<PAGE> 1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D. C. 20549
FORM 10-Q
X QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
- --- EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 1997
---------------------------------------------
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 0-27540
ENDOVASCULAR TECHNOLOGIES, INC.
(Exact Name of Registrant as Specified in its Charter)
DELAWARE 94-3096794
(State of Incorporation) (I.R.S. Employer Identification No.)
1360 O'BRIEN DRIVE
MENLO PARK, CALIFORNIA 94025
415-325-1600
(Address, Zip Code and Telephone Number of Principal Executive Offices)
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
----- -----
The number of shares outstanding of the issuer's common stock as of May 5, 1997
was 8,486,868.
This document contains 23 pages and the Exhibit Index is on Page 20
Page 1 of 23
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ENDOVASCULAR TECHNOLOGIES, INC.
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PART I. FINANCIAL INFORMATION PAGE
- ----------------------------------------- ----
<S> <C>
Item 1. Financial Statements
Condensed Balance Sheets as of March 31, 1997 and
December 31, 1996 3
Condensed Statements of Operations for the Three Month
Periods Ended March 31, 1997 and March 31, 1996 4
Condensed Statements of Cash Flows for the Three Months Ended
March 31, 1997 and March 31, 1996 5
Notes to Condensed Financial Statements 6
Risk Factors 7
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations 14
PART II. OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K 18
Signatures 19
Exhibit Index 20
Exhibits 21
</TABLE>
Page 2 of 23
<PAGE> 3
ENDOVASCULAR TECHNOLOGIES, INC.
CONDENSED BALANCE SHEETS
<TABLE>
<CAPTION>
March 31, December 31,
1997 1996
------------ ------------
<S> <C> <C>
(unaudited)
ASSETS
Current Assets
Cash and cash equivalents $ 575,476 $ 2,530,792
Securities available-for-sale 12,799,706 15,328,545
Accounts receivable 730,528 505,440
Interest receivable 211,193 269,329
Inventory 242,354 --
Prepaids and other 620,017 306,837
Notes receivable from employees 281,501 31,501
------------ ------------
Total current assets 15,460,775 18,972,444
Property and equipment, net 2,247,782 1,905,579
Other assets 73,611 74,361
------------ ------------
Total assets $ 17,782,168 $ 20,952,384
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable 305,170 714,323
Accrued and other liabilities 2,856,698 1,563,384
------------ ------------
Total current liabilities 3,161,868 2,277,707
Stockholders' Equity
Common stock, $0.00001 par value:
Authorized: 30,000,000 shares at March 31, 1997 and December 31,
1996, respectively; issued and outstanding: 8,481,868 and 8,402,371
shares at March 31, 1997 and December 31, 1996, respectively 85 84
Additional paid-in capital 56,805,742 56,298,754
Deferred compensation (75,107) (81,934)
Accumulated deficit (42,110,420) (37,542,227)
------------ ------------
Total stockholders' equity 14,620,300 18,674,677
------------ ------------
Total liabilities and stockholders' equity $ 17,782,168 $ 20,952,384
============ ============
</TABLE>
SEE ACCOMPANYING NOTES TO CONDENSED FINANCIAL STATEMENTS
Page 3 of 23
<PAGE> 4
ENDOVASCULAR TECHNOLOGIES, INC.
CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
<TABLE>
<CAPTION>
Quarter Ended March 31,
--------------------------------------
1997 1996
--------------- ---------------
<S> <C> <C>
Net product sales $ 843,125 $ 103,000
Cost of goods sold 775,822 117,040
--------------- ---------------
Gross margin 67,303 (14,040)
Operating costs and expenses
Research and development 3,650,216 2,453,443
General and administrative 1,192,320 436,778
--------------- ---------------
Total operating costs and expenses 4,842,536 2,890,221
Loss from operations (4,775,233) (2,904,261)
Interest income 207,040 238,317
--------------- ---------------
Net loss $ (4,568,193) $ (2,665,944)
=============== ===============
Net loss per share $ (0.54) (0.35)
=============== ===============
Shares used in computing net loss per share 8,438,454 7,660,677
=============== ===============
</TABLE>
SEE ACCOMPANYING NOTES TO CONDENSED FINANCIAL STATEMENTS
Page 4 of 23
<PAGE> 5
ENDOVASCULAR TECHNOLOGIES, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
<TABLE>
<CAPTION>
Quarter Ended March 31,
------------------------------------
1997 1996
--------------- ---------------
<S> <C> <C>
NET CASH USED IN OPERATING ACTIVITIES (4,342,563) (2,397,045)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of securities available-for-sale (4,471,161) (22,801,254)
Sale/maturity of securities available-for-sale 7,000,000 4,600,000
Purchases of property and equipment (470,402) (340,372)
--------------- ---------------
Net cash provided by (used in) investing activities 2,058,437 (18,541,626)
CASH FLOWS FROM FINANCING ACTIVITIES:
Repayment of capital lease obligations (15,131)
Proceeds from company stock plans 328,810 17,701
Proceeds from sale of common stock 24,000,000
Stock issuance costs (2,380,818)
--------------- ---------------
Net cash provided by (used in) financing activities 328,810 21,621,752
--------------- ---------------
NET INCREASE IN CASH AND CASH EQUIVALENTS (1,955,316) 683,081
CASH AND CASH EQUIVALENTS, beginning of period 2,530,792 2,203,937
--------------- ---------------
CASH AND CASH EQUIVALENTS, end of period $ 575,476 $ 2,887,018
=============== ===============
</TABLE>
SEE ACCOMPANYING NOTES TO CONDENSED FINANCIAL STATEMENTS
Page 5 of 23
<PAGE> 6
ENDOVASCULAR TECHNOLOGIES, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Interim Unaudited Financial Information
The accompanying unaudited condensed financial statements have been
prepared in accordance with the rules and regulations of the Securities and
Exchange Commission. 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 adjustments
(consisting of normal recurring accruals) considered necessary for a fair
presentation have been included. Operating results for the three month
period ended March 31, 1997 are not necessarily indicative of the results
that may be expected for the year ended December 31, 1997. The condensed
financial statements should be read in conjunction with the Company's
annual audited financial statements included in the Company's Form 10K for
the year ended December 31, 1996.
Revenue Recognition
Revenue from product sales is related to the sale of the Company's EGS
systems consisting of an endovascular prosthesis and delivery catheter. As
the Company's products are in clinical trials, the Company recognizes
revenue once the EGS system has been used in a surgical procedure with the
exception of ancillary devices sold to its international distributors.
Costs of goods sold include costs attributable to the manufacture of the
products.
Net Loss Per Share
Net loss per share is computed using the weighted average number of common
shares outstanding. Common equivalent shares from stock options are
excluded from the computation as their effect is anti-dilutive, except
that, pursuant to the Commission's Staff Accounting Bulletins, common and
common equivalents (stock options and preferred stock) issued during the
12-month period prior to the initial public offering of the Company's
common stock at prices below the initial public offering price of $12.00
per share have been included in the calculation as if they were outstanding
for all periods prior to the initial public offering (using the treasury
stock method).
