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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 SEPTEMBER 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 12,861,873 shares of common stock, $.01 par value per share,
outstanding as of October 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 14
Item 4. Controls and Procedures 14
PART II. OTHER INFORMATION
Item 1. Legal Proceedings 14
Item 2. Changes in Securities and Use of Proceeds 15
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
SEPTEMBER 30, DECEMBER 31,
2003 2002
-----------------------------
unaudited) (see note)
ASSETS
Current assets:
Cash and cash equivalents .......................... $ 1,823,575 $ 1,835,059
Available-for-sale securities ...................... 6,067,682 14,914,444
Accounts receivable, net of reserves of $110,000 and
$130,000 in 2003 and 2002, respectively .......... 1,426,618 1,357,946
Inventories ........................................ 3,224,587 2,132,516
Prepaid expenses ................................... 493,627 326,773
-----------------------------
Total current assets .................................. 13,036,089 20,566,738
Property and equipment, net ........................... 759,505 795,885
Intangible assets, net ................................ 754,470 917,595
-----------------------------
Total assets .......................................... $ 14,550,064 $ 22,280,218
=============================
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable ................................... $ 693,387 $ 771,078
Accrued compensation ............................... 822,823 886,130
Accrued expenses ................................... 309,286 253,777
-----------------------------
Total current liabilities ............................. 1,825,496 1,910,985
Shareholders' equity:
Common stock, $0.01 par value:
Authorized shares - 40,000,000
Issued and outstanding shares -
12,857,343 - 2003; 12,880,839 - 2002 ........... 128,573 128,808
Additional paid-in capital ......................... 70,326,367 70,355,343
Other .............................................. 28,559 (21,278)
Accumulated deficit ................................ (57,758,931) (50,093,640)
-----------------------------
Total shareholders' equity ............................ 12,724,568 20,369,233
-----------------------------
Total liabilities and shareholders' equity ............ $ 14,550,064 $ 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 NINE MONTHS ENDED
SEPTEMBER 30, SEPTEMBER 30,
2003 2002 2003 2002
---------------------------------------------------------------
(unaudited) (unaudited)
Net sales ................................ $ 2,708,626 $ 3,040,758 $ 8,401,631 $ 9,172,707
Cost of goods sold ....................... 1,101,875 1,224,151 3,410,059 3,757,329
---------------------------------------------------------------
Gross profit ............................. 1,606,751 1,816,607 4,991,572 5,415,378
Operating expenses:
Research and development .............. 884,421 817,850 2,788,527 2,571,214
Clinical and regulatory ............... 385,231 330,865 1,134,388 1,025,440
Sales and marketing ................... 2,217,466 2,870,147 7,274,791 9,458,240
General and administrative ............ 480,547 520,616 1,428,717 1,606,578
Amortization of purchased technology .. 54,375 54,375 163,125 90,625
---------------------------------------------------------------
Total operating expenses ................. 4,022,040 4,593,853 12,789,548 14,752,097
---------------------------------------------------------------
Operating loss ........................... (2,415,289) (2,777,246) (7,797,976) (9,336,719)
Interest income .......................... 30,021 143,292 132,685 408,629
---------------------------------------------------------------
Net loss ................................. $ (2,385,268) $ (2,633,954) $ (7,665,291) $ (8,928,090)
===============================================================
Basic and diluted net loss per share ..... $ (0.19) $ (0.20) $ (0.60) $ (0.67)
===============================================================
Shares used in computing basic and diluted
net loss per share .................... 12,836,099 13,368,006 12,832,065 13,360,889
===============================================================
SEE ACCOMPANYING NOTES.
