UNITED STATES SECURITIES AND EXCHANGE COMMISSION
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the quarterly period ended September 30, 2004 | ||
Or | ||
o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the transition period from to . |
Aradigm Corporation
California | 94-3133088 | |
(State or other jurisdiction of | (I.R.S. Employer | |
incorporation or organization) | Identification No.) |
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 issuers classes of common stock, as of the latest practicable date.
Common Stock, no par value | 63,962,335 | |
(Class) | (Outstanding at October 31, 2004) |
ARADIGM CORPORATION
INDEX
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EXHIBIT 10.29 | ||||||||
EXHIBIT 31.1 | ||||||||
EXHIBIT 31.2 | ||||||||
EXHIBIT 32.1 |
1
PART I. FINANCIAL INFORMATION
Item 1. Condensed Financial Statements
ARADIGM CORPORATION
September 30, | December 31, | |||||||
2004 |
2003 |
|||||||
(Unaudited) |
(Note 1) |
|||||||
(In thousands, except shares data) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 6,657 | $ | 18,327 | ||||
Short-term investments |
6,449 | 11,443 | ||||||
Receivables |
72 | 140 | ||||||
Current portion of notes receivable from officers and
employees |
77 | 104 | ||||||
Prepaid expenses and other current assets |
2,142 | 1,910 | ||||||
Total current assets |
15,397 | 31,924 | ||||||
Property and equipment, net |
60,387 | 62,612 | ||||||
Noncurrent portion of notes receivable from officers and employees |
259 | 294 | ||||||
Other assets |
447 | 388 | ||||||
Total assets |
$ | 76,490 | $ | 95,218 | ||||
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND SHAREHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,334 | $ | 885 | ||||
Accrued clinical and cost of other studies |
363 | 149 | ||||||
Accrued compensation |
4,573 | 2,021 | ||||||
Deferred revenue |
8,818 | 7,891 | ||||||
Current portion of capital lease obligations |
| 427 | ||||||
Other accrued liabilities |
1,299 | 843 | ||||||
Total current liabilities |
16,387 | 12,216 | ||||||
Noncurrent portion of deferred revenue |
4,271 | 5,040 | ||||||
Noncurrent portion of deferred rent |
1,749 | 1,323 | ||||||
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, 2004
and at December 31, 2003; liquidation preference of $37,380 at September 30,
2004 and at December 31, 2003 |
23,669 | 23,669 | ||||||
Shareholders equity: |
||||||||
Common stock, no par value; 150,000,000 and 100,000,000 shares authorized at
September 30, 2004 and December 31, 2003, respectively; issued and
outstanding shares: 63,564,493 at September 30, 2004 and 62,751,196 at
December 31, 2003 |
269,270 | 268,406 | ||||||
Accumulated deficit |
(238,856 | ) | (215,436 | ) | ||||
Total shareholders equity |
30,414 | 52,970 | ||||||
Total liabilities,
redeemable
convertible
preferred stock and
shareholders
equity |
$ | 76,490 | $ | 95,218 | ||||
See accompanying notes.
2
ARADIGM CORPORATION
Three Months Ended | ||||||||
September 30, |
||||||||
2004 |
2003 |
|||||||
(Unaudited) | ||||||||
(In thousands, except per share data) | ||||||||
Contract revenues (Including amounts from related parties: |
||||||||
2004 $5,918; 2003 $9,840) |
$ | 6,352 | $ | 9,843 | ||||
Operating expenses: |
||||||||
Research and development |
11,407 | 11,988 | ||||||
General and administrative |
3,217 | 2,428 | ||||||
Total operating expenses |
14,624 | 14,416 | ||||||
Loss from operations |
(8,272 | ) | (4,573 | ) | ||||
Interest income |
45 | 68 | ||||||
Interest expense |
(3 | ) | (27 | ) | ||||
Net loss |
$ | (8,230 | ) | $ | (4,532 | ) | ||
Basic and diluted net loss per share |
$ | (0.13 | ) | $ | (0.08 | ) | ||
Shares used in computing basic and diluted net loss per share |
63,564 | 54,263 | ||||||
See accompanying notes.
