18 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 1996 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number 0-28402 ARADIGM CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) California (I.R.S. Employer Identification No.) 94-3133088 26219 Eden Landing Road, Hayward, CA 94545 (Address of principal executive offices including zip code) (510) 783-0100 (Registrant's telephone number, including area code) (Former name, former address and former fiscal year, if changed since last report) 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. (1) Yes X No (2) Yes No X Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date. Common Stock, no par value 10,216,820 shareS (Class) (Outstanding at July 31, 1996) ARADIGM CORPORATION INDEX PART I. FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS Page No. Statements of Operations (Unaudited) Three months ended June 30, 1995 and 1996 and period from January 30, 1991 (inception) through June 30, 1996 3 Six months ended June 30, 1995 and 1996 4 Balance Sheets (Unaudited) December 31, 1995 and June 30, 1996 5 Statements of Cash Flows (Unaudited) Six months ended June 30, 1995 and 1996 and period from January 30, 1991 (inception) through June 30, 1996 6 Notes to Unaudited Financial Statements 8 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF 10 FINANCIAL CONDITION AND RESULTS OF OPERATIONS PART II. OTHER INFORMATION ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF 13 SECURITY HOLDERS ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K 14 Signatures 15 Exhibits 16 PART 1. FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS ARADIGM CORPORATION (A development stage company) STATEMENTS OF OPERATIONS (Unaudited) Three months ended June 30, 1995 1996 Contract revenues $ - $ 86,250 Expenses: Research and development 650,281 1,549,732 General and administrative 483,644 788,616 Total expenses 1,133,925 2,338,348 Loss from operations (1,133,925) (2,252,098) Interest income 55,843 142,013 Interest expense 0 (12,035) Net loss $ (1,078,082) $( 2,122,120) Net loss per share $ (0.30) $ (0.27) Shares used in computing net loss per share 3,624,635 7,757,948 See notes to the unaudited financial statements. ARADIGM CORPORATION (A development stage company) STATEMENT OF OPERATIONS (Unaudited) Period from January 30, 1991 Six months ended (inception) June 30, through 1995 1996 June 30, 1996 Contract revenues $ 125,000 $ 172,500 $ 452,500 Expenses: Research and development 1,384,401 2,788,908 10,091,443 General and administrative 1,068,129 1,379,768 6,611,432 Total expenses 2,452,530 4,168,676 16,702,875 Loss from operations (2,327,530) (3,996,176) (16,250,375) Interest income 129,732 289,226 554,037 Interest expense - (22,918) (102,063) Net loss $(2,197,798) $(3,729,868) $(15,798,401) Net loss per share $ (0.61) $ (0.78) Shares used in computing net loss per share 3,624,635 4,752,227 See notes to the unaudited financial statements ARADIGM CORPORATION (A development stage company) BALANCE SHEETS December 31, June 30, 1995 1996 (unaudited) Assets Current assets: Cash and cash equivalents $ 12,117,355 $ 34,450,133 Contract receivable 260,000 - Other current assets 74,127 186,696 Total current assets 12,451,482 34,636,829 Property and equipment, net 636,351 812,223 Notes receivable from officers 150,444 165,262 Other assets 68,099 75,063 Total assets $ 13,306,376 $ 35,689,377 Liabilities and shareholder's equity Current liabilities: Accounts payable $ 243,302 $ 1,150,704 Accrued compensation 217,643 506,661 Deferred revenue 230,000 57,500 Current portion of capital lease 167,003 261,277 obligations Total current liabilities 857,948 1,976,142 Noncurrent portion of capital lease 327,407 440,984 obligations Commitments Shareholders' equity: Preferred stock, no par value, issuable in series; shares authorized: 10,000,000 at December 31, 1995 and 5,000,000 at June 30, 1996; issued and outstanding shares, all of which are convertible: at December 31, 1995 - 5,611,910; at June 30, 1996 - none; aggregate liquidation preference of $25,284,342 at December 31, 1995 24,119,060 - Common stock, no par value, shares authorized: 20,000,000 at December 31, 1995 and 40,000,000 at June 30, 1996; issued and outstanding shares: 1995 - 1,327,025; 1996 - 10,209, 267,158 49,964,570 Notes receivable from shareholders (196,664) (483,245) Deferred compensation - (410,675) Deficit accumulated during (12,068,533) (15,798,399) development stage Total shareholders' equity 12,121,021 33,272,251 Total liabilities and shareholders' equity $ 13,306,376 $ 35,689,377 See notes to the unaudited financial statements ARADIGM CORPORATION (A development stage company) STATEMENTS OF CASH FLOWS (Unaudited) Period from January 30, 1991 Six months ended (inception) June 30, through 1995 1996 June 30, 1996 Cash flows used in operating activities: Net loss $(2,197,798) $(3,729,866) $(15,798,399) Adjustments to reconcile net loss to net cash flow used in operating activities: Depreciation and amortization 131,837 165,729 495,485 Amortization of deferred - 84,218 84,218 compensation Accrued interest on note exchanged for preferred stock - - 32,622 Loss on disposal of property - - 37,666 and equipment Loss on sale-leaseback - - 95,294 transaction Changes in operating assets and