In February 1997, the Financial Accounting Standards Board (FASB) issued
Statement of Financial Accounting Standards ("SFAS") No. 128, Earnings per
Share, which simplifies the standards for computing earnings per share
previously found in Accounting Principles Board Opinion ("APBO") No. 15.
SFAS No. 128 replaces the presentation of primary earnings per share with a
presentation of basic earnings per share, which excludes dilution. SFAS No.
128 also requires dual presentation of basic and diluted earnings per share
on the face of the income statement for all entities wit complex capital
structures and requires a reconciliation. Diluted earnings per share is
computed similarly to fully diluted earnings per share pursuant to APBO No.
15. SFAS No. 128 must be adopted for financial statements issued for
periods ending after December 15, 1997, including interim periods; earlier
application is not permitted. SFAS No. 128 requires restatement of all
prior-period earnings per share data presented. For the three months ended
March 31, 1997, basic and diluted loss per share would be equivalent to the
loss per share presented in the accompanying condensed statement of
operations.
Page 6 of 23
<PAGE> 7
2. CREDIT AGREEMENT
In February 1997, the Company entered into a $30 million credit agreement.
Borrowings under the agreement bear interest at 16.5% to 19%. Interest accruing
during the first thirty months in which loans are outstanding is payable in full
thirty months after the date the first loan is made. Interest accruing
thereafter is due quarterly. Principal payments are due in full on March 31,
2002. Balances owed under the agreement may be prepaid subject to a prepayment
fee, which is initially set at 5% of the prepayment amount and is reduced on
each anniversary date of the agreement by 1%. Further, all principal outstanding
will be due upon the occurrence of certain asset sales and issuances of equity
securities, and will be due at the lender's discretion upon a change in control
of the Company. Among other requirements, the agreement prohibits the Company
from paying dividends and incurring additional indebtedness.
There are no balances outstanding under this agreement.
RISK FACTORS
Early Stage of Clinical Trials; No Assurance of Safety and Efficacy
The Company's EGS systems for endovascular abdominal aortic aneurysm (AAA)
repair are at an early stage of clinical testing. There can be no assurance that
the Company's products will prove to be safe and effective in clinical trials or
will ultimately be cleared for marketing by United States or foreign regulatory
authorities. The Company does not expect to submit a PMA for any of its EGS
systems until 1998, and there can be no assurance that the Company will ever
submit a PMA or that, if submitted, such PMA will be approved by the FDA. If the
Tube, Bifurcated or Aortoiliac EGS systems do not prove to be safe and effective
in clinical trials or if the Company is otherwise unable to commercialize either
system successfully, the Company's business, financial condition and results of
operations will be materially adversely effected and cessation of the Company's
business could occur.
During the course of its clinical trials, the Company identifies technical
difficulties and areas of improvement for its products. The clinical trials may
identify significant technical or other obstacles to be overcome prior to
obtaining necessary regulatory or reimbursement approvals. For example, the
Company continues to observe blood flow outside the implant ("Perigraft Flow")
in patients treated with the Tube and Bifurcated EGS systems. The clinical
significance of Perigraft Flow is unknown. There can be no assurance that
Perigraft Flow or other difficulties will not have a material adverse effect on
the safety and efficacy of the Company's EGS systems or any follow-on devices
and thereby prevent the Company from obtaining PMA approval from the FDA.
Attachment System Fractures; Suspension of Clinical Trials January 1995
In January 1995, the Company discovered fractures in the attachment system
component of the Tube EndoGraft prosthesis during routine follow-up tests. Based
on this discovery, the Company suspended its clinical trials worldwide. As of
May 5, 1997 a total of 42 patients, representing approximately 46% of 91
patients, implanted prior to February 1995, with the Tube EndoGraft prosthesis
in place for more than six weeks, have experienced attachment system fractures.
In eight patients with fractures, the Tube EndoGraft prosthesis was removed and
the AAA was treated by open surgery. Three patients with fractures have died for
reasons unrelated to the attachment system fractures. The remaining patients are
closely monitored by their physicians and the Company for fractures or the onset
of adverse clinical consequences. The Company expects additional fractures to
occur in these attachment systems. There can be no assurance that additional
adverse clinical consequences will not occur in the future, which could result
in the suspension of clinical trials or otherwise have a material adverse effect
on the Company's business, financial condition and results of operations.
Page 7 of 23
<PAGE> 8
Following suspension of clinical trials in January 1995, the Company determined
that the fractures were caused by metal fatigue resulting from higher than
anticipated forces acting on the attachment systems. As a result, the Company
has implemented a number of significant modifications to the attachment systems
and subjected the redesigned attachment systems to accelerated fatigue testing.
There can be no assurance, however, that the accelerated fatigue testing
accurately simulates the actual forces present in the human body. In addition,
there can be no assurance that fractures will not occur in the redesigned
attachment systems, which may not be apparent for a substantial period of time,
or that the Company will not experience additional problems with the redesigned
attachment systems. Any future attachment system fractures that might occur
could result in another suspension or termination of clinical trials, which
would have a material adverse effect on the Company's business, financial
condition and results of operations.
Limited Operating History; History of Losses; Substantial Additional Losses;
Fluctuations in Operating Results
The Company has a limited history of operations. Since its inception in June
1989, the Company has been primarily engaged in research and development of the
EGS systems. The Company has experienced significant operating losses since
inception, and as of March 31, 1997, the Company's accumulated deficit was
approximately $42.1 million. The Company will incur substantial additional
losses until it can achieve significant commercial sales of its EGS systems
which are dependent on a number of factors, including receipt of marketing
approval. There can be no assurance that the EGS systems or any other products
of the Company will be approved, can be successfully commercialized or that the
Company will achieve significant revenues from either international or domestic
sales of such products. In addition, there can be no assurance that the Company
will achieve or sustain profitability in the future. Failure to achieve
significant revenues or profitability would have a material adverse effect on
the Company's business, financial condition and results of operations. Moreover,
results of operations have varied and are expected to fluctuate significantly
from quarter to quarter depending upon numerous factors, including the results
of clinical trials, the introduction and market acceptance of products by the
Company or competitors, the results of regulatory and reimbursement actions, the
timing of orders by distributors, the expenditures incurred in the research and
development of new products, competitive pricing and the expansion of
manufacturing capacity. See "Management's Discussion and Analysis of Financial
Condition and Results of Operations."
Government Regulation; Significant Time Before Submission of any PMA
The Company's EGS systems are subject to extensive regulation by the FDA and
most foreign governments. The Company does not anticipate filing a PMA for any
of the EGS systems until 1998 and does not anticipate receiving approval for at
least one or two years after a PMA is accepted for filing, if at all. There can
be no assurance as to when, or if, the Company will complete clinical trials of
any of its EGS systems or that data from such trials, if completed, will be
adequate to support approval of a PMA. See "-Early Stage of Clinical Trials; No
Assurance of Safety and Efficacy" and "-Attachment System Fractures; Suspension
of Clinical Trials." Furthermore, there can be no assurance that the Company
will be able to obtain PMA approval on a timely basis, or at all, and delays in
the receipt of or failure to receive such approvals would have a material
adverse effect on the Company's business, financial condition and results of
operations and could result in cessation of the Company's business.
