UNITED STATES SECURITIES AND EXCHANGE COMMISSION
(Mark One)
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the quarterly period ended June 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
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
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes o No x
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 | 54,295,481 | |
(Class) | (Outstanding at July 31, 2003) |
ARADIGM CORPORATION
INDEX
Page No. | ||||||||||
PART I. FINANCIAL INFORMATION | ||||||||||
ITEM 1. | Financial
Statements |
|||||||||
Balance Sheets |
||||||||||
At June 30, 2003 and December 31, 2002 (unaudited) |
2 | |||||||||
Statements of Operations
|
||||||||||
Three Months Ended June 30, 2003 and 2002 (unaudited) |
3 | |||||||||
Six months ended June 30, 2003 and 2002 (unaudited) |
4 | |||||||||
Statements of Cash Flows
|
||||||||||
Six months ended June 30, 2003 and 2002 (unaudited) |
5 | |||||||||
Notes to Unaudited Financial Statements |
6 | |||||||||
ITEM 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations |
8 | ||||||||
ITEM 3. | Quantitative and Qualitative Disclosure About Market Risk
|
13 | ||||||||
ITEM 4. | Controls and Procedures |
13 | ||||||||
PART II. OTHER INFORMATION | ||||||||||
ITEM 1. | Legal Proceedings |
14 | ||||||||
ITEM 4. | Submission of Matters to a Vote of Security Holders |
14 | ||||||||
ITEM 6. | Exhibits and Reports on Form 8-K |
15 | ||||||||
Signature | 16 | |||||||||
Index to Exhibits | 17 |
1
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
ARADIGM CORPORATION
BALANCE SHEETS
June 30, | December 31, | ||||||||||
2003 | 2002 | ||||||||||
(Unaudited) | (Note 1) | ||||||||||
(In thousands, except shares data) | |||||||||||
ASSETS |
|||||||||||
Current assets: |
|||||||||||
Cash and cash equivalents |
$ | 24,392 | $ | 22,800 | |||||||
Short-term investments |
3,837 | 7,090 | |||||||||
Receivables |
167 | 282 | |||||||||
Current portion of notes receivable from officers and employees
|
138 | 136 | |||||||||
Prepaid expenses and other current assets |
1,376 | 1,457 | |||||||||
Total current assets |
29,910 | 31,765 | |||||||||
Property and equipment, net |
64,207 | 63,233 | |||||||||
Noncurrent portion of notes receivable from officers and employees |
332 | 169 | |||||||||
Long-term investments |
| 1,553 | |||||||||
Other assets |
399 | 409 | |||||||||
Total
assets |
$ | 94,848 | $ | 97,129 | |||||||
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED |
|||||||||||
STOCK AND SHAREHOLDERS EQUITY |
|||||||||||
Current liabilities: |
|||||||||||
Accounts payable |
$ | 1,010 | $ | 1,951 | |||||||
Accrued clinical and cost of other studies |
207 | 291 | |||||||||
Accrued compensation |
3,368 | 2,195 | |||||||||
Deferred revenue |
8,909 | 10,682 | |||||||||
Current portion of capital lease obligations |
992 | 1,753 | |||||||||
Other accrued liabilities |
648 | 407 | |||||||||
Total current liabilities |
15,134 | 17,279 | |||||||||
Noncurrent portion of deferred revenue |
5,142 | 6,170 | |||||||||
Noncurrent portion of capital lease obligations |
73 | 497 | |||||||||
Noncurrent portion of deferred rent |
1,216 | 1,108 | |||||||||
Commitments and contingencies |
|||||||||||
Redeemable convertible preferred stock, no par value; 5,000,000 shares
authorized; issued and outstanding shares: 1,794,626 at June 30, 2003 and
2,001,236 at December 31, 2002; liquidation preference of $43,430 at June 30,
2003 and $48,430 at December 31, 2002 |
27,499 | 30,665 | |||||||||
Shareholders equity: |
June 30, | December 31, | ||||||||||
2003 | 2002 | ||||||||||
(Unaudited) | (Note 1) | ||||||||||
(In thousands, except shares data) | |||||||||||
Common stock, no par value; 100,000,000 shares authorized; issued and
outstanding shares: 53,295,481 at June 30, 2003 and 31,157,612 at December 31,
2002 |
250,587 | 230,853 | |||||||||
Accumulated deficit |
(204,803 | ) | (189,443 | ) | |||||||
Total shareholders equity |
45,784 | 41,410 | |||||||||
Total liabilities,
redeemable
convertible
preferred stock and
shareholders
equity |
$ | 94,848 | $ | 97,129 | |||||||
See accompanying notes.