3
VASCULAR SOLUTIONS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 30, SEPTEMBER 30,
2003 2002 2003 2002
----------------------------------------------------------------
(unaudited) (unaudited)
OPERATING ACTIVITIES
Net loss .......................................... $ (2,385,268) $ (2,633,954) $ (7,665,291) $ (8,928,090)
Adjustments to reconcile net loss to net cash used
in operating activities:
Depreciation ................................. 81,795 123,194 302,287 365,127
Amortization ................................. 54,375 54,375 163,125 90,625
Deferred compensation expense ................ 6,834 17,672 38,841 56,774
Changes in operating assets and liabilities:
Accounts receivable ........................ (87,610) 345,109 (68,671) 41,186
Inventories ................................ 27,321 62,354 (1,092,071) 99,511
Prepaid expenses ........................... (287,214) (167,614) (166,854) (53,646)
Accounts payable ........................... (8,148) 385,470 (77,692) 778,697
Accrued compensation and expenses .......... (10,289) (169,552) (7,798) (134,913)
----------------------------------------------------------------
Net cash used in operating activities ............. (2,608,204) (1,982,946) (8,574,124) (7,684,729)
INVESTING ACTIVITIES
Purchase of property and equipment, net ........... (120,215) (45,370) (265,906) (243,165)
Purchase of Acolysis assets ....................... -- -- -- (1,550,203)
Purchase of securities ............................ (54,459) (5,326,894) (6,818,238) (31,819,537)
Proceeds from sales of securities ................. 2,000,000 5,444,634 15,665,000 35,197,030
----------------------------------------------------------------
Net cash provided by (used in) investing
activities ..................................... 1,825,326 72,370 8,580,856 1,584,125
FINANCING ACTIVITIES
Proceeds from exercise of stock options and sale of
stock .......................................... 53,159 -- 110,422 129,200
Repurchase of common stock ........................ -- (212,552) (139,633) (212,552)
----------------------------------------------------------------
Net cash (used in) provided by financing
activities ..................................... 53,159 (212,552) (29,211) (83,352)
Effect of exchange rate changes on cash and cash
equivalents .................................... (15,478) (17,847) 10,995 (27,880)
----------------------------------------------------------------
Decrease in cash and cash equivalents ............. (745,197) (2,140,975) (11,484) (6,211,836)
Cash and cash equivalents at beginning of
period ......................................... 2,568,772 5,020,779 1,835,059 9,091,640
----------------------------------------------------------------
Cash and cash equivalents at end of period ........ $ 1,823,575 $ 2,879,804 $ 1,823,575 $ 2,879,804
===============================================================
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 September 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 NINE MONTHS ENDED
SEPTEMBER 30 SEPTEMBER 30
2003 2002 2003 2002
----------------------------------------------------------------
(unaudited) (unaudited)
Net loss, as reported ........... $ (2,385,268) $ (2,633,954) $ (7,665,291) $ (8,928,090)
Deduct: Total stock-based employee
compensation expense determined
under fair-value-based method
for all awards ................. (215,082) (585,024) (631,536) (1,755,072)
----------------------------------------------------------------
Pro forma net loss ............... $ (2,600,350) $ (3,318,978) $ (8,296,827) $(10,683,162)
===============================================================
Net loss per share:
Basic and diluted - as
reported ....................... $ (0.19) $ (0.20) $ (0.60) $ (0.67)
===============================================================
Basic and diluted - pro
forma .......................... $ (0.20) $ (0.24) $ (0.65) $ (0.80)
===============================================================
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 nine months ended September 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 nine months
ended September 30, 2003 and September 30, 2002 were as follows:
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 30 SEPTEMBER 30
2003 2002 2003 2002
-----------------------------------------------------------
(unaudited) (unaudited)
Net loss ......... $(2,385,268) $(2,633,954) $(7,665,291) $(8,928,090)
Foreign currency
translation
adjustments ...... (15,478) (17,847) 10,995 (27,880)
-----------------------------------------------------------
Comprehensive loss $(2,400,746) $(2,651,801) $(7,654,296) $(8,955,970)
===========================================================
(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, net of returns.
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.
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:
SEPTEMBER 30, DECEMBER 31,
2003 2002
-----------------------------
(unaudited)
Raw materials .......... $2,366,541 $1,561,943
Work-in process ........ 341,083 138,134
Finished goods ......... 516,963 432,439
-----------------------------
$3,224,587 $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 nine
months ended September 30, 2003 and 2002 were 88% and 89% in the United
States, respectively, and 12% and 11% in international markets,
respectively. There have been no material losses on accounts
receivable.
The Company operates in a single industry segment and sells its product
directly to hospitals and clinics in the United States and Germany. In
Germany, the Company sells its product in Euros. In all other
international markets, the Company sells its product in United States
dollars to distributors who, in turn, sell to medical clinics in the
local currency. Loss, termination or ineffectiveness of distributors to
effectively promote the Company's product would have a material adverse
effect on the Company's financial condition and results of operations.