Sales of EGS systems outside of the United States are subject to regulatory
requirements that vary widely from country to country. The time required to
obtain approval for sale in foreign countries may be longer or shorter than that
required for FDA approval, and the requirements may differ. In addition, there
may be foreign regulatory barriers other than premarket approval, and the FDA
must approve exports of devices that require a PMA but are not yet approved
domestically. Countries in which the Company intends to market EGS systems may
adopt regulations in the future that could prevent the Company from marketing
its EGS systems in those countries. In addition, the Company may be required to
spend significant amounts of capital in order to respond to requests for
additional information by the FDA or foreign regulatory bodies or may otherwise
be required to spend significant amounts of capital in order to obtain FDA and
foreign regulatory approvals. Any such events could substantially delay or
preclude the Company from marketing its EGS systems in the United States or
foreign countries.
Page 8 of 23
<PAGE> 9
Any devices manufactured or distributed by the Company pursuant to FDA
clearances or approvals are subject to pervasive and continuing regulation by
the FDA and certain state agencies. Foreign and domestic regulatory approvals,
if granted, may include significant limitations on the indicated uses for which
the product may be marketed. In addition, the FDA and certain foreign regulatory
authorities impose numerous other requirements with which medical device
manufacturers must comply. Product approvals could be withdrawn for failure to
comply with regulatory standards or the occurrence of unforeseen problems
following initial marketing. The Company will also be required to adhere to
applicable FDA regulations setting forth current Good Manufacturing Practices
("GMP") requirements, which include testing, control and documentation
requirements. Ongoing compliance with GMP and other applicable regulatory
requirements are monitored through periodic inspections by state and federal
agencies, including the FDA, and by comparable agencies in other countries.
Changes in existing regulations or adoption of new regulations or policies could
prevent the Company from obtaining, or affect the timing of, future regulatory
approvals or clearances.
Substantial Dependence on Limited Product Line
The Company anticipates that for the foreseeable future it will be substantially
dependent on the successful development and commercialization of endovascular
products for AAA repair. Failure of the Company to successfully develop and
commercialize these products would have a material adverse effect on the
Company's business, financial condition and results of operations.
No Assurance of Market Acceptance
There can be no assurance that the Tube, Bifurcated or Aortoiliac EGS systems
will gain any significant degree of market acceptance among physicians, patients
or health care payors, even if necessary regulatory and reimbursement approvals
are obtained. The Company believes that recommendations by physicians and health
care payors will be essential for market acceptance of the EGS systems, and
there can be no assurance that any such recommendations will be obtained.
Physicians will not recommend the Tube, Bifurcated or Aortoiliac EGS systems
unless they conclude, based on clinical data and other factors, that the EGS
systems represent an acceptable alternative to open AAA surgical repair. In
particular, physicians may elect not to recommend the Tube, Bifurcated or
Aortoiliac EGS procedure until such time, if ever, as successful resolution of
the attachment fractures is established and the clinical significance of
unresolved Perigraft Flow is better understood. Widespread use of the Company's
EGS systems would require the training of numerous physicians, and the time
required to complete such training could result in a delay or dampening of
market acceptance. Even if the safety and efficacy of the Company's EGS systems
is established, physicians may elect not to use them for a number of reasons
including unfavorable reimbursement from health care payors. Failure of the
Company's products to achieve any significant market acceptance would have a
material adverse effect on the Company's business, financial condition and
results of operations.
Risk of Need for Substantial Additional Capital
The Company's development efforts have consumed substantial capital to date. The
Company's future liquidity and capital requirements will depend upon numerous
factors, including: the progress of clinical trials; the timing and costs of
filing future IDEs, PMAs and PMA supplements; the timing and costs required to
receive both domestic and international governmental approvals; the extent to
which the Company's products gain market acceptance; the timing and costs of
product introductions; the extent of the Company's ongoing research and
development programs; and the costs of developing marketing and distribution
capabilities, if regulatory approvals are received. In February 1997, the
Company entered into a credit agreement pursuant to which the Company may borrow
up to $30,000,000 (the "Funds"), subject to the terms and conditions of the
credit agreement. The Company believes that the amount of Funds available
thereunder, together with existing cash, cash equivalents and short-term
investments will allow the Company to meet capital requirements for at least the
next 12 months. However, the credit agreement requires the Company to satisfy
certain conditions, the failure of which would prevent the Company from drawing
the Funds. Furthermore, any default by the Company under the credit agreement
would result in the acceleration of the Company's obligation to repay any drawn
Funds. In the event that the Company is unable to borrow Funds under the credit
agreement or repay Funds previously borrowed on an accelerated basis, the
Company's business, financial condition and results of operations could be
materially adversely affected. Furthermore, the Company may be required to seek
additional debt or equity financing. Issuance of additional equity securities
could result in substantial dilution to stockholders. There can be no assurance
that such financing will be available on terms acceptable to the Company, or at
all. The Company's inability to fund its capital requirements would have a
material adverse effect on the Company's business, financial condition and
results of operations. See "Management's Discussion and Analysis of Financial
Condition and Results of Operations."
Page 9 of 23
<PAGE> 10
Uncertainty Regarding Patents and Protection of Proprietary Technology
The Company holds a number of issued United States and foreign patents and has
filed a number of United States and counterpart patent applications in other
countries. There can be no assurance that the Company's United States and
foreign issued patents or pending applications will offer any protection or that
they will not be challenged, invalidated or circumvented. In addition, there can
be no assurance that competitors will not obtain patents that will prevent,
limit or interfere with the Company's ability to make, use or sell its products
either in the United States or in international markets.
The Company typically enters into confidentiality and assignment agreements in
connection with employment, consulting or advisory relationships. There can be
no assurance, however, that these agreements will not be breached or that the
Company will have adequate remedies for any breach. Furthermore, no assurance
can be given that competitors will not independently develop substantially
equivalent proprietary information and techniques or otherwise gain access to
the Company's proprietary technology, or that the Company can meaningfully
protect its rights in unpatented proprietary technology.
Patent applications in the United States are maintained in secrecy until patents
issue, and patent applications in foreign countries are maintained in secrecy
for a period after filing. In addition, patents issued and patent applications
filed relating to medical devices are voluminous. Accordingly, there can be no
assurance that current and potential competitors or other third parties have not
or will not file applications for, or have not or will not receive, patents and
will not obtain additional proprietary rights relating to materials or processes
used or proposed to be used by the Company.
The Company has received letters from two medical device companies, Cook, Inc.
