10-Q 1 f83230e10vq.htm FORM 10-Q Aradigm Corporation Form 10-Q 6-30-02
Table of Contents



UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549


Form 10-Q


     
(Mark One)
   
þ
  QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
 
    For the quarterly period ended June 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 þ     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
  30,905,253
(Class)   (Outstanding at July 25, 2002)




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
PART II. OTHER INFORMATION
Item 2. Changes in Securities and Use of Proceeds
Item 4. Submission of Matters to a Vote of Security Holders
Item 6. Exhibits
SIGNATURE
INDEX TO EXHIBITS
EXHIBIT 99.1


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ARADIGM CORPORATION

INDEX

             
Page
No.

PART I.  FINANCIAL INFORMATION
 
ITEM 1.
  Financial Statements        
    Statements of Operations (Unaudited)        
      Three months ended June 30, 2002 and 2001     2  
      Six months ended June 30, 2002 and 2001     3  
    Balance Sheets        
      June 30, 2002 (Unaudited) and December 31, 2001     4  
    Statements of Cash Flows (Unaudited)        
      Six months ended June 30, 2002 and 2001     5  
    Notes to Unaudited Financial Statements     6  
ITEM 2.
  Management’s Discussion and Analysis of Financial Condition and Results of Operations     9  
ITEM 3.
  Quantitative and Qualitative Disclosure About Market Risk     14  
PART II.  OTHER INFORMATION
 
ITEM 2.
  Changes in Securities and Use of Proceeds     15  
ITEM 4.
  Submission of Matters to a Vote of Security Holders     15  
ITEM 6.
  Exhibits and Reports on Form 8-K     16  
Signature     17  
Exhibits     18  

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PART I.     FINANCIAL INFORMATION

Item 1.     Financial Statements

ARADIGM CORPORATION

 
STATEMENTS OF OPERATIONS
(In thousands, except per share data)
                     
Three Months Ended
June 30,

2002 2001


(Unaudited)
Contract revenues (Including amounts from related parties:
2002 — $6,558; 2001 — $7,279)
  $ 7,295     $ 8,520  
     
     
 
Operating expenses:
               
 
Research and development
    14,588       15,298  
 
General and administrative
    2,809       2,322  
     
     
 
   
Total operating expenses
    17,397       17,620  
     
     
 
Loss from operations
    (10,102 )     (9,100 )
Interest income
    210       299  
Interest expense and other
    (84 )     (364 )
     
     
 
Net loss
  $ (9,976 )   $ (9,165 )
     
     
 
Basic and diluted net loss per share
  $ (0.34 )   $ (0.47 )
     
     
 
Shares used in computing basic and diluted net loss per share
    29,723       19,338  
     
     
 

See accompanying notes.

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ARADIGM CORPORATION

 
STATEMENTS OF OPERATIONS
(In thousands, except per share data)
                     
Six Months Ended
June 30,

2002 2001


(Unaudited)
Contract revenues (Including amounts from related parties:
2002 — $14,157; 2001 — $13,128)
  $ 15,413     $ 15,207  
     
     
 
Operating expenses:
               
 
Research and development
    28,901       29,458  
 
General and administrative
    5,267       4,650  
     
     
 
   
Total operating expenses
    34,168       34,108  
     
     
 
Loss from operations
    (18,755 )     (18,901 )
Interest income
    501       967  
Interest expense and other
    (250 )     (626 )
     
     
 
Loss before extraordinary gain
    (18,504 )     (18,560 )
Extraordinary gain
          6,675  
     
     
 
Net loss
  $ (18,504 )   $ (11,885 )
     
     
 
Basic and diluted net loss per share:
               
 
Loss before extraordinary gain
  $ (0.62 )   $ (0.97 )
 
Extraordinary gain
          0.35  
     
     
 
Net loss per share
  $ (0.62 )   $ (0.62 )
     
     
 
Shares used in computing basic and diluted net loss per share
    29,634       19,090  
     
     
 

See accompanying notes.