3
ARADIGM CORPORATION
Nine Months Ended | ||||||||
September 30, |
||||||||
2004 |
2003 |
|||||||
(Unaudited) | ||||||||
(In thousands, except per share data) | ||||||||
Contract revenues (Including amounts from related parties: |
||||||||
2004 $19,534; 2003 $26,664) |
$ | 20,073 | $ | 26,911 | ||||
Operating expenses: |
||||||||
Research and development |
34,706 | 38,988 | ||||||
General and administrative |
8,920 | 7,941 | ||||||
Total operating expenses |
43,626 | 46,929 | ||||||
Loss from operations |
(23,553 | ) | (20,018 | ) | ||||
Interest income |
160 | 262 | ||||||
Interest expense |
(18 | ) | (122 | ) | ||||
Net loss |
$ | (23,411 | ) | $ | (19,878 | ) | ||
Basic and diluted net loss per share: |
||||||||
Net loss per share |
$ | (0.37 | ) | $ | (0.42 | ) | ||
Shares used in computing basic and diluted net loss per share |
63,350 | 47,088 | ||||||
See accompanying notes.
4
ARADIGM CORPORATION
Nine Months Ended | ||||||||
September 30, |
||||||||
2004 |
2003 |
|||||||
(Unaudited) | ||||||||
(In thousands) | ||||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (23,411 | ) | $ | (19,878 | ) | ||
Adjustments to reconcile net loss to cash used in operating activities: |
||||||||
Depreciation and amortization |
3,240 | 4,646 | ||||||
Loss on disposal of fixed assets |
257 | | ||||||
Issuance of warrants and common stock for services |
78 | 14 | ||||||
Changes in operating assets and liabilities: |
||||||||
Receivables |
68 | (8,677 | ) | |||||
Prepaid expenses and other current assets |
(232 | ) | (244 | ) | ||||
Other assets |
(59 | ) | 16 | |||||
Accounts payable |
449 | (805 | ) | |||||
Accrued compensation |
2,552 | 1,680 | ||||||
Other accrued liabilities |
670 | 264 | ||||||
Deferred rent |
426 | 161 | ||||||
Deferred revenue |
158 | (3,788 | ) | |||||
Net cash used in operating activities |
(15,804 | ) | (26,611 | ) | ||||
Cash flows from investing activities: |
||||||||
Capital expenditures |
(1,272 | ) | (5,298 | ) | ||||
Sale (purchase) of available-for-sale investments |
(6,376 | ) | 1,417 | |||||
Proceeds from maturities of available-for-sale investments |
11,361 | 4,597 | ||||||
Net cash provided by investing activities |
3,713 | 716 | ||||||
Cash flows from financing activities: |
||||||||
Proceeds from issuance of common stock, net |
481 | 16,557 | ||||||
Proceeds from exercise of options and warrants for common stock |
305 | | ||||||
Notes receivable from officers |
62 | (151 | ) | |||||
Payments on lease obligations and equipment loans |
(427 | ) | (1,605 | ) | ||||
Net cash provided by financing activities |
421 | 14,801 | ||||||
Net decrease in cash and cash equivalents |
(11,670 | ) | (11,094 | ) | ||||
Cash and cash equivalents at beginning of period |
18,327 | 22,800 | ||||||
Cash and cash equivalents at end of period |
$ | 6,657 | $ | 11,706 | ||||
Supplemental disclosure of cash flow information: |
||||||||
Cash paid for interest |
$ | 16 | $ | 122 | ||||
Non-cash investing and financing activities: |
||||||||
Issuance of common stock through conversion of Series A preferred stock |
$ | | $ | 6,995 | ||||
Issuance of warrants in conjunction with private placement of common stock |
$ | | $ | 2,469 | ||||
Issuance of warrants and options to purchase common stock for services |
$ | 78 | $ | 14 | ||||
See accompanying notes.