2
ARADIGM CORPORATION
STATEMENTS OF OPERATIONS
Three Months Ended | ||||||||||
June 30, | ||||||||||
2003 | 2002 | |||||||||
(Unaudited) | ||||||||||
(In thousands, except per share data) | ||||||||||
Contract revenues (Including amounts from related parties: |
||||||||||
2003 $9,255; 2002 $6,558) |
$ | 9,378 | $ | 7,295 | ||||||
Operating expenses: |
||||||||||
Research and development |
14,001 | 14,588 | ||||||||
General and administrative |
2,844 | 2,809 | ||||||||
Total operating expenses |
16,845 | 17,397 | ||||||||
Loss from operations |
(7,467 | ) | (10,102 | ) | ||||||
Interest income |
86 | 210 | ||||||||
Interest expense and other |
(39 | ) | (84 | ) | ||||||
Net loss |
$ | (7,420 | ) | $ | (9,976 | ) | ||||
Basic and diluted net loss per share |
$ | (0.15 | ) | $ | (0.34 | ) | ||||
Shares used in computing basic and diluted net loss per share |
51,144 | 29,723 | ||||||||
See accompanying notes.
3
ARADIGM CORPORATION
STATEMENTS OF OPERATIONS
Six Months Ended | ||||||||||
June 30, | ||||||||||
2003 | 2002 | |||||||||
(Unaudited) | ||||||||||
(In thousands, except per share data) | ||||||||||
Contract revenues (Including amounts from related parties: |
||||||||||
2003 $16,824; 2002 $14,157 |
$ | 17,068 | $ | 15,413 | ||||||
Operating expenses: |
||||||||||
Research and development |
27,000 | 28,901 | ||||||||
General and administrative |
5,513 | 5,267 | ||||||||
Total operating expenses |
32,513 | 34,168 | ||||||||
Loss from operations |
(15,445 | ) | (18,755 | ) | ||||||
Interest income |
194 | 501 | ||||||||
Interest expense and other |
(95 | ) | (250 | ) | ||||||
Net loss |
(15,346 | ) | (18,504 | ) | ||||||
Basic and diluted net loss per share: |
||||||||||
Net loss per share |
$ | (0.35 | ) | $ | (0.62 | ) | ||||
Shares used in computing basic and diluted net loss per share |
43,440 | 29,634 | ||||||||
See accompanying notes.
