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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, 2000
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 333-36160
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RITA MEDICAL SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
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Delaware 94-3199149
(State or other jurisdiction of incorporation (I.R.S. Employer Identification No.)
or organization)
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967 N. Shoreline Blvd.
Mountain View, CA 94043
(Address of principal executive offices, including zip code)
650-390-8500
(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 Securities 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 [_]
As of August 31, 2000, there were 13,969,407 shares of the registrant's
Common Stock outstanding.
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Table of Contents
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Page
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements (unaudited).
Condensed Balance Sheets - June 30, 2000 and 3
December 31, 1999
Condensed Statements of Operations - Three and six months 4
ended June 30, 2000 and 1999
Condensed Statements of Cash Flows - Three and six months 5
ended June 30, 2000 and 1999
Notes to Condensed Financial Statements 6
Item 2. Management's Discussion and Analysis of Financial Condition and 8
Results of Operations.
Item 3. Quantitative and Qualitative Disclosures About Market Risk. 16
PART II. OTHER INFORMATION
Item 1. Legal Proceedings. 16
Item 2. Changes in Securities and Use of Proceeds. 16
Item 3. Defaults Upon Senior Securities. 17
Item 4. Submission of Matters to a Vote of Security Holders. 17
Item 5. Other Information. 18
Item 6. Exhibits and Reports on Form 8-K. 18
SIGNATURES 19
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
RITA MEDICAL SYSTEMS, INC.
CONDENSED BALANCE SHEETS
(In thousands, except per share data, unaudited)
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June 30, December 31,
2000 1999
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Assets
Current assets:
Cash and cash equivalents........................................................... $ 6,759 $ 7,067
Marketable securities............................................................... 2,742 5,086
Accounts receivable, net............................................................ 1,942 1,149
Inventories, net.................................................................... 1,045 845
Prepaid assets and other current assets............................................. 550 616
-------- --------
Total current assets............................................................... 13,038 14,763
Property and equipment, net........................................................... 961 875
Other assets.......................................................................... 64 67
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Total assets....................................................................... $ 14,063 $ 15,705
======== ========
Liabilities, Convertible Preferred Stock and Stockholders' Deficit
Current liabilities:
Accounts payable.................................................................... $ 625 $ 892
Accrued liabilities................................................................. 1,042 956
Current portion of long term obligations............................................ 1,256 478
-------- --------
Total current liabilities............................................................. 2,923 2,326
Long term notes payable............................................................... 1,841 1,091
Long term obligations................................................................. 1,396 763
-------- --------
Total liabilities.................................................................. 6,160 4,180
-------- --------
Contingency (Note 7)
Convertible preferred stock, $.001 par value.......................................... 37,910 37,911
Preferred stock warrants.............................................................. 605 605
-------- --------
Stockholders' deficit:
Common stock, $0.001 par value........................................................ 1 1
Additional paid-in capital............................................................ 11,546 3,651
Deferred stock compensation........................................................... (6,502) (1,935)
Receivable from stockholder........................................................... (239) (73)
Accumulated other comprehensive loss (5) (7)
Accumulated deficit................................................................... (35,413) (28,628)
-------- --------
Total stockholders' deficit........................................................ (30,612) (26,991)
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$ 14,063 $ 15,705
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See accompanying notes.
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RITA MEDICAL SYSTEMS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share data, unaudited)
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Three Months Ended Six Months Ended
June 30, June 30,
--------------------- ---------------------
2000 1999 2000 1999
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Sales................................... $ 2,427 $ 1,062 $ 4,268 $ 1,899
Cost of goods sold...................... 1,494 618 2,676 1,308
-------- -------- -------- --------
Gross profit......................... 933 444 1,592 591
Operating expenses:
Research and development.............. 1,442 813 3,073 1,550
Selling, general and administrative... 2,683 1,334 5,324 2,672
-------- -------- -------- --------
Total operating expenses............. 4,125 2,147 8,397 4,222
-------- -------- -------- --------
Loss from operations.................... (3,192) (1,703) (6,805) (3,631)
Interest and other expense, net......... (15) 40 20 110
-------- -------- -------- --------
Net loss................................ $(3,207) $(1,663) $(6,785) $(3,521)
======== ======== ======== ========
Net loss per share, basic and diluted... $ (2.79) $ (2.11) $ (6.26) $ (4.49)
======== ======== ======== ========
Shares used in computing basic and
diluted net loss per share............. 1,150 789 1,083 784
Pro forma net loss per share, basic and
diluted................................ $ (0.32) $ (0.22) $ (0.69) $ (0.47)
======== ======== ======== ========
Shares used in computing pro forma net
loss per share, basic and diluted...... 9,954 7,483 9,888 7,443
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See accompanying notes.
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RITA MEDICAL SYSTEMS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(In thousands, unaudited)
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Six Months Ended
June 30,
2000 1999
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Operating activities:
Net loss...................................................... $(6,785) $(3,521)
Adjustments to reconcile net loss to net cash used in
operating activities:
Depreciation and amortization................................ 399 187
Amortization of stock-based compensation..................... 2,937 456
Changes in operating assets and liabilities
Accounts receivable......................................... (793) (512)
Inventory................................................... (200) (343)
Prepaid and other current assets............................ (50) 197
Accounts payable and accrued liabilities.................... (181) 61
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Net cash used in operating activities...................... (4,673) (3,475)
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Investing activities:
Purchase of property and equipment........................... (123) (45)
Purchases of short term investments.......................... (1,210) (870)
Maturities of short term investments......................... 3,556 1,564
Notes receivable and other assets............................ 3 (27)
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Net cash provided in investing activities.................. 2,226 622
---------- ---------
Financing activities:
Proceeds from issuance of common and preferred stock......... 224 985
Proceeds from borrowings of long-term debt................... 1,500 1,500
Proceeds from revolving term loan............................ 539 401
Payments on capital lease obligations........................ (124) (72)
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Net cash provided by financing activities.................. 2,139 2,814
---------- ---------
Net increase (decrease) in cash and cash equivalents.......... (308) (39)
Cash and cash equivalents at beginning of period.............. 7,067 5,322
---------- ---------
Cash and cash equivalents at end of period.................... $ 6,759 $ 5,283
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See accompanying notes.
