---




UNITED
STATES SECURITIES AND EXCHANGE COMMISSION


Washington, D.C. 20549





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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, 2002.
|- |  | --------------------------------------------------------------------------------------------------------------------------------------




OR





| ̈ |  | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROMTO.
|- |  | --------------------------------------------------------------------------------------------------------------------------




Commission File No. 000-23767





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SYMPHONIX DEVICES, INC.


(Exact name of registrant as specified in its charter)





Delaware

77-0376250(State or other jurisdiction of incorporation or
organization)

(I.R.S. Employer Identification No.)





2331 Zanker Road


San Jose, California 95131-1107


(Address of principal executive offices, including zip code)





(408) 232-0710


(Registrants telephone number, including area code)





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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 March 31, 2002; 35,635,000 shares of the registrants common stock were outstanding.





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SYMPHONIX DEVICES, INC.





TABLE OF CONTENTS





PART I.    FINANCIAL INFORMATIONItem 1.

Financial Statements (unaudited)Condensed Consolidated Balance Sheets as of March 31, 2002 and December 31, 2001

1Condensed Consolidated Statements of Operations for the three months ended March 31, 2002 and 2001

2Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2002 and 2001

3Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2002 and 2001

4Notes to Condensed Consolidated Financial Statements

5Item 2.

Managements Discussion and Analysis of Financial Condition and Results of Operations

7Item 3.

Quantitative and Qualitative Disclosures About Market Risk

20PART II.    OTHER INFORMATIONItem 1.

Legal Proceedings

21Item 2.

Changes in Securities and Use of Proceeds

21Item 3.

Defaults Upon Senior Securities

21Item 4.

Submission of Matters to a Vote of Security Holders

21Item 5.

Other Information

21Item 6.

Exhibits and Reports on Form 8-K

21







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PART I.    FINANCIAL INFORMATION





Item 1.Financial Statements





SYMPHONIX DEVICES, INC.





CONDENSED CONSOLIDATED BALANCE SHEETS


(in thousands)


(unaudited)





March 31, 2002


December 31, 2001ASSETSCurrent assets:Cash and cash equivalents

$
376


$
1,343Short-term investments


7,527



10,774Restricted cash


590



Accounts receivable, net


220



329Inventories


692



656Prepaid expenses and other current assets


754



566Total current assets


10,159



13,668Property and equipment, net


1,158



1,313Restricted cash


510



174Total assets

$
11,827


$
15,155LIABILITIES AND STOCKHOLDERS EQUITYCurrent liabilities:Accounts payable

$
351


$
451Accrued compensation


494



976Other accrued liabilities


2,463



2,708Current portion of bank borrowings


500



500Total current liabilities


3,808



4,635Deferred revenue


645



732Bank borrowings, less current portion


375



500Total liabilities


4,828



5,867Stockholders equity:Common stock


36



36Notes receivable from stockholders


(400
)


(400
)Additional paid-in capital


92,068



92,107Accumulated other comprehensive income


121



260Accumulated deficit


(84,826
)


(82,715
)Total stockholders equity


6,999



9,288Total liabilities and stockholders equity

$
11,827


$
15,155





The accompanying notes are an integral part of these condensed consolidated financial
statements.




1




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SYMPHONIX DEVICES, INC.





CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS


(in thousands, except per share data)


(unaudited)





Three months ended March 31,2002


2001Revenue

$
480


$
576Costs and expenses:Costs of goods sold


636



1,188Research and development


876



1,651Selling, general and administrative


1,323



2,843Total costs and expenses


2,835



5,682Operating loss


(2,355
)


(5,106
)Interest income


266



287Interest expense


(22
)


(34
)Net loss

$
(2,111
)

$
(4,853
)Basic and diluted net loss per common share

$
(0.06
)

$
(0.23
)Shares used in computing basic and diluted net loss per common share


35,595



20,974








The accompanying notes are an integral part of
these condensed consolidated financial statements




2




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SYMPHONIX DEVICES, INC.





CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS


(in thousands)


(unaudited)





Three months ended March 31,2002


2001Net loss

$
(2,111
)

$
(4,853
)Change in unrealized gain (loss) on short-term investments


(130
)


63Translation adjustments


(9
)


7Comprehensive loss

$
(2,250
)

$
(4,783
)











The
accompanying notes are an integral part of these condensed consolidated financial statements.




3




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SYMPHONIX DEVICES, INC.





CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS


(in thousands)


(unaudited)





Three months ended March 31,2002


2001Cash flows from operating activities:Net loss

$
(2,111
)

$
(4,853
)Adjustments to reconcile net loss to cash used in operating activities:Amortization of deferred compensation






34Depreciation and amortization


166



183Amortization of premium on short-term investments


32



24Gain on sale of short-term investments


(40
)


Changes in operating assets and liabilities:Accounts receivable


109



51Inventories


(36
)


152Prepaid expenses and other current assets


(188
)


(642
)Accounts payable


(100
)


356Accrued compensation


(482
)


(508
)Deferred revenue


(87
)


(95
)Other accrued liabilities


(245
)


(526
)Net cash used in operating activities


(2,982
)


(5,824
)Cash flows from investing activities:Purchases of short-term investments






(22,236
)Sales and maturities of short-term investments


3,125



2,012Purchases of property and equipment


(11
)


(315
)Increase in restricted cash


(926
)


(271
)Change in other assets






2Net cash provided by (used in) investing activities


2,188



(20,808
)Cash flows from financing activities:Payments on bank borrowings


(125
)


(125
)Proceeds (issuance costs) from issuance of common stock, net


(39
)


178Net cash provided by (used in) financing activities


(164
)


53Net decrease in cash and cash equivalents


(958
)


(26,579
)Effect of exchange rates on cash and cash equivalents


(9
)


7Cash and cash equivalents, beginning of period


1,343



29,535Cash and cash equivalents, end of period

$
376


$
2,963





The accompanying notes are an integral part of these condensed consolidated financial
statements.




4




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SYMPHONIX DEVICES, INC.





NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS


(Unaudited)





1.    Basis of Presentation:





The accompanying unaudited condensed
consolidated financial statements as of March 31, 2002 of Symphonix Devices, Inc. (the Company or Symphonix) have been prepared in accordance with accounting principles generally accepted in the United States of America for
interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United
States of America for complete financial statements. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, consisting of normal
recurring adjustments, considered necessary for a fair presentation. Operating results for the three month period ended March 31, 2002 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2002,
or any future interim period.





These financial statements and notes should be read in conjunction with the Companys
audited financial statements for the year ended December 31, 2001 and footnotes thereto, included in the Companys Annual Report on Form 10-K.





These financial statements contemplate the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has sustained significant losses for the last several years. The
Company will require additional funding and may sell additional shares of its common stock or preferred stock through private placement or further public offerings. There can be no assurance that the Company will be able to obtain additional debt or
equity financing, if and when needed, on terms acceptable to the Company. Any additional equity or debt financing may involve substantial dilution to the Companys stockholders, restrictive covenants or high interest costs. The failure to raise
needed funds on sufficiently favorable terms could have a material adverse effect on the Companys business, operating results and financial condition. The Companys long-term liquidity also depends upon its ability to increase revenues
from the sale of its products and achieve profitability. The failure to achieve these goals could have a material adverse effect on the operating results and financial condition of the Company.





2.    Computation of Basic and Diluted Net Loss per Common Share:





Basic earnings per share (EPS) is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted EPS reflects the potential dilution that could occur from common shares issuable
through stock options, warrants and other convertible securities, if dilutive. The following table is a reconciliation of the numerator (net loss) and the denominator (number of shares) used in the basic and diluted EPS calculations and sets forth
potential shares of common stock that are not included in the diluted net loss per share calculation as their effect is antidilutive (in thousands, except per share data):




5




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SYMPHONIX DEVICES, INC.





NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS(Continued)










Three months ended March 31,2002


2001NumeratorBasic and DilutedNet loss

$
(2,111
)

$
(4,853
)DenominatorBasic and DilutedWeighted average common shares outstanding


35,635



21,038Weighted average unvested common shares subject to repurchase


(40
)


(64
)Total

$
35,595


$
20,974Basic and diluted net loss per common share

$
(0.06
)

$
(0.23
)Antidilutive Securities:Options to purchase common stock


4,951



2,613Common stock subject to repurchase


35



60Warrants


7



74,993



2,680





3.    Inventories:





Inventories comprise (in thousands):





March 31, 2002

December 31, 2001Raw materials

$
242

$
227Work in progress


375


340Finished goods


75


89$
692

$
656





4.    Restricted Cash:





In March 2002, the Company placed $926,000 in a certificate of deposit with a financial institution to comply with existing loan covenants as outlined in the amended loan agreement.
The amount required to be held in a certificate of deposit will be reduced as the Company makes payments on the outstanding loan balance.





5.    Recent Accounting Pronouncements:





In July 2001, the Financial Accounting and
Standards Board (FASB) issued Statements of Financial Accounting Standards No. 142 (SFAS 142), Goodwill and Other Intangible Assets.




6




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SYMPHONIX DEVICES, INC.





NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS(Continued)










SFAS 142 requires that goodwill no longer be amortized to earnings,
but instead be reviewed for impairment upon initial adoption of the Statement and on an annual basis going forward. The amortization of goodwill will cease upon adoption of SFAS 142. The provisions of SFAS 142 will be effective for fiscal years
beginning after December 15, 2001. The adoption of SFAS 142 did not have a material effect on the financial position or results of operations of the Company.





In October 2001, the FASB issued Statement of Financial Accounting Standards No. 144 (SFAS 144), Accounting for the Impairment or Disposal of Long-Lived Assets, which is effective for fiscal
years beginning after December 15, 2001 and interim periods within those fiscal periods. SFAS 144 supersedes FASB Statement No. 121 and APB Opinion No. 30, however, it retains the requirement of Opinion No. 30 to report discontinued operations
separately from continuing operations and extends that reporting to a component of an entity that either has been disposed of (by sale, by abandonment, or in a distribution to owners) or is classified as held for sale. SFAS 144 addresses financial
accounting and reporting for the impairment of certain long-lived assets and for long-lived assets to be disposed of. The adoption of SFAS 144 did not have a material impact on the financial position or results of operations of the Company.





Item 2.    Managements Discussion and Analysis of Financial Condition and Results of Operations





The following discussion should be read in conjunction with the condensed consolidated financial statements and footnotes thereto, and with Symphonixs audited financial statements
for the year ended December 31, 2001 and the footnotes thereto.





Overview





Statements in this Managements Discussion and Analysis of Financial Condition and Results of Operations which express that the company believes, anticipates
or plans to... as well as other statements which are not historical fact, are forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially as a
result of the risks and uncertainties described herein and elsewhere including, in particular, those factors described under Factors That May Affect Future Results.





Symphonix has developed a family of proprietary implantable Soundbridges for the management of mild to severe hearing impairment. Our family of Vibrant Soundbridges is based on our
patented core FMT technology. Late in 2000, we received approval from the Food and Drug Administration to commercially market our products in the United




7




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States. Subsequent to FDA approval, our products were successfully launched to the otology community. Otologists are ear
surgeons within the ear, nose and throat group of doctors.





Symphonix has established a United States sales and marketing
organization which, as of March 31, 2002, was comprised of sixteen sales, marketing and clinical support personnel. Symphonix has initiated marketing efforts focused on otologists, audiologiststhe health professionals who assess hearing
problems and recommend hearing devicesand directly to those suffering hearing loss.





Symphonix received the authorization
to affix the CE Mark to the first generation Vibrant Soundbridge and the second generation Vibrant P, Model 302 Soundbridge in March 1998. Authorization to affix the CE Mark to the Soundbridge and the Vibrant D, Model 304 Soundbridge was received in
July 1998 and in May 1999, respectively. Symphonix began selling activities for the Vibrant P, Model 302 Soundbridge and for the Vibrant D, Model 304 Soundbridge in the European Union in March 1998 and in June 1999, respectively. In August 2000,
Symphonix received FDA approval for its premarket approval application, or PMA, for the Vibrant P, Model 302 and Vibrant D, Model 304 Soundbridges. In October 2000, Symphonix received its device license for the Vibrant Soundbridge from Health
Canada. Symphonix was authorized to begin marketing the Vibrant D, Model 404 in Europe in May 2000 and received Premarket Approval by the FDA in January 2001. Symphonix has recently completed a clinical trial for adults with a mild hearing loss.
Symphonix has filed a PMA supplement to expand its application for adults with a mild to severe sensorineural hearing loss and expects approval of this supplement in 2002.





In December 1999, Symphonix established a distribution partnership with Siemens Audiologische Technik GmbH covering most of the markets in Europe. As of January 1, 2001, Siemens was
granted full distributorship of the European market. Symphonix believes this partnership will significantly enhance its presence, especially within the audiology community.





Symphonixs initial selling efforts in Europe have been targeted primarily at those ENT surgeons specializing in otology. Symphonix intends to continue to market its products to
these specialists; however, with the Siemens agreement, it also plans to focus on referring physicians, audiologists, the general population of ENT physicians and potential patients in an attempt to increase the patient flow to the otology centers.





Symphonix has a limited operating history. Through March 31, 2002 Symphonix had not generated significant revenue from product
sales. Symphonix expects to incur substantial losses through at least 2002. To date, Symphonixs principal sources of funding have been net proceeds from its initial public offering completed in February 1998, private equity financings
including investments by Siemens, an equipment lease facility and bank borrowings.




8




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Results of Operations





Revenue.    Revenue was $0.5 million in the three months ended March 31, 2002 compared to $0.6 million in the three months ended March 31, 2001. Revenue in these periods was the result of
selling activities to distributors in Europe and direct sales in the United States. Revenue in each of the three months ended March 31, 2002 and 2001 included $94,000, representing the amortization of the difference between the purchase price and
fair value of the Companys common stock purchased by Siemens in connection with a Marketing and Distribution Agreement. The remaining deferred revenue will be amortized on a straight line basis over the life of the agreement.





Costs of Goods Sold.    Costs of goods sold decreased to $0.6 million for the three months ended March 31, 2002
from $1.2 million for the three months ended March 31, 2001 primarily due to lower manufacturing overhead and direct labor costs. Costs of goods sold represents the direct cost of the products sold as well as manufacturing variances and provisions
for warranty. For the three months ended March 31, 2002, Symphonix charged $50,000 in warranty costs against accrued warranty. Due to the recent implementation of serviceability and reliability improvements we expect that our warranty costs on a per
unit basis will decline on a go forward basis.





Research and Development Expenses.    Research and
development expenses were $0.9 million in the three months ended March 31, 2002 compared to $1.7 million in the three months ended March 31, 2001. The $0.8 million decrease was due to the completion of a number of key research and development
milestones during 2001 and the reduced level of investment in the totally-implantable Vibrant Soundbridge which resulted in lower headcount, consulting and project costs during the three months ended March 31, 2002 compared to the same period ended
March 31, 2001. Research and development expenses consist primarily of personnel costs, professional services, materials, supplies and equipment in support of product development, clinical trials, regulatory submissions, and the preparation and
filing of patent applications.





Selling, General and Administrative Expenses.    Selling, general and
administrative expenses were $1.3 million in the three months ended March 31, 2002 compared to $2.8 million in the three months ended March 31, 2001. The $1.5 million decrease for the three months ended March 31, 2002 was primarily due to certain
marketing activities in support of the Companys product introduction post FDA approval which occurred in 2001 and not in 2002. Selling, general and administrative expenses consist primarily of personnel costs, promotional costs, legal and
consulting costs.





Interest Income (Expense).    Interest income, net of expense, decreased to $0.2
million in the three months ended March 31, 2002 from $0.3 million in the three months ended March 31, 2001. The decrease in net interest income was due to the decrease in the Companys cash and short-term investment balances as well as a
decrease in interest rates. Interest earned in the future will depend on the Companys funding cycles and prevailing interest rates.





Income Taxes.    To date, the Company has not incurred any U.S. income tax obligations. At December 31, 2001, the Company had net operating loss carryforwards of approximately $74.9




9




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million for federal and $39.0 million for state income tax purposes, which will expire at various dates through 2021 and 2011, respectively, if not utilized.
The principal differences between losses for financial and tax reporting purposes are the result of the capitalization of research and development and start-up expenses for tax purposes. Federal and state tax laws contain provisions that may limit
the net operating loss carryforwards that can be used in any given year, should certain changes in the beneficial ownership of the Companys outstanding common stock occur. Such events could limit the future of the Companys net operating
loss carryforwards.





Liquidity and Capital Resources





Since inception, the Company has funded its operations and its capital investments from proceeds from its initial public offering completed in February 1998 totaling $28.4 million, net
of issuance costs, from the private sale of equity securities totaling approximately $62.5 million, from an equipment lease financing totaling $1.3 million and from bank borrowings totaling $2.0 million. At March 31, 2002, the Company had $6.4
million in working capital, and its primary source of liquidity was $7.9 million in cash and cash equivalents and short-term investments. Additionally, the Company had $1.1 million of short-term and long-term restricted cash held in certificates of
deposit as collateral for a bank loan and letters of credit.





Symphonix used $3.0 million in cash for operations in the three
months ended March 31, 2002, compared to $5.8 million in the three months ended March 31, 2001 primarily in funding its operating losses.





Capital expenditures, primarily related to the Companys research and development and manufacturing activities, were $11,000 and $315,000 in the three months ended March 31, 2002 and 2001, respectively. At March
31, 2002, the Company did not have any material commitments for capital expenditures.





The Company has a loan agreement with a
bank that provided for borrowings of up to $2.0 million and for the issuance of letters of credit up to $250,000. At March 31, 2002, the Company had borrowings outstanding of $875,000, outstanding letters of credit in the amount of $225,000 and no
amounts available for future borrowings under the loan agreement. Borrowings under the loan agreement are repayable over four years and commenced in January 2000.





Although Symphonix has reduced its spending on research and development, preclinical and clinical testing, capital expenditures and the manufacturing, marketing and sale of its products
during the three months ended March 31, 2002 as compared to recent prior quarters, these expenditures could increase in the future. The timing and amount of spending of such capital resources cannot be accurately predicted and will depend on several
factors, including: market acceptance and demand for Symphonixs products in the United States and internationally, the availability of third party reimbursement, the progress of Symphonixs research and development efforts and preclinical
and clinical activities, competing technological and market developments, the time and costs of obtaining regulatory approvals, the time and costs involved in filing, prosecuting and enforcing patent claims, the progress and cost of
commercialization of products currently under development, and other factors not within Symphonixs control. While Symphonix believes that its




10




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existing capital will be sufficient to fund its operations and its capital investments through 2002, Symphonix may require additional financing beyond that time
and there can be no assurance that financing will be available. In addition, there can be no assurance that such additional financing will be available on a timely basis on terms acceptable to Symphonix, or at all, or that such financing will not be
dilutive to stockholders. If adequate funds are not available, Symphonix could be required to delay development or commercialization of certain of its products, license to third parties the rights to commercialize certain products or technologies
that Symphonix would otherwise seek to commercialize for itself, or reduce the marketing, customer support or other resources devoted to certain of its products, any of which could have a material adverse effect on Symphonixs business,
financial condition and results of operations.




11




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Factors That May Affect Future Results





Symphonix may be Delisted on the Nasdaq National Market.





To maintain a listing on the NASDAQ National Market, a company must maintain a minimum bid price per share of $1.00 as required under Marketplace Rules 4450(a)(2) and 4450(a)(5). Our common stock has traded below $1.00 since August 2, 2001.
On February 14, 2002 we received a letter from the NASDAQ National Market informing us that we have until May 15, 2002, to regain compliance or apply to list our securities on the NASDAQ SmallCap Market. Symphonix intends to list its securities on
the NASDAQ SmallCap Market. Like the NASDAQs National Market, the NASDAQ SmallCap Market is a NASDAQ regulated exchange with its own set of maintenance requirements. We can provide no assurance that in the future we would be able to meet the
maintenance requirements of the NASDAQ SmallCap Market.





A delisting from the NASDAQ National Market could impair our ability to
raise additional working capital. If we are able to raise additional capital, the terms may not be favorable and your investment may be diluted. A delisting may impair the liquidity of our common stock and may make it difficult for you to sell your
shares, and you may lose some or all of your investment.





We have a History of Losses and Negative Cash Flows, and we may
never be Profitable.





We have incurred losses every year since we began operations in 1994. At March 31, 2002, we had an
accumulated deficit of $84.8 million. This deficit resulted primarily from expenses we incurred from dedicating substantially all of our resources to research and development, clinical trials and establishment of a U.S. sales and marketing
organization. The Vibrant P, Model 302 and Vibrant D, Model 304 Soundbridges became available for sale in the European Union in 1998 and in the United States and Canada in 2000. Symphonix was authorized to begin marketing the Vibrant D, Model 404 in
Europe in May 2000 and received Premarket Approval by the FDA in January 2001. However, we have not generated significant revenues from product sales to date. We may never realize significant product revenues. Even if we do achieve significant
product revenues, we may never be profitable. We expect our operating losses to continue at least through the year 2002 as we continue to, among other things:





| |  |  | invest in sales and marketing capabilities;
| | - |  | -------------------------------------------




| |  |  | establish commercial-scale manufacturing capabilities;
| | - |  | ------------------------------------------------------




| |  |  | continue research and development activities; and
| | - |  | -------------------------------------------------




| |  |  | conduct clinical trials in support of regulatory approvals.
| | - |  | -----------------------------------------------------------



12




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Since Third-Party Reimbursement is not Widely Available for Procedures using our Soundbridge
Products, our Products may not Achieve Market Acceptance.





In the United States and abroad, patients generally rely on
third-party payors, principally Medicare, Medicaid, private health insurance plans, health maintenance organizations and other sources of reimbursement, to pay health care expenses, including reimbursement of all or part of the cost of the procedure
in which our medical device is being used. These third-party payors are increasingly attempting to limit both the coverage and the level of reimbursement of procedures involving new devices. Currently, we have had only a small number of cases
covered by third-party payors. If third-party payors do not establish adequate levels of reimbursement for procedures using our products, we may not achieve market acceptance.





If our Soundbridge Products do not Achieve Market Acceptance, our Business may Fail.





We have sold the semi-implantable Vibrant Soundbridge in Europe since 1998 and in the United States since 2000 and, as of March 31, 2002, have sold approximately 825 units. This product has not yet achieved market
acceptance and may never achieve market acceptance. Market acceptance of our current and future Soundbridge products will depend upon their acceptance by the medical community and patients as safe, effective, and cost-effective compared to other
devices. Our Soundbridge products may not be preferable alternatives to existing or future products, some of which, such as the acoustic hearing aid, do not require surgery. Patient acceptance of our Soundbridge products will depend in part upon
physician, audiologist and surgeon recommendations as well as other factors, including the effectiveness, safety, reliability and invasiveness of the procedure as compared to established approaches. Prior to undergoing surgery for the implantation
of our Soundbridge, a patient may speak with a number of medical professionals, including the patients primary care physician, an audiologist, an ear, nose and throat specialist, as well as surgeons who specialize in ear surgery. The failure
by any of these medical professionals to favorably recommend our products and the surgery required to implant the Soundbridge could limit the number of potential patients who are introduced to an ear surgeon as candidates for our Soundbridge
products. If our Soundbridge products do not achieve market acceptance, our business may fail.





We may not be able to Secure
Additional Funding to Support our Substantial Future Capital Requirements.





We will expend substantial funds in the future
for research and development, preclinical and clinical testing, capital expenditures and the manufacturing, marketing and sale of our products. The timing and amount of spending of such capital resources cannot be accurately predicted and will
depend upon several factors not within our control, including:





| |  |  | market acceptance and demand for our products in the United States and internationally;
| | - |  | ---------------------------------------------------------------------------------------




| |  |  | competing technological and market developments;
| | - |  | ------------------------------------------------



13




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| |  |  | the progress of our research and development efforts and preclinical and clinical activities;
| | - |  | ---------------------------------------------------------------------------------------------




| |  |  | the time and costs involved in obtaining regulatory approvals;
| | - |  | --------------------------------------------------------------




| |  |  | the time and costs involved in filing, prosecuting and enforcing patent claims; and
| | - |  | -----------------------------------------------------------------------------------




| |  |  | the progress and cost of commercialization of products currently under development.
| | - |  | -----------------------------------------------------------------------------------




We believe that our cash, cash equivalents, short-term investments and restricted cash of approximately $8.5 million at March 31, 2002 will be sufficient to fund our operations and
capital investments through 2002. However, we may require additional financing after that time. Such additional financing, if required, may not be available on a timely basis on terms acceptable to us, or at all. If adequate funds are not available,
we could be required to delay development or commercialization of some of our products, to license to third parties the rights to commercialize some products or technologies that we would otherwise seek to commercialize for ourselves, or to reduce
the marketing, customer support or other resources devoted to some of our products, any of which could have a material adverse effect on our business, financial condition and results of operations.





If we Fail to Successfully Develop and Commercialize our next Generation of Vibrant Soundbridge Products, we may not Achieve Profitability.





Although we have offered the semi-implantable Vibrant Soundbridge for sale in Europe since 1998, we have not realized
significant sales revenues to date. Our success depends on our ability to successfully commercialize an improved semi-implantable Soundbridge and may also depend on the success of a totally implantable Soundbridge. Our totally-implantable
Soundbridge, currently under development, will require additional development, clinical trials and regulatory approval prior to commercialization. Successful completion of clinical trials for the totally-implantable Soundbridge products may never
occur. Completion of clinical trials my be delayed by many factors, including research and development difficulties, slower than anticipated patient enrollment or adverse events occurring during clinical trials. Any delays in our clinical trials or
any failure to obtain regulatory approval for these next generation Soundbridge products would impair our ability to achieve profitability.





If we do not Receive and Maintain Regulatory Approvals for new Products, we will not be able to Manufacture or Market new Products.





Approval from the FDA is necessary to manufacture and market medical devices in the United States. Other countries have similar requirements. Since we have not realized significant
revenues from sales of our current products, we must receive and maintain regulatory approval for new products or our business will fail.





The process that medical devices must undergo to receive necessary approval is extensive, time-consuming and costly, and there is no guarantee that regulatory authorities will approve any of our




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product candidates. FDA approval can be delayed, limited or not granted for many reasons, including:





| |  |  | a product candidate may not be safe or effective;
| | - |  | -------------------------------------------------




| |  |  | even if we believe data from preclinical testing and clinical trials should justify approval, FDA officials may disagree;
| | - |  | -------------------------------------------------------------------------------------------------------------------------




| |  |  | the FDA might not approve our manufacturing processes or facilities or the processes or facilities of our contract manufacturers or raw material suppliers;
| | - |  | -----------------------------------------------------------------------------------------------------------------------------------------------------------




| |  |  | the FDA may change its approval policies or adopt new regulations; and
| | - |  | ----------------------------------------------------------------------




| |  |  | the FDA may approve a product candidate for indications that are narrow, which may limit our sales and marketing activities.
| | - |  | ----------------------------------------------------------------------------------------------------------------------------




The process of obtaining approvals in foreign countries is subject to delay and failure for the same reasons.





We face Intense Competition in our Current and Potential Markets and if we Cannot Demonstrate the Superiority of our Products, we may fail to Achieve
Profitability.





The medical device industry and the acoustic hearing aid market are subject to intense competition in the
United States and abroad. We believe our products will compete primarily with hearing aids. Principal manufacturers of acoustic hearing aids include Siemens Hearing Instruments, Inc., Starkey Laboratories, Inc., GN ReSound, Inc., Oticon, Inc., Widex
Hearing Aid Co., Inc., Sonic Innovations, Inc. and Phonak, Inc. Our products may not be as reliable or effective as established hearing aid products. If our products are not perceived as high quality, reliable and effective alternatives to
conventional hearing aids, we may not successfully compete with established hearing aid products. Our competitors may also develop technologies and products in the future that are more reliable and effective and less expensive than those being
developed by us or that do not require surgery.





Several companies have active research and development and marketing programs
related to alternative direct drive devices, which employ a middle ear implant designed to vibrate the small bones in the middle ear for sensorineural hearing loss. This type of hearing loss is the most common form of hearing loss that affects the
majority of the 28 million people in the United States who suffer from hearing loss. Otologics, LLC, has developed a semi-implantable direct drive device for sensorineural hearing loss called the Middle Ear Transducer (MET). This device has begun
the FDA regulatory process and initiated multicenter clinical trials. Otologics has recently obtained the CE Mark in Europe that allows the company to market and sell its product in Europe. Symphonix believes that St. Croix has begun clinical trials
in Europe and has recently received an IDE approval to begin clinical studies on its fully implantable pizo electric device for sensorineural hearing loss. Soundtec, Inc., has completed clinical trials in the United States on a hybrid
implantable/ear canal based hearing aid and has recently obtained FDA approval to market their product in the U.S. In




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addition, some large medical device companies, some of which are currently marketing implantable medical devices, may develop programs in hearing management.
Many of these companies have substantially greater financial, technical, manufacturing, marketing and other resources than we have. If we fail to compete effectively with any or all of these companies and products, we will not achieve profitability.





Our lack of sales, Marketing and Distribution Experience could delay and Increase the Costs of Introducing Our Soundbridge
Products into those Markets where we have Received Regulatory Approvals.





In the United States, a direct sales force is
concentrating our product marketing efforts on approximately 400 specialists in ear surgery and a targeted group of professional audiologists. In Europe, our sales and marketing effort is conducted through a distribution partnership with Siemens.





We may fail to build a direct sales force or marketing organization that is cost effective or successful. In addition, there
can be no assurance that we will be able to enter into distribution agreements similar to our agreement with Siemens on a timely basis on terms acceptable to us, or at all, or that potential distributors will develop adequate resources to sell our
products. If we fail to establish an adequate direct sales force domestically and in select international markets, or to enter into successful distribution relationships, we will have difficulty selling our products and our business may fail.





We have Limited Manufacturing Experience, and may be unable to Expand our Manufacturing Capabilities Sufficiently, which
could Limit our Ability to Develop and Deliver Sufficient Quantities of Products in a Timely Manner.





We currently
manufacture our products in small quantities for commercial sales, laboratory testing and for clinical trials. The manufacture of our Soundbridge products is a complex operation involving a number of separate processes, components and assemblies. We
have no experience manufacturing our products in the volumes or with the yields that will be necessary for us to achieve significant commercial sales, and there can be no assurance that we can establish high volume manufacturing capacity or, if
established, that we will be able to manufacture our products in high volumes with commercially acceptable yields. We will need to expend significant capital resources and develop manufacturing expertise to establish commercial-scale manufacturing
capabilities. Our inability to successfully manufacture or commercialize our Soundbridge products in a timely manner may harm our competitive position and market success.





If Siemens does not Perform its Duties under our Agreements, our Ability to Commercialize our Products may be Impaired.





We depend on Siemens Audiologische Technik GmbH to market and distribute our product in Europe. For the three months ended March 31, 2002, the products sold under our marketing and
distribution collaboration with Siemens in Europe accounted for approximately $0.2 million or 45.0%, of our total product revenues over the same period. The marketing and distribution agreement which governs this arrangement remains effective until
December 1, 2004, and is subject




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to automatic renewal for successive one-year periods thereafter unless terminated by either Symphonix or Siemens with at least 12 months prior written
notice. The marketing and distribution agreement may be terminated sooner if Symphonix or Siemens fails to cure a material breach within 30 days of notice of the breach, upon insolvency or bankruptcy of Symphonix or Siemens, or if Symphonix is
acquired.





We also depend on Siemens to provide integrated circuits and software for use in our Soundbridge products. The supply
agreement which governs this arrangement remains effective until September 30, 2004, and is subject to automatic renewal for successive one-year periods thereafter unless terminated by either Symphonix or Siemens with at least three months
prior written notice. The supply agreement may also be terminated sooner if Symphonix or Siemens fails to cure a material breach within 30 days of notice of the breach. In addition to marketing and distributing our products in Europe, Siemens
also manufactures and distributes its own acoustic hearing aids. Since the hearing aids manufactured and distributed by Siemens are competitive products to our Soundbridge products, Siemens could have an incentive to breach or terminate our
agreements. Termination or breach by Siemens of either its marketing and distribution agreement or supply agreement with us could delay or stop the commercialization of our products.





We rely on several sole Source or Limited Source Suppliers, and our Production will be Seriously Harmed if these Suppliers are not able to meet our Demand and Alternative Sources are
not available.





A number of components and sub-assemblies, such as silicone, signal processing electronics implant
packaging, as well as sterilization services are provided by single source suppliers. Furthermore, the key analog and digital signal processing microcircuits of the Vibrant P, Model 302, Vibrant D, Model 304 and Vibrant D, Model 404 Soundbridges are
provided by sole source suppliers. None of our suppliers is contractually obligated to continue to supply us nor are we contractually obligated to buy from a particular supplier. For some of these components and sub-assemblies, there are relatively
few alternative sources of supply, and we cannot quickly establish additional or replacement suppliers for such components and sub-assemblies. In addition, additional approvals will be required form the FDA before we can significantly modify our
manufacturing processes or change the supplier of a critical component. Because of the long lead time for some components and subassemblies that are currently available from a single source, a suppliers inability or failure to supply such
components or subassemblies in a timely manner or our decision to change suppliers could have a material adverse effect on our business, financial condition and results of operation.





If we are unable to Protect our Intellectual Property, our Competitors could Develop and Market Products with Similar Features that may Reduce Demand for our Products.





Our success depends in part on our ability to protect our issued and pending patents, trade secrets and other intellectual
property. The strength of this protection is uncertain. Our competitors could challenge, invalidate or circumvent our issued patents as well as any future patents. Even if upheld, our issued patents may not exclude competitors or otherwise provide
competitive advantages to us.




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In addition, a competitor may obtain patents that will interfere with our ability to make, use
or sell our products either in the United States or in international markets. There may be pending applications, which if issued, might provide proprietary rights to third parties relating to products or processes used or proposed to be used by us.
We may be required to obtain licenses to patents or proprietary rights of others. Further, the laws of some foreign countries do not protect our intellectual property rights to the same extent as do the laws of the United States. Litigation or
regulatory proceedings, which could result in substantial cost and uncertainty to us, may also be necessary to enforce our patent or other intellectual property rights or to determine the scope and validity of other parties proprietary rights.
We may not have the financial resources to defend our patents from infringement or claims of invalidity.





We also rely upon
trade secrets and other unpatented proprietary technology. Our competitors may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to or disclose our proprietary technology. Our policy is to
require each of our employees, consultants, investigators and advisors to execute a confidentiality agreement upon commencement of an employment or consulting relationship with us. However, these agreements may not provide meaningful protection for
our proprietary information in the event of unauthorized use or disclosure of such information.





Title 35, Section 287 of the
United States Code limits the enforcement of patents relating to the performance of surgical or medical procedures on a body. This law precludes medical practitioners and health care entities, which practice these procedures, from being sued for
patent infringement. Therefore, depending upon how these limitations are interpreted by the courts, they could have a material adverse effect on our ability to enforce any of our proprietary methods or procedures deemed to be surgical or medical
procedures on a body. In some countries other than the United States, patent coverage relating to the performance of surgical or medical procedures is not available. Therefore, patent coverage in such countries will be limited to the Floating Mass
Transducer, the patented core direct drive technology upon which all of our Soundbridge products are based, or to narrower aspects of the Floating Mass Transducer.





The medical device industry in general has been characterized by substantial litigation. Litigation regarding patent and other intellectual property rights, whether with our without
merit, could be time-consuming and expensive to respond to and could distract our technical and management personnel. Symphonix has filed a complaint against Soundtec, Inc., the Central Ear Research Institute (CERI) and three senior Soundtec
executives alleging actions that include misappropriation of trade secrets, breach of contract and inducing breach of contract. Central to the complaint is Symphonixs contention that Soundtec and its three executives utilized Symphonixs
confidential, proprietary and trade secret information to develop and market the Direct System  , Soundtecs
implantable middle ear hearing device. Prior to their tenure at Soundtec, the three executives named in the complaint were employed by CERI, which, in December 1994, entered into an agreement to undertake a research and development project with
Symphonix on the development of an implantable hearing device. The agreement permanently transferred exclusive rights to Symphonix for all technology developed during the research period. It further required that CERI disclose and permanently
transfer rights to Symphonix for all improvements invented, development or otherwise acquired by CERI for five years after termination of the agreement. Two of the named executives in




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the complaint executed this agreement on CERIs behalf. Soundtec was founded in March 1997, five months after CERI terminated its agreement with Symphonix.
Among other requests, Symphonix is seeking to restrain Soundtec from selling its Direct System device for a period of two years and to collect related damages.





We may also become involved in litigation to enforce our patents or to defend against claims of infringement. If any relevant claims of third-party patents are held as infringed and not invalid in any litigation or
administrative proceeding, we could be prevented from practicing the subject matter claimed in such patents, or would be required to obtain licenses from the patent owners of each such patent, or to redesign our products or processes to avoid
infringement. In addition, in the event of any possible infringement, there can be no assurance that we would be successful in any attempt to redesign our products or processes to avoid such infringement or in obtaining licenses on terms acceptable
to us, if at all. Accordingly, an adverse determination in a judicial or administrative proceeding or failure by us to redesign our products or processes or to obtain necessary licenses could prevent us from manufacturing and selling our products,
which would have a material adverse effect on our business, financial condition and results of operations. Although we have not been involved in any litigation to date, in the future, costly and time-consuming litigation brought by us may be
necessary to enforce patents issued to us, to protect our trade secrets or know-how, or to determine the enforceability, scope and validity of the proprietary rights of others.





If We Cannot Retain Or Hire Key Personnel, Our Business Will Suffer.





Our future success depends in significant part upon the continued service of key sales and marketing, management, and technical personnel. Competition for such personnel is intense. There can be no assurance that we
can retain our key sales and marketing, managerial, and technical personnel or that we can attract, assimilate or retain other highly qualified sales and marketing, managerial, and technical personnel in the future. The loss of key personnel,
especially if without advance notice, or the inability to hire or retain qualified personnel could impair our ability to commercialize our Vibrant Soundbridge products and develop future products.





Complications May Result From The Use Of Our Soundbridge Products, And Insurance May Be Insufficient Or Unavailable To Cover Potentially Significant
Product Liability Expenses If We Are Sued.





Our business involves the inherent risk of product liability claims. We maintain
limited product liability insurance at coverage levels which we believe to be commercially reasonable and adequate given our current operations. However, this insurance may not be available in the future on commercially reasonable terms, or at all.
Even if it is available, it may not be adequate to cover liabilities that may arise. If we are sued for an injury caused by our products, the resulting liability could result in significant expense, which could harm our business, financial condition
and cash flows.




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Our International Sales and Operation expose us to Foreign Currency and Political Risks.





We may continue to expand our operations outside of the United States and may enter additional international markets, which
would require significant management attention and financial resources and subject us further to the risks of operating internationally. These risks include:





| |  |  | unexpected changes in regulatory requirements;
| | - |  | ----------------------------------------------




| |  |  | delays resulting from difficulty in obtaining export licenses for certain technology;
| | - |  | -------------------------------------------------------------------------------------




| |  |  | tariffs and other barriers and restrictions;
| | - |  | --------------------------------------------




| |  |  | the burdens of complying with a variety of foreign laws and regulations; and
| | - |  | ----------------------------------------------------------------------------




| |  |  | difficulty in staffing and managing international operations.
| | - |  | -------------------------------------------------------------




We would also be subject to general political and economic risks if we expand our international operations, such as political instability, changes in diplomatic and trade relationships and general economic
fluctuations in specific countries or markets.





We cannot predict whether quotas, duties, taxes, or other charges or
restrictions will be imposed by the United States, the European Union, Japan, or other countries upon the import or export of our products in the future, or what effect any such actions would have on our business, financial condition or results of
operations. There can be no assurance that regulatory, geopolitical and other factors will not adversely affect our business in the future or require us to modify our current business practices.





In addition, because most of our international sales, and a large portion of the associated expenses, are denominated in foreign currencies, gains and losses on the conversion to
U.S. dollars of accounts receivable and accounts payable arising from international operations may contribute to fluctuations in our operating results. Further, fluctuations in currency exchange rates may negatively impact our ability to compete in
terms of price against products denominated in local currencies. To date, we have not found it appropriate to hedge the risks associated with fluctuations in exchange rates. However, even if we undertake such transactions in the future, they may
fail.





Item 3.Quantitative and Qualitative Disclosures About Market Risk





The Company considered the provisions of Financial Reporting Release No. 48 Disclosure of Accounting Policies for Derivative Financial Instruments and Derivative Commodity Instruments, and Disclosure of Quantitative and Qualitative
Information about Market Risk Inherent in Derivative Financial Instruments, Other Financial Instruments and Derivative Commodity Instruments. The Company had no holdings of derivative financial or commodity instruments at March 31, 2002. The
Company is exposed to financial market risks, including changes in interest rates and foreign currency exchange rates. The fair value of the Companys investment portfolio or related income




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would not be significantly impacted by either a 100 basis point increase or decrease in interest rates due mainly to the short-term nature of the Companys
investment portfolio. The Companys fixed rate debt obligations are subject to interest rate risk but due to the minimal amount of debt, the risk is insignificant. An increase in interest rates would not significantly affect the Companys
net loss. Much of the Companys revenue and all of its capital spending is transacted in U.S. dollars. However, the Company does enter into transactions in other currencies, primarily certain European currencies. Gains and losses on the
conversion to U.S. dollars of accounts receivable and accounts payable resulting from these transactions may contribute to fluctuations in our operating results. However, these transactions in other currencies were not material relative to
transactions in U.S. dollars. At March 31, 2002, the Company performed sensitivity analyses to assess the potential effect of this risk and concluded that near-term changes in interest rates and foreign currency exchange rates should not materially
adversely affect the Companys financial position, results of operations or cash flows.





PART II.    OTHER
INFORMATION





Item 1.Legal Proceedings.





In late 2001, Symphonix filed a
complaint in the Northern District of California against Soundtec, Inc., the Central Ear Research Institute (CERI) and three senior Soundtec executives alleging actions that include misappropriation of trade secrets, breach of contract and inducing
breach of contract. Central to the complaint is Symphonixs contention that Soundtec and its three executives utilized Symphonixs confidential, proprietary and trade secret information to develop and market the Direct System  , Soundtecs implantable middle ear hearing device. Prior to their tenure at Soundtec, the three executives named in the
complaint were employed by CERI, which, in December 1994, entered into an agreement to undertake a research and development project with Symphonix on the development of an implantable hearing device. The agreement permanently transferred exclusive
rights to Symphonix for all technology developed during the research period. It further required that CERI disclose and permanently transfer rights to Symphonix for all improvements invented, developed or otherwise acquired by CERI for five years
after termination of the agreement. Two of the named executives in the complaint executed this agreement on CERIs behalf. Soundtec was founded in March 1997, five months after CERI terminated its agreement with Symphonix. Among other requests,
Symphonix is seeking to restrain Soundtec from selling its Direct System device for a period of two years and to collect related damages.





Item 2.Changes in Securities and Use of Proceeds.





None





Item 3.Defaults upon Senior Securities.





None





Item 4.Submission of Matters to a Vote of Security Holders.





None





Item 5.Other Information.





None





Item 6.Exhibits and Reports on Form 8-K





(a)Exhibits





None





(b)Reports





None




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Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this 10-Q report to be signed on its behalf by the undersigned thereunto duly authorized.





SYMPHONIX DEVICES, INC.By:

/s/    KIRK B. DAVISKirk B. DavisChairman of the Board, President and Chief Executive
Officer





By:

/s/    TERENCE J. GRIFFINTerence J. GriffinVice President Finance and Chief Financial Officer (Principal Financial and Accounting Officer





Date:    May 15, 2002




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