No single customer represented greater than 10% of the total net sales
for the three and nine months ended September 30, 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(R) flowable hemostat, the
D-Stat Dry hemostatic bandage, the D-Stat Radial hemostat band, the
Vari-Lase(TM) endovenous laser procedure kit, the Pronto(TM) extraction catheter
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 a new version of the Duett named the
Diagnostic Duett in the United States in December 2001, and we commenced sales
of the D-Stat Flowable 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 launched for sale four new products in 2003. On June 19, 2003,
we received clearance of our 510(k) application from the FDA for the Vari-Lase
endovenous laser procedure kit, and during the third quarter of 2003 we actively
commenced sales of the Vari-Lase kit. The Vari-Lase product is a treatment for
superficial venous reflux, otherwise known as varicose veins.
On August 25, 2003, we received CE Mark approval for the Pronto
extraction catheter and we immediately commenced sales of that product in
Europe. The Pronto extraction catheter consists of a catheter with a proprietary
atraumatic distal tip and large extraction lumen for the removal of soft
thrombus from arteries.
On September 22, 2003, we received clearance of our 510(k) application
from the FDA for the D-Stat Dry bandage and D-Stat Radial hemostat band. The
D-Stat Dry 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 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. We
immediately launched the D-Stat Dry bandage. We are in the process of completing
a design improvement of the D-Stat Radial and plan on launching the D-Stat
Radial in the fourth quarter of 2003. We also received CE Mark approval for the
D-Stat Dry bandage and D-Stat Radial on September 25, 2003 and immediately
commenced active sales of the D-Stat Dry bandage in Europe.
8
We have a limited history of operations and have experienced
significant operating losses since inception. As of September 30, 2003, we had
an accumulated deficit of $57.8 million. We may never achieve profitability, or
if we achieve profitability it may not be sustained in future periods.
RESULTS OF OPERATIONS
THREE MONTHS ENDED SEPTEMBER 30, 2003 COMPARED TO THREE MONTHS ENDED
SEPTEMBER 30, 2002
Net sales decreased 11% to $2,708,626 for the three months ended
September 30, 2003 from $3,040,758 for the three months ended September 30,
2002. The 11% decrease in net sales was in line with our focus on our very
recent new product introductions as well as our 23% decrease in sales and
marketing expenses from the year-prior period. Net sales of the Duett, D-Stat
Flowable, D-Stat Dry, Vari-Lase, Pronto and Acolysis product lines were
$2,195,425, $313,813, $39,850, $108,263, $11,455 and $39,820, respectively, for
the three months ended September 30, 2003. Net sales of the Duett, D-Stat
Flowable and Acolysis product lines were $2,756,455, $244,578 and $39,725,
respectively for the three months ended September 30, 2002.
Gross profit as a percentage of net sales declined slightly to 59.3%
for the three months ended September 30, 2003 from 59.7% for the three months
ended September 30, 2002. We expect gross profit as a percentage of sales to
increase in the fourth quarter of 2003 as we benefit from the launch of our four
new products which have a combined gross margin in excess of the Duett product
line.
Research and development expenses increased 8% to $884,421 for the
three months ended September 30, 2003 from $817,850 for the three months ended
September 30, 2002. Research and development expenses consist primarily of
expenses associated with new interventional devices as well as development of
next generation Duett devices. The increase is the direct result of our four new
products that we launched in the third quarter of 2003. We expect our research
and development expenses to stabilize at approximately $800,000 to $900,000 per
quarter in the foreseeable future as we continue work on product improvements,
new products and product line extensions.
Clinical and regulatory expenses increased 16% to $385,231 for the
three months ended September 30, 2003 from $330,865 for the three months ended
September 30, 2002. This increase is attributable to a modest increase in
clinical study expenses as we are incurring costs for an additional indication
for our existing D-Stat Flowable hemostat called the D-Stat "Pocket Protector"
clinical study. We expect clinical and regulatory expenses to slightly increase
to approximately $400,000 to $500,000 per quarter in the future as we pursue new
products and continue our D-Stat Flowable "Pocket Protector" clinical study.
