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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549


FORM 10-Q


     
(Mark One)
   
x   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
 
For the quarterly period ended September 30, 2002
 
OR
 
o   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 0-28402

ARADIGM CORPORATION

(Exact name of registrant as specified in its charter)
     
California
  94-3133088
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification No.)

3929 Point Eden Way

Hayward, CA 94545
(Address of principal executive offices including zip code)

(510) 265-9000

(Registrant’s telephone number, including area code)

     Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.     Yes x      No o

      Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

     
Common Stock, no par value
  31,157,612
(Class)
  (Outstanding at October 24, 2002)




TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS
BALANCE SHEETS
STATEMENTS OF CASH FLOWS
NOTES TO THE UNAUDITED FINANCIAL STATEMENTS
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Item 4. Controls and Procedures
PART II. OTHER INFORMATION
Item 2. Changes in Securities and Use of Proceeds
Item 6. Exhibits
SIGNATURE
CERTIFICATION
CERTIFICATION
Index to Exhibits
EXHIBIT 99.1


Table of Contents

ARADIGM CORPORATION

INDEX

             
Page
No.

PART I.  FINANCIAL INFORMATION
ITEM 1.
  Financial Statements     1  
    Statements of Operations (Unaudited)        
         Three months ended September 30, 2002 and 2001     1  
         Nine months ended September 30, 2002 and 2001     2  
    Balance Sheets        
         September 30, 2002 (Unaudited) and December 31, 2001     3  
    Statements of Cash Flows (Unaudited)        
         Nine months ended September 30, 2002 and 2001     4  
    Notes to Unaudited Financial Statements     5  
ITEM 2.
  Management’s Discussion and Analysis of Financial Condition and Results of Operations     8  
ITEM 3.
  Quantitative and Qualitative Disclosure About Market Risk     13  
ITEM 4.
  Controls and Procedures     13  
PART II.  OTHER INFORMATION
ITEM 2.
  Changes in Securities and Use of Proceeds     14  
ITEM 6.
  Exhibits and Reports on Form 8-K     14  
Signature     15  
Certifications     16  
Exhibits     18  


Table of Contents

PART I.     FINANCIAL INFORMATION

Item 1.     Financial Statements

ARADIGM CORPORATION

 
STATEMENTS OF OPERATIONS
(In thousands, except per share data)
                     
Three months ended
September 30,

2002 2001


(Unaudited)
Contract revenues (Including amounts from related parties:
               
2002 — $5,525; 2001 — $6,324)
  $ 5,951     $ 6,889  
     
     
 
Operating expenses:
               
 
Research and development
    13,660       14,890  
 
General and administrative
    2,636       2,233  
     
     
 
   
Total operating expenses
    16,296       17,123  
     
     
 
Loss from operations
    (10,345 )     (10,234 )
Interest income
    164       167  
Interest expense and other
    (100 )     (216 )
     
     
 
Net loss
  $ (10,281 )   $ (10,283 )
     
     
 
Basic and diluted net loss per share
  $ (0.34 )   $ (0.48 )
     
     
 
Shares used in computing basic and diluted net loss per share
    30,597       21,581  
     
     
 

See accompanying notes.

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ARADIGM CORPORATION

 
STATEMENTS OF OPERATIONS
(In thousands, except per share data)
                     
Nine months ended
September 30,

2002 2001


(Unaudited)
Contract revenues (Including amounts from related parties:
               
2002 – $19,682; 2001 – $19,453)
  $ 21,364     $ 22,096  
     
     
 
Operating expenses:
               
 
Research and development
    42,561       44,349  
 
General and administrative
    7,903       6,883  
     
     
 
   
Total operating expenses
    50,464       51,232  
     
     
 
Loss from operations
    (29,100 )     (29,136 )
Interest income
    664       1,134  
Interest expense and other
    (349 )     (841 )
     
     
 
Loss before extraordinary gain
    (28,785 )     (28,843 )
Extraordinary gain
          6,675  
     
     
 
Net loss
  $ (28,785 )   $ (22,168 )
     
     
 
 
Basic and diluted net loss per share:
               
Loss before extraordinary gain
  $ (0.96 )   $ (1.45 )
Extraordinary gain
          0.34  
     
     
 
Net loss per share
  $ (0.96 )   $ (1.11 )
     
     
 
Shares used in computing basic and diluted net loss per share
    29,958       19,929  
     
     
 

See accompanying notes.