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RITA MEDICAL SYSTEMS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
1. Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared by
Rita Medical Systems, Inc. (the "Company") in accordance with generally accepted
accounting principles for interim financial information that are consistent in
all material respects with those applied in the company's financial statements
contained in our Registration Statement on Form S-1 (No. 333-36160) for the
fiscal year ended December 31, 1999 and pursuant to the instructions to Form 10-
Q and Article 10 of Regulation S-X promulgated by the Securities and Exchange
Commission. 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, the accompanying unaudited
condensed financial statements contain all adjustments (all of which are normal
and recurring in nature) necessary to present fairly the financial position,
results of operations and cash flows of the Company for the periods indicated.
Interim results of operations are not necessarily indicative of the results to
be expected for the full year or any other interim periods. These condensed
consolidated financial statements should be read in conjunction with the
financial statements and footnotes thereto for the years ended December 31,
1997, 1998 and 1999 contained in our Registration Statement on Form S-1.
2. Net loss per share and pro forma net loss per share
Basic earnings per share is calculated based on the weighted-average number of
common shares outstanding during the period. Diluted earnings per share would
give effect to the dilutive effect of common stock equivalents consisting of
stock options, common stock subject to repurchase and shares issuable upon
conversion of the preferred stock and warrants. Potentially dilutive securities
of 11,198,122 and 8,771,241 have been excluded from the dilutive earnings per
share computations for the periods ended June 30, 2000 and June 30, 1999
respectively as they have an antidilutive effect due to the Company's net
losses.
The computation of pro forma net loss per share includes shares issuable upon
the conversion of outstanding shares of convertible preferred stock (using the
as-if-converted method) from the original date of issuance.
3. Comprehensive Loss
Comprehensive loss is comprised of net loss and other comprehensive loss such as
unrealized gains or losses on available-for-sale marketable securities. For the
three and six month periods ended June 30, 2000 and June 30, 1999, reported net
loss approximated comprehensive net loss.
4. Inventories (in thousands)
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June 30, December 31,
2000 1999
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Inventory:
Raw materials...................... $ 128 $ 250
Work-in-process.................... 162 28
Finished goods..................... 755 567
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$1,045 $ 845
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5. Recent Accounting Pronouncements
In June 1998, the Financial Accounting Standards Board issued Statement of
Financial Accounting Standards ("SFAS") No. 133, "Accounting for Derivative
Instruments and Hedging Activities." SFAS No., 133 establishes new
standards of accounting and reporting for derivative instruments and
hedging activities. SFAS No. 133 requires that all derivatives be
recognized at fair value in the statement of financial position, and that
the corresponding gains or losses be reported either in the statement of
operations or as a component of comprehensive income, depending on the type
of relationship that exists. The Company, to date, has not engaged in
derivative or hedging activities. The Company will adopt SFAS No. 133, as
required, in fiscal year 2001.
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In December 1999, the Securities and Exchange Commission issued Staff
Accounting Bulletin No. 101 "Revenue Recognition in Financial Statements"
("SAB 101"). SAB 101 summarizes some areas of the Staff's views in applying
generally accepted accounting principles to revenue recognition in
financial statements. The Company believes that its current revenue
recognition principles comply with SAB 101.
In March 2000, the FASB issued Interpretation No. 44, ("FIN 44"),
"Accounting for Certain Transactions Involving Stock compensation-an
Interpretation of APB 25." This Interpretation clarifies (a) the definition
of employee for purposes of applying Opinion 25, (b) the criteria for
determining whether a plan qualifies as a noncompensatory plan, (c) the
accounting consequence of various modifications to the terms of a
previously fixed stock option or award, and (d) the accounting for an
exchange of stock compensation awards in a business combinations. This
Interpretation is effective July 1, 2000, but certain conclusions in this
Interpretation cover specific events that occur after either December
15,1998, or January 12, 2000. To the extent that this Interpretation covers
events occurring during the period after December 15, 1998, or January 12,
2000, but before the effective date of July 1, 2000, the effects of
applying this Interpretation are recognized on a prospective basis from
July 1, 2000. The adoption of FIN 44 does not have a material impact on the
Company's financial statements.
6. Stock Split
On May 1, 2000, the board of directors approved a 3-for-5 reverse stock
split of the common and preferred stock. Stockholders' approval of the
reverse stock split was obtained on June 20, 2000. All share and per share
amounts in the accompanying financial statements have been adjusted
retroactively.
7. Contingency
The Company is involved in a patent interference proceeding with
RadioTherapeutics Corporation in which the validity of a patent issued to
the Company has been called into question. Although the Company believes it
has meritorious defenses, if it does not prevail in this interference, it
could be prevented from selling the RITA System or be required to pay
license fees and or royalties on past and future product sales.
8. Subsequent Events
Initial Public Offering
The Company effected a registration with the Securities and Exchange
Commission on Form S-1, as amended, Registration No. 333-36160 (the
"Registration Statement"), whereby the Company registered up to 3,600,000
shares of its Common Stock. On August 1, 2000, the Company completed its
initial public offering of 3,600,000 shares of Common stock, at a price of
$12.00 per share, that raised approximately $39.0 million, net of
underwriting discounts, commissions and other offering costs. Upon the
closing of the offering, all of the Company's convertible preferred stock
converted into approximately 8.9 million shares of common stock.
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Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations.
This Management's Discussion and Analysis of Financial Condition and
Results of Operations and other parts of this Form 10-Q contain forward-looking
statements that involve risks and uncertainties. Words such as "anticipates",
"expects", "intends", "plans", "believes", "seeks", "estimates", and similar
expressions identify such forward-looking statements. These statements are not
guarantees of future performance and are subject to risks and uncertainties,
which could cause actual results to differ materially from those expressed or
forecasted. Factors that might cause such a difference include, but are not
limited to, those discussed in the section entitled "Factors That May Affect
Future Results" and those appearing elsewhere in this Form 10-Q. Readers are
cautioned not to place undue reliance on these forward-looking statements which
reflect management's analysis only as of the date hereof. We assume no
obligation to update these forward-looking statements to reflect actual results
or changes in factors or assumptions affecting such forward-looking statements.
Overview
We develop, manufacture and market innovative products that use
radiofrequency energy to treat patients with solid cancerous or benign tumors.
From inception in 1994 through 1996, our operations consisted primarily of
various start-up activities, including development of technologies central to
our business, recruiting personnel and raising capital. In 1997, we began
commercial shipment of our products. In the second quarter of 2000, we
commercially launched our next-generation Model 1500 generator and StarBurst XL
disposable devices.