liabilities: Contract receivable (53,618) 260,000 - Other current assets (28,825) (112,569) (186,696) Other assets (3,600) (6,964) (75,063) Accounts payable (152,048) 907,402 1,150,704 Accrued compensation (24,335) 289,018 506,661 Deferred revenue - (172,500) 57,500 Net cash used in operating (2,328,387) (2,315,532) (13,600,008) activities Cash flows used in investing activities: Capital expenditures (587,733) (4,830) (888,991) Cash flows provided by financing activities: Proceeds from issuance of notes payable to shareholders - - 2,111,395 Repayment of notes payable to - - (298,972) shareholders Proceeds from issuance of - - 22,274,014 preferred stock Proceeds from issuance of common - 24,796,878 24,853,946 stock Repurchase of common stock - - (6,574) Proceeds from sale of equipment in sale-leaseback transaction - - 389,621 Notes receivable from officers - (14,818) (165,262) Payments on lease obligations - (128,920) (219,036) Net cash provided by financing - 24,653,140 48,939,132 activities Net increase(decrease) in cash and cash equivalents (2,916,120) 22,332,778 34,450,133 Cash and cash equivalents at beginning of period 6,086,912 12,117,355 - Cash and cash equivalents at end of period $ 3,170,792 $ 34,450,133 $ 34,450,133 See notes to the unaudited financial statements ARADIGM CORPORATION (A development stage company) NOTES TO UNAUDITED FINANCIAL STATEMENTS (Information at June 30, 1996 and for the three and six month periods ended June 30, 1995 and 1996 is unaudited) 1. Summary of Significant Accounting Policies Organization and Description of Business Aradigm Corporation (the "Company") was incorporated in the State of California on January 30, 1991. Since inception, the Company has been engaged in the development of non-invasive pulmonary drug delivery products. The Company's principal activities to date have been conducting research and development, recruiting personnel, focusing on business development, raising capital and acquiring assets. Accordingly, the Company is considered a development stage company. Basis of Presentation The financial information at June 30, 1996 and for the three-and six-month periods ended June 30, 1995 and 1996 is unaudited but includes all adjustments (consisting only of normal recurring adjustments) which the Company considers necessary for a fair presentation of the financial position at such date and the operating results and cash flows for those periods. Results for the interim periods are not necessarily indicative of the results for the entire year. Although the Company believes that the disclosures in these financial statements are adequate to make the information presented not misleading, certain information and footnote information normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). The accompanying financial statements should be read in conjunction with the Company's audited financial statements for the year ended December 31, 1995 included in the Company's registration statement no. 333- 4236 on Form S-1, filed with the SEC on April 30, 1996, as subsequently amended. Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. The Company maintains its cash and cash equivalents in depository and money market accounts with a single financial institution. The recorded amounts approximate fair value. In July, 1996, the Company invested certain of its excess cash and the net proceeds of its initial public offering in cash equivalents and short term investments. Short term investments consist of federal and municipal government securities, repurchase agreements or corporate paper and debt instruments with A1/P1 ratings with maturities at date of purchase of greater than 90 days and less than 18 months. The Company limits its concentration of risk by diversifying its investments among a variety of industries and issuers. Net Loss Per Share Net loss per share is computed using the weighted average number of common and dilutive common equivalent shares outstanding during the period. Common equivalent shares consist of the incremental common shares issuable upon conversion of the convertible preferred stock (using the if-converted method) and shares issuable upon the exercise of stock options and warrants (using the treasury stock method) when their effect is dilutive. In addition, pursuant to SEC Staff Accounting Bulletins and Staff policy, such computations include the effect of all dilutive and antidilutive common and common equivalent shares issued within 12 months of the proposed public offerings date as if they were outstanding for all periods presented determined using the treasury stock method and the estimated per share public offering price. 2. Initial Public Offering - Common Stock In June 1996, the Company completed an initial public offering of 2,500,000 shares of common stock resulting in net proceeds to the Company of approximately $24,700,000. In connection with and immediately prior to the closing of the initial public offering (i) 3,741,283 shares of preferred stock were converted to an equal number of shares of common stock, (ii) 5,068,308 shares of common stock, including the shares of common stock issued in the conversion of the preferred stock, were exchanged for 7,594,064 shares of common stock, respectively, in a three for two stock split, (iii) warrants to purchase 115,256 shares of common stock (on a post-split basis) were exercised, and (iv) the Board of Directors was authorized to issue 5,000,000 shares of preferred stock and 40,000,000 shares of common stock. ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion of the financial condition and results of operations of the Company should be read in conjunction with the Financial Statements and the related Notes thereto included in this Form 10-Q. This discussion contains forward-looking statements which involve risks and uncertainties, except for historical information contained herein. The Company's actual results could differ materially from those anticipated in the 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 registration statement no. 333-4236 on Form S-1 filed with the SEC on April 30, 1996, as subsequently amended. The Company's business is subject to significant risks including, but not limited to, the success of its research and development efforts, its dependence on corporate partners for marketing and distribution resources, obtaining and enforcing patents important to the Company's business, clearing the lengthy and expensive regulatory process and possible competition from other products. Even if the Company's 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 will be found to be ineffective during clinical trials, fail to receive necessary regulatory approvals, be difficult to manufacture on a large scale, be uneconomical to market, be precluded from commercialization by proprietary rights of third parties or may not gain acceptance from health care professionals and patients. Overview Since its inception in 1991, Aradigm has been a development stage company engaged in the advancement of pulmonary drug delivery systems. As of June 30, 1996 the Company had an accumulated deficit of $15.8 million. The Company has been unprofitable each year and expects to incur further significant and increasing operating losses over the next several years primarily due to the expansion of research efforts and to the establishment of manufacturing capabilities to support clinical trials and, if any of its products are successfully developed and receive necessary regulatory approvals, commercialization of such products. To date, Aradigm has not sold any products and does not anticipate receiving any revenue from products or product royalties in the current year. The Company has not declared or paid any cash dividends on its capital stock and does not anticipate paying cash dividends in the foreseeable future. The Company anticipates that its results of operations may fluctuate for the foreseeable future due to several factors, including, the timing of research and development expenses (including clinical trial-related expenditures), actions related to regulatory and third-party reimbursement matters, the Company's ability to manufacture its products, if any, efficiently, the timing of new product introductions, if any, and competition. In addition, the Company's results of operations will be affected by its ability to enter into corporate collaborations. Results of Operations Three and Six Months Ended June 30, 1996 and 1995 Contract Revenue. Contract revenue for the three- and six- month periods ended June 30, 1996 increased to $86,250 and $172,500, respectively, from none and $125,000 for the same periods in 1995, respectively. These increases resulted from a new feasibility research contract that was initiated in the fourth quarter of 1995 and the conclusion of a feasibility research contract in the first quarter of 1995. Research and Development Expenses. Research and development expenses for the three-and six-month periods ended June 30, 1996 increased to $1.5 million and $2.8 million, respectively, from $650,000 and $1.4 million for the same periods in 1995, respectively. These increases were primarily due to the expansion of a research and development project which began preliminary clinical testing during 1996 and additional clinical testing. The Company expects research and development spending to increase significantly over the next few years as the Company expands its development efforts. General and Administrative Expenses. General and administrative expenses for the three- and six-month periods ended June 30, 1996 increased to $789,000 and $1.4 million, respectively, from $483,644 and $1.1 million for the same periods in 1995, respectively. These increases were primarily due to compensation expense associated with stock options recorded in the first and second quarters of 1996, the expansion of the Company's facilities and an increase in the number of employees. The Company expects to incur significantly greater general and administrative expenses in the future as it expands its operations and meets its obligations as a public company. Interest Income. Interest income for the three- and six-month periods ended June 30, 1996 increased to $142,013 and $289,226, respectively, from $55,843 and $129,732 for the same periods in 1995, respectively. These increases were due to interest income earned on the proceeds received from the sale of Series E preferred stock in the fourth quarter of 1995 and from the sale of common shares