4
ARADIGM CORPORATION
STATEMENTS OF CASH FLOWS
Six Months Ended | ||||||||||
June 30, | ||||||||||
2003 | 2002 | |||||||||
(Unaudited) | ||||||||||
(In thousands) | ||||||||||
Cash flows from operating activities: |
||||||||||
Net loss |
$ | (15,346 | ) | $ | (18,504 | ) | ||||
Adjustments to reconcile net loss to cash used in operating activities: |
||||||||||
Depreciation and amortization |
3,177 | 2,954 | ||||||||
Issuance of warrants and common stock for services |
10 | 2 | ||||||||
Amortization of deferred compensation |
| 54 | ||||||||
Changes in operating assets and liabilities: |
||||||||||
Receivables |
115 | 1,023 | ||||||||
Other current assets |
81 | (822 | ) | |||||||
Other assets |
10 | 24 | ||||||||
Accounts payable |
(941 | ) | (3,280 | ) | ||||||
Accrued compensation |
1,173 | 1,714 | ||||||||
Other accrued liabilities |
157 | (2,308 | ) | |||||||
Deferred rent |
108 | 150 | ||||||||
Deferred revenue |
(2,801 | ) | (5,267 | ) | ||||||
Net cash used in operating activities |
(14,257 | ) | (24,260 | ) | ||||||
Cash flows from investing activities: |
||||||||||
Capital expenditures |
(2,488 | ) | (6,627 | ) | ||||||
Purchase of available-for-sale investments |
(1,663 | ) | (7,410 | ) | ||||||
Proceeds from maturities of available-for-sale investments |
4,792 | 4,762 | ||||||||
Net cash provided by (used) in investing activities |
641 | (9,275 | ) | |||||||
Cash flows from financing activities: |
||||||||||
Proceeds from issuance of common stock, net |
16,560 | 722 | ||||||||
Cost from issuance of redeemable convertible preferred stock |
| (70 | ) | |||||||
Notes receivable from officers |
(165 | ) | (53 | ) | ||||||
Payments on lease obligations and equipment loans |
(1,185 | ) | (2,006 | ) | ||||||
Net cash provided by (used in) financing activities |
15,208 | (1,407 | ) | |||||||
Net increase (decrease) in cash and cash equivalents |
1,592 | (34,942 | ) | |||||||
Cash and cash equivalents at beginning of period |
22,800 | 69,965 |
Six Months Ended | ||||||||||
June 30, | ||||||||||
2003 | 2002 | |||||||||
(Unaudited) | ||||||||||
(In thousands) | ||||||||||
Cash and cash equivalents at end of period |
$ | 24,392 | $ | 35,023 | ||||||
Supplemental disclosure of cash flow information: |
||||||||||
Cash paid for interest |
$ | 95 | $ | 292 | ||||||
Non-cash investing and financing activities: |
||||||||||
Issuance of common stock through conversion of Series A preferred stock |
$ | 3,165 | $ | | ||||||
Issuance of warrants in conjunction with private placement of common stock |
$ | 2,469 | $ | | ||||||
Issuance of warrants and options to purchase common stock for services |
$ | 10 | $ | 2 | ||||||
See accompanying notes.
5
ARADIGM CORPORATION
NOTES TO THE UNAUDITED FINANCIAL STATEMENTS
June 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. 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, 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 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 Sheets and amortized as a charge to operations 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 (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.
Three Months Ended | Six Months Ended | ||||||||||||||||
June 30, | June 30, | ||||||||||||||||
2003 | 2002 | 2003 | 2002 | ||||||||||||||
Net loss applicable to |
$ | (7,420 | ) | $ | (9,976 | ) | $ | (15,346 | ) | $ | (18,504 | ) | |||||
Add: |
|||||||||||||||||
Stock-based employee compensation
expense included in reported net loss |
$ | | $ | 41 | $ | | $ | 54 | |||||||||
Less: |
|||||||||||||||||
Total stock-based employee compensation
expense determined under fair value based
method for all awards |
$ | (1,327 | ) | $ | (1,750 | ) | $ | (2,883 | ) | $ | (3,951 | ) | |||||
Pro forma net loss applicable to |
$ | (8,747 | ) | $ | (11,685 | ) | $ | (18,229 | ) | $ | (22,401 | ) | |||||
Basic and diluted net loss per share
as reported |
$ | (0.15 | ) | $ | (0.34 | ) | $ | (0.35 | ) | $ | (0.62 | ) | |||||
Pro forma |
$ | (0.17 | ) | $ | (0.39 | ) | $ | (0.42 | ) | $ | (0.76 | ) |
The Company accounts for options and warrants issued to non-employees under SFAS 123 and Emerging Issues Task Force Issue No. 96-18. 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.