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ARADIGM CORPORATION

 
BALANCE SHEETS
(In thousands, except shares data)
                       
September 30, December 31,
2002 2001


(Unaudited)
ASSETS
Current assets:
               
 
Cash and cash equivalents
  $ 29,016     $ 69,965  
 
Short-term investments
    6,220       1,199  
 
Receivables
    5       1,349  
 
Prepaid expenses and other current assets
    2,210       957  
     
     
 
   
Total current assets
    37,451       73,470  
Property and equipment, net
    62,296       57,940  
Notes receivable from officers and employees
    209       160  
Other assets
    477       530  
     
     
 
   
Total assets
  $ 100,433     $ 132,100  
     
     
 
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED
STOCK AND SHAREHOLDERS’ EQUITY
Current liabilities:
               
 
Accounts payable
  $ 1,532     $ 5,297  
 
Accrued clinical and cost of other studies
    511       703  
 
Accrued compensation
    5,150       1,761  
 
Deferred revenue
    7,459       11,115  
 
Current portion of capital lease obligations
    2,536       3,526  
 
Other accrued liabilities
    663       2,760  
     
     
 
   
Total current liabilities
    17,851       25,162  
Noncurrent portion of deferred revenue
    2,070       2,327  
Noncurrent portion of capital lease obligations
    718       2,427  
Noncurrent portion of deferred rent
    525       300  
Commitments and contingencies
               
Redeemable convertible preferred stock, no par value; 5,000,000 shares authorized; issued and outstanding shares: 2,001,236 at September 30, 2002 and December 31, 2001; liquidation preference of $48,430 at September 30, 2002 and December 31, 2001
    30,665       30,735  
Shareholders’ equity:
               
Common stock, no par value; 100,000,000 shares authorized; issued and outstanding shares: 31,157,612 at September 30, 2002 and 29,536,383 at December 31, 2001
    230,906       224,738  
Deferred compensation
          (54 )
Accumulated deficit
    (182,302 )     (153,535 )
     
     
 
   
Total shareholders’ equity
    48,604       71,149  
     
     
 
     
Total liabilities, redeemable convertible preferred stock and shareholders’ equity
  $ 100,433     $ 132,100  
     
     
 

See accompanying notes.

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ARADIGM CORPORATION

 
STATEMENTS OF CASH FLOWS
(In thousands)
                       
Nine months ended
September 30,

2002 2001


(Unaudited)
Cash flows from operating activities:
               
 
Net loss
  $ (28,785 )   $ (22,168 )
 
Adjustments to reconcile net loss to cash used in operating activities:
               
   
Depreciation and amortization
    4,289       3,280  
   
Extraordinary gain related to Genentech note
          (6,675 )
   
Issuance of common stock for services
    6       48  
   
Amortization of deferred compensation
    54       121  
   
Changes in operating assets and liabilities:
               
     
Receivables
    1,344       (264 )
     
Prepaid expenses and other current assets
    (1,263 )     (841 )
     
Other assets
    54       148  
     
Accounts payable
    (3,765 )     (532 )
     
Accrued compensation
    3,388       1,773  
     
Other accrued liabilities
    (2,063 )     (932 )
     
Deferred revenue
    (3,914 )     3,980  
     
     
 
Net cash used in operating activities
    (30,655 )     (22,062 )
     
     
 
Cash flows from investing activities:
               
 
Capital expenditures
    (8,644 )     (29,863 )
 
Purchase of available-for-sale investments
    (9,786 )     (5,733 )
 
Proceeds from maturities of available-for-sale investments
    4,784       26,414  
     
     
 
Net cash used in investing activities
    (13,646 )     (9,182 )
     
     
 
Cash flows from financing activities:
               
 
Proceeds from issuance of common stock, net
    6,161       30,724  
 
Cost from issuance of redeemable convertible preferred stock
    (70 )      
 
Proceeds from repayments of shareholder notes
          130  
 
Notes receivable from officers
    (40 )     14  
 
Payments on lease obligations and equipment loans
    (2,699 )     (2,310 )
     
     
 
Net cash provided by financing activities
    3,352       28,558  
     
     
 
Net decrease in cash and cash equivalents
    (40,949 )     (2,686 )
Cash and cash equivalents at beginning of period
    69,965       20,732  
     
     
 
Cash and cash equivalents at end of period
  $ 29,016     $ 18,046  
     
     
 
Supplemental disclosure of cash flow information:
               
 
Cash paid for interest
  $ 392     $ 714  
     
     
 
Non-cash investing and financing activities:
               
 
Issuance of common stock for services
  $ 6     $ 48  
     
     
 

See accompanying notes.