in the initial public offering in June 1996. As of December 31, 1995, the Company had federal net operating loss tax carry forwards of approximately $11.5 million. These carry forwards will expire beginning in the year 2006. Utilization of net operating loss carry forwards may be subject to substantial annual limitation due to the ownership change limitation provided for by the Internal Revenue Code of 1986. The annual limitation may result in the expiration of net operating loss carry forwards before utilization. Liquidity and Capital Resources The Company has financed its operations since inception primarily through private placement of its capital stock, proceeds from financing of equipment acquisitions, contract revenue and interest earned on investments. In June 1996, the Company completed an initial public offering resulting in net proceeds of approximately $24.7 million. As of June 30, 1996, the Company had realized approximately $48.9 million in net proceeds from sales of its capital stock since inception. The Company also has a secured line of credit of $l.8 million for equipment purchases, of which approximately $900,000 remained available at June 30, 1996. The draw down period under the line of credit terminates in June, 1997. At June 30, 1996, the Company had cash and cash equivalents of approximately $34.5 million. Net cash used in operating activities in the six months ended June 30, 1996, of $2.3 million approximately equaled that in the comparable period of 1995 due to the increase in the net loss of approximately $1.5 million, being offset by the increases in accounts payable, accrued compensation and the collection of the contract receivable. The increase in accounts payable was primarily as a result of the costs incurred during the initial public offering. From inception through June 30, 1996 the Company's cash utilized for operating activities totaled approximately $13.6 million. Net cash used in investing activities for both the six months ended June 30, 1996 and the six months ended June 30, 1995, relates solely to capital expenditures by the Company. Net cash provided by financing activities for the six months ended June 30, 1996 of $24.7 million was primarily due to the proceeds from the initial public offering. The Company expects that its cash requirements will increase due to expected increases in expenses related in research and development activities, the scale up of manufacturing processes and increases in general and administrative costs. The Company's cash requirements will be affected by the extent and duration of the foreign and domestic regulatory approval processes for its potential products. Although there can be no assurance that the Company will receive regulatory approval for any of its products, if the Company does so, its cash requirements may increase due to the significant expenses associated with initial commercial production and marketing efforts. These expenses include, but are not limited to, increases in personnel and related costs, capital expenditures, product prototype development expenses and the costs of facilities expansion. The Company expects that its existing capital resources and the proceeds from the initial public offering will enable the Company to maintain current and planned operations through 1997. The Company's cash requirements, however, may vary materially from those now planned because of results of research and development efforts, including capital expenditures and funding preclinical and clinical trials, and for manufacturing process development in connection with the commercialization of the SmartMist Asthma Management System and to provide manufacturing capacity for preclinical, clinical and full scale manufacturing requirements of the AERx Pain Management System. The Company may need to raise substantial additional capital to fund its operations before the end of 1997. The Company expects that it will seek such additional funding through collaborations, or through public or private equity or debt financing. The Company has not yet established any corporate development collaborations and there can be no assurance that it will be able to do so on reasonable terms, or at all. Nor can there be any assurance that additional financing can be obtained on acceptable terms, or at all. If additional funds are raised by issuing equity securities, dilution to shareholders may result. If adequate funds are not available, the Company may be required to delay, to reduce the scope of or to eliminate one or more of its research and development programs or to obtain funds through arrangements with collaborative partners or others that may require the Company to relinquish rights to certain of its technologies or products that the Company would not otherwise relinquish. PART II - OTHER INFORMATION ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY-HOLDERS As of June 5, 1996, prior to the completion of the Company's initial public offering, the shareholders of the company approved the following: (i) the amendment and restatement of the Company's Articles of Incorporation effecting a 3-for-2 stock split of the Company's outstanding capital stock and adopting certain shareholder protection measures; (ii) the amendment and restