INVESTING ACTIVITIES
Purchase of property and equipment, net ........... (126,456) (40,233) (145,693) (197,795)
Purchase of Acolysis assets ....................... -- (1,550,203) -- (1,550,203)
Purchase of securities ............................ (1,887,903) (19,154,181) (6,763,779) (26,492,643)
Proceeds from sales of securities ................. 5,500,000 22,384,647 13,665,000 29,752,396
---------------------------------------------------------------------
Net cash provided by (used in) investing
activities ................................... 3,485,641 1,640,030 6,755,528 1,511,755
FINANCING ACTIVITIES
Proceeds from exercise of stock options and sale of
stock .......................................... 57,263 109,200 57,263 129,200
Repurchase of common stock ........................ (76,105) -- (139,633) --
---------------------------------------------------------------------
Net cash (used in) provided by financing
activities ..................................... (18,842) 109,200 (82,370) 129,200
Effect of exchange rate changes on cash and cash
equivalents .................................... (6,581)
103,255 26,474 (10,033)
---------------------------------------------------------------------
(Decrease) increase in cash and cash
equivalents .................................... 795,825 (348,063) 733,713 (4,070,861)
Cash and cash equivalents at beginning of
period ......................................... 1,772,947 5,368,842 1,835,059 9,091,640
---------------------------------------------------------------------
Cash and cash equivalents at end of period ........ $ 2,568,772 $ 5,020,779 $ 2,568,772 $ 5,020,779
=====================================================================
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 June 30, 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.
THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30 JUNE 30
2003 2002 2003 2002
------------------------------------------------------------
(unaudited) (unaudited)
Net loss, as reported ........... $(2,683,001) $(2,743,138) $(5,280,022) $(6,294,136)
Deduct: Total stock-based employee
compensation expense determined
under fair-value-based method
for all awards ................. (200,600) (585,024) (408,827) (1,170,048)
------------------------------------------------------------
Pro forma net loss ............... $(2,883,601) $(3,328,162) $(5,688,849) $(7,464,184)
===========================================================
Net loss per share:
Basic and diluted - as
reported ....................... $ (0.21) $ (0.20) $ (0.41) $ (0.47)
===========================================================
Basic and diluted - pro
forma .......................... $ (0.22) $ (0.25) $ (0.44) $ (0.56)
===========================================================
5
VASCULAR SOLUTIONS, INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(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 and six months ended June 30, 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 share, because the effect of
outstanding options and warrants is antidilutive.
(4) COMPREHENSIVE LOSS
Comprehensive loss for the Company includes net loss and foreign
currency translation. Comprehensive loss for the three and six months
ended June 30, 2003 and June 30, 2002 were as follows:
THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30 JUNE 30
2003 2002 2003 2002
-----------------------------------------------------------
(unaudited) (unaudited)
Net loss ......... $(2,683,001) $(2,743,138) $(5,280,022) $(6,294,136)
Foreign currency
translation
adjustments ...... 103,255 (6,581) 26,474 (10,033)
-----------------------------------------------------------
Comprehensive loss $(2,579,746) $(2,749,719) $(5,253,548) $(6,304,169)
===========================================================
(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, who 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
VASCULAR SOLUTIONS, INC.
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(6) 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,
2003 2002
---- ----
(unaudited)
Raw materials....................... $ 2,485,001 $ 1,561,943
Work-in process..................... 462,705 138,134
Finished goods...................... 304,202 432,439
----------- -----------
$ 3,251,908 $ 2,132,516
=========== ===========
(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
and six months ended June 30, 2003 and 2002 were 87% and 87% in the
United States, respectively, and 13% and 13% 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 six months ended June 30, 2003 and 2002.
(8) RECLASSIFICATION
Certain 2002 amounts have been reclassified to conform to the 2003
presentation.