5
ARADIGM CORPORATION
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. 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. These factors indicate that the Companys 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 Companys Annual Report on Form 10-K. The results of the Companys 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, 2003 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. (APB) 25, Accounting for Stock Issued to Employees, and related interpretations in accounting for its employee stock options. Compensation expense is based on the difference, if any, between the fair value of the Companys common stock and the exercise price of the option or share right on the measurement date, which is typically the date of grant. This amount is recorded as Deferred Stock Compensation in the Balance Sheet and amortized as a charge over the vesting period of the applicable options or share rights. In accordance with Statement of Financial Accounting Standards (SFAS) 123, Accounting for Stock-Based Compensation, 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 (in thousands, except per share data).
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, |
September 30, |
|||||||||||||||
2004 |
2003 |
2004 |
2003 |
|||||||||||||
Net loss applicable to common
shareholders as reported |
$ | (8,230 | ) | $ | (4,532 | ) | $ | (23,411 | ) | $ | (19,878 | ) | ||||
Less: |
||||||||||||||||
Total stock-based
employee
compensation
expense determined
under fair value
based method for
all awards |
$ | (827 | ) | $ | (1,319 | ) | $ | (3,230 | ) | $ | (4,230 | ) | ||||
Pro forma net loss applicable to
common shareholders |
$ | (9,057 | ) | $ | (5,851 | ) | $ | (26,641 | ) | $ | (24,108 | ) | ||||
Basic and diluted net loss per
share applicable
to common shareholders |
||||||||||||||||
As reported |
$ | (0.13 | ) | $ | (0.08 | ) | $ | (0.37 | ) | $ | (0.42 | ) | ||||
Pro forma |
$ | (0.14 | ) | $ | (0.11 | ) | $ | (0.42 | ) | $ | (0.51 | ) |
6
The Company accounts for options and warrants issued to non-employees under SFAS 123 and Emerging Issues Task Force (EITF) Issue No. 96-18, Accounting for Equity Instruments that are Issued to Other than Employees for Acquiring, or in Conjunction with Selling Goods or Services, using the Black-Scholes option pricing model. The value of options and warrants are periodically remeasured over their vesting terms.
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. Shareholders Equity
In January and April 2004, holders of warrants to purchase 455,693 shares of common stock elected to exercise the warrants, either with cash or by operation of cashless exercise provisions contained in the warrants. The Company issued an aggregate of 371,002 shares of common stock in connection with the exercise of these warrants, 406 shares of common stock in connection with the exercise of options, and 441,889 shares of common stock under the Employee Stock Purchase Plan during the nine months ending September 30, 2004.
In January 2004, the Company amended the operating lease for one of its facilities. Effective January 1, 2004, the new agreement reduces the aggregate annual lease payments by $1.1 million through 2006 and increases the aggregate annual payments by $1.1 million from 2007 through 2010. In consideration for the amended lease agreement, the Company replaced warrants to purchase 135,000 shares of common stock at prices ranging from $10.16 to $21.72 per share with new warrants to purchase 135,000 shares of common stock at $1.71 per share. The repricing resulted in additional expense of $88,000 that is being amortized on a straight-line basis over the remaining life of the lease.
4. Related Party
Novo Nordisk and its affiliate, Novo Nordisk Pharmaceuticals, Inc., are considered related parties and at September 30, 2004 own approximately 11.3% of the Companys total outstanding common stock (on an as-converted basis). Contract revenue from Novo Nordisk represent 93.2% and 97.3% of total contract revenue for the three months and the nine months ended September 30, 2004, respectively. Contract revenue from Novo Nordisk was 99.9% and 99.1% of total contract revenue for the three months and the nine months ended September 30, 2003, respectively.
In September 2004, we announced an expansion and restructuring of our original licensing agreement with Novo Nordisk for the AERx insulin program. As part of this agreement, we will receive approximately $55 million dollars in cash, based on the net book value of the assets being transferred to Novo Nordisk Delivery Technologies, an affiliate of Novo Nordisk, which will be adjusted for depreciation of the assets from June 30, 2004, the date of the initial valuation for this purpose, up to the date of closing. As of September 30, 2004, the assets being transferred had a net book value of $54.4 million dollars. The Closing is subject to the fulfillment of
7
closing conditions, including approval by our shareholders, regulatory approvals, the agreement by a substantial number of our employees to transfer their employment and services to Novo Nordisk Delivery Technologies and the receipt of third-party consents to assignment.
Item 2. Managements 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 Companys 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 that 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 Medical, we are building a solid platform in needle-free drug delivery. As of September 30, 2004, we had an accumulated deficit of approximately $239 million. We have never 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.
Our lead development program is developing pulmonary delivery systems to manage diabetes using insulin 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. In April 2004, Novo Nordisk and we announced results from a planned interim analysis of the initial Phase 3 trial. Although the results showed that the trial met its primary safety and efficacy endpoints, the analysis showed delayed post-meal plasma glucose suppression in Type 1 diabetics using the AERx system. Because of the unexpected nature of these observations, Novo Nordisk decided to amend the current trial protocol. Novo Nordisk will make decisions concerning the structure and timing of additional clinical trials.
In September 2004, we announced an expansion and restructuring of our original licensing agreement with Novo Nordisk for the AERx insulin program. As part of this agreement, we will receive approximately $55 million dollars in cash, based on the net book value of the assets being transferred to Novo Nordisk Delivery Technologies, an affiliate of Novo Nordisk, which will be adjusted for depreciation of the assets from June 30,
8
2004, the date of the initial valuation for this purpose, up to the date of closing. As of September 30, 2004, the assets being transferred had a net book value of $54.4 million dollars. The Closing is subject to the fulfillment of closing conditions, including approval by our shareholders, regulatory approvals, the agreement by a substantial number of our employees to transfer their employment and services to Novo Nordisk Delivery Technologies and the receipt of third-party consents to assignment. Following the close of the transaction, Novo Nordisk will be responsible for all future clinical and commercial manufacturing and development of the program. We expect to receive future royalties on the commercialized product which will amount to approximately 75% of the original royalty stream. As we will no longer participate in the development program, we will not be entitled to future milestone as such payments were tied to development and regulatory timelines. Going forward we will work with Novo Nordisk as a contract organization in manufacturing AERx devices and dosage forms for use in our other programs. This transaction is subject to approval by Aradigm shareholders at a special meeting to be scheduled. We expect the transaction to close by the end of the year.
We have filed a preliminary proxy statement with the SEC relating to the special meeting of our shareholders related to the proposed transactions with Novo Nordisk. At the special meeting our shareholders will also be asked to approve an amendment to our Amended and Restated Articles of Incorporation to effect a reverse stock split pursuant to which any whole number of outstanding shares between and including two and seven (such number to be selected by our Board) would be combined into one share of our common stock.
The existing collaborative agreement with Novo Nordisk provides for reimbursement of research and development expenses as well as additional payments to Aradigm as we achieve certain significant milestones. 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, 2004, this partner-funded program has contributed approximately 97.3% of our total contract revenues. At September 30, 2004, Novo Nordisk and its affiliate, Novo Nordisk Pharmaceuticals, Inc., own approximately 11.3% of our total outstanding common stock (on an as-converted basis) and are considered related parties.
Recently, we completed a clinical performance verification trial of our Intraject subcutaneous delivery system. Based on the positive results from this trial that showed that the system met performance and reliability endpoints, we will be presenting this configuration to potential partners and investigating self-funded opportunities in the near future.
With respect to new development partners and new applications for our delivery systems, 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.
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 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.
9
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 stock options and warrants. Actual results could differ from these estimates.
Three Months Ended September 30, 2004 and 2003
Contract and License Revenues: Contract revenues for the three months ended September 30, 2004 decreased to $6.4 million from $9.8 million for the same period in 2003. Revenue from Novo Nordisk was $5.9 million for the three months ended September 30, 2004 and $9.8 million for the same period in 2003. Clinical supply and product development activities for the ongoing Phase 3 clinical program with Novo Nordisk were higher for the same period in 2003 and are decreasing as the program matures. Costs associated with collaborative agreements are included in research and development expenses. The Company expects that the revenue from Novo Nordisk may increase in the fourth quarter of 2004 over the third quarter.