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ARADIGM CORPORATION

 
NOTES TO THE UNAUDITED FINANCIAL STATEMENTS
September 30, 2002

1.     Summary of Significant Accounting Policies

 
Organization and Basis of Presentation

      Aradigm Corporation (the “Company”) is a California corporation. Since inception, Aradigm has been engaged in the development and commercialization of non-invasive pulmonary drug delivery systems. The Company does not anticipate receiving any revenue from the sale of products in the upcoming year. Principal activities to date have included obtaining financing, recruiting management and technical personnel, securing operating facilities, conducting research and development, and expanding commercial production capabilities. The Company’s ability to continue its research, development and commercialization activities is dependent upon the ability of management to obtain additional financing as required.

      The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, the financial statements reflect all adjustments, which are of a normal recurring nature, necessary for a fair presentation. The accompanying financial statements should be read in conjunction with the financial statements and notes thereto included with the Company’s Annual Report on Form 10-K. The results of the Company’s operations for the interim periods presented are not necessarily indicative of operating results for the full fiscal year or any future interim period.

      The Balance Sheet at December 31, 2001 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. Certain amounts have been reclassified to conform with the current period’s presentation.

 
Net Loss Per Share

      Historical net loss per share has been calculated under Statement of Financial Accounting Standards No. 128, “Earnings Per Share.” Basic net loss per share has been computed using the weighted average number of shares of common stock outstanding less the weighted average number of shares subject to repurchase during the period. No diluted loss per share information has been presented in the accompanying statements of operations since potential common shares from stock options and warrants are antidilutive.

2.     Shareholders’ Equity

      In July 2002, the Company raised $5 million through the sale of 1,182,034 shares of common stock at a price of $4.23 per share to Novo Nordisk Pharmaceuticals, Inc., an affiliate of Novo Nordisk A/ S (“Novo Nordisk”) under the terms of a common stock purchase agreement signed in October 2001.

3.     Contingencies

      In June 1998, Eli Lilly and Company (“Lilly”) filed a complaint against the Company in the United States District Court for the Southern District of Indiana. The complaint made various allegations against the Company, arising from the Company’s decision to enter into an exclusive collaboration with Novo Nordisk with respect to the development and commercialization of a pulmonary delivery system for insulin and insulin analogs. The Company has sponsored various studies of the pulmonary delivery of insulin and insulin analogs using materials supplied by Lilly under a series of agreements dating from January 1996. The Company and Lilly had also conducted negotiations concerning a long-term supply agreement under which Lilly would supply bulk insulin to the Company for commercialization in the Company’s AERx insulin Diabetes Management System, and a separate agreement under which the Company would license certain intellectual property to Lilly. These negotiations were terminated after the Company proceeded with its agreement with Novo Nordisk. The complaint sought a declaration that Lilly scientists were co-inventors of a patent

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application filed by the Company relating to pulmonary delivery of an insulin analog or, in the alternative, enforcement of an alleged agreement to grant Lilly a nonexclusive license under such patent application. The complaint also contained allegations of misappropriation of trade secrets, breach of fiduciary duty, conversion and unjust enrichment and seeks unspecified damages and injunctive relief. The Company filed an answer denying all material allegations of the complaint. The Court granted summary judgment in favor of the Company as to Lilly’s claims relating to an alleged license agreement, for misappropriation of trade secrets, breach of fiduciary duty, conversion, estoppel and breach of contract (in part), dismissing those claims from the case. The remaining claims were tried before a jury during April 2002. The jury returned verdicts in favor of the Company and against Lilly on three of four of Lilly’s asserted claims of co-inventorship and on Lilly’s unjust enrichment claim. The jury returned verdicts in favor of Lilly on one of Lilly’s claims of co-inventorship and on two breach of contract claims, awarding Lilly damages of $1 for each breach of contract claim. These verdicts will be subject to various post-trial motions and possible appeals by both parties. Although there can be no assurance that the Company will ultimately prevail in this matter, management believes that the ultimate outcome of this litigation will not in any event have a material adverse effect on the Company’s financial position or results of operations.

4.     Related Party

      Novo Nordisk and its affiliate, Novo Nordisk Pharmaceuticals, Inc., are considered related parties and at September 30, 2002 own approximately 20% of the Company’s total outstanding common stock (on an as-converted basis).

5.     Recent Accounting Pronouncements

      In July 2001, the Financial Accounting Standards Board (FASB) issued Statements of Financial Accounting Standards (SFAS) No. 141, “Business Combinations”, and SFAS No. 142, “Goodwill and Other Intangible Assets”. The new rules require business combinations initiated after June 30, 2001 to be accounted for using the purchase method of accounting and goodwill acquired after this date will no longer be amortized, but will be subject to annual impairment tests. All other intangible assets will continue to be amortized over their estimated useful lives. The Company adopted the standard effective January 1, 2002. The Company has not completed any business combinations and as a result the adoption of these standards did not have a material impact on its financial position or operating results.

      In August 2001, the FASB issued SFAS No. 144, “Accounting for the Impairment or Disposal of Long-lived Assets”. SFAS No. 144 supercedes SFAS No. 121, “Accounting for the Impairment of Long-lived Assets and for Long-lived Assets to be Disposed of,” and the accounting and reporting provisions of Accounting Principles Board Opinion No. 30, “Reporting the Results of Operations — Reporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and Transactions,” for the disposal of a segment of a business (as previously defined in that Opinion). SFAS No. 144 also amends Accounting Research Bulletin No. 51, “Consolidated Financial Statements,” to eliminate the exception to consolidation of a subsidiary for which control is likely to be temporary. Companies are required to adopt SFAS No. 144 for fiscal years beginning after December 15, 2001, and interim periods within those fiscal years, but early adoption is encouraged. The Company adopted the standard effective January 1, 2002, and the adoption of this standard did not have a material impact on the Company’s financial position or results of operations.

      In April 2002, the FASB issued SFAS No. 145, “Rescission of FASB Statements No. 4, 44, and 64, Amendment of FASB Statement No. 13, and Technical Corrections”. Previous to the issuance of SFAS No. 145, SFAS No. 4 had required that all gains and losses from extinguishment of debt were to be aggregated and, if material, classified as an extraordinary item, net of related income tax effect. SFAS No. 145 rescinds SFAS No. 4 and the related required classification of extraordinary items. Companies are required to retroactively adopt SFAS No. 145 for fiscal years beginning after May 15, 2002, and interim periods within those fiscal years. The Company believes the impact of adopting this standard will be to reclassify the $6.7 million extraordinary gain related to Genentech in 2001 as a component of operating results and does not

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anticipate that the adoption of this standard will have a material impact on the Company’s financial position, results of operations or cash flows.

      In July 2002, the FASB issued SFAS No. 146, “Accounting for Costs Associated with Exit or Disposal Activities”. The standard requires companies to recognize costs associated with exit or disposal activities when they are incurred rather than at the date of a commitment to an exit or disposal plan. Examples of costs covered by the standard include lease termination costs and certain employee severance costs that are associated with a restructuring, discontinued operation, plant closing, or other exit or disposal activity. SFAS 146 is to be applied prospectively to exit or disposal activities initiated after December 31, 2002. The Company believes that the adoption of this standard will not have a material impact on the Company’s financial position or results of operations.

6.     Subsequent Event

      In October 2002, the Company received a milestone payment from Novo Nordisk pursuant to the development agreement milestone payment schedule, upon initiation of the Phase III clinical study (first patient, first dose). Revenue related to this milestone payment will be recognized over the remaining life of the insulin program.

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

      The discussion below contains forward-looking statements that are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. Our future results, performance or achievements could differ materially from those expressed in, or implied by, any such forward-looking statements as a result of certain factors, including, but not limited to, those discussed in this section as well as in the section entitled “Risk Factors” and elsewhere in the Company’s Form 10-K filed with the Securities and Exchange Commission on March 29, 2002.

      The business is subject to significant risks including, but not limited to, the success of research and development efforts, dependence on corporate partners for marketing and distribution resources, obtaining and enforcing patents important to the business, clearing the lengthy and expensive regulatory process and possible competition from other products. Even if the products appear promising at various stages of development, they may not reach the market or may not be commercially successful for a number of reasons. Such reasons include, but are not limited to, the possibilities that the potential products may be found to be ineffective during clinical trials, fail to receive necessary regulatory approvals, are difficult to manufacture on a large scale, are uneconomical to market, are precluded from commercialization by proprietary rights of third parties or may not gain acceptance from health care professionals and patients. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein. We undertake no obligation to publicly release the results of any revision to these forward-looking statements which may be made to reflect events or circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events.

Overview

      Since our inception in 1991, we have been engaged in the development of pulmonary drug delivery systems, including our AERx systems. As of September 30, 2002, we had an accumulated deficit of $182 million. We have not been profitable since inception and expect to incur additional operating losses over the next several years as research and development efforts, preclinical and clinical testing activities and manufacturing scale-up efforts expand and as we plan and build our late-stage clinical and early commercial production capabilities. To date, we have not had any material product sales and do not anticipate receiving any revenue from the sale of products during 2002. Our sources of working capital have been equity financings, equipment lease financings, contract revenues and interest earned on investments.

      We have performed initial feasibility work on a number of compounds and have been compensated for expenses incurred while performing this work in several cases pursuant to feasibility study agreements with third parties. Once feasibility is demonstrated with respect to a potential product, we seek to enter into development contracts with pharmaceutical corporate partners. We currently have such agreements pursuant to which we are developing pulmonary delivery systems with Novo Nordisk A/ S, to manage diabetes using insulin and other blood glucose regulating compounds, and with GlaxoSmithKline plc, to manage acute and breakthrough pain using opioid analgesics.

      The collaborative agreement with Novo Nordisk provides for reimbursement of research and development expenses as well as additional payments to us as we achieve certain significant milestones. We also expect to receive royalties from this development partner based on revenues from product sales and to receive revenue from the manufacturing of unit dose packets and hand-held devices. We recognize revenues under the terms of our collaborative agreement as the research and development expenses are incurred, to the extent they are reimbursable. For the three and nine months ended September 30, 2002, this partner-funded program has contributed approximately 93% and 92%, respectively, of our total contract revenues. At September 30, 2002, Novo Nordisk and its affiliate Novo Nordisk Pharmaceuticals, Inc. own approximately 20% of our total outstanding common stock (on an as-converted basis) and are considered a related party.

      During December 2000, GlaxoSmithKline and we amended the product development and commercialization agreement whereby we assumed full control and responsibility for conducting and financing the remainder of all development activities. Under the amendment, unless we have terminated the agreement, GlaxoSmithKline can restore its rights to participate in the development and commercialization of the product under the amended agreement upon payment of a restoration fee to us. We anticipate that GlaxoSmithKline

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will review its restoration election upon the delivery of Phase 2b trial results, which was made available to them during the second quarter of 2002, but there can be no assurance that GlaxoSmithKline will elect to restore its rights. If we elect to terminate the agreement and continue or intend to continue any development activities, either alone or in collaboration with a third party, we will be obligated to pay an exit fee to GlaxoSmithKline. If we elect to pay the exit fee, it will not have a material impact on our financial position or operating results. This development program is currently being funded through existing working capital.

      In February 2001, we announced that Genentech had discontinued the development of dornase alfa using our proprietary AERx Respiratory Management System. We also entered into a new agreement allowing Genentech to evaluate the feasibility of using the AERx Pulmonary Drug Delivery System for pulmonary delivery of other Genentech compounds. Under the terms of the agreement, Genentech did not require us to repay the loan of funds required to conduct product development under the discontinued program. Forgiveness of the loan and accrued interest resulted in an extraordinary gain during the first quarter of 2001 of approximately $6.7 million. During 2001, we reimbursed Genentech $773,000 for unspent project prepayments.

      In addition to the diabetes and pain management programs, we have three additional partner-funded programs and two gene therapy efforts, one of which is funded through the National Institutes of Health. It is our policy not to disclose the identity of the partner or the drug until we have entered into long-term development agreements with a partner or until data from a study has been published.

Critical Accounting Policies

      We consider certain accounting policies related to revenue recognition and the use of estimates to be critical accounting policies that require the use of significant judgments and estimates relating to matters that are inherently uncertain and may result in materially different results under different assumptions and conditions.

 
Revenue Recognition

      Contract revenues consist of revenue from collaboration agreements and feasibility studies. We recognize revenue under the agreements as costs are incurred. Deferred revenue represents the portion of all refundable and nonrefundable research payments received that have not been earned. In accordance with contract terms, milestone payments from collaborative research agreements are considered reimbursements for costs incurred under the agreements and, accordingly, are generally recognized as revenue either upon the completion of the milestone effort when payments are contingent upon completion of the effort or are based on actual efforts expended over the remaining term of the agreements when payments precede the required efforts. Costs of contract revenues approximate such revenue and are included in research and development expenses. Refundable development and license fee payments are deferred until the specified performance criteria are achieved. Refundable development and license fee payments are generally not refundable once the specific performance criteria are achieved.

 
Use of Estimates

      The preparation of financial statements in conformity with generally accepted accounting principles requires us to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes to the financial statements. These estimates include useful lives for property and equipment and related depreciation calculations, estimated amortization period for payments received from product development and license agreements as they relate to the revenue recognition of deferred revenue and assumptions for valuing options and warrants. Actual results could differ from these estimates.

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Results of Operations

 
Three Months Ended September 30, 2002 and 2001

      Contract Revenues: Contract revenues for the three months ended September 30, 2002 decreased to $6.0 million from $6.9 million for the same period in 2001. The decrease in revenue is primarily due to a reduction in partner-funded project development revenue from Novo Nordisk, which was $5.5 million for the three months ended September 30, 2002 and $6.3 million for the same period in 2001, and no partner-funded revenue earned from the pain management program during the current quarter, which contributed revenue of $200,000 for the same period in 2001. The decrease in Novo Nordisk contract revenues was partially offset by a modest increase in contract revenues from other partner-funded programs. Costs associated with collaborative agreements approximate contract revenues as these expenses are incurred under the program agreements. These costs are included in research and development expenses.