7
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, the
Vari-Lase(TM) endovenous laser procedure kit 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 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. On June 19, 2003, we received
clearance of our 510(k) application from the FDA for the Vari-Lase endovenous
laser procedure kit.
We have a limited history of operations and have experienced
significant operating losses since inception. As of June 30, 2003, we had an
accumulated deficit of $55.4 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 JUNE 30, 2003 COMPARED TO THREE MONTHS ENDED JUNE 30, 2002
Net sales decreased 18% to $2,724,721 for the three months ended June
30, 2003 from $3,328,529 for the three months ended June 30, 2002. The decrease
in net sales was attributable to lower Duett sales as a result of our decision
to concentrate on making our direct U.S. sales force more efficient. We reduced
our direct sales force by 27% in the second quarter of 2003 compared to the
second quarter of 2002. Net sales for the three months ended June 30, 2003 for
the Duett, D-Stat flowable hemostat, Acolysis and Vari-Lase were $2,358,588,
$304,654, $52,360 and $9,119 respectively.
Gross profit as a percentage of net sales was consistent with the year
ago period at 60% for the three months ended June 30, 2003. We expect gross
profit as a percentage of sales to increase in the second half of the year as we
benefit from the expected launch of our four new products.
Research and development expenses increased 40% to $1,070,536 for the
three months ended June 30, 2003 from $762,501 for the three months ended June
30, 2002. Research and development expenses consist primarily of development of
next generation Duett devices as well as new interventional devices. The
increase is the direct result of our planned launch of four new products in the
second half of the year. The four interventional medical devices that we
incurred research and development expenses on include
8
the D-Stat Dry hemostatic bandage, the D-Stat Radial hemostat band, the Pronto
extraction catheter and the Vari-Lase endovenous laser procedure kit.
The D-Stat Dry hemostatic bandage consists of a freeze-dried pad of our
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 containing a freeze-dried pad of the D-Stat procoagulant for sealing the
arterial puncture following catheterization procedures utilizing the radial
artery in the wrist. The Pronto extraction catheter consists of an catheter with
a proprietary atraumatic distal tip and large extraction lumen for the removal
of soft thrombus from arteries. We expect our research and development expenses
to increase slightly in the future as we continue work on product improvements,
new products and product line extensions.
Clinical and regulatory expenses increased 8% to $408,465 for the three
months ended June 30, 2003 from $379,302 for the three months ended June 30,
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 and perform a clinical study for an additional indication for our
existing D-Stat flowable hemostat called the D-Stat "Pocket Protector" clinical
study.
General and administrative expenses decreased 23% to $447,327 for the
three months ended June 30, 2003 from $581,932 for the three months ended June
30, 2002. The three months ended June 30, 2002 included approximately $150,000
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 around $500,000 for
the foreseeable future.
Sales and marketing expenses decreased 24% to $2,381,941 for the three
months ended June 30, 2003 from $3,112,935 for the three months ended June 30,
2002. The decrease in sales and marketing is the result of a 27% reduction in
our sales force compared to the prior year. We expect our sales force 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 June 30, 2003 and $36,250 for the three months ended June 30, 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 $40,514 for the three months ended June
30, 2003 from $127,513 for the three months ended June 30, 2002 primarily as a
result of lower interest rates and lower cash balances compared to the previous
comparable period.
SIX MONTHS ENDED JUNE 30, 2003 COMPARED TO SIX MONTHS ENDED JUNE 30, 2002
Net sales decreased 7% to $5,693,005 for the six months ended June 30,
2003 from $6,131,948 for the six months ended June 30, 2002. The decrease in net
sales was attributable to lower Duett sales as a result of our decision to
concentrate on making our direct U.S. sales force more efficient. Net sales for
the six months ended June 30, 2003 for the Duett, D-Stat flowable, Acolysis and
Vari-Lase were $5,020,138, $576,242, $87,506 and $9,119, respectively.
Gross profit as a percentage of net sales was consistent with the year
ago period at 59% for the six months ended June 30, 2003.