All of our sales are generated from the sale of our disposable devices and
radiofrequency generators. For the six months ended June 30, 2000, sales through
our direct sales force in the United States accounted for 35% of our total sales
while sales to our international distributors accounted for 65% of our total
sales. We currently intend to continue building our direct sales force in the
United States and selling through third-party distribution partners
internationally. We expect that a significant portion of our revenue will
continue to come from international operations because of the high incidence of
primary liver cancer in Asian and European markets. In the six months ended June
30, 2000, 61% of our sales were derived from our disposable devices and 39% were
derived from the sale of our generators. We plan to focus on expanding our base
of customer accounts and increasing usage of our disposable products.
We recognize revenue upon receipt of a purchase order and shipment of
products to customers. Our return policy allows customers to return products
received in damaged or non-working condition up to 60 days after receipt of the
product. To date, returns have been insignificant.
Our manufacturing costs consist of raw materials, including generators
produced for us by third-party suppliers, labor to produce our disposable
devices and to inspect incoming, in-process and finished goods, sterilization
performed by an outside service provider and general overhead expenses. Gross
profit margins are affected by production volumes and average selling prices.
In the six months ended June 30, 2000, 37% of our operating expenses were
related to research and development activities, while 63% of our operating
expenses were related to selling, general and administrative activities. We
expect to continue to devote a large portion of our resources to product
development and clinical research programs. However, we expect to devote a
growing proportion of our operating expenses to selling, general and
administrative activities, particularly to our sales and marketing efforts.
These efforts include increasing the size of our domestic sales force and our
international distribution support activities as well as establishing formal
physician and patient awareness and education programs.
In connection with the grant of stock options to employees and non-
employees, we record deferred stock-based compensation as a component of
stockholders' equity. This stock-based compensation is amortized as charges to
operations over the vesting periods of the options. We recorded amortization of
deferred compensation of $403,000 for the year ended December 31, 1998, $991,000
for the year ended December 31, 1999 and $2.9 million for the six months ended
June 30, 2000. We expect to record additional amortization expense for deferred
compensation in future periods.
We incurred net losses of approximately $6.8 million in the first six
months of 2000. As of June 30, 2000, we had an accumulated deficit of $35.4
million. Due to the high costs associated with continued research and
development programs, expanded clinical research programs and increased sales
and marketing efforts, we expect to continue to incur net losses for the next
few years.
Our product sales have mainly been to a group of early adopting physicians
who treat patients with cancerous tumors of the liver. Our opportunity for
further market penetration and increased revenues will depend on additional
sales efforts, longer-term supporting clinical data and physician awareness and
education programs.
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Our future growth depends on expanding product usage in our current market
and finding new large markets in which we can leverage our core technologies of
applying radiofrequency energy to treat cancerous and benign tumors. To the
extent our current or any additional markets do not materialize in accordance
with our expectations, our sales could be lower than expected.
We are currently involved in patent proceedings and may become a party to
additional patent or product liability proceedings. The costs of such lawsuits
or proceedings may be material and could affect our earnings and financial
position. An adverse outcome in a patent lawsuit could require us to cease sales
of affected products or to pay royalties and/or license fees, which could harm
our results of operations.
Results of Operations
Sales increased 129% to $2.4 million in the quarter ended June 30, 2000
from $1.1 million for the quarter ended June 30, 1999. For the six-month period
ended June 30, 2000 sales increased 125% to $4.3 million from $1.9 million in
the comparable period in 1999. Higher unit shipments of generators and
disposables resulted from increased physician awareness of our technology,
expansion of our domestic sales force, increased geographical representation
through the appointment of new international distributors and the launch of our
next-generation Model 1500 generator and StarBurst XL disposable devices.
Cost of goods sold for the quarter ended June 30, 2000 was $1.5 million as
compared to $618,000 for the corresponding period in 1999. Cost of goods sold
for the six months ended June 30, 2000 was $2.7 million as compared to $1.3
million for the six months ended June 30, 1999. The growth in cost of goods
sold was attributable primarily to higher material, labor, and overhead costs
associated with increased unit shipments, including increases in amortization of
deferred stock-based compensation. Amortization of deferred stock-based
compensation was $270,000 in the three-month period ended June 30, 2000 as
compared to $30,000 in the corresponding period in 1999 and $375,000 in the six-
month period ended June 30, 2000 as compared to $55,000 in the corresponding
period in 1999.
Research and development expenses for the three months ended June 30, 2000
were $1.4 million as compared to $813,000 for the corresponding period in 1999.
Research and development expenses for the six months ended June 30, 2000 were
$3.1 million as compared to $1.6 million for the corresponding period in 1999.
The expense increase was attributable primarily to additional personnel,
expenses associated with the development of our next-generation disposable
devices and generators, increased clinical program spending, increased expenses
related to the growth and protection of our patent portfolio as well as
increases in the amortization of deferred stock-based compensation. Amortization
of deferred stock-based compensation was $293,000 in the three-month period
ended June 30, 2000 as compared to $82,000 in the corresponding period in 1999
and $601,000 in the six-month period ended June 30, 2000 as compared to $162,000
in the corresponding period of 1999.
Selling, general and administrative expenses for the three months ended
June 30, 2000 were $2.7 million as compared to $1.3 million in the corresponding
period in 1999. Selling, general and administrative expenses for the six months
ended June 30, 2000 were $5.3 million as compared to $2.7 million in the
corresponding period of 1999. The increase resulted from the addition of sales
and clinical support personnel as well as spending associated with the launch of
our next-generation disposable devices and generators. General and
administrative expenses increased due to added personnel to support our growth
in operations as well as increases in the amortization of deferred stock-based
compensation. Amortization of deferred stock-based compensation was $817,000 in
the three-month period ended June 30, 2000 as compared to $124,000 in the
corresponding period in 1999 and $2.0 million in the six-month period ended June
30, 2000 as compared to $239,000 in the corresponding period of 1999.
Net interest and other (expense) income for the three months ended June 30,
2000 was ($15,000) as compared to $40,000 in the corresponding period of 1999.
Net interest and other income for the six months ended June 30, 2000 was $20,000
as compared to $110,000 in the corresponding period of 1999. The change in net
interest and other income was primarily attributable to the interest expense
associated with the loan and security agreement transacted in June 1999 with
increases to the revolving credit note and funding of the second term loan in
the first quarter of 2000.