("Cook") and InnerDyne Medical, Inc. ("InnerDyne"). The Cook letter, dated July
9, 1993, suggested potential infringement of a Cook-owned patent by future
commercial sale of the Company's attachment system component of the EndoGraft
prosthesis. The Company has reviewed the Cook matter and the Company believes
that no such infringement exists. The InnerDyne letter, dated November 2, 1994,
proposed that the Company discuss licensing an InnerDyne-owned patent that
InnerDyne believed to be pertinent to the Company's EVT Expandable Sheath. The
Company has reviewed the InnerDyne matter and the Company believes that it is
not necessary to enter into a licensing arrangement with InnerDyne. There can be
no assurance, however, that the Company's products do not infringe upon the
patent rights or other intellectual property rights of Cook, InnerDyne or other
companies, that the Company will not be required to seek licenses from these or
other companies or that these or other companies will not bring claims of
infringement against the Company. Although patent and intellectual property
disputes in the medical device industry have sometimes been settled through
licensing or similar arrangements, costs associated with such arrangements may
be substantial and could include ongoing royalties. There can be no assurance
that necessary licenses would be available to the Company on satisfactory terms
or at all. Furthermore, any litigation or administrative proceeding could result
in substantial costs to the Company and distraction of the Company's management,
even if the Company ultimately prevails in such litigation. An adverse ruling in
any litigation or administrative proceeding could have a material adverse effect
on the Company's business, financial condition and results of operations.
If any relevant claims of third-party patents are upheld as valid and
enforceable, the Company could be prevented from practicing the subject matter
claimed in such patents, or would be required to obtain licenses or to redesign
its products or processes to avoid infringement. There can be no assurance that
such licenses would be available at all or on terms acceptable to the Company or
that the Company could redesign its products or processes to avoid infringement.
Litigation may be necessary to defend against claims of infringement, to enforce
patents issued to the Company or to protect trade secrets and could result in
substantial cost to, and diversion of effort by, the Company.
Page 10 of 23
<PAGE> 11
Volatility of Stock Price
The market price for the Company's Common Stock has been subject to significant
fluctuations and may be volatile in the future. The Company believes that
factors such as announcements of developments related to the Company's business,
announcements of clinical results, regulatory approvals, technological
innovations or new products or enhancements by the Company or its competitors,
developments in the Company's relationships with its customers, partners,
distributors, and suppliers, changes in analysts' estimates, regulatory
developments, political and economic instability, fluctuations in results of
operations and general conditions in the Company's market or the markets served
by the Company's customers or the economy could cause the price of the Company's
Common Stock to fluctuate, perhaps substantially. The Company may be
particularly vulnerable to fluctuations in the market price of its Common Stock
given the substantial amount of time before it may achieve significant revenues
from commercial sales of its products. In addition, in recent years the stock
market in general, and the market for shares of small capitalization health care
stocks in particular, have experienced extreme price fluctuations, which have
often been unrelated to the operating performance of affected companies. Such
fluctuations could adversely affect the market price of the Company's Common
Stock. There can be no assurance that the market price of the Company's Common
Stock will not continue to experience significant fluctuations in the future,
including fluctuations that are unrelated to the Company's performance. Further,
it is likely that in some future quarter the Company's net sales or operating
results will be below the expectations of public market analysts and investors.
In such event, the price of the Company's Common Stock would likely be
materially adversely affected.
Risks Associated with International Sales
International sales are expected to account for a substantial portion
of the Company's revenues in the foreseeable future. A number of risks are
inherent in international transactions. International sales may be limited or
disrupted by the imposition of government controls, export license
requirements, economic or political instability, trade restrictions, changes in
tariffs or difficulties in staffing and management. Additionally, although the
Company's sales are denominated in U.S. dollars, the Company's business,
financial condition and results of operations may be adversely affected by
fluctuations in currency exchange rates as well as increases in duty rates and
difficulties in obtaining export licenses. The financial condition, expertise
and performance of the Company's international distributors and any future
international distributors could affect sales of the Company's products
internationally and could have a material adverse effect on the Company's
business, financial condition and results of operations.
Dependence on Key Suppliers; Limited Manufacturing Experience
The Company uses or relies on sole source suppliers for certain components and
services used to manufacture its EGS systems. The Company utilizes materials
supplied by third parties, including raw material manufactured by Dow Chemical
Co. ("Dow Chemical") and DuPont, in its products. In recent years, in the wake
of litigation surrounding silicone breast implants, both Dow Chemical and DuPont
have ceased supplying chemical raw materials for use in implantable medical
devices, including DuPont raw material used to produce the graft material
utilized in the Company's EndoGraft prostheses. There can be no assurance that
use of such graft material by the Company will not be restricted or that the
Company will be able to obtain additional quantities of such graft material in
the future. Moreover, the continued use by the Company of graft material based
on chemical raw materials manufactured by third parties could subject the
Company to liability exposure. The Company believes that the cessation of the
supply of components and materials for implantable medical devices may be
addressed through legislative action. There can be no assurance that such
legislative action will occur on a timely basis, if at all. The establishment of
additional or replacement suppliers for certain of these components of raw
materials cannot be accomplished quickly, particularly because of the time and
effort required to obtain FDA approval to use materials from alternative
suppliers. Although the Company routinely attempts to identify primary and
alternative vendors, the qualification of additional or replacement vendors for
certain components or services is a lengthy process. Any significant supply
interruption would have a material adverse effect on the Company's ability to
manufacture its products and, therefore, a material adverse effect on its
business, financial condition and results of operations.
The Company manufactures its products at its Menlo Park, California facility. To
date, the Company's manufacturing activities have consisted primarily of
producing limited quantities of products for use in clinical trials and
controlled market release. The manufacture of the Company's products is a
complex and costly operation involving a number of separate processes and
components. Certain manufacturing processes of the EGS systems are labor
intensive and achieving significant cost reductions will depend in part upon
reducing the time required to complete these processes. There can be no
assurance that the Company will be able to achieve cost reductions in the
manufacture of its products. The Company does not have experience in
manufacturing its products in the commercial quantities that might be required
if the Company receives PMA approval. Manufacturers often encounter difficulties
in scaling up manufacturing of new products, including problems
Page 11 of 23
<PAGE> 12
involving product yields, quality control and assurance, component and service
availability, adequacy of control policies and procedures and lack of qualified
personnel. The Company has and will continue to consider as appropriate the
internal manufacture of components currently provided by third parties, as well
as the implementation of new production processes. There can be no assurance
that manufacturing yields or costs will not be adversely affected by the
transition to in-house production or to new production processes when and if
such efforts are undertaken, and thereby materially and adversely affect the
Company's business, financial condition and results of operations.
Limitations on Third-Party Reimbursement
In the United States, the Company's products will be purchased primarily by
medical institutions which then bill various third-party payors, such as
Medicare, Medicaid and other government programs and private insurance plans,
for the health care services provided to their patients. Medicare traditionally
has considered items or services involving devices that have not been approved
or cleared for marketing by the FDA to be precluded from Medicare coverage.
There can be no assurance, however, that any of the EGS systems and related
services will be covered when they are used in clinical trials and, if covered,
whether the payment amounts for their use will be considered to be adequate by
hospitals and physicians. If the devices are not covered or the payments are
considered to be inadequate, the Company may need to bear additional costs to
sponsor such trials, and such costs could have a material adverse effect on the
Company's business, financial condition and results of operations. Even if a
device has received approval or clearance for marketing by the FDA, there can be
no assurance that Medicare will cover the device and related services.