General and administrative expenses decreased 8% to $480,547 for the
three months ended September 30, 2003 from $520,616 for the three months ended
September 30, 2002. The three months ended September 30, 2002 included
approximately $100,000 for legal expenses relating to our settlement of
intellectual property litigation with Datascope Corporation, which occurred in
December 2002. We currently anticipate that general and administrative expenses
will be around $500,000 per quarter for the foreseeable future.
Sales and marketing expenses decreased 23% to $2,217,466 for the three
months ended September 30, 2003 from $2,870,147 for the three months ended
September 30, 2002. The decrease in sales and marketing was the result of a 25%
reduction in the size of our direct sales force which occurred in the first half
of 2003. We expect our direct sales force to slightly increase through the end
of 2003 as we
9
evaluate our need for additional sales representatives with our launching of our
new products. As a result, we expect our sales and marketing expenses to
slightly increase in the fourth quarter of 2003.
Amortization of purchased technology was $54,375 for the three months
ended September 30, 2003 and September 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 of the purchase price to purchased
technology and are amortizing the amount over four years.
Interest income decreased to $30,021 for the three months ended
September 30, 2003 from $143,292 for the three months ended September 30, 2002
primarily as a result of lower interest rates and lower cash balances compared
to the previous comparable period.
NINE MONTHS ENDED SEPTEMBER 30, 2003 COMPARED TO NINE MONTHS ENDED
SEPTEMBER 30, 2002
Net sales decreased 8% to $8,401,631 for the nine months ended
September 30, 2003 from $9,172,707 for the nine months ended September 30, 2002.
The decrease in net sales was in line with our focus on our very recent new
product introductions as well as our 23% decrease in sales and marketing
expenses from the year-prior period. Net sales during the nine months ended
September 30, 2003 of the Duett, D-Stat Flowable, D-Stat Dry, Vari-Lase, Pronto
and Acolysis product lines were $7,216,063, $889,755, $39,850, $117,382, $11,455
and $127,126, respectively. Net sales during the nine months ended September 30,
2002 of Duett, D-Stat Flowable and Acolysis product lines were $8,612,704,
$515,409 and $44,594, respectively, for the nine months ended September 30,
2002.
Gross profit as a percentage of net sales increased slightly from the
year ago period to 59.4% for the nine months ended September 30, 2003 compared
to 59.0% for the nine months ended September 30, 2002.
Research and development expenses increased 8% to $2,788,527 for the
nine months ended September 30, 2003 from $2,571,214 for the nine months ended
September 30, 2002. Research and development expenses consist primarily of
expenses associated with the development of new interventional devices as well
as development of next generation Duett concepts. Additional interventional
medical devices that we incurred research and development expenses during this
period 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 11% to $1,134,388 for the
nine months ended September 30, 2003 from $1,025,440 for the nine months ended
September 30, 2002. This increase is attributable to our increase in the number
of products and product improvements compared to the prior year.
General and administrative expenses decreased 11% to $1,428,717 for the
nine months ended September 30, 2003 from $1,606,578 for the nine months ended
September 30, 2002. The nine months ended September 30, 2002 included
approximately $350,000 for legal expenses relating to our settlement of
intellectual property litigation with Datascope Corporation, which occurred in
December 2002.
Sales and marketing expenses decreased 23% to $7,274,791 for the nine
months ended September 30, 2003 from $9,458,240 for the nine months ended
September 30, 2002. The decrease in sales and marketing was the result of a 25%
reduction in the size of our direct sales force during the first half of 2003.
10
Amortization of purchased technology was $163,125 for the nine months
ended September 30, 2003 and $90,625 for the nine months ended September 30,
2002. The increase was the result of a full nine months of amortization for the
nine months ended September 30, 2003.
Interest income decreased to $132,685 for the nine months ended
September 30, 2003 from $408,629 for the nine months ended September 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 September 30, 2003, we had approximately $53.0 million of federal
net operating loss carryforwards available to offset future taxable income which
begin to expire in the year 2013. As of September 30, 2003, 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 and, to a lesser extent, sales of our products.
Through September 30, 2003, we have sold common stock and preferred stock
generating aggregate net proceeds of $71.2 million. At September 30, 2003, we
had $7.9 million in cash, cash equivalents and available-for-sale securities
on-hand.
During the three months ended September 30, 2003, we used $2.6 million
of cash in operating activities. The cash used in operating activities was
primarily used to fund our net loss for the period of $2.4 million, which was
offset by depreciation and amortization of $136,170. We generated cash of
$1,825,326 from investing activities, primarily from the sale of $2,000,000 of
investment securities. We generated $53,159 in financing activities entirely
through exercise of common stock options.