Liquidity and Capital Resources
We have financed our operations since inception principally through private
placements of equity securities, net of expenses, of $37.9 million of
convertible preferred stock. To a lesser extent, we also financed our operations
through equipment financing and other loans, which totaled $4.5 million in
principal outstanding at June 30, 2000. As of June 30, 2000, we had $6.8 million
of cash and cash equivalents, $2.7 million of marketable securities and $10.1
million of working capital.
For the six months ended June 30, 2000, net cash used in operating
activities was $4.7 million principally due to our net loss and increases in
accounts receivable and inventory resulting from higher revenues and increased
unit shipments. Our investing activities for the six months ended June 30, 2000
were limited to the purchase of property and equipment in the amount of $123,000
and net purchases or sales of short-term investments. For the six months ended
June 30, 2000, net cash provided by financing activities was $2.1 million
primarily attributable to increases in our debt obligations.
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In June 1999, we entered into a loan and security agreement for a loan
facility of up to $5.0 million. The facility consists of two term loans of $1.5
million each and a revolving credit note of up to $2.0 million. As of June 30,
2000, we had drawn down two term loans of $1.5 million each and $1.1 million of
the revolving credit note.
Our primary source of liquidity at June 30, 2000 consisted of $9.5 million
of cash, cash equivalents and marketable securities. In addition, we completed
our initial public offering (see Notes to Condensed Financial Statements) on
August 1, 2000, raising net proceeds of approximately $39.0 million. Our capital
requirements depend on numerous factors including our research and development
expenditures, expenses related to selling and marketing and working capital to
support business growth. Although it is difficult for us to predict future
liquidity requirements with certainty, we believe that the net proceeds from the
initial public offering, together with our existing liquidity sources and
anticipated funds from operations, will satisfy our cash requirements for at
least the next 18 months. During or after this period, if cash generated by
operations is insufficient to satisfy our liquidity requirements, we may need to
sell additional equity or debt securities. There can be no assurance that
additional financing will be available to us or, if available, that such
financing will be available on terms favorable to the company and our
stockholders.
Factors That May Affect Future Results
In addition to the other information in this report, the following factors
should be considered carefully in evaluating the Company's business and
prospects.
Due to our dependence on the RITA system, failure to achieve market acceptance
in a timely manner could harm our business.
Because all of our revenue comes from the sale of the RITA system, our
financial performance will depend upon physician adoption and patient awareness
of this system. If we are unable to convince physicians to use the RITA system,
we may not be able to generate revenues because we do not have alternative
products.
We have a history of losses, anticipate significant increases in our operating
expenses over the next several years and may never achieve profitability.
We anticipate that our operating expenses will increase substantially in
absolute dollars for the foreseeable future as we expand our sales and
marketing, manufacturing, clinical research and product development efforts. To
become profitable, we must continue to increase our sales. If sales do not
continue to grow, we may not be able to achieve or maintain profitability in the
future. In particular, we incurred net losses of $6.7 million in 1998 and $7.5
million in 1999. As of June 30, 2000, we had an accumulated deficit of
approximately $35.4 million.
We currently lack long-term data regarding the safety and efficacy of our
products and may find that long-term data does not support our short-term
clinical results.
Our products are supported by an average clinical follow-up of between five
and 14 months in published clinical reports. If longer-term studies fail to
confirm the effectiveness of our products, our sales could decline. If longer-
term patient follow-up or clinical studies indicate that our procedures cause
unexpected, serious complications or other unforeseen negative effects, we could
be subject to significant liability. Further, because some of our data has been
produced in studies that were not randomized and/or included small patient
populations, our clinical data may not be reproduced in wider patient
populations. We are involved in two clinical studies using our system which are
expected to produce twelve month or longer follow-up data. Both studies are at
an early stage. We do not know when these studies will be completed or published
and we do not have preliminary data from either of these studies. If the data
produced is not favorable, our business could be harmed.
Because we face significant competition from companies with greater resources
than we have, we may be unable to compete effectively.
The market for our products is intensely competitive, subject to rapid
change and significantly affected by new product introductions and other market
activities of industry participants.
We compete directly with two companies: RadioTherapeutics Corporation, a
privately held company, and Radionics, Inc., a division of Tyco International, a
publicly traded company with substantial resources. Both RadioTherapeutics and
Radionics sell products that use radiofrequency energy to ablate soft tissue.
RadioTherapeutics has entered into a distribution arrangement with Boston
Scientific Corporation, a publicly traded company with substantially greater
resources than we have.
Alternative therapies could prove to be superior to the RITA system, and
physician adoption could be negatively affected.
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In addition to competing against other companies offering products which
use radiofrequency energy to ablate soft tissue, we also compete against
companies developing, manufacturing and marketing alternative therapies that
address both cancerous and benign tumors. If these alternative therapies prove
to offer treatment options that are superior to our system, physician adoption
of our products could be negatively affected and our revenues could decline.
We are currently involved in a patent interference action and a patent
opposition action involving RadioTherapeutics Corporation and if we do not
prevail in these actions, we may be unable to sell the RITA system.
In July 1999, the United States Patent and Trademark Office declared an
interference involving us which was provoked by RadioTherapeutics Corporation, a
competitor of ours, in which the validity of a patent claim previously issued to
us is being called into question. The claim being questioned is one of a number
of issued patent claims that covers the curvature of the array at the tip of our
disposable devices. We believe that the inventor named in our patent was the
first to invent this subject matter. RadioTherapeutics believes they invented
this curvature first. In March 2000, RadioTherapeutics Corporation filed an
opposition to our European Patent No. 0777445. This patent also covers the
curvature of the array at the tip of our disposable devices. In this opposition,
the validity of our issued patent is being questioned. Final resolution of these
matters is not expected for several years.
Patent issues involve complex legal and factual issues. In the event we do
not prevail in the interference action, we could be prevented from selling the
RITA system unless we could, either obtain a license from RadioTherapeutics to
use the relevant patent or were able to modify our product. We may not be able
to modify the RITA system successfully, and we cannot be certain that any
modified system would achieve market acceptance or regulatory approval. If we
were unable to sell our system and unable to develop a commercially successful
alternative or obtain a license, to the relevant patent or patents on
commercially reasonable terms, our business could be materially harmed. If we do
not prevail in the opposition proceeding, we could lose our only currently
issued patent in Europe.
Patents and other proprietary rights provide uncertain protections, and we may
be unable to protect our intellectual property.
