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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 September 30, 2003

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 by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).     Yes  o  No  þ

     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
(Class)
  54,725,435
(Outstanding at October 31, 2003)

 


TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
BALANCE SHEETS
STATEMENTS OF OPERATIONS
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 6. Exhibits and Reports on Form 8-K
SIGNATURES
INDEX TO EXHIBITS
EXHIBIT 31.1
EXHIBIT 31.2
EXHIBIT 32.1


Table of Contents

ARADIGM CORPORATION
INDEX

                   
              Page
              No.
             
       
PART I. FINANCIAL INFORMATION
       
ITEM 1.
  Financial Statements        
       
Balance Sheets
       
          At September 30, 2003 and December 31, 2002 (unaudited)   2
       
Statements of Operations
       
          Three months ended September 30, 2003 and 2002 (unaudited)   3
          Nine months ended September 30, 2003 and 2002 (unaudited)   4
       
Statements of Cash Flows
       
          Nine months ended September 30, 2003 and 2002 (unaudited)   5
        Notes to Unaudited Financial Statements   6
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   14
       
PART II. OTHER INFORMATION
       
ITEM 6.
  Exhibits and Reports on Form 8-K   14
Signature   15
Certifications    
Exhibits    

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

ARADIGM CORPORATION
BALANCE SHEETS

                       
          September 30,   December 31,
          2003   2002
         
 
          (Unaudited)   (Note 1)
          (In thousands, except shares data)
ASSETS
Current assets:
               
 
Cash and cash equivalents
  $ 11,706     $ 22,800  
 
Short-term investments
    2,612       7,090  
 
Receivables
    8,959       282  
 
Current portion of notes receivable from officers and employees
    139       136  
 
Prepaid expenses and other current assets
    1,700       1,457  
 
   
     
 
   
Total current assets
    25,116       31,765  
Property and equipment, net
    63,885       63,233  
Noncurrent portion of notes receivable from officers and employees
    317       169  
Long-term investments
    0       1,553  
Other assets
    394       409  
 
   
     
 
   
Total assets
  $ 89,712     $ 97,129  
 
   
     
 
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED
STOCK AND SHAREHOLDERS’ EQUITY
Current liabilities:
               
 
Accounts payable
  $ 1,146     $ 1,951  
 
Accrued clinical and cost of other studies
    214       291  
 
Accrued compensation
    3,875       2,195  
 
Deferred revenue
    8,281       10,682  
 
Current portion of capital lease obligations
    645       1,753  
 
Other accrued liabilities
    748       407  
 
   
     
 
   
Total current liabilities
    14,909       17,279  
Noncurrent portion of deferred revenue
    4,782       6,170  
Noncurrent portion of capital lease obligations
    0       497  
Noncurrent portion of deferred rent
    1,270       1,108  
Commitments and contingencies
               
Redeemable convertible preferred stock, no par value; 5,000,000 shares authorized; issued and outstanding shares: 1,544,626 at September 30, 2003 and 2,001,236 at December 31, 2002; liquidation preference of $37,380 at September 30, 2003 and $48,430 at December 31, 2002
    23,669       30,665  
Shareholders’ equity:
               
Common stock, no par value; 100,000,000 shares authorized; issued and outstanding shares: 54,295,481 at September 30, 2003 and 31,157,612 at December 31, 2002
    254,420       230,853  
Accumulated deficit
    (209,338 )     (189,443 )
 
   
     
 
   
Total shareholders’ equity
    45,082       41,410  
 
   
     
 
     
Total liabilities, redeemable convertible preferred stock and shareholders’ equity
  $ 89,712     $ 97,129  
 
   
     
 

See accompanying notes.

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ARADIGM CORPORATION
STATEMENTS OF OPERATIONS

                     
        Three Months Ended
        September 30,
       
        2003   2002
       
 
        (Unaudited)
        (In thousands, except per share data)
Contract revenues (Including amounts from related parties:
2003 — $9,840; 2002 — $5,525)
  $ 9,843     $ 5,951  
 
   
     
 
Operating expenses:
               
 
Research and development
    11,988       13,660  
 
General and administrative
    2,428       2,636  
 
   
     
 
   
Total operating expenses
    14,416       16,296  
 
   
     
 
Loss from operations
    (4,573 )     (10,345 )
Interest income
    68       164  
Interest expense and other
    (27 )     (100 )
 
   
     
 
Net loss
  $ (4,532 )   $ (10,281 )
 
   
     
 
Basic and diluted net loss per share
  $ (0.08 )   $ (0.34 )
 
   
     
 
Shares used in computing basic and diluted net loss per share
    54,263       30,597  
 
   
     
 

See accompanying notes.