Furthermore, Medicare may place certain restrictions on the circumstances in
which coverage will be available. Limited or no coverage of the Company's
products would have a material adverse effect on the Company's business,
financial condition and results of operations.
Acute care hospitals are now generally reimbursed by Medicare for inpatient
operating costs under a prospective payment system ("PPS"). Under PPS, acute
care hospitals receive a prospectively determined payment amount for each
covered inpatient based upon the Diagnosis-Related Group ("DRG") to which the
patient is assigned, regardless of the actual cost of the services provided. The
Health Care Financing Administration ("HCFA") has not made any decision
concerning which DRG will be generally assigned to patients who undergo AAA
diagnosis and endovascular repair procedures in which the Company's products are
used, and there can be no assurance that the DRG to which such patients will be
assigned will result in Medicare payment levels that are considered by hospitals
to be adequate. Because the DRG system is also used by other government and
private payors, HCFA's decision concerning the DRG assignment for these patients
also may affect the amount of payment made by other payors.
Physician services are reimbursed by Medicare based on a physician fee schedule
which has not been determined for AAA diagnosis and endovascular repair
procedures in which the Company's products are used. There can be no assurance
that the physicians fee schedule for endovascular AAA procedures using the
Company's products will result in Medicare payment levels that physicians
consider to be adequate. In addition, Medicare payment levels are used by many
other third-party payors in addition to Medicare. Failure by hospitals and
physicians to receive what they consider to be adequate reimbursement for AAA
diagnosis and repair procedures in which the Company's products are used would
have a material adverse effect on the Company's business, financial condition
and results of operations. See "Business-Government Regulation."
Competition
The Company expects that significant competition in the endovascular grafting
market will develop. There are many large companies, with significantly greater
financial, manufacturing, marketing, distribution and technical resources and
experience than the Company, focusing on the development of endovascular
technology. Many of these companies have vascular stents, as well as vascular
graft and catheter technologies that may be applicable to endovascular repair.
The Company may compete against a number of these companies including: Boston
Scientific Corporation; Medtronic Corporation; Pfizer Corporation; Johnson &
Johnson; C.R. Bard, Inc.; and United States Surgical Corporation. Several of
these companies have designed and developed products that compete directly with
the Company's products. There can be no assurance that one or more of these or
other companies will not develop technologies that are more effective or less
costly than the Company's products, or that would otherwise render the Company's
products and technology non-competitive or obsolete. Such competition could have
a material, adverse effect on the Company's business, financial condition and
results of operations. In addition, the Company's products could be rendered
obsolete as a result of future innovations in AAA surgical techniques, which
could have a material adverse effect on the Company's business, financial
condition and results of operations.
Page 12 of 23
<PAGE> 13
Any product developed by the Company that gains regulatory approval will have to
compete for market acceptance and market share. An important factor in such
competition may be the timing of market introduction of competitive products.
Accordingly, the relative speeds with which the Company can develop products,
complete clinical testing and regulatory approval processes, gain reimbursement
acceptance and supply commercial quantities of the product to the market are
expected to be important competitive factors. In addition, the Company believes
that the primary competitive factors in the market for endovascular grafting
products are safety, long-term efficacy, ease of delivery, reliability,
innovation and price. The Company also believes that physician relationships and
customer support are important competitive factors. There can be no assurance
that the Company's competitive position will be maintained or that the Company
will be first to market endovascular products for the treatment of AAA's in the
United States.
Risk of Technological Obsolescence
The medical device industry is characterized by rapid and significant
technological change. There can be no assurance that third parties will not
succeed in developing or marketing technologies and products that are more
effective than those developed or marketed by the Company or that would render
the Company's technology and products obsolete or noncompetitive. Additionally,
new less invasive surgical procedures and medications could be developed that
replace or reduce the importance of current procedures that use the Company's
products. Accordingly, the Company's success will depend in part on its ability
to respond quickly to medical and technological changes through the development
and introduction of new products. Product development involves a high degree of
risk and there can be no assurance that the Company's new product development
efforts will result in any commercially successful products.
Risk of Federal Reform of Health Care
There are widespread efforts to control health care costs in the United States
on the federal, state and local levels. For example, the U.S. Congress is
currently considering various legislative proposals to reform the Medicare and
Medicaid programs. Current proposals call for reductions in the annual updates
for hospital PPS rates and physician reimbursement rates, reductions in the
amount of added payments made to teaching hospitals and hospitals that serve a
disproportionate share of low-income persons, increased incentives and
opportunities for Medicare beneficiaries to obtain their benefits through
managed care plans, and the establishment of a "block grant" program that would
give states greater discretion in designing and administering state Medicaid
programs. If enacted into law, any of these proposals could affect the amount of
Medicare and Medicaid payment that is made to hospitals and physicians and, in
turn, demand for the Company's products. Lower demand for the Company's products
resulting from federal healthcare reform could have a material adverse effect on
the Company's business, financial condition and results of operations.
Lack of Sales and Marketing Experience; Dependence on International Distributors
The Company currently has a small sales and marketing function and has no
experience in marketing and selling its EGS systems. There can be no assurance
that the Company will be able to recruit and train adequate sales and marketing
personnel. The Company plans to rely on distributors for substantially all of
its international sales. Any foreign sales by the Company may be subject to
certain risks, including exchange rate fluctuations, international monetary
conditions, tariffs, import licenses, trade policies, domestic and foreign tax
policies and foreign medical regulations. The loss of major international
distributors could have a material adverse effect on the Company's business,
financial condition and results of operations.
Product Liability and Availability of Insurance
The clinical use and sale of the Company's products involve significant risk of
product liability claims. There can be no assurance that the coverage limits of
the Company's insurance policies will be adequate. Product liability insurance
is expensive and in the future may not be available to the Company on acceptable
terms or at all. While there have been no product liability claims to date,
there can be no assurance that a product liability claim will not be brought
against the Company either for injuries occurring in the past or in the future,
including, but not limited to, injuries due to fractures in the attachment
system of the Tube EndoGraft prosthesis. A successful claim brought against the
Company in excess of its insurance coverage could have a material adverse effect
on the Company's business, financial condition and results of operations. See
"-Attachment System Fractures: Suspension of Clinical Trials in 1995."
Page 13 of 23
<PAGE> 14
Dependence on Key Personnel
The Company's future business and operating results depend in significant part
upon the continued contributions of its key technical personnel and senior
management, many of whom would be difficult to replace. None of such persons is
subject to a noncompete agreement. The Company's business and future operating
results also depend in significant part upon its ability to attract and retain
qualified management, manufacturing, technical, marketing and sales and support
personnel for its operations. Competition for such personnel is intense, and
there can be no assurance that the Company will be successful in attracting or
retaining such personnel. The loss of key employees, the failure of any key
employee to perform or the Company's inability to attract and retain skilled
employees, as needed, could materially adversely affect the Company's business,
financial condition and results of operations.