Our success depends significantly on our ability to protect our proprietary
rights to the technologies used in our products, and yet we may be unable to do
so. A number of companies in our market, as well as universities and research
institutions, have issued patents and have filed patent applications which
relate to the use of radiofrequency energy to ablate soft tissue. Our pending
United States and foreign patent applications may not issue or may issue and be
subsequently successfully challenged by others and invalidated. In addition, our
pending patent applications include claims to material aspects of our products
that are not currently protected by issued patents. Both the patent application
process and the process of managing patent disputes can be time consuming and
expensive.
Competitors may be able to design around our patents or develop products
which provide outcomes which are comparable to ours. In addition, the laws of
some foreign countries may not protect our intellectual property rights to the
same extent as do the laws of the United States. In the event a competitor
infringes upon our patent or other intellectual property rights, enforcing those
rights may be difficult and time consuming. Even if successful, litigation to
enforce our intellectual property rights or to defend our patents against
challenge could be extensive and time consuming and could divert our
management's attention. We may not have sufficient resources to enforce our
intellectual property rights or to defend our patents against a challenge.
In addition, confidentiality agreements executed by our employees,
consultants and advisors may not be enforceable or may not provide meaningful
protection for our trade secrets or other proprietary information in the event
of unauthorized use or disclosure.
Because the medical device industry is characterized by competing intellectual
property, we may be sued for violating the intellectual property rights of
others.
The medical device industry is characterized by a substantial amount of
litigation over patent and other intellectual property rights. Determining
whether a product infringes a patent involves complex legal and factual issues,
and the outcome of patent litigation actions is often uncertain. Our competitors
may assert that our products and the methods we employ in the use of our
products are covered by United States or foreign patents held by them. However,
we do not believe that we infringe any valid patent rights held by others. In
addition, because patent applications can take many years to issue, there may be
applications now pending of which we are unaware, which may later result in
issued patents which our products may infringe. There could also be existing
patents that one or more of our products may inadvertently be infringing of
which we are unaware. As the number of competitors in the market for less
invasive cancer treatment alternatives grows, and as the number of patents
issued in this area grows, the possibility of a patent infringement claim
against us increases.
-11-
<PAGE>
To address patent infringement or other intellectual property claims, we
may have to enter into licensing agreements or agree to pay royalties at a
substantial cost to our business. We may be unable to obtain necessary licenses.
A valid claim against us, and our failure to license the technology at issue,
could prevent us from selling our products.
If we are sued for patent infringement, we could be prevented from selling our
products and our business could suffer.
We are aware of the existence of patents held by competitors in our market
which could result in a patent lawsuit against us. In the event that we are
subject to a patent infringement lawsuit and if the relevant patents were upheld
as valid and enforceable and we were found to infringe, we could be prevented
from selling our products unless we could obtain a license or were able to
redesign the product to avoid infringement. If we were unable to obtain a
license or successfully redesign our system, we may be prevented from selling
our system and our business could suffer.
You may have a difficult time evaluating our company as an investment because we
have a limited operating history.
You can only evaluate our business based on a limited operating history
because we began selling the RITA system in 1997. This short history may not be
adequate to enable you to fully assess our ability to achieve market acceptance
of our products and respond to competition.
Our dependence on international revenues, which accounted for a significant
portion of our 1999 revenues, could harm our business.
Because our future profitability will depend in part on our ability to grow
product sales in international markets, we are exposed to risks specific to
business operations outside the United States. These risks include:
. obtaining reimbursement for procedures using our devices in some foreign
markets;
. the burden of complying with complex and changing foreign regulatory
requirements;
. longer accounts receivable collection time;
. significant currency fluctuations which could cause our distributors to
reduce the number of products they purchase from us because the cost of our
products to them could increase relative to the price they could charge
their customers;
. reduced protection of intellectual property rights in some foreign
countries; and
. contractual provisions governed by foreign laws.
We are substantially dependent on two distributors in our international markets,
and if we lose either distributor or are unable to attract additional
distributors, our international and total revenues could decline.
We are substantially dependent on a limited number of significant
distributors in our international markets, and if we lose these distributors and
fail to attract additional distributors, our international revenues could
decline. Nissho Iwai Corporation, which is our primary distributor in Asia,
accounted for 44 percent of our international revenues for the six months ended
June 30, 2000 and 63 percent of our international revenues in fiscal 1999.
M.D.H.s.r.l. Forniture Ospedaliere, which is our distributor in Italy, accounted
for 20 percent of our international revenues for the six months ended June 30,
2000 and 22 percent of our international revenues for fiscal 1999. Because
international revenues accounted for 65 percent of our total revenues for the
six months ended June 30, 2000 and these two distributors represented 64 percent
of that total, the loss of either distributor could cause revenues to decline
substantially. If we are unable to attract additional international
distributors, our international revenues may not grow.
Our relationships with third-party distributors could negatively affect our
sales.
We sell our products in international markets through third-party
distributors over whom we have limited control, and, if they fail to adequately
support our products, our sales could decline. If we or our distributors
terminate our existing agreements, finding companies to replace them could be an
expensive and time-consuming process and sales could decrease during any
transition period.
Any failure to build and manage our direct sales organization may negatively
affect our revenues.
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<PAGE>
We are currently building a direct sales force in the United States and if
we do not expand our sales force substantially over the next twelve months, we
may not achieve our revenue growth goals. There is intense competition for
skilled sales and marketing employees, especially for people who have experience
selling disposable devices and generators to the physicians in our target
market, and we may be unable to hire skilled individuals to sell our products.
Any inability to build our direct sales force could negatively impact our
growth.
We depend on key employees in a competitive market for skilled personnel and
without additional employees, we cannot grow or achieve profitability.
We are highly dependent on the principal members of our management,
operations and research and development staff. Our future success will depend in
part on the continued service of these individuals and our ability to identify,
hire and retain additional personnel, including sales and marketing staff. The
market for qualified management personnel in Northern California, where our
offices are located, is extremely competitive and is expected to continue to be
highly competitive. Because the environment for good personnel is so
competitive, costs related to compensation may increase significantly. If we are
unable to attract and retain the personnel we need to support and grow our
business, our business will suffer.
If third-party payors do not reimburse health care providers for use of the RITA
system, purchases could be delayed and our revenues could decline.