      Research and Development Expenses: Research and development expenses for the three months ended September 30, 2002 decreased to $13.7 million from $14.9 million for the same period in 2001. The decrease in research and development expenses is primarily due to a reduction in development efforts to support the ongoing program with Novo Nordisk and the pain management program and a reduction in manufacturing scale-up efforts offset by increases in expenses in other funded and unfunded development programs. Research and development expenses associated with collaborative agreements approximate contract revenues as these expenses are incurred under the program agreements.

      These expenses represent proprietary research expenses as well as costs related to contract revenues and include salaries and benefits of scientific and development personnel, laboratory supplies, consulting services and expenses associated with the development of manufacturing processes. We expect research and development spending to increase over the next few years as we continue to expand our development activities to support current and potential future collaborations and initiate commercial manufacturing of the AERx systems. The increase in research and development expenditures cannot be predicted accurately as it depends in part upon future success and funding levels supported by our existing development collaborations, as well as obtaining new collaborative agreements.

      Our lead development program is developing pulmonary delivery systems to manage diabetes using insulin and other blood glucose regulating compounds with our partner Novo Nordisk. Since Novo Nordisk and we successfully completed during 2001 a Phase 2b clinical trial using the AERx insulin Diabetes Management System, and successfully initiated Phase 3 clinical trials in September 2002, we are focused on preparing for additional Phase 3 clinical trials for regulatory submission along with commercial scale-up activities.

      Our next major program is with our partner GlaxoSmithKline pursuant to our development agreement, as amended, which covers the use of the AERx Pain Management System for the delivery of narcotic analgesics. During December 2001, we successfully completed Phase 2b clinical trials for the AERx morphine Pain Management System. During the second quarter of 2002, we made available to GlaxoSmithKline data from the Phase 2b clinical trials. We are working with GlaxoSmithKline to determine the next steps for the AERx morphine program. We are in a position to move forward with this program for a Phase 3 start in 2003, however, future progress for this program is contingent on either GlaxoSmithKline recommitting to this program or our entering into another development agreement with a new partner

      We have three other partner-funded programs and two gene therapy feasibility efforts, one of which is funded through the National Institutes of Health. Three of these will have completed Phase 1 clinical trials this year. Future research and development efforts for these partner-funded programs are difficult to predict at this time due to their early stage of development. In addition, we are funding the development of inhaled testosterone until such time that a partner is found for this program.

      General and Administrative Expenses: General and administrative expenses for the three months ended September 30, 2002 increased to $2.6 million from $2.2 million for the same period in 2001. The increase is primarily due to higher business development expenses, including the hiring of additional personnel and higher facility support costs.

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      Interest Income: Interest income for the three months ended September 30, 2002 decreased to $164,000 from $167,000 for the same period in 2001.

      Interest Expense and Other: Interest expense for the three months ended September 30, 2002 decreased to $100,000 from $216,000 for the same period in 2001. The decrease is primarily due to lower outstanding capital lease and equipment loan balances under various equipment and lease lines of credit.

      Net Loss: Net loss for the three months ended September 30, 2002 remained relatively unchanged at $10.3 million compared to the same period in 2001.

 
Nine Months Ended September 30, 2002 and 2001

      Contract Revenues: Contract revenues for the nine months ended September 30, 2002 decreased to $21.4 million from $22.1 million for the same period in 2001. The decrease in revenue is primarily due to no partner-funded revenue earned from the pain management program, which contributed revenue of $1.5 million for the same period in 2001, offset by an increase in partner-funded project development revenue from Novo Nordisk and an increase in revenue from other partner-funded programs. Costs associated with collaborative agreements approximate contract revenues as these expenses are incurred under the program agreements. These costs are included in research and development expenses.

      Research and Development Expenses: Research and development expenses for the nine months ended September 30, 2002 decreased to $42.6 million from $44.3 million for the same period in 2001. The decrease in research and development expenses is primarily due to a reduction in development efforts to support the ongoing program with Novo Nordisk and the pain management program and a reduction in manufacturing scale-up efforts, but offset by increases in expenses in other funded and unfunded development programs. Research and development expenses associated with collaborative agreements approximate contract revenue as these expenses are incurred under the program agreements.

      General and Administrative Expenses: General and administrative expenses for the nine months ended September 30, 2002 increased to $7.9 million from $6.9 million for the same period in 2001. The increase is primarily due to higher business development expenses, including the hiring of additional personnel, and higher facility support costs.