We signed a purchase agreement with MedArt Corporation on September 22,
2003. Under that agreement, we are obligated to purchase laser consoles with an
aggregate purchase price of $1,197,000 for our Vari-Lase business during the
first year of the agreement, which commences upon our receipt of regulatory
approval for sales of the console in the U.S., but not later than July 2004. We
plan to start selling our laser consoles during the first quarter of 2004
pending FDA regulatory approval. We do not have any other significant cash
commitments related to supply agreements, nor do we have any significant
commitments for capital expenditures.
We purchase our requirements for thrombin (a component in the Duett and
D-Stat products) under a Purchase Agreement dated June 10, 1999 with a
subsidiary of King Pharmaceuticals, Inc. The agreement provides for a fixed
price, with adjustments based on the supplier's manufacturing costs and the
11
supplier's annual percentage increase in the wholesale price of thrombin. The
agreement expires on May 29, 2005. During 2004 and the first half of 2005, we
intend to increase our purchases of thrombin to benefit from the pricing
provisions of the agreement, which we expect will substantially increase our
inventory of thrombin. We believe that these purchases will satisfy our thrombin
requirements for 2004, 2005 and most of 2006. We are currently exploring a new
thrombin supply agreement and evaluating alternative potential suppliers,
although there currently is no other source of commercially-available thrombin
approved for use in the United States.
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.
Depending on market conditions, we may seek to raise additional funds
for working capital purposes at any time through the sale of equity or debt
securities. 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.
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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.
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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 Acting 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 Acting Chief
Financial Officer concluded that, as of the Evaluation Date, our disclosure
controls and procedures were effective in timely alerting him 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.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
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.
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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 $22.3 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, $5.9
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
None.
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits:
Exhibit
Number Description
- ------ ------------
3.1 Amended and Restated Articles of Incorporation of Vascular Solutions,
Inc. (incorporated by reference to Exhibit 3.1 to Vascular Solutions'
Form 10-Q for the quarter ended September 30, 2000).
3.2 Bylaws of Vascular Solutions, Inc. (incorporated by reference to
Exhibit 3.2 of Vascular Solutions' Registration Statement on Form S-1
(File No. 333-84089)).
4.1 Specimen of Common Stock certificate (incorporated by reference to
Exhibit 4.1 of Vascular Solutions' Registration Statement on Form S-1
(File No. 333-84089)).
4.2 Form of warrant dated January 31 and February 14, 1997 issued to
representatives of Miller, Johnson & Kuehn, Incorporated (incorporated
by reference to Exhibit 4.2 of
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Vascular Solutions' Registration Statement on Form S-1 (File No.
333-84089)).
4.3 Form of warrant dated December 29, 1997 issued to representatives of
Miller, Johnson & Kuehn, Incorporated (incorporated by reference to
Exhibit 4.3 of Vascular Solutions' Registration Statement on Form S-1
(File No. 333-84089)).
4.4 Amended and Restated Investors' Rights Agreement dated December 9,
1998, by and between Vascular Solutions, Inc. and the purchasers of
Series A and Series B preferred stock (incorporated by reference to
Exhibit 4.4 of Vascular Solutions' Registration Statement on Form S-1
(File No. 333-84089)).
4.5 Stock Purchase Warrant dated June 10, 1999 by and between Vascular
Solutions, Inc. and Jones Pharma, Incorporated (incorporated by
reference to Exhibit 4.7 of Vascular Solutions' Registration Statement
on Form S-1 (File No. 333-84089)).
10.18* Private Label Purchase Agreement dated September 22, 2003 by and
between Vascular Solutions and MedArt Corporation
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.
32.1 Certification of Chief Executive Officer and Acting Chief Financial
Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
* Certain portions of this exhibit have been omitted pending a request for
confidential treatment from the SEC.
(b) Reports on Form 8-K:
We furnished a Form 8-K on October 15, 2003 to report our press
release dated October 15, 2003 on our third 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: October 24, 2003 By: /s/ Howard Root
-------------------------
Howard Root
CHIEF EXECUTIVE OFFICER
(principal financial officer and
duly authorized officer)
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