Reclassifications |
Certain reclassifications of prior year amounts have been made to conform with current year presentation.
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. Westons business involved the design, development, manufacture and exploitation of drug delivery technologies, including a proprietary needle-free injection technology known as Intraject. The Company has acquired test and production equipment, intellectual property and other assets associated with Westons drug delivery technologies for a cash consideration of approximately $2.0 million. The initial purchase price and subsequent transfer costs have been capitalized and preliminarily included in property and equipment on the balance sheet at June 30, 2003. The Company will finalize determination of fair value of the acquired assets and the allocation of the capitalized costs between property and equipment and intangible assets in the subsequent quarter.
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 $1,366,964 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 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 $1,101,798 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 and June 2003, holders of an aggregate of 206,610 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 826,440 shares of common stock in connection with the conversion.
5. | 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 seeking a declaration that Lilly scientists were co-inventors of patent applications 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 applications. The complaint also contained allegations of breach of contract, misappropriation of trade secrets, breach of fiduciary duty, conversion and unjust enrichment and sought unspecified damages and injunctive relief. Prior to trial, the Court granted summary judgment in favor of the Company as to Lillys claims relating to an alleged license agreement, for misappropriation of trade secrets, breach of fiduciary duty, conversion, estoppel and breach of contract (in part), dismissing those claims from the case. The remaining claims were tried before a jury during April 2002. The jury returned verdicts in favor of the Company and against Lilly on three of four of Lillys asserted claims of co-inventorship and on Lillys unjust enrichment claim. The jury returned verdicts in favor of Lilly on one of Lillys claims of co-inventorship and on two breach of contract claims, awarding Lilly damages of $1 for each breach of contract claim. On appeal to the Court of Appeals for the Federal Circuit, Lilly has pursued only claims regarding co-inventorship, entitlement to a royalty free license under unspecified related patents and/or restrictions on Aradigms ability to use certain data generated in studies conducted with Lilly-supplied material. Accordingly, management now believes that even an adverse outcome in this litigation would not have a material adverse effect on the Company.
6. | Related Party |
Novo Nordisk and its affiliate, Novo Nordisk Pharmaceuticals, Inc., are considered related parties and at June 30, 2003 own approximately 13% of the Companys total outstanding common stock (on an as-converted basis).
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 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 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 June 30, 2003, we had an accumulated deficit of $205 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 2003. 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 licensed for various compounds to GlaxoSmithKline, Roche Laboratories and Abbott Laboratories, as well as several smaller companies. We are planning to enter into renegotiated replacement license agreements with these companies, but we may elect to assume the existing licenses, depending on the circumstances. In some cases, a partnership may not be disclosed until a long-term development agreement has been established.
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 six months ended June 30, 2003, this partner-funded program has contributed approximately 99% of our total contract revenues. At June 30, 2003, Novo Nordisk and its affiliate Novo Nordisk Pharmaceuticals, Inc. own approximately 13% of our total outstanding common stock (on an as-converted basis) and are considered a related party.
During December 2000, GlaxoSmithKline and we amended the product development and commercialization agreement covering the use of the AERx Pain Management System for the delivery of narcotic analgesics 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 we will successfully enter into an alternative partnership agreement for this product if GlaxoSmithKline does not elect to restore its rights.
No product development or milestone payments were received from GlaxoSmithKline during 2002 or in the first half of 2003.
In addition to the diabetes, morphine and fentanyl programs, we have four additional AERx programs in development, three of which are partner funded. 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 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 such payments are no longer refundable.
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 June 30, 2003 and 2002
Contract and License Revenues: Contract revenues for the three months ended June 30, 2003 increased to $9.4 million from $7.3 million for the same period in 2002. Revenue from Novo Nordisk was $9.3 million for the three months ended June 30, 2003 and $6.6 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 and offset by lower revenue from other funded programs. Costs associated with collaborative agreements are included in research and development expenses. The Company expects 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.