Physicians, hospitals and other health care providers may be reluctant to
purchase our products if they do not receive substantial reimbursement for the
cost of the procedures using our products from third-party payors, such as
Medicare, Medicaid and private health insurance plans. Procedures using our
products are currently reimbursed based on established general reimbursement
codes. Because there is no specific reimbursement code for procedures using the
RITA system, physicians need to submit a patient case history and data
supporting the applicability of our system to the patient's condition in order
to obtain reimbursement. Each payor then determines whether and to what extent
to reimburse for a medical procedure or product. Payors may refuse to provide
reimbursement for procedures covered by general codes because the applicability
of the code must be determined on a case-by-case basis. If a payor refuses to
reimburse the cost of our procedure under existing reimbursement codes, we could
be required to establish new specific codes. This process is time consuming and
costly and requires us to provide extensive supporting scientific, clinical and
cost-effectiveness data for our products to the American Medical Association.
Even if we were successful in establishing a new code, a payor still may not
reimburse adequately for the procedure or product. In addition, we believe the
advent of fixed payment schedules has made it difficult to receive reimbursement
for disposable products, even if the use of these products improves clinical
outcomes. Fixed payment schedules typically permit reimbursement for a procedure
rather than a device. If physicians believe that our system will add cost to a
procedure but will not add sufficient offsetting economic or clinical benefits,
physician adoption could be slowed.
We may be subject to costly and time-consuming product liability actions.
We manufacture medical devices that are used on patients in both minimally
invasive and open surgical procedures and as a result, we may be subject to
product liability lawsuits. To date, we have not been subject to a product
liability claim; however, any product liability claim brought against us, with
or without merit, could result in the increase of our product liability
insurance rates or the inability to secure coverage in the future. In addition,
we could have to pay any amount awarded by a court in excess of policy limits.
Finally, even a meritless or unsuccessful product liability claim could be time
consuming and expensive to defend and could result in the diversion of
management's attention from managing our core business.
Any failure in our physician training efforts could result in lower than
expected product sales.
It is critical to our sales effort to train a sufficient number of
physicians and to instruct them properly in the procedures which utilize our
products. We plan to establish formal physician training programs and will rely
on physicians to devote adequate time to understanding how our products should
be used. If physicians are not properly trained, they may misuse or
ineffectively use our products. This may result in unsatisfactory patient
outcomes, patient injury and related liability or negative publicity which could
have an adverse effect on our product sales.
If we fail to support our anticipated growth in operations, our business could
suffer.
If we fail to execute our sales strategy and develop further our products,
our business could suffer. To manage anticipated growth in operations, we must
increase our quality assurance staff for both our generators and our disposable
devices and expand our manufacturing staff and facility for our disposable
devices. Our systems, procedures and controls may not be adequate to support our
expected growth in operations.
-13-
<PAGE>
We have limited experience manufacturing our disposable devices in substantial
quantities, and if we are unable to hire sufficient additional personnel,
purchase additional equipment or are otherwise unable to meet customer demand
our business could suffer.
To be successful, we must manufacture our products in substantial
quantities in compliance with regulatory requirements at acceptable costs. If we
do not succeed in manufacturing quantities of our disposable devices which meet
customer demand, we could lose customers and our business could suffer. At the
present time, we have limited manufacturing experience. Our manufacturing
operations are currently focused on the in-house assembly of our disposable
devices. As we increase our manufacturing volume and the number of product
designs for our disposable devices, the complexity of our manufacturing
processes will increase. Because our manufacturing operations are primarily
dependent upon manual assembly, if demand for our system increases we will need
to hire additional personnel and may need to purchase additional equipment. If
we are unable to sufficiently staff our manufacturing operations or are
otherwise unable to meet customer demand for our products, our business could
suffer.
We are dependent on one supplier which is the only source of a component that we
use in our disposable devices, and any disruption in the supply of this
component could negatively affect our revenues.
Because there is only one supplier that provides us with a component that
we include in our disposable devices, a disruption in the supply of this
component could negatively affect revenues. This supplier is the only source of
this component. If we were unable to remedy a disruption in supply of this
component within twelve months, we could be required to redesign the handle of
our disposable devices which could significantly impair our ability to sell our
products. In addition, a new or supplemental filing with applicable regulatory
authorities may require clearance prior to our marketing a product containing
new materials. This clearance process may take a substantial period of time, and
we may be unable to obtain necessary regulatory approvals for any new material
to be used in our products on a timely basis, if at all. This could also create
supply disruptions that could negatively affect our business.
We are dependent on third-party contractors for the supply of our generators,
and any failure to deliver generators to us could result in lower than expected
revenues.
One of the generators we sell is currently manufactured according to our
specifications by one third-party supplier. There is only one other third-party
contractor who we have used who could readily assume this manufacturing
function. Our second-generation generator is produced by two third-party
suppliers. We have agreements with both of these suppliers. Any delay in
shipments of generators to us could result in our failure to ship generators to
customers and could negatively affect revenues.
Complying with the FDA and other domestic and international regulatory
authorities is an expensive and time-consuming process, and any failure to
comply could result in substantial penalties.
We are subject to a host of federal, state, local and international
regulations regarding the manufacture and marketing of our products. In
particular, our failure to comply with FDA regulations could result in, among
other things, seizures or recalls of our products, an injunction, substantial
fines and/or criminal charges against us and our employees. The FDA's medical
device reporting regulations require us to report any incident in which our
products may have caused or contributed to a death or serious injury, or in
which our products malfunctioned in a way that would be likely to cause or
contribute to a death or serious injury if the malfunction recurred. As of June
30, 2000, we had filed eight medical device reports with the FDA related to skin
burns caused by a ground pad primarily due to placement, one report related to
an arterial bleed caused by improper needle placement and one report related to
an abscess which resulted from the large volume of ablated tissue. We believe
that none of these incidents were attributed to a device malfunction. None of
these incidents resulted in permanent injury or death.
Sales of our products outside the United States are subject to foreign
regulatory requirements that vary from country to country. The time required to
obtain approvals from foreign countries may be longer than that required for FDA
approval or clearance, and requirements for foreign licensing may differ from
FDA requirements.
Product introductions or modifications may be delayed or canceled as a result of
the FDA regulatory process which could cause our revenues to be below
expectations.