Research and Development Expenses: Research and development expenses for the three months ended September 30, 2004 decreased to $11.4 million from $12.0 million for the same period in 2003. The decrease in research and development expenses is due to the decrease in Novo Nordisk program activities and continued cost saving efforts off-set by increased spending on Intraject and other self-funded projects.
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, increase development expense to support Intraject subcutaneous delivery technology. 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.
General and Administrative Expenses: General and administrative expenses for the three months ended September 30, 2004 increased by 33.3% to $3.2 million from $2.4 million for the same period in 2003 due primarily to cost associated with the restructuring agreement with Novo Nordisk in 2004.
Interest Income: Interest income for the three months ended September 30, 2004 decreased to $45,000 from $68,000 for the same period in 2003. The decrease is due to lower average investment portfolio balances.
Interest Expense: Interest expense for the three months ended September 30, 2004 decreased to $3,000 from $27,000 for the same period in 2003. The decrease is primarily due to the repayment of the 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, 2004 increased by 82% to $8.2 million from $4.5 million for the same period in 2003, reflecting lower Novo Nordisk contract revenues and increased general and administrative costs.
Nine Months Ended September 30, 2004 and 2003
Contract Revenues: Contract revenues for the nine months ended September 30, 2004 decreased by 25.4% to $20.1 million from $26.9 million for the same period in 2003. Revenue from Novo Nordisk was $19.5 million for the nine months ended September 30, 2004 and $26.7 million for the same period in 2003. The decrease in
10
revenue is related to lower budgeted Novo Nordisk activities for clinical supply and product development activities for the ongoing phase 3 clinical program. The Company expects that the revenue from Novo Nordisk may increase in the fourth quarter of 2004 over the third quarter.
Research and Development Expenses: Research and development expenses for the nine months ended September 30, 2004 decreased to $34.7 million from $39.0 million for the same period in 2003. The decrease in research and development expenses is due to the decrease in Novo Nordisk program activities and continued cost saving efforts.
General and Administrative Expenses: General and administrative expenses for the nine months ended September 30, 2004 increased by 12.7% to $8.9 million from $7.9 million for the same period in 2003. The increase is primarily due to costs related the restructuring agreement with Novo Nordisk in 2004.
Interest Income: Interest income for the nine months ended September 30, 2004 decreased to $160,000 from $262,000 for the same period in 2003. The decrease is due to lower invested balances.
Interest Expense: Interest expense for the nine months ended September 30, 2004 decreased to $18,000 from $122,000 for the same period in 2003. The decrease is primarily due to the repayment of the 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, 2004 increased to $23.4 million from $19.9 million for the same period in 2003, reflecting lower Novo Nordisk contract revenues and primarily offset by reduced associated development expense.
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, 2004, we had cash, cash equivalents and short-term investments of approximately $13.1 million.
In January and April 2004, the Company received net proceeds of approximately $786,000 and issued an aggregate of 813,297 shares of Common Stock in connection with the exercise of options and warrants, and the sale of common stock under the Employee Stock Purchase Plan.
On September 28, 2004, the Company entered into a Restructuring Agreement with Novo Nordisk A/S and Novo Nordisk Delivery Technologies, Inc. The Restructuring Agreement, subject to certain conditions, provides for the restructuring of the license agreement between the Company and Novo Nordisk to enlarge the license rights of Novo Nordisk to include the right to develop and manufacture the AERx insulin Diabetes Management System (iDMS) and other AERx products for use in managing blood glucose levels and, in connection therewith, the sale of certain equipment, leasehold improvements and other tangible assets currently utilized by the Company in the AERx iDMS program to Novo Nordisk Delivery Technologies, for an estimated cash payment of $55 million, based on the net book value of the assets being transferred to Novo Nordisk Delivery Technologies, which will be adjusted for depreciation of the assets from June 30, 2004, the date of the initial valuation for this purpose, up to the date of closing. As of September 30, 2004, the assets being transferred had a net book value of $54.4 million dollars. This transaction is subject to approval by Aradigm shareholders at a special meeting to be scheduled. We expect the transaction to close by the end of the year.