Research and Development Expenses: Research and development expenses for the three months ended June 30, 2003 decreased to $14.0 million from $14.6 million for the same period in 2002. The decrease in research and development expenses is primarily due to a reduction in unfunded 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.
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.
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. Activity in this program has been limited since delivery to GlaxoSmithKline of data from the Phase 2b clinical trials in the second quarter of 2002. We are in a position to move forward with this program and start Phase 3 trials within a year; however, future progress for this program is contingent on either GlaxoSmithKline recommitting to this program or our entering into another development agreement with a new partner.
We have four additional programs, three of which are 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 $2.8 million for both of the three month periods ended June 30, 2003 and June 30, 2002.
Interest Income: Interest income for the three months ended June 30, 2003 decreased to $86,000 from $210,000 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 June 30, 2003 decreased to $39,000 from $84,000 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 June 30, 2003 of $7.4 million was lower compared to the $10.0 million loss for the same period in 2002, reflecting higher Novo Nordisk contract revenues and reduced expenses for unfunded projects.
Six Months Ended June 30, 2003 and 2002
Contract Revenues: Contract revenues for the six months ended June 30, 2003 increased to $17.1 million from $15.4 million for the same period in 2002. Revenue from Novo Nordisk was $16.8 million for the six months ended June 30, 2003 and $14.2 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 offset by lower revenue from other funded programs. Costs associated with collaborative agreements are included in research and development expenses. The Company expects 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.
Research and Development Expenses: Research and development expenses for the six months ended June 30, 2003 decreased to $27.0 million from $28.9 million for the same period in 2002. The decrease in research and development expenses is primarily due to a reduction in unfunded development efforts and cost reduction programs.
General and Administrative Expenses: General and administrative expenses for the six months ended June 30, 2003 increased to $5.5 million from $5.3 million for the same period in 2002. The increase is primarily due to higher business development and investor relations expenses and higher facility support costs.
Interest Income: Interest income for the six months ended June 30, 2003 decreased to $194,000 from $501,000 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 six months ended June 30, 2003 decreased to $95,000 from $250,000 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 six months ended June 30, 2003 decreased to $15.3 million from $18.5 million for the same period in 2002 reflecting our focus on the Novo Nordisk funded project and cost reduction efforts in other area.
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 June 30, 2003, we had cash, cash equivalents and investments of approximately $28.2 million.
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, 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.
Net cash used in operating activities for the six months ended June 30, 2003 decreased to $14.3 million from $24.3 million for the same period in 2002. Net cash used was substantially higher in 2002 due to the greater operating loss, payments of accrued accounts payable and accrued liabilities and greater recognition of deferred revenue carried over from 2001.
Investing activities for the six months ended June 30, 2003 provided cash $641,000 in contrast to the use of cash of $9.3 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 assets and intellectual property.
On May 12, 2003, we completed the purchase of certain assets from Weston, a UK public company currently in bankruptcy. Westons 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 Westons drug delivery technologies for a cash consideration of $2.0 million. The acquisition was funded out of our working capital. We will continue the development of Westons 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 six months ended June 30, 2003 was $15.2 million compared to a use of $1.4 million for the same period in 2002. The increase in cash provided is the result of the completion of the private placement 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 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 $10 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 June 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 24 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 June 30, 2003, we had cash and cash equivalents and short-term investments of $28.2 million consisting of cash and highly liquid short-term investments. Our short-term investments will decline by an immaterial amount if market interest rates increase, and therefore, our exposure to interest rate changes has been immaterial. Declines of interest rates over time will, however, reduce our interest income from our short-term investments. Our outstanding capital lease obligations are all at fixed interest rates and, therefore, have minimal exposure to changes in interest rates.