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ARADIGM CORPORATION
STATEMENTS OF OPERATIONS

                       
          Nine Months Ended
          September 30,
         
          2003   2002
         
 
          (Unaudited)
          (In thousands, except per share data)
Contract revenues (Including amounts from related parties:
2003 — $26,664; 2002— $19,682
  $ 26,911     $ 21,364  
 
   
     
 
Operating expenses:
               
   
Research and development
    38,988       42,561  
   
General and administrative
    7,941       7,903  
 
   
     
 
     
Total operating expenses
    46,929       50,464  
 
   
     
 
Loss from operations
    (20,018 )     (29,100 )
Interest income
    262       664  
Interest expense and other
    (122 )     (349 )
 
   
     
 
Net loss
    (19,878 )     (28,785 )
 
   
     
 
Basic and diluted net loss per share:
               
Net loss per share
  $ (0.42 )   $ (0.96 )
 
   
     
 
Shares used in computing basic and diluted net loss per share
    47,088       29,958  
 
   
     
 

See accompanying notes.

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ARADIGM CORPORATION
STATEMENTS OF CASH FLOWS

                       
        Nine Months Ended
        September 30,
       
        2003   2002
       
 
        (Unaudited)
        (In thousands)
Cash flows from operating activities:
               
 
Net loss
  $ (19,878 )   $ (28,785 )
 
Adjustments to reconcile net loss to cash used in operating activities:
               
   
Depreciation and amortization
    4,646       4,289  
   
Issuance of warrants and common stock for services
    14       6  
   
Amortization of deferred compensation
          54  
   
Changes in operating assets and liabilities:
               
     
Receivables
    (8,677 )     1,344  
     
Other current assets
    (244 )     (1,263 )
     
Other assets
    16       54  
     
Accounts payable
    (805 )     (3,765 )
     
Accrued compensation
    1,680       3,388  
     
Other accrued liabilities
    264       (2,063 )
     
Deferred rent
    161        
     
Deferred revenue
    (3,788 )     (3,914 )
 
   
     
 
Net cash used in operating activities
    (26,611 )     (30,655 )
 
   
     
 
Cash flows from investing activities:
               
 
Capital expenditures
    (5,298 )     (8,644 )
 
Sale of available-for-sale investments
    1,417       (9,786 )
 
Proceeds from maturities of available-for-sale investments
    4,597       4,784  
 
   
     
 
Net cash provided by (used) in investing activities
    716       (13,646 )
 
   
     
 
Cash flows from financing activities:
               
 
Proceeds from issuance of common stock, net
    16,557       6,161  
 
Cost from issuance of redeemable convertible preferred stock
    0       (70 )
 
Notes receivable from officers
    (151 )     (40 )
 
Payments on lease obligations and equipment loans
    (1,605 )     (2,699 )
 
   
     
 
Net cash provided by financing activities
    14,801       3,352  
 
   
     
 
Net (decrease) in cash and cash equivalents
    (11,094 )     (40,949 )
Cash and cash equivalents at beginning of period
    22,800       69,965  
 
   
     
 
Cash and cash equivalents at end of period
  $ 11,706     $ 29,016  
 
   
     
 
Supplemental disclosure of cash flow information:
               
 
Cash paid for interest
  $ 122     $ 392  
 
   
     
 
Non-cash investing and financing activities:
               
 
Issuance of common stock through conversion of Series A preferred stock
  $ 6,995     $ 0  
 
Issuance of warrants in conjunction with private placement of common stock
  $ 2,469     $ 0  
 
Issuance of warrants and options to purchase common stock for services
  $ 14     $ 6  
 
   
     
 

See accompanying notes.