9
Research and development expenses increased 15% to $1,904,107 for the
six months ended June 30, 2003 from $1,659,626 for the six months ended June 30,
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 Vari-Lase endovenous laser
procedure kit.
Clinical and regulatory expenses increased 8% to $749,157 for the six
months ended June 30, 2003 from $694,575 for the six months ended June 30, 2002.
This increase is attributable to a modest increase in the number of products and
product improvements compared to the prior year.
General and administrative expenses decreased 20% to $948,170 for the
six months ended June 30, 2003 from $1,179,699 for the six months ended June 30,
2002. The six months ended June 30, 2002 included approximately $240,000 for
legal expenses relating to our settlement with Datascope Corporation (See "Legal
Proceedings" in Item 1 of Part II of this Form 10-Q).
Sales and marketing expenses decreased 23% to $5,057,324 for the six
months ended June 30, 2003 from $6,588,094 for the six months ended June 30,
2002. The decrease in sales and marketing is the result of a 27% reduction in
our sales force compared to the prior year.
Amortization of purchased technology was $108,750 for the six months
ended June 30, 2003 and $36,250 for the six months ended June 30, 2002. The
increase is the result of a full six months of amortization for the six months
ended June 30, 2003.
Interest income decreased to $102,664 for the six months ended June 30,
2003 from $265,338 for the six months ended June 30, 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 June 30, 2003, we had approximately $50.8 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, 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.
10
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 June 30, 2003, we have sold common stock and preferred stock generating
aggregate net proceeds of $71.1 million. At June 30, 2003, we had $10.6 million
in cash, cash equivalents and available-for-sale securities on-hand.
During the three months ended June 30, 2003, we used $2.8 million in
operating activities. The cash used in operating activities was primarily used
to fund our net loss for the period of $2.7 million, which was offset by
depreciation and amortization of $143,613. We generated proceeds of $3,485,641
in investing activities, primarily from the sale of investment securities of
$5,500,000. We used $76,105 in financing activities for the repurchase of 85,300
shares of our common stock, and have now purchased a total of 762,300 shares
under our stock repurchase program. In July of 2003, the Board of Directors
cancelled the stock repurchase plan.
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.
11
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.
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
12
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.
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
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-15(e) under the Exchange Act) as of the last
day of the period covered by this quarterly report (the "Evaluation Date").
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.
Changes in internal controls.
There were no significant changes made in our internal controls over
financial reporting (as defined in Rule 13 a-15(f) under the Exchange Act)
during the period covered by this report that materially affected or are
reasonably likely to materially affect our internal controls over financial
reporting.
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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 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
14
offering were approximately $44.0 million. To date, we have spent
approximately $21.3 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, $0.7 million for
our stock repurchase program, $4.2 million for research and
development of new products and $4.5 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 15,
2003 at which time (i) seven nominees were elected to the Board of Directors for
one-year terms and (ii) 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
For Against Withheld Non-Votes
--- ------- -------- ---------
Election of Directors:
Paul O'Connell 12,022,570 0 74,117 0
James Jacoby, Jr. 12,024,270 0 72,417 0
Michael Kopp 12,025,920 0 70,767 0
John L. Erb 12,025,920 0 70,767 0
Gary S. Dorfman 12,029,720 0 66,967 0
Richard Nigon 11,845,325 0 251,362 0
Howard Root 11,922,125 0 174,562 0
Approval of Independent Auditors 11,974,931 114,491 7,265 0
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits:
31.1 Certification of Chief Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2003.
31.2 Certification of Acting Chief Financial Officer
pursuant to Section 302 of the Sabanes-Oxley Act of
2002.
15
32.1 Certification of Chief Executive Officer and Acting
Chief Financial Officer pursuant to Section 906 of
the 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: August 7, 2003 By: /s/ Howard Root
-------------------------
Howard Root
CHIEF EXECUTIVE OFFICER
(Duly authorized officer)
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