Net cash used in operating activities for the nine months ended September 30, 2004 decreased to $15.8 million from $26.6 million for the same period in 2003. As the net loss for the two periods was similar, the significant decline in net cash used in operating activities was primarily the result of the timing of cash payments and receipts for accounts receivable, accounts payable, and deferred revenue. Accounts receivable was higher in the third quarter of 2003 due to a bank transaction delay for funds from Novo for the iDMS research advance payment. The accounts payable balance at the end of the third quarter of 2004 was lower than in 2003 due to lower research and development activities. The amortization of deferred revenue decreased in 2004 relative to 2003 due to resource allocation to projects other then AERx.
Investing activities for the nine months ended September 30, 2004 provided cash of $3.7 million, compared to $0.7 million for the same period in 2003. Higher capital expenditures in 2003 related to the acquisition of certain assets and the intellectual property of related Intraject subcutaneous delivery technology from Weston Medical Group.
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Net cash provided by financing activities for the nine months ended September 30, 2004 was $0.4 million, compared to $14.8 million for the same period in 2003. Net cash provided in the nine months ended September 30, 2003 was higher as a result of the completion of a private placement financing in March 2003.
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 2004 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 2004 will be from $2.0 to $3.0 million. In January 2004, we amended the operating lease for one of our facilities. Effective January 1, 2004, the new agreement reduces the aggregate annual lease payments by $1.1 million through 2006 and increases the aggregate annual payments by $1.1 million from 2007 through 2010. Assuming completion of the pending restructuring of our licensing agreement with Novo Nordisk Delivery Technologies, we believe that our existing cash balances at September 30, 2004, along with the $55 million from the transaction and interest earned on our investments should be sufficient to meet our needs for at least the next 30 months. However, if the restructuring is not completed, we believe that our existing cash balances at September 30, 2004 and existing and potential future funding from corporate development partners and financial institutions should be sufficient to meet our needs for at least the next 12 months. There can be no assurance that funding from corporate development partners or financial institutions 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.
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 may 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, 2004, we had cash, cash equivalents and short-term investments of $13.1 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.
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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 Rules 13a15(e) and 15d-15(e) 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 the Chief Executive Officer and the 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 controls over financial reporting.
PART II. OTHER INFORMATION
Item 5. Other Information
On July 26, 2004, we received a letter from Nasdaq advising us that our common stock had not met Nasdaqs minimum bid price requirement for 30 consecutive trading days and that, if we were unable to demonstrate compliance with this requirement during the 180 calendar days ending January 24, 2005, our common stock would be subject to delisting at that time. Subsequent to the July 26, 2004 letter from Nasdaq, we sustained a closing bid price greater than $1.00 per share for more than 10 consecutive trading days, beginning on September 13, 2004 and we are therefore in compliance with Nasdaqs minimum bid price requirement.
Item 6. Exhibits
(a) Exhibits
10.29* | Restructuring Agreement, dated as of September 28, 2004, among Aradigm Corporation, Novo Nordisk A/S and Novo Nordisk Delivery Technologies, Inc. | |||||
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 pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
* The Company has sought confidential treatment for portions of the referenced exhibit.
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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/ V. BRYAN LAWLIS | ||||
V. Bryan Lawlis | ||||
President and Chief Executive Officer | ||||
/s/ THOMAS C. CHESTERMAN | ||||
Thomas C. Chesterman | ||||
Senior Vice President and Chief Financial Officer | ||||
Dated: November 15, 2004
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INDEX TO EXHIBITS
Exhibit | ||
Number |
Description |
|
10.29*
|
Restructuring Agreement, dated as of September 28, 2004, among Aradigm Corporation, Novo Nordisk A/S and Novo Nordisk Delivery Technologies, Inc. | |
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 pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
* The Company has sought confidential treatment for portions of the referenced exhibit.
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