Control by Officers, Directors and Principal Stockholders
The Company's officers, directors and principal stockholders beneficially own a
significant portion of the Company's Common Stock (assuming exercise of
immediately exercisable options held by such directors and officers). As a
result, such persons may have the ability effectively to control the Company and
direct its affairs and business. Such concentration of ownership may also have
the effect of delaying, deferring or preventing a change in control of the
Company.
Anti-takeover Effects of Certain Charter Provisions, Delaware Law and Rights
Plan
Under the Company's Certificate of Incorporation, the Board of Directors has the
power to authorize the issuance of up to 5,000,000 shares of Preferred Stock and
to determine the price, rights, preferences, privileges and restrictions,
including voting rights, of those shares without further vote or action by the
stockholders. The rights of the holders of Common Stock will be subject to, and
may be adversely affected by, the rights of the holders of any Preferred Stock
that may be issued in the future. The issuance of Preferred Stock, while
providing desirable flexibility in connection with possible acquisitions and
other corporate purposes, may have the effect of delaying, deferring or
preventing a change in control of the Company, may discourage bids for the
Common Stock at a premium over the market price of the Common Stock and may
adversely affect the market price of and the voting or other rights of the
holders of the Common Stock. The Company has no present plans to issue shares of
Preferred Stock. In addition, the Company's Certificate of Incorporation
provides for a classified Board of Directors such that approximately only
one-third of the members of the Board are elected at each annual meeting of
stockholders. Classified Boards may have the effect of delaying, deferring or
discouraging changes in control of the Company. Further, certain provisions of
the Company's Bylaws and of Delaware law could discourage, delay or prevent a
merger, tender offer or proxy contest involving the Company. Furthermore, the
Company has adopted a stockholder rights plan that, in conjunction with certain
provisions of the Company's charter documents and Delaware law, could delay or
make more difficult a merger, tender offer, or proxy contest involving the
Company.
Absence of Dividends
The Company has never paid cash dividends and does not anticipate paying
cash dividends on the Common Stock in the foreseeable future. In addition, the
Company entered into a credit agreement in February, 1997, pursuant to which
the Company has agreed not to make or declare any dividends on the Common Stock
for so long as it is indebted under such credit agreement. See "Management's
Discussion and Analysis of Financial Condition and Results of Operations -
Liquidity and Capital Resources."
Page 14 of 23
<PAGE> 15
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
This report on Form 10-Q contains forward-looking statements that involve risks
and uncertainties. The Company's actual results may differ materially from the
results discussed in the forward-looking statements. Factors that might cause
such a difference include, but are not limited to, those discussed in "Risk
Factors".
OVERVIEW
Since its inception in June 1989, the Company has been engaged in the research
and development of its EGS systems and related technology for the endovascular
repair of abdominal aortic aneurysms. To date, the Company has generated limited
revenues and has been unprofitable since inception. For the period from
incorporation to March 31, 1997, the Company has an accumulated deficit of
approximately $42.1 million. The Company does not expect to begin generating
significant revenues from sales of its products until it receives U.S. marketing
approval and market launch, and will continue to incur substantial losses for
the next several years. Furthermore, the Company expects its expenses in all
categories to increase as its clinical trials and other business activities
expand.
The research, manufacture, sale and distribution of medical devices such as the
Company's EGS systems are subject to numerous regulations imposed by
governmental authorities, principally the FDA and corresponding state and
foreign agencies. The regulatory process is lengthy, expensive and uncertain.
FDA approval of a PMA application is required before any EGS system can be
marketed in the United States. Securing FDA approvals and clearances will
require submission to the FDA of extensive clinical data and technical
information. Many foreign governments and the European Union also have a review
process for medical devices.
The Company commenced U.S. clinical trials of its original Tube EGS system in
February 1993 and its Bifurcated EGS system in September 1994. Following
suspension of all clinical trials in January 1995 due to attachment system
fractures, and after receiving FDA clearance to reinitiate clinical trials, the
Company re-initiated Phase II clinical trials of the Tube EGS system in November
1995 and reached its Phase II target enrollment in January 1997. The Company
re-initiated Phase I clinical trials of the Bifurcated EGS system in December
1995. In June 1996, the Phase I clinical trial of the Bifurcated EGS system was
completed, and the Phase II clinical trial of that device was initiated in
August 1997 and reached its Phase II target enrollment in April 1997. Patient
enrollment in each of these Phase II trials is continuing. Additional clinical
testing of the Tube and Bifurcated EGS systems is required and the Company does
not believe it will be able to complete clinical trials of, obtain regulatory
approval for, and begin commercial sales of its EGS systems in the United States
before mid-1999, if ever.
In October 1996, the Company received approval from the FDA to begin Phase II
clinical trials of the Aortoiliac EGS system, bypassing the Phase I trial. The
Aortoiliac EGS system utilizes an endovascular prosthesis that is a hybrid
between the Company's Tube EndoGraft and Bifurcated EndoGraft. The device is
designed to address aneurysms in which one iliac artery is unsuitable for
endovascular attachment of an implant.
In June 1995, the Company became ISO 9001/EN 46001 certified and in May 1997
received CE Mark approval from an independent Dutch Notified Body for Medical
Devices to market its products throughout the European Community. The Company
anticipates that a substantial portion of its revenues from product sales over
the next several years will be derived from international sales through its
distributor network. Any such international sales will be subject to a number of
risks, including exchange rate fluctuations, international monetary conditions,
tariffs, import licenses, trade policies, domestic and foreign tax policies and
foreign medical regulations.
There can be no assurance that the Company's research and development efforts
will be successfully completed. Given that clinical testing is at an early
stage, there can be no assurance that the Company's EGS systems will be shown to
be safe and effective. Accordingly, the Company is unable to predict the
likelihood that its products will be approved for marketing by the FDA or any
foreign government agency, and there can be no assurance that the Company will
ever achieve either significant revenues from sales of its EGS systems or
profitable operations.
Page 15 of 23
<PAGE> 16
Results of operations will fluctuate significantly from quarter to quarter and
will depend upon, among other factors: actions relating to foreign and domestic
regulatory and reimbursement matters; the extent to which the Company's products
gain market acceptance; the rate at which the Company establishes its
international distributor network; the progress of clinical trials; and
introduction of competing products or alternative treatments for AAA. See "Risk
Factors - Limited Operating History; History of Losses; Substantial Additional
Losses; Fluctuations in Operating Results."
RESULTS OF OPERATIONS
The Periods Ended March 31, 1997 and March 31, 1996
In 1996, the Company began recognizing revenue on sales of its products used in
clinical trials. During the three month period ended March 31, 1997, the Company
recognized approximately $843,000 in sales, 31% of which were international
sales. During this period, sales from the Bifurcated EGS System accounted for
approximately 58% of total sales, the Aortoiliac EGS System for 18% of total
sales, and the Tube EGS System for 17% of total sales. Sales of various
ancillary devices to international distributors accounted for 7% of total sales.