Item 4. Controls and Procedures
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 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 control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
In June 1998, Eli Lilly and Company (Lilly) filed a complaint against us in the United States District Court for the Southern District of Indiana seeking a declaration that Lilly scientists were co-inventors of patent applications filed by us 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 applications. The complaint also contained allegations of breach of contract, misappropriation of trade secrets, breach of fiduciary duty, conversion and unjust enrichment and sought unspecified damages and injunctive relief. Prior to trial, the Court granted summary judgment in our favor as to Lillys claims relating to an alleged license agreement, for misappropriation of trade secrets, breach of fiduciary duty, conversion, estoppel and breach of contract (in part), dismissing those claims from the case. The remaining claims were tried before a jury during April 2002. The jury returned verdicts in our favor and against Lilly on three of four of Lillys asserted claims of co-inventorship and on Lillys unjust enrichment claim. The jury returned verdicts in favor of Lilly on one of Lillys claims of co-inventorship and on two breach of contract claims, awarding Lilly damages of $1 for each breach of contract claim. On appeal to the Court of Appeals for the Federal Circuit, Lilly has pursued only claims regarding co-inventorship, entitlement to a royalty free license under unspecified related patents and/or restrictions on our ability to use certain data generated in studies conducted with Lilly-supplied material. Accordingly, we now believe that even an adverse outcome in this litigation would not have a material adverse effect on us.
Item 4. Submission of Matters to a Vote of Security Holders
(a) The Annual Meeting of Shareholders of Aradigm Corporation was held on May 15, 2003.
(b) Frank H. Barker, Stan M. Benson, Igor Gonda, John M. Nehra, Wayne I. Roe, Richard P. Thompson and Virgil D. Thompson, 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:
(1a) 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: Against: |
38,055,773 573,093 |
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(1b) 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: Against: |
37,917,031 711,835 |
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(1c) 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: Against: |
37,306,001 1,322,865 |
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(1d) 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: Against: |
38,058,077 570,789 |
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(1e) 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: Against: |
38,060,473 568,393 |
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(1f) 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: Against: |
38,064,186 564,680 |
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(1g) 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: Against: |
37,912,531 716,335 |
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(2) Proposal to amend the 1996 Equity Incentive Plan to increase the maximum number of shares available for issuance under the evergreen feature of the 1996 Plan by 2,000,00 shares to 10,000,000: |
For: Against: Abstained: |
28,030,868 1,236,376 48,394 |
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(3) Proposal to amend the Employee Stock Purchase Plan to increase the number of shares authorized for issuance under the Purchase Plan by 2,000,000 to 3,250,000 shares: |
For: Against: Abstained: |
29,012,444 260,561 42,633 |
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(4) Proposal to authorize future issuances of common stock to Novo Nordisk: |
For: Against: Abstained: |
28,687,465 606,790 21,383 |
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(5) Ratification of the selection of Ernst & Young LLP as independent auditors of the Company for its fiscal year ending December 31, 2003: |
For: Against: Abstained: |
38,552,466 58,277 18,123 |
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Item 6. Exhibits and Reports on Form 8-K
(a) | Exhibits |
10.1(1) | The Companys 1996 Equity Incentive Plan, as amended. | |
10.2(1) | The Companys Employee Stock Purchase Plan, as amended. | |
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. |
(1) | Incorporated by reference to the Companys definitive proxy statement filed on April 4, 2003. |
(b) | Reports on Form 8-K | ||
We filed a Current Report on Form 8-K dated April 24, 2003 to furnish a press release in which we announced our financial results for the first quarter ended March 31, 2003. |
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) |
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/s/ RICHARD P. THOMPSON
Richard P. Thompson Chief Executive Officer |
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/s/ THOMAS C. CHESTERMAN
Thomas C. Chesterman Senior Vice President and Chief Financial Officer |
Dated: August 11, 2003
INDEX TO EXHIBITS
Exhibit | |||
Number | Description | ||
10 | .1(1) | The Companys 1996 Equity Incentive Plan, as amended. | |
10 | .2(1) | The Companys Employee Stock Purchase Plan, as amended. | |
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. |
(1) | Incorporated by reference to the Companys definitive proxy statement filed on April 4, 2003. |