Unless we are exempt, before we can sell a new medical device in the United
States, we must obtain the appropriate FDA approval or clearance which can be a
lengthy and time-consuming process. To date, all of our products have received
clearances from the FDA through premarket notification under Section 510(k) of
the Federal Food, Drug and Cosmetic Act. However, if the FDA requires us to
submit a new premarket notification under Section 510(k) for modifications to
our existing products, or if the FDA requires us to go through a lengthier, more
rigorous examination than we had expected, our product introductions or
modifications could be delayed or canceled which could cause our revenues to be
below expectations. The FDA may determine
-14-
<PAGE>
that future products will require the more costly, lengthy and uncertain
premarket approval process. In addition, modifications to medical device
products cleared via the 510(k) process may require a new 510(k) submission. We
have made minor modifications to our system. Using the guidelines established by
the FDA, we have determined that these modifications do not require us to file
new 510(k) submissions. If the FDA disagrees with our determinations, we may not
be able to sell the RITA system until the FDA has cleared new 510(k) submissions
for these modifications. In addition, we intend to request additional label
indications, such as approvals or clearances for the ablation of tumors in
additional organs, including lung, bone and breast, for our current products.
The FDA may either deny these requests outright, require additional extensive
clinical data to support any additional indications or impose limitations on the
intended use of any cleared product as a condition of approval or clearance.
Therefore, obtaining necessary approvals or clearances for these additional
applications could be an expensive and lengthy process.
We may incur significant costs related to a class action lawsuit due to the
likely volatility of our stock.
Our stock price may fluctuate for a number of reasons including:
. failure of the public market to support the valuation established in our
initial public offering;
. our ability to successfully commercialize our products;
. announcements of technological or competitive developments;
. announcements regarding patent litigation or the issuance of patents to
us or our competitors;
. regulatory developments regarding us or our competitors;
. acquisitions or strategic alliances by us or our competitors;
. quarterly fluctuations in our results of operations;
. changes in estimates of our financial performance or changes in
recommendations by securities analysts; and
. general market conditions, particularly for companies with small market
capitalizations.
Securities class action litigation is often brought against a company after
a period of volatility in the market price of its stock. If our future quarterly
operating results are below the expectations of securities analysts or
investors, the price of our common stock would likely decline. Stock price
fluctuations may be exaggerated if the trading volume of our common stock is
low. Any securities litigation claims brought against us could result in
substantial expense and divert management's attention from our core business.
We may need to raise additional capital in the future which could result in
dilution to our stockholders.
While we believe the proceeds from this offering will provide us with
adequate capital to fund operations for the next eighteen months, we may need to
raise additional funds prior to that time. We may seek to sell additional equity
or debt securities or to obtain an additional credit facility. The sale of
additional equity or convertible debt securities could result in additional
dilution to our stockholders. If additional funds are raised through the
issuance of debt securities, these securities could have rights that are senior
to holders of common stock and could contain covenants that would restrict our
operations. Any additional financing may not be available in amounts or on terms
acceptable to us, if at all.
Our executive officers and directors own a large percentage of our voting stock
and could exert significant influence over matters requiring stockholder
approval.
Because our executive officers and directors, and their respective
affiliates, own approximately 36 percent of our outstanding common stock, these
stockholders may, as a practical matter, be able to exert significant influence
over matters requiring approval by our stockholders, including the election of
directors and the approval of mergers or other business combinations. This
concentration of voting stock could have the effect of delaying or preventing a
change in control.
Our certificate of incorporation and Delaware law contain provisions that could
discourage a takeover or prevent or delay a merger that stockholders believe is
favorable for the company.
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<PAGE>
Our amended and restated certificate of incorporation and bylaws contain
provisions that could delay or prevent a change in control of our company. Some
of these provisions:
. authorize the issuance of preferred stock which can be created and issued
by the board of directors without prior stockholder approval, commonly
referred to as "blank check" preferred stock, with rights senior to those
of common stock;
. provide for a classified board of directors; and
. prohibit stockholder action by written consent.
In addition, we are governed by the provisions of Section 203 of Delaware
General Corporate Law. These provisions may prohibit large stockholders, in
particular those owning 15 percent or more of our outstanding voting stock, from
merging or combining with us. These and other provisions in our amended and
restated certificate of incorporation and bylaws and under Delaware law could
reduce the price that investors might be willing to pay for shares of our common
stock in the future and result in the market price being lower than it would be
without these provisions.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our market risk disclosures have not changed significantly from those
set forth in Management's Discussion and Analysis of Financial Condition and
Results of Operations in our Form S-1 filing dated July 26, 2000.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
We are not currently subject to any material legal proceedings, other than
the patent disputes described in "Factors That May Affect Future Results - We
are currently involved in a patent interference action and a patent opposition
action involving RadioTherapeutics Corporation and if we do not prevail in these
actions, we may be unable to sell the RITA system." The patent interference
proceeding is pending before the Board of Patent Appeals and Interferences of
the United States Patent and Trademark Office. On July 16, 1999 the United
States Patent and Trademark Office declared an interference between a claim of
one of our issued patents and claims of a patent application controlled by
RadioTherapeutics Corporation. The principal parties in the proceeding are
RadioTherapeutics and RITA. The factual basis underlying the claim is the
determination by the commissioner of the United States Patent and Trademark
Office that our patent and the RadioTherapeutics patent application interfere.
In the interference proceeding, RadioTherapeutics seeks to invalidate our patent
claim and to establish the patentability of the claims in their patent
application. We seek to maintain the priority of our patent claim. The
European opposition is pending before the European Patent Office and was
instituted on March 2, 2000. The principal parties are RadioTherapeutics and
RITA. The factual basis underlying the claim is the allegation by
RadioTherapeutics that our European patent is not valid. In the opposition,
RadioTherapeutics seeks to have our patent declared invalid and to have our
patent cancelled. We are defending our patent and seek to defend it as issued.
In addition to these patent proceedings, we may from time to time become a party
to various legal proceedings arising in the ordinary course of our business.
Item 2. Changes in Securities.
During the second quarter ended June 30, 2000, we granted options to
purchase an aggregate of 131,500 shares of Common Stock to employees and
consultants pursuant to the 1994 Incentive Stock Plan and 51,585 shares were
issued to employees and consultants on exercise of options under the Company's
stock plans. These issuances were deemed exempt from registration under the
Securities Act of 1933 (the "Securities Act") in reliance upon Rule 701 of the
Securities Act
On July 26, 2000, in connection with our initial public offering, a
Registration Statement on Form S-1 (No. 333-36160) was declared effective by the
Securities and Exchange Commission, pursuant to which 3,600,000 shares of our
Common Stock were sold on August 1, 2000 for the account of the Company at a
price of $12.00 per share, generating aggregate gross proceeds of $43.2 million
before payment of underwriting discounts and commissions and transaction
expenses. The managing underwriters were Salomon Smith Barney and Robertson
Stephens. After deducting approximately $3.0 million in underwriting discounts
and commissions and an estimated $1.2 million in other transaction expenses, the
net proceeds of the offering were approximately $39.0 million. None of the
payments for underwriting discounts and commissions and other transaction
expenses represented direct or indirect payments to directors, officers or other
affiliates of the Company. The net proceeds of the offering have been invested
in short-term, investment grade, interest bearing securities. We intend to use
such proceeds to expand sales,
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<PAGE>
marketing and physician and patient awareness and education programs, to
continue product development and clinical research programs, to repay debt and
to fund general corporate purposes, including working capital. As of August 31,
2000, we had applied the estimated aggregated net proceeds of $39.0 million from
our initial public offering as follows:
Temporary investments: $39.0 million
Item 3. Defaults Upon Senior Securities. Not applicable.
Item 4. Submission of Completed Matters to a Vote of Security Holders.
The numbers shown below do not reflect the three-for-five reverse stock
split completed in connection with our initial public offering.
a. At our annual meeting of stockholders held on June 20, 2000, our
stockholders:
(i) elected the following directors to serve until the next annual meeting of
stockholders or until their successors are duly elected and qualified:
<TABLE>
<CAPTION>
---------------------------------------------------------------------------------------------
FOR WITHHELD ABSTENTIONS
---------------------------------------------------------------------------------------------
<S> <C> <C> <C>
Barry Cheskin 12,950,146 0 3,438,295
---------------------------------------------------------------------------------------------
Vincent Bucci 12,950,146 0 3,438,295
---------------------------------------------------------------------------------------------
Janet Effland 12,945,641 4,505 3,438,295
---------------------------------------------------------------------------------------------
John Gilbert 12,950,146 0 3,438,295
---------------------------------------------------------------------------------------------
Scott Halsted 12,950,146 0 3,438,295
---------------------------------------------------------------------------------------------
Gordon Russell 12,950,146 0 3,438,295
---------------------------------------------------------------------------------------------
</TABLE>
(ii) approved a three-for-five (3:5) reverse stock split of the Company's
outstanding capital stock in connection with the Company's initial public
offering.
The number of votes cast in favor of the previous resolution was 12,894,425 out
of total shares outstanding of 16,388,441.
(iii) approved our reincorporation from California into Delaware, including the
adoption and approval of indemnification agreements with our officers and
directors.
The number of votes cast in favor of the previous resolution was 12,948,507 out
of total shares outstanding of 16,388,441.
(iv) approved the amendment and restatement of the Certificate of
Incorporation of our then wholly-owned Delaware subsidiary, which was effective
and contingent upon the closing of our initial public offering, authorizing,
among other things: (a) the authorization of 100,000,000 shares of Common Stock,
(b) the authorization of 2,000,000 shares of undesignated Preferred Stock; (c)
the elimination of our shareholders' ability to take corporate action by written
consent; (d) the elimination of cumulative voting, and (f) the establishment of
a classified board of directors.
The number of votes cast in favor of the previous resolution was 12,919,008 out
of total shares outstanding of 16,388,441.
(v) approved the adoption of our 2000 Directors' Stock Option Plan and the
reservation of 500,000 shares of our Common Stock for issuance thereunder,
effective and contingent upon the closing of our initial public offering.
The number of votes cast in favor of the previous resolution was 12,919,008 out
of total shares outstanding of 16,388,441.
(vi) approved the adoption of our 2000 Employee Stock Purchase Plan and the
reservation of 650,000 shares of our Common Stock for issuance thereunder, plus
an increase in shares in each of fiscal years 2002, 2003 and 2004 of a maximum
of 650,000 shares of our Common Stock for issuance thereunder, effective and
contingent upon the closing of our initial public offering.
The number of votes cast in favor of the previous resolution was 12,922,285 out
of total shares outstanding of 16,388,441.
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(vii) approved the adoption of our 2000 Stock Plan and the reservation of
2,000,000 shares of our Common Stock for issuance thereunder, plus an automatic
annual increase in shares in each of the fiscal years beginning in 2001 and
ending in 2010 of a maximum of 750,000 shares of our Common Stock for issuance
thereunder.
The number of votes cast in favor of the previous resolution was 12,688,264 out
of total shares outstanding of 16,388,441.
(viii) the holders of the majority of the then outstanding shares of Series D
Preferred Stock and Series E Preferred Stock, approved an amendment of our
Articles of Incorporation and of the Certificate of Incorporation of our then
wholly-owned Delaware subsidiary, to change the commencement date for the
dividends to the holders of shares of Series D Preferred Stock and Series E
Preferred Stock to become cumulative from January 31, 2000 to December 31, 2000.
The number of votes cast in favor of the previous resolution was 6,626,650
shares of Series D Preferred Stock and Series E Preferred Stock out of total
shares of Series D Preferred Stock and Series E Preferred Stock outstanding of
8,925,983.
(ix) the holders of the majority of the then outstanding shares of Preferred
Stock approved the amendment of the Articles of Incorporation and the
Certificate of Incorporation of our then wholly-owned Delaware subsidiary, to
change the minimum per share price for our initial public offering at which the
outstanding shares of Preferred Stock were automatically converted into shares
of Common Stock from $6.88 per share to $4.50 per share.
The number of votes cast in favor of the previous resolution was 11,372,234 out
of total shares of Preferred Stock outstanding of 14,299,302.
(x) ratified the appointment of PricewaterhouseCoopers LLP as our independent
accountants for the fiscal year ending December 31, 2000.
The number of votes cast in favor of the previous resolution was 12,948,507 out
of total shares outstanding of 16,388,441.
Item 5. Other Information. Not applicable
Item 6. Exhibits and Reports on Form 8-K.
(a) Exhibits:
27.1 Financial Data Schedule
(b) Reports on Form 8-K: Not applicable.
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SIGNATURES
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.
RITA MEDICAL SYSTEMS, INC.
By: /s/ Marilynne Solloway
-----------------------------
Marilynne Solloway
Chief Financial Officer and Vice
President, Finance and
Administration
Date: September 8, 2000
<PAGE>
EXHIBIT INDEX
-------------
27.1 Financial Data Schedule.