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ARADIGM CORPORATION

BALANCE SHEETS

(In thousands, except shares data)
                       
June 30, December 31,
2002 2001


(Unaudited)
ASSETS
Current assets:
               
 
Cash and cash equivalents
  $ 35,023     $ 69,965  
 
Short-term investments
    3,859       1,199  
 
Receivables
    326       1,349  
 
Prepaid expenses and other current assets
    1,769       957  
     
     
 
   
Total current assets
    40,977       73,470  
Property and equipment, net
    61,613       57,940  
Notes receivable from officers and employees
    223       160  
Other assets
    506       530  
     
     
 
   
Total assets
  $ 103,319     $ 132,100  
     
     
 
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED
STOCK AND SHAREHOLDERS’ EQUITY
Current liabilities:
               
 
Accounts payable
  $ 2,017     $ 5,297  
 
Accrued clinical and cost of other studies
    346       703  
 
Accrued compensation
    3,475       1,761  
 
Deferred revenue
    6,429       11,115  
 
Current portion of capital lease obligations
    2,695       3,526  
 
Other accrued liabilities
    809       2,760  
     
     
 
   
Total current liabilities
    15,771       25,162  
Noncurrent portion of deferred revenue
    1,746       2,327  
Noncurrent portion of capital lease obligations
    1,252       2,427  
Noncurrent portion of deferred rent
    450       300  
Commitments and contingencies
               
Redeemable convertible preferred stock, no par value; 5,000,000 shares authorized; issued and outstanding shares: 2,001,236 at June 30, 2002 and December 31, 2001; liquidation preference of $48,430 at June 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: 29,723,219 at June 30, 2002 and 29,536,383 at December 31, 2001
    225,462       224,738  
Deferred compensation
          (54 )
Accumulated deficit
    (172,027 )     (153,535 )
     
     
 
   
Total shareholders’ equity
    53,435       71,149  
     
     
 
     
Total liabilities, redeemable convertible preferred stock and shareholders’ equity
  $ 103,319     $ 132,100  
     
     
 

See accompanying notes.

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ARADIGM CORPORATION

 
STATEMENTS OF CASH FLOWS
(In thousands)
                     
Six Months Ended
June 30,

2002 2001


(Unaudited)
Cash flows from operating activities:
               
 
Net loss
  $ (18,504 )   $ (11,885 )
 
Adjustments to reconcile net loss to cash used in operating activities:
               
   
Depreciation and amortization
    2,954       2,100  
   
Extraordinary gain related to Genentech note
          (6,675 )
   
Issuance of common stock for services
    2       48  
   
Amortization of deferred compensation
    54       81  
   
Changes in operating assets and liabilities:
               
   
Receivables
    1,023       (271 )
   
Prepaid expenses and other current assets
    (822 )     (579 )
   
Other assets
    24       128  
   
Accounts payable
    (3,280 )     (373 )
   
Accrued compensation
    1,714       1,352  
   
Other accrued liabilities
    (2,158 )     40  
   
Deferred revenue
    (5,267 )     2,704  
     
     
 
Net cash used in operating activities
    (24,260 )     (13,330 )
     
     
 
Cash flows from investing activities:
               
 
Capital expenditures
    (6,627 )     (24,758 )
 
Purchase of available-for-sale investments
    (7,410 )     (5,733 )
 
Proceeds from maturities of available-for-sale investments
    4,762       21,152  
     
     
 
Net cash used in investing activities
    (9,275 )     (9,339 )
     
     
 
Cash flows from financing activities:
               
 
Proceeds from issuance of common stock, net
    722       15,875  
 
Cost from issuance of redeemable convertible preferred stock
    (70 )      
 
Proceeds from repayments of shareholder notes
          110  
 
Notes receivable from officers
    (53 )     14  
 
Payments on lease obligations and equipment loans
    (2,006 )     (1,469 )
     
     
 
Net cash provided by (used in) financing activities
    (1,407 )     14,530  
     
     
 
Net decrease in cash and cash equivalents
    (34,942 )     (8,139 )
Cash and cash equivalents at beginning of period
    69,965       20,732  
     
     
 
Cash and cash equivalents at end of period
  $ 35,023     $ 12,593  
     
     
 
Supplemental disclosure of cash flow information:
               
 
Cash paid for interest
  $ 292     $ 502  
     
     
 
Non-cash investing and financing activities:
               
 
Issuance of common stock for services
  $ 2     $ 48  
     
     
 

See accompanying notes.

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ARADIGM CORPORATION

 
NOTES TO THE UNAUDITED FINANCIAL STATEMENTS
June 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.     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 A/S (“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 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

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ARADIGM CORPORATION

NOTES TO THE UNAUDITED FINANCIAL STATEMENTS — (Continued)

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 the week of April 22, 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.

3.     Related Party

      Novo Nordisk and its affiliate, Novo Nordisk Pharmaceuticals, Inc., are considered related parties and at June 30, 2002 own approximately 18% of the Company’s total outstanding common stock (on an as-converted basis).

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

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ARADIGM CORPORATION

NOTES TO THE UNAUDITED FINANCIAL STATEMENTS — (Continued)

5.     Subsequent Event

      In July 2002, the Company received $5 million from the sale of 1,182,034 shares of its common stock at a price of $4.23 per share to Novo Nordisk Pharmaceuticals, Inc., an affiliate of Novo Nordisk pursuant to a common stock purchase agreement entered into during 2001. As of the date of this transaction, Novo Nordisk and its affiliate, which are considered related parties, own approximately 20% of the Company’s total outstanding common stock (on an as-converted basis).

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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. As of June 30, 2002, we had an accumulated deficit of $172 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 six months ended June 30, 2002, this partner-funded program has contributed approximately 90% and 92%, respectively, of our total contract revenues. At June 30, 2002, Novo Nordisk and its affiliate Novo Nordisk Pharmaceuticals, Inc. own approximately 18% of our total outstanding common stock (on an as-converted basis). In July 2002, Novo Nordisk and its affiliate increased its ownership percentage to 20% (on an as-converted basis) through the purchase of common stock directly from the Company.

      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,

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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 will review its restoration election upon the delivery of Phase 2b trial results, which was made available to them during the current quarter, 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 a gene therapy effort, 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 June 30, 2002 and 2001

      Contract Revenues: Contract revenues for the three months ended June 30, 2002 decreased to $7.3 million from $8.5 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 $6.6 million for the three months ended June 30, 2002 and $7.3 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 $700,000 for the same period in 2001. The decrease in 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 June 30, 2002 decreased to $14.6 million from $15.3 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 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, we are focused on preparing for Phase 3 clinical trials, which Novo Nordisk intends to commence during the summer of 2002.

      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 current quarter 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. 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 continue to move forward with this program for a Phase 3 start, which is anticipated to occur in 2003.

      We have three other partner-funded programs and a gene therapy effort, which is funded through the National Institutes of Health, that are all in various stages of Phase 1 clinical trials. The three Phase 1 clinical trials are expected to be completed during 2002. Future research and development efforts for these partner-funded programs are difficult to predict at this time due to their early stage of development.

      General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2002 increased to $2.8 million from $2.3 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 June 30, 2002 decreased to $210,000 from $299,000 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 three months ended June 30, 2002 decreased to $84,000 from $364,000 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 June 30, 2002 increased to $10.0 million from $9.2 million for the same period in 2001. The increase in net loss is primarily due to a decrease in contract revenues, an increase in general and administrative expenses and a decrease in interest income partially offset by a reduction in research and development expenses and a reduction in interest expense and other.

 
Six Months Ended June 30, 2002 and 2001

      Contract Revenues: Contract revenues for the six months ended June 30, 2002 increased to $15.4 million from $15.2 million for the same period in 2001. The increase in revenue is primarily due to an increase in partner-funded project development revenue from Novo Nordisk and an increase in revenue from other partner-funded programs, but offset by no partner-funded revenue earned from the pain management program, which contributed revenue of $1.3 million for the same period in 2001. 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 six months ended June 30, 2002 decreased to $28.9 million from $29.5 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 six months ended June 30, 2002 increased to $5.3 million from $4.7 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 six months ended June 30, 2002 decreased to $501,000 from $967,000 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 six months ended June 30, 2002 decreased to $250,000 from $626,000 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 six months ended June 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 Pulmozyme program that had been funded by Genentech.

      Net Loss: Net loss for the six months ended June 30, 2002 increased to $18.5 million from $11.9 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

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investments. As of June 30, 2002, we had cash, cash equivalents and investments of approximately $38.9 million.

      Net cash used in operating activities for the six months ended June 30, 2002 increased to $24.3 million from $13.3 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, 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 six months ended June 30, 2002 remained relatively unchanged at $9.3 million compared to 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 including the acquisition of related production equipment.

      Net cash used in financing activities for the six months ended June 30, 2002 was $1.4 million compared to net cash provided by financing activities of $14.5 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 $19 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 June 30, 2002, including the $5 million proceeds received from the Novo Nordisk stock purchase in July 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 partners are

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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 June 30, 2002, we had cash and cash equivalents and short-term investments of $38.9 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.

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PART II.     OTHER INFORMATION

Item 2.     Changes in Securities and Use of Proceeds

      Pursuant to a Common Stock Purchase Agreement between the Company and Novo Nordisk Pharmaceuticals, Inc., dated October 22, 2001, the Company issued 1,182,032 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 4.     Submission of Matters to a Vote of Security Holders

      (a) The Annual Meeting of Shareholders of Aradigm Corporation was held on May 17, 2002.

      (b) Frank H. Barker, Wayne I. Roe, Richard P. Thompson, Virgil D. Thompson, Igor Gonda, Stan M. Benson, and John M. Nehra were elected to the Board of Directors to hold office until the next Annual Meeting of Shareholders and until their successors are elected and qualified.

      (c) The matters voted upon at the meeting and the voting of the shareholders with respect thereto were as follows:

        (1) The election of Frank H. Barker as Director to hold office until the next Annual Meeting of Shareholders and until his successor is elected and qualified:

For: 18,426,949                    Against: 114,471

        (2) The election of Wayne I. Roe as Director to hold office until the next Annual Meeting of Shareholders and until his successor is elected and qualified:

For: 18,427,749                    Against: 113,671

        (3) The election of Richard P. Thompson as Director to hold office until the next Annual Meeting of Shareholders and until his successor is elected and qualified:

For: 18,377,346                    Against: 164,074

        (4) The election of Virgil D. Thompson as Director to hold office until the next Annual Meeting of Shareholders and until his successor is elected and qualified:

For: 18,427,249                    Against: 114,171

        (5) The election of Igor Gonda as Director to hold office until the next Annual Meeting of Shareholders and until his successor is elected and qualified:

For: 18,426,218                    Against: 115,202

        (6) The election of Stan M. Benson as Director to hold office until the next Annual Meeting of Shareholders and until his successor is elected and qualified:

For: 18,427,749                    Against: 113,671

        (7) The election of John M. Nehra as Director to hold office until the next Annual Meeting of Shareholders and until his successor is elected and qualified:

For: 18,427,749                    Against: 113,671

        (8) Ratification of the selection of Ernst & Young LLP as independent auditors of the company for its fiscal year ending December 31, 2002:

For: 18,496,691          Against: 34,701          Abstained: 10,028

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Item 6.     Exhibits

      (a) Exhibit

         
  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 June 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: August 2, 2002

  ARADIGM CORPORATION
  (Registrant)
 
  /s/ RICHARD P. THOMPSON
 
  Richard P. Thompson
  President and Chief Executive Officer
 
  /s/ MICHAEL MOLKENTIN
 
  Michael Molkentin
  Acting 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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