For the same period in 1996, the Company recognized $103,000 in sales, comprised
primarily of sales of the Tube EGS System made to clinical centers in the United
States. The international sales price to European distributors is expected to
increase due to receipt of CE Mark approval. Currently prices range from
approximately 55% to 60% of the U.S. price. Revenue, with the exception of
ancillary devices, is recognized only upon successful implantation of an
EndoGraft prosthesis.
Gross margin for the three month period ended March 31, 1997 was approximately
$67,000, or 7% of product sales. Negative gross margin for the three month
period ended March 31, 1996 was approximately $14,000, or 13% of product sales.
A positive gross margin was reported for the first quarter of 1997 due to higher
sales volume. Higher volume allows fixed costs to be spread over a greater
number of units, thereby decreasing the cost per unit. The negative gross margin
reported in 1996 reflected the Company's early stage of manufacturing.
Research and development expenses include research, development, clinical and
regulatory expenses and certain manufacturing expenses. Research and development
for the three month period ended March 31, 1997 increased to approximately
$3,650,000 from approximately $2,453,000 for the comparable three month period
in 1996. The increase in spending was due primarily to higher clinical trial
costs, which is directly related to the increased sales volume in the U.S. The
balance of the increased spending is due primarily to personnel costs associated
with headcount increases. The Company believes that research and development
expenses will continue to increase in the future due to clinical trial expenses
and continuing research spending and regulatory requirements.
Selling, general and administrative expenses increased to approximately
$1,192,000 during the three month period ended March 31, 1997 from approximately
$437,000 in the first quarter of 1996. The increase in spending was due
primarily to the establishment of a sales and marketing function during the
second quarter of 1996, and the 1997 period includes the costs associated with
the Company's European operations. Increases in personnel account for the
balance of the increased spending. The Company anticipates continued increases
in administrative expenses due to the increased level of business activities.
The net loss of approximately $4,568,000 for the three months ended March 31,
1997 was greater than the net loss of approximately $2,666,000 for the
comparable period in 1996 due primarily to the increase in research and
development spending and the establishment of a marketing organization in
Europe.
The Company has not incurred any income tax expense since inception due to its
history of operating losses.
Page 16 of 23
<PAGE> 17
LIQUIDITY AND CAPITAL RESOURCES
In February 1996, the Company completed an initial public offering of two
million shares of Common Stock with net proceeds to the Company of approximately
$21.6 million after deducting the underwriters discount, commissions and
offering expenses. Cash, cash equivalents and available-for-sale securities were
approximately $13.4 million at March 31, 1997. Prior to its initial public
offering, the Company had financed its operations since inception through
private sales of capital stock and interest income on proceeds from such
financings.
Cash used in operating activities for the three months ended March 31, 1997
increased to approximately $4,521,000 from approximately $2,397,000 for the
comparable period in 1996, reflecting an increased net loss principally related
to increased research and development expenditures and the establishment of a
marketing organization in Europe.
Cash used for purchases of property and equipment in the three month period
ended March 31, 1997 was approximately $470,000, as compared to approximately
$340,000 for the same period in 1996. The increase was due primarily to
increased research and development activities.
In February 1997, the Company secured a credit facility of $30 million (the
"Funds"). However, the credit agreement requires the Company to satisfy certain
conditions, the failure of which would prevent the Company from drawing the
Funds. Furthermore, any default by the Company under the credit agreement would
result in the acceleration of the Company's obligation to repay any drawn Funds.
In the event that the Company is unable to borrow Funds or repay Funds
previously borrowed on an accelerated basis, the Company's business, financial
condition and results of operations could be materially adversely affected.
Pursuant to the credit agreement the Company has agreed not to make or declare
any dividends on the Common Stock for so long as it is indebted under such
agreement.
The Company expects to continue to incur substantial expenses in support of
additional research and development activities, including costs of clinical
studies, manufacturing, the establishment of a sales and marketing organization
and ongoing administrative activities. The Company anticipates that the proceeds
of the initial public offering and interest thereon, together with the
pre-existing cash and cash equivalents and available-for-sale securities, and
capital available under its credit facility will be sufficient to fund its
operations and planned new product development, including increased working
capital expenditures, through the next 12 months.
The Company's cash requirements may vary materially from those now planned
because of results of research, development, and clinical testing, the
development of regulatory submissions and the FDA regulatory process, the
development of commercial-scale manufacturing capability, the development of
sales, distribution and marketing capabilities, and other factors. The Company
may be required to seek additional funds through debt or equity financing.
Issuance of additional equity securities could result in substantial dilution to
stockholders. There can be no assurance that such financing will be available on
terms acceptable to the Company, or at all. The Company's inability to fund its
capital requirements would have a material adverse effect on the Company's
business, financial condition and results of operations. The Company may also
enter into collaborative arrangements with corporate partners that could provide
the Company with additional funding.
Page 17 of 23
<PAGE> 18
PART II OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
a) Exhibits
See Exhibits incorporated by reference on Page 20
See Exhibits 11.1 and 10.15 beginning on Page 21
b) Reports on form 8-K
There were no reports filed of Form 8-K during the quarterly period
ended March 31, 1997.
Page 18 of 23
<PAGE> 19
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.
ENDOVASCULAR TECHNOLOGIES, INC.
(Registrant)
<TABLE>
<S> <C> <C>
Date: May 12, 1997 /s/ W. James Fitzsimmons
------------------------------------------ --------------------------------------------
W. James Fitzsimmons
President and
Chief Executive Officer
(Principal Executive Officer)
Date: May 12, 1997 /s/ G. Bradley Cole
------------------------------------------ --------------------------------------------
G. Bradley Cole
Vice President, Finance and
Chief Financial Officer
(Principal Financial and Accounting Officer)
</TABLE>
Page 19 of 23
<PAGE> 20
ENDOVASCULAR TECHNOLOGIES, INC.
(A DEVELOPMENT STAGE COMPANY)
EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT NO. DESCRIPTION PAGE NO.
----------- ----------- --------
<S> <C> <C>
*3.1 Restated Certificate of Incorporation of the Company.
****3.2 Bylaws of the Company.
****4.1 Reference is made to Exhibits 3.1 and 3.2.
*4.2 Specimen Common Stock certificate.
*4.3 Fourth Amended and Restated Investor Rights Agreement,
dated August 15, 1994, among the Company and the
investors and the founders named therein.
****4.4 Credit Agreement between the Company and Guidant Corporation,
dated February 28, 1997.
*10.1 Form of Indemnification Agreement.
*10.2 1989 Stock Option Plan.
*10.3 1995 Stock Option Plan.
*10.4 Employee Stock Purchase Plan.
*10.5 1996 Incentive Compensation Plan.
*10.6 Employment agreement between the Company and W. James Fitzsimmons.
*10.7 Employment agreement between the Company and Victor M. Bernhard.