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ARADIGM CORPORATION
NOTES TO THE UNAUDITED FINANCIAL STATEMENTS
September 30, 2003

1. Organization and Basis of Presentation

     Organization

     Aradigm Corporation (the “Company”) is a California corporation engaged in the development and commercialization of non-invasive drug delivery systems. 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 does not anticipate receiving any revenue from the sale of products in the upcoming year. These factors indicate that 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.

     Basis of Presentation

     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, 2002 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.

2. Summary of Significant Accounting Policies

     Stock Based Compensation

     The Company has elected to follow Accounting Principles Board Opinion No. 25 “Accounting for Stock Issued to Employees” and related interpretations in accounting for its employee stock options, including Financial Accounting Standard Board Interpretation 44 “Accounting for Certain Transactions Involving Stock Compensation.” Compensation expense is based on the difference, if any, between the fair value of the Company’s common stock and the exercise price of the option or share right on the measurement date, which is typically the date of grant. In accordance with Statement of Financial Accounting Standards (SFAS) 123 “Accounting for Stock-Based Compensation” (“SFAS 123”) as amended by SFAS 148 “Accounting for Stock-Based Compensation — Transition and Disclosure,” the Company has provided below, the pro forma disclosures of the effect on net loss and loss per share as if SFAS 123 had been applied in measuring compensation expense for all periods presented.

 


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      Three Months Ended   Nine Months Ended
      September 30,   September 30,
     
 
      2003   2002   2003   2002
     
 
 
 
Net loss applicable to common shareholders — as reported
  $ (4,532 )   $ (10,281 )   $ (19,878 )   $ (28,785 )
Add:
                               
 
Stock-based employee compensation expense included in reported net loss
  $     $     $     $ 54  
Less:
                               
 
Total stock-based employee compensation expense determined under fair value based method for all awards
  $ (1,319 )   $ (1,754 )   $ (4,230 )   $ (5,705 )
 
   
     
     
     
 
Pro forma net loss applicable to common shareholders
  $ (5,851 )   $ (12,035 )   $ (24,108 )   $ (34,436 )
 
   
     
     
     
 
Basic and diluted net loss per share applicable
to common shareholders —
                               
As reported
  $ (0.08 )   $ (0.34 )   $ (0.42 )   $ (0.96 )
Pro forma
  $ (0.11 )   $ (0.39 )   $ (0.51 )   $ (1.15 )

     The Company accounts for options and warrants issued to non-employees under SFAS 123 and Emerging Issues Task Force Issue No. 96-18.

     Computation of Net Loss 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, warrants and redeemable convertible preferred stocks are antidilutive.

3. Asset Acquisition

     On May 12, 2003, the Company completed the purchase of certain assets from the Weston Medical Group (“Weston”), a UK public company currently in bankruptcy. Weston’s business involved the design, development, manufacture and exploitation of drug delivery technologies, including a proprietary needle-free injection technology known as “Intraject.” The Company acquired test and production equipment, intellectual property and other assets associated with Weston’s drug delivery technologies for an initial cash consideration of approximately $2.0 million and subsequent transfer costs of approximately $0.9 million. The initial purchase price and subsequent transfer costs are included in property and equipment on the balance sheet at September 30, 2003.

4. Shareholders’ Equity

     Pursuant to a Securities Purchase Agreement entered into as of February 10, 2003, the Company issued in a private placement 18,992,391 shares of common stock at $0.79 per share and warrants to purchase 4,273,272 shares of common stock at $1.07 per share to certain investors for an aggregate purchase price of approximately $15.0 million. The warrants are exercisable at the election of the warrant holders for a four-year term. The Company valued the warrants using the Black-Scholes option pricing model using the following assumptions: estimated volatility of 62%, risk-free interest rate of 4.4%, no dividend yield, and an expected life of 4 years, and recorded approximately $1.4 million as issuance costs related to the private placement. In addition, in connection with this private placement, the Company issued warrants (“repriced warrants”) to purchase an aggregate of 4,016,024 shares of its common stock at $1.12 per share to certain of the investors in the private placement in exchange for the cancellation of an equal number of warrants to purchase shares of the common stock at $6.97 per share, held by the same investors. The Company valued

 


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the repriced warrants using the Black-Scholes option pricing model using the following assumptions: estimated volatility of 62%, risk-free interest rate of 4.4%, no dividend yield, and an expected life of 3.8 years, and recorded an additional $1.1 million as issuance costs related to the private placement.