      Interest Income: Interest income for the nine months ended September 30, 2002 decreased to $664,000 from $1.1 million for the same period in 2001. The decrease is due to an overall decrease in interest rates earned on invested cash balances.

      Interest Expense and Other: Interest expense for the nine months ended September 30, 2002 decreased to $349,000 from $841,000 for the same period in 2001. The decrease is primarily due to lower outstanding capital lease and equipment loan balances under various equipment and lease lines of credit.

      Extraordinary Gain: No extraordinary gain was reported for the nine months ended September 30, 2002. For the same period in 2001, we reported an extraordinary gain of approximately $6.7 million. The extraordinary gain results from the cancellation of outstanding loans and accrued interest required to conduct development for the program that had been funded by Genentech.

      Net Loss: Net loss for the nine months ended September 30, 2002 increased to $28.8 million from $22.2 million for the same period in 2001. The increase in net loss is primarily due to the prior year period including an extraordinary gain of approximately $6.7 million that resulted from the cancellation of outstanding loans and accrued interest required for product development under the program that had been funded by Genentech.

Liquidity and Capital Resources

      The Company has financed its operations since inception primarily through private placements and public offerings of capital stock, proceeds from equipment lease financing, contract revenues and interest earned on investments. As of September 30, 2002, we had cash, cash equivalents and investments of approximately $35.2 million.

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      In July 2002, we raised $5 million through the sale of 1,182,034 shares of common stock at a price of $4.23 per share to Novo Nordisk Pharmaceuticals, Inc., an affiliate of Novo Nordisk under the terms of a common stock purchase agreement signed in October 2001.

      Net cash used in operating activities for the nine months ended September 30, 2002 increased to $30.7 million from $22.1 million for the same period in 2001. The increase in net cash used in operating activities resulted primarily from an increase in net loss and prepaid expenses and other current assets and a decrease in accounts payable, other accrued liabilities, and deferred revenue offset by a decrease in accounts receivable and an increase in accrued compensation. The increase in the net loss was primarily due to the prior year period including an extraordinary gain for the forgiveness of outstanding loans and accrued interest under the cancellation of a development agreement with Genentech. The increase in prepaid expenses and other current assets is primarily due to prepayments made to vendors for services they will perform over a future contractual period. The prepayments will be expensed to operations over the contractual period the services are performed by the vendor. The decrease in accounts payable and other accrued liabilities results primarily from increased payments for expenses associated with our development programs and capital expenditures, while the decrease in deferred revenue is due primarily to our partners funding future development at a lower level. The decrease in receivables is due to the receipt of payments from our partners for billings associated with our development activities. The increase in accrued compensation is due primarily to an increase in estimated accruals for employee compensation and other employee benefits.

      Net cash used in investing activities for the nine months ended September 30, 2002 increased to $13.6 million from $9.2 million for the same period in 2001. Net cash used in investing activities resulted primarily from a reduction in capital expenditures and proceeds from maturing investments offset by an increase in the purchase of investments. Capital expenditures for the current year relate primarily to the acquisition of manufacturing production equipment while in the prior year period capital expenditures related primarily to the construction of our large-scale commercial manufacturing facility.

      Net cash used in financing activities for the nine months ended September 30, 2002 decreased to $3.4 million from $28.6 million for the same period in 2001. The change results primarily from a significant reduction in proceeds from the issuance of equity funding during the current year and an increase in principal payments on lease obligations and equipment loans.

      The development of our technology and proposed products will require a commitment of substantial funds to conduct the costly and time-consuming research, preclinical studies and clinical trial activities necessary to develop and refine the technology and proposed products and bring such products to market. Our future capital requirements will depend on many factors, including continued progress and results from research and development for the technology and drug delivery systems, the ability to establish and maintain favorable collaborative arrangements with others, progress with preclinical studies and clinical trials and the results thereof, the time and costs involved in obtaining regulatory approvals, the cost of development and the rate of scale-up for the required production technologies, the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and the need to acquire licenses or other rights to new technology.

      We continue to review our planned operations through the end of 2002 and beyond. We particularly focus on capital spending requirements to ensure that capital outlays are not expended sooner than necessary. We expect our total annual capital outlays for 2002 will be approximately $15 million. Since December 31, 2001, there have been no material changes in our contractual obligations or commitments. We believe that our existing cash balances at September 30, 2002, together with the $20 million unused common stock purchase commitment from Novo Nordisk, research and development funding commitments from corporate development partners and interest earned on our investments should be sufficient to meet our needs for at least the next twelve months. The sale of additional common stock to Novo Nordisk is subject to certain conditions including, if applicable, obtaining any requisite shareholder approval. In addition, there can be no assurance that our funding commitments from corporate development partners will not be amended or terminated. If we cannot exercise our option to sell additional shares of common stock to Novo Nordisk because of the need for shareholder approval or otherwise or if our current funding commitments from corporate development

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partners are amended or terminated, we will need to obtain additional sources of capital sooner than would otherwise be the case.