**10.8 Employment agreement between the Company and Ronald R. Giannotti.
***10.9 Employment agreement between the Company and Elizabeth A. McDermott.
**10.10 Lease by and between Menlo Business Park and Patrician
Associates, Inc. and the Company, as amended by First
Amendment to Lease Agreement, dated February 26, 1996.
****10.11 Rights Agreement between the Company and ChaseMellon Shareholder
Services dated February 5, 1997.
****10.12 Promissory Note Secured by Second Deed of Trust between the
Company and Ronald R. Giannotti dated February 9, 1997.
****10.13 Officer Severance Plan and Summary Plan Description effective
September 24, 1996.
****10.14 Multimedia Development Agreement between the Company and
Engineering Animation, Inc. dated March 19, 1997.
10.15 Promissory Note Secured by Second Deed of Trust between the
Company and Lori E. Adels dated April 11, 1997.
11.1 Computation of Net Loss Per Share.
27.1 Financial Data Schedule.
</TABLE>
- ----------
* Incorporated by reference from an exhibit to the Company's Registration
Statement on Form S-1, as amended, (File No. 33-80557) declared
effective by the Commission on February 6, 1996.
** Incorporated by reference from an exhibit to the Company Annual Report
on Form 10-K filed with the Commission on March 29, 1996.
*** Incorporated by reference from an exhibit to the Company Report on Form
10-Q filed with the Commission on November 12, 1996.
**** Incorporated by reference from an exhibit to the Company Annual Report
on Form 10-K filed with the Commission on March 28, 1997.
Page 20 of 23
<PAGE> 1
EXHIBIT 11.1
ENDOVASCULAR TECHNOLOGIES, INC.
COMPUTATION OF NET LOSS PER SHARE
(IN THOUSANDS, EXCEPT PER SHARE DATA)
<TABLE>
<CAPTION>
For the Quarter Ended March 31,
--------------------------------------
1997 1996
--------------- ---------------
<S> <C> <C>
Net Loss $ (4,568) $ (2,666)
=============== ===============
Weighted average common shares outstanding 8,438 7,473
Common shares and options granted (using the treasury
stock method assuming an initial public offering price
of $12.00) since December 15, 1994 included pursuant
to Securities and Exchange Commission Rules 187
--------------- ---------------
Weighted average common and equivalent shares 8,438 7,660
=============== ===============
Net loss per common and equivalent share $ (0.54) $ (0.35)
=============== ===============
</TABLE>
Page 21 of 23
<PAGE> 1
EndoVascular Technologies
Exhibit 10.15
PROMISSORY NOTE
$100,000.00 April 11, 1997
Menlo Park, California
FOR VALUE RECEIVED, the undersigned Borrower promises to pay to
EndoVascular Technologies, Inc. (the "Company"), at its principal offices at
1360 O'Brien Drive, Menlo Park, CA 94025, the principal sum of one hundred
thousand dollars ($100,000), on the unpaid principal balance upon the terms and
conditions specified below.
1. Principal and Interest. The principal balance of this Note
shall be due and payable on the fifth anniversary of this Note.
2. Rate of Interest. No interest shall accrue under the Note.
3. Prepayment. Prepayment of principal may be made at any time
without penalty.
4. Events of Acceleration. The entire unpaid principal sum of
this Note shall become immediately due and payable upon one or more of the
following events:
A. the date that Borrower shall cease to be employed by
EndoVascular Technologies, Inc.;
B. the failure of the Borrower to pay when due the
principal balance on this Note and the continuation of such default for more
than thirty (30) days; or
C. the insolvency of the Borrower, the commission of an
act of bankruptcy by the Borrower, the execution by the Borrower of a general
assignment for the benefit of creditors, the filing by or against the Borrower
of a petition in bankruptcy or a petition for relief under the provisions of
the federal bankruptcy act or another state or federal law for the relief of
debtors and the continuation of such petition without dismissal for a period of
ninety (90) days or more; or
D. the failure of the Maker to execute a deed of trust on
his principal residence in California within five (5) days of a request from
the Company; or
E. the sale, transfer, mortgage, assignment, encumbrance or
lease, whether voluntarily or involuntarily or by operation of law or otherwise
of the property covered by any such deed of trust, or any portion thereof or
interest therein without the prior written consent of the Company; or
F. the occurrence of a material event of default under any
such deed of trust securing this Note or any obligation secured thereby.
page 22 of 23
<PAGE> 2
5. Security. The proceeds of the loan evidenced by this Note shall
be applied solely to the purchase of the Borrower's principal residence in
California. Payment of this Note shall be secured by any shares of Company
common stock Borrower shall acquire from time to time. Borrower further agrees
to execute a Stock Pledge Agreement in substantially the form attached hereto
each time Borrower acquires shares of Company common stock, including shares
acquired pursuant to the exercise of any stock options granted to Borrower by
the Company. Borrower, however, shall remain personally liable for payment of
this Note, and assets of the Borrower, in addition to the collateral under the
Stock Pledge Agreement, may be applied to the satisfaction of the Borrower's
obligations hereunder. In the event the Company files a deed of trust as
security for this Note, the Borrower shall be released from the terms of the
Stock Pledge Agreement.
6. Collection. If action is instituted to collect this Note, the
Borrower promises to pay all reasonable costs and expenses (including
reasonable attorney fees) incurred in connection with such action.
7. Waiver. No previous waiver and no failure or delay by the
Company or Borrower in acting with respect to the terms of this Note or the
Stock Pledge Agreement or any deed of trust shall constitute a waiver of any
breach, default, or failure of condition under this Note, the Stock Pledge
Agreement or any deed of trust, or the obligations secured thereby. A waiver of
any term of this Note, the Stock Pledge Agreement or any deed of trust, or of
any of the obligations secured thereby must be made in writing and signed by a
duly authorized officer of the Company and shall be limited to the express
terms of such waiver.
Borrower hereby expressly waives presentment and demand for payment at
such time as any payments are due under this Note.
8. Conflicting Agreements. In the event of any inconsistencies
between the terms of this Note and the terms of any other document related to
the loan evidenced by the note, the terms of this Note shall prevail.
9. Governing Law. This Note shall be construed in accordance with
the laws of the State of California.
/s/ Mark Lazar /s/ Lori E. Adels
Signature of Borrower's Spouse Signature of Borrower
MARK LAZAR LORI E. ADELS
- ------------------------------- --------------------------------
Print Name of Borrower's Spouse Print Name of Borrower
Address: 2228 Belmont Cnyn Address: 2728 Belmont Cnyn
---------------------- -----------------------
Belmont, CA 94002 Belmont, CA 94002
---------------------- -----------------------
2
page 23 of 23
<TABLE> <S> <C>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-1997
<PERIOD-START> JAN-01-1997
<PERIOD-END> MAR-31-1997
<CASH> 575,476
<SECURITIES> 12,799,706
<RECEIVABLES> 730,528
<ALLOWANCES> 0
<INVENTORY> 242,354
<CURRENT-ASSETS> 15,460,775
<PP&E> 3,307,048
<DEPRECIATION> 1,059,266
<TOTAL-ASSETS> 17,782,168
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0
0
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</TABLE>