     In June 2003 the Company received net proceeds of approximately $2.3 million and issued an aggregate of 2,171,964 shares of common stock in connection with the exercise of warrants by three investors.

     In March, June and July 2003, holders of an aggregate of 456,610 shares of redeemable convertible preferred stock (“preferred stock”) elected to convert shares of preferred stock to common stock under the terms of a preferred stock purchase agreement entered into as of December 14, 2001. Each share of preferred stock, together with accrued and unpaid dividends, is convertible at the option of the holder, into four shares of common stock. The Company issued 1,826,440 shares of common stock in connection with the conversion.

5. Related Party

     Novo Nordisk and its affiliate, Novo Nordisk Pharmaceuticals, Inc., are considered related parties, and in addition to being the Company’s primary revenue source and at September 30, 2003 own approximately 13.0% of the Company’s total outstanding common stock (on an as-converted basis).

6. Subsequent Event

     On November, 10 2003, the Company closed a private placement in which it sold 7,502,774 shares of common stock at a price of $1.80 per share and warrants to purchase 1,875,690 shares of common stock at $2.50 per share for an aggregate consideration of approximately $13.5 million.

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 most recent Form 10-K and Form 10-Q filed with the Securities and Exchange Commission.

     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, distribution and other 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 innovative drug delivery systems. Beginning with our AERx pulmonary delivery system and more recently with the Intraject subcutaneous delivery technology acquired in May 2003 from Weston, we are building a solid platform in needle-free drug delivery. As of September 30, 2003, we had an accumulated deficit of $209.3 million. We

 


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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 in the upcoming year. 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 with the AERx system 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 an agreement 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.

     We expect to perform various studies evaluating our Intraject subcutaneous delivery platform for both existing and future partnerships. The Intraject technology is currently being evaluated for application with several worldwide pharmaceutical corporations as well as with several other smaller-sized biotechnology companies for various compounds. In some cases, a partnership may not be disclosed until a long-term development agreement has been established.

     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 initiated Phase 3 clinical trials in September 2002, we have been focused on supporting our partner in the existing and planned additional Phase 3 clinical trials that will be needed for their regulatory submission and commercial scale-up activities. Current activities in this area focus on the elimination of a blemish discovered on a certain percentage of AERx strips. Through extensive quality testing we have determined that the blemish is strictly cosmetic and has no impact on the functionality of the product nor does it cause the product to fail sterility testing. The source of the appearance of the blemish must now be resolved before initiation of additional clinical studies. Novo Nordisk has announced that they do not expect to initiate these additional studies until the end of 2004. During this investigation, Aradigm and Novo Nordisk will also be undertaking steps to improve the design of the AERx device to facilitate our commercial manufacturing program.

     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 nine months ended September 30, 2003, this partner-funded program has contributed approximately 99.0% of our total contract revenues. At September 30, 2003, Novo Nordisk and its affiliate Novo Nordisk Pharmaceuticals, Inc. own approximately 13.0% of our total outstanding common stock (on an as-converted basis) and are considered a related party.

     Our next program has been conducted to date 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 2000, GlaxoSmithKline and Aradigm 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 GlaxoSmithKline or 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. GlaxoSmithKline has been in a position to exercise its restoration election since delivery of Phase 2b trial results, which were made available to them during the second quarter of 2002. Since they have not done so and it appears unlikely that they will do so in the future, we are currently in discussions with several alternate partners for this product. There can be no assurance that

 


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we will successfully enter into an alternative partnership agreement for this product if GlaxoSmithKline does not elect to restore its rights.

     In addition to the diabetes, morphine and fentanyl programs, we have additional partner funded programs in development, including two gene therapy programs. In general, it is our policy not to disclose the partner and/or the drug until a long-term development agreement has been established; both parties agree to highlight a clinical advancement in the program or under special circumstances in which both parties agree to disclosure. In 2002, we announced successful clinical results from one partnered trial with interferon alpha when an abstract was accepted at a leading scientific session, in which the partner was not disclosed. In addition, a gene therapy collaboration with geneRx+ was disclosed in which we hold certain potentially beneficial licensing rights.