      If we continue to make good progress in our development programs, we would expect our cash requirements for capital spending and operations to increase in future periods. We will need to raise additional capital to fund our capital spending and operations before we become profitable. We may seek additional funding through collaborations, borrowing arrangements or through public or private equity financings. There can be no assurance that additional financing can be obtained on acceptable terms, or at all. Dilution to shareholders may result if funds are raised by issuing additional equity securities. If adequate funds are not available, we may be required to delay, to reduce the scope of, or to eliminate one or more of our research and development programs, or to obtain funds through arrangements with collaborative partners or other sources that may require us to relinquish rights to certain of our technologies or products that we would not otherwise relinquish.

 
Item 3.      Quantitative and Qualitative Disclosures About Market Risk
 
Market Risk Disclosures

      In the normal course of business, our financial position is routinely subject to a variety of risks, including market risk associated with interest rate movement. We regularly assess these risks and have established policies and business practices to protect against these and other exposures. As a result, we do not anticipate material potential losses in these areas.

      As of September 30, 2002, we had cash and cash equivalents and short-term investments of $35.2 million consisting of cash and highly liquid short-term investments. Our short-term investments will decline by an immaterial amount if market interest rates increase, and therefore, our exposure to interest rate changes has been immaterial. Declines of interest rates over time will, however, reduce our interest income from our short-term investments. Our outstanding capital lease obligations are all at fixed interest rates and, therefore, have minimal exposure to changes in interest rates.

 
Item 4.      Controls and Procedures

(a) Evaluation of Disclosure Controls and Procedures

      Based on their evaluation of our disclosure controls and procedures conducted within 90 days of the date of filing this report on Form 10-Q, our Chief Executive Officer and the Chief Financial Officer have concluded that our disclosure controls and procedures (as defined in Rules 13a - 14(c) and 15d - 14(c) promulgated under the Securities Exchange Act of 1934) are effective.

(b) Changes in Internal Controls

      There were no significant changes in our internal controls or in other factors that could significantly affect these controls subsequent to the date of their evaluation.

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PART II.     OTHER INFORMATION

 
Item 2.      Changes in Securities and Use of Proceeds

      In July 2002, pursuant to a Common Stock Purchase Agreement between the Company and Novo Nordisk Pharmaceuticals, Inc., dated October 22, 2001, the Company issued 1,182,034 shares of its common stock to Novo Nordisk Pharmaceuticals, Inc. for an aggregate purchase price of $5 million. The shares were issued in reliance on Rule 506 of Regulation D of the Securities Act of 1933, as amended.

 
Item 6.      Exhibits

      (a) Exhibits

     
99.1
  Certification by Chief Executive Officer and Chief Financial Officer

      (b) Reports on Form 8-K

      The Company did not file any reports on Form 8-K during the quarter ended September 30, 2002.

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SIGNATURE

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

Dated: November 8, 2002

  ARADIGM CORPORATION
  (Registrant)
 
  /s/ RICHARD P. THOMPSON
 
  Richard P. Thompson
  President and Chief Executive Officer
 
  /s/ THOMAS C. CHESTERMAN
 
  Thomas C. Chesterman
  Senior Vice President and Chief Financial Officer

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CERTIFICATION

I, Richard P. Thompson, certify that:

  1. I have reviewed this quarterly report on Form 10-Q of Aradigm Corporation;
 
  2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
 
  3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
 
  4. The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:

  a)  designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
 
  b)  evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the “Evaluation Date”); and
 
  c)  presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;

  5. The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):

  a)  all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and
 
  b)  any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and

  6. The registrant’s other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

Date: November 8, 2002

  /s/ RICHARD P. THOMPSON
 
  Richard P. Thompson
  President and Chief Executive Officer

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CERTIFICATION

I, Thomas C. Chesterman, certify that:

  1. I have reviewed this quarterly report on Form 10-Q of Aradigm Corporation;
 
  2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
 
  3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
 
  4. The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:

  a)  designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
 
  b)  evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the “Evaluation Date”); and
 
  c)  presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;

  5. The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):

  d)  all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and
 
  e)  any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and

  6. The registrant’s other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

Date: November 8, 2002

  /s/ THOMAS C. CHESTERMAN
 
  Thomas C. Chesterman
  Senior Vice President and Chief Financial Officer

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Index to Exhibits

         
Exhibit Number Description


  99.1     Certification by Chief Executive Officer and Chief Financial Officer

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