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 are approximate to or are greater than 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 and accepted and such payments are no longer refundable.

Impairment of Long-Lived Assets

     We review for impairment whenever events or changes in circumstances indicate that the carrying amount of property and equipment may not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values and the loss is recognized on the Statements of Operations.

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.

Three Months Ended September 30, 2003 and 2002

     Contract and License Revenues: Contract revenues for the three months ended September 30, 2003 increased to $9.8 million from $6.0 million for the same period in 2002. Revenue from Novo Nordisk was $9.8 million for the three months ended September 30, 2003 and $5.5 million for the same period in 2002. The increase in contract and license revenues is related to increased reimbursement by Novo Nordisk for

 


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clinical supply and product development activities for the ongoing Phase 3 clinical program as well as payment of unreimbursed expenses from prior quarters; offset by lower revenues from other funded programs. Costs associated with collaborative agreements are included in research and development expenses. We expect that the revenue from Novo Nordisk may trend down over the coming quarter(s) due to the expected level of activity in support of the ongoing Phase 3 clinical program and the fact that at September 30, 2003 payments for all unreimbursed expenses were received.

     Research and Development Expenses: Research and development expenses for the three months ended September 30, 2003 decreased to $12.0 million from $13.7 million for the same period in 2002. The decrease in research and development expenses is primarily due to a reduction in self-funded development efforts and cost reduction programs.

     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 the future success of, and funding levels supported by, our existing development collaborations, as well as obtaining new collaborative agreements.

     We have additional partner-funded programs, including two gene therapy programs. 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 were $2.4 million for the three month period ended September 30, 2003 and $2.6 million for the same period in 2002. The decrease is primarily due to cost reduction programs.

     Interest Income: Interest income for the three months ended September 30, 2003 decreased to $68,000 from $164,000 for the same period in 2002. The decrease is due to lower invested balances and lower interest rates.

     Interest Expense and Other: Interest expense for the three months ended September 30, 2003 decreased to $27,000 from $100,000 for the same period in 2002. 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, 2003 of $4.5 million was lower compared to the $10.3 million loss for the same period in 2002, reflecting higher Novo Nordisk contract revenues and reduced expenses for self-funded projects.

Nine Months Ended September 30, 2003 and 2002

     Contract Revenues: Contract revenues for the nine months ended September 30, 2003 increased to $26.9 million from $21.4 million for the same period in 2002. Revenue from Novo Nordisk was $26.7 million for the nine months ended September 30, 2003 and $19.7 million for the same period in 2002. The increase in revenue is related to increased reimbursement by Novo Nordisk for clinical supply and product development activities for the ongoing Phase 3 clinical program as well as payment of unreimbursed expenses from prior quarters; offset by lower revenue from other funded programs.

     Research and Development Expenses: Research and development expenses for the nine months ended September 30, 2003 decreased to $39.0 million from $42.6 million for the same period in 2002. The decrease in research and development expenses is primarily due to a reduction in self-funded development efforts and cost reduction programs.

 


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     General and Administrative Expenses: General and administrative expenses remained unchanged at $7.9 million for the nine months ended September 30, 2003 and for the same period in 2002.

     Interest Income: Interest income for the nine months ended September 30, 2003 decreased to $262,000 from $664,000 for the same period in 2002. The decrease is due to lower invested balances and lower interest rates.

     Interest Expense and Other: Interest expense for the nine months ended September 30, 2003 decreased to $122,000 from $349,000 for the same period in 2002. 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 nine months ended September 30, 2003 decreased to $19.9 million from $28.8 million for the same period in 2002 reflecting our focus on the Novo Nordisk funded project and cost reduction efforts in other areas.

Liquidity and Capital Resources

     We have financed our 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, 2003, we had cash, cash equivalents and investments of approximately $14.3 million. The receivable balance of $8.9 million at September 30, 2003, was paid on October 2, 2003.

     In March 2003, we raised approximately $15.0 million through the sale of 18,992,391 shares of common stock at a price of $0.79 per share and warrants to purchase 4,273,272 shares of common stock at $1.07 per share to certain investors in a private placement.

     In June 2003, we received net proceeds of approximately $2.3 million and issued an aggregate of 2,171,964 shares of Common Stock in connection with the exercise of warrants by three investors.

     Net cash used in operating activities for the nine months ended September 30, 2003 decreased to $26.6 million from $30.7 million for the same period in 2002. Net cash used was lower in 2003 due to the substantially lower operating loss and lower cash usage for accounts payable and other accrued liabilities; offset by decrease in cash provided from accounts receivable and other assets.

     Investing activities for the nine months ended September 30, 2003 provided cash of $716,000 in contrast to the use of cash of $13.6 million for the same period in 2002. Lower net cash used in investing activities is primarily due to lower capital expenditures offset by a net increase of $6.0 million from matured investments and from sales of short-term securities. The capital expenditures for the nine months ended September 30, 2003 were $5.3 million compared to $8.6 million for the same period in 2002. Higher capital expenditures in 2002 related to the acquisition of manufacturing production equipment for commercial production. The majority of the capital expenditures in 2003 relate to the acquisition of the Intraject property and equipment.

     On May 12, 2003, we completed the purchase of certain assets from Weston, a UK public company currently in bankruptcy. Weston’s business involved the design, development, manufacture and exploitation of drug delivery technologies, including a proprietary needle-free injection technology known as “Intraject.” We acquired test and production equipment, intellectual property and other assets associated with Weston’s drug delivery technologies for an initial cash consideration of $2.0 million. The initial purchase price and subsequent transfer costs totaling $2.9 million have been funded out of our working capital. We will continue the development of Weston’s technologies and drug delivery systems at our existing US facilities. We will continue development of Intraject by re-allocating existing resources and we are not anticipating more than a small increase in our current cash burn rate.

     Net cash provided by financing activities for the nine months ended September 30, 2003 was $14.8 million compared to net cash provided of $3.4 million for the same period in 2002. The increase in cash

 


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provided is the result of the completion of the private placement in March 2003 and lower payments on lease obligations and equipment loans.

     The development of our technology and proposed products, including the Intraject development program, 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 2003 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 2003 not to exceed $8.0 million. Other than in connection with the acquisition of the Intraject related assets, since December 31, 2002, there have been no material changes in our contractual obligations or commitments. We believe that our existing cash balances at September 30, 2003, together with the $20.0 million unused common stock purchase commitment from Novo Nordisk A/S, 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 21 months. The sale of additional common stock to Novo Nordisk A/S is subject to certain conditions and 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 or if our current funding commitments from corporate development partners are amended or terminated, we will need to obtain additional sources of capital sooner than would otherwise be the case.

     If our development programs, including the Intraject development program, continue to progress, 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, 2003, we had cash and cash equivalents and short-term investments of $14.3 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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Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

     Based on their evaluation of our disclosure controls and procedures (as defined in the rules promulgated under the Securities Exchange Act of 1934), our chief executive officer and our chief financial officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this report.

     We believe that a controls system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives, and our chief executive officer and our chief financial officer have concluded that these controls and procedures are effective at the “reasonable assurance” level.

Changes in Internal Controls

     There were no significant changes in our internal control over financial reporting during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

Item 6. Exhibits and Reports on Form 8-K

(a) Exhibits

    31.1 Certification by Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

    31.2 Certification by Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

    32.1 Certification by Chief Executive Officer and Chief Financial Officer

(b) Reports on Form 8-K

     We filed a Current Report on Form 8-K dated July 23, 2003 to furnish (i) a press release in which we announced our financial results for the second quarter endedJune 30, 2003 and (ii) a transcript of our conference call held on July 23, 2003.

     We filed a Current Report on Form 8-K dated August 6, 2003 to furnish a transcript of our conference call held on August 6, 2003.

 


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SIGNATURES

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

     
    ARADIGM CORPORATION
(Registrant)
     
    /s/ RICHARD P. THOMPSON
   
    Richard P. Thompson
    Chairman and Chief Executive Officer
     
    /s/ THOMAS C. CHESTERMAN
   
    Thomas C. Chesterman
    Senior Vice President and Chief Financial Officer
     
Dated: November 11, 2003    

 


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INDEX TO EXHIBITS

     
Exhibit    
Number   Description

 
31.1   Certification by Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2   Certification by Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1   Certification by Chief Executive Officer and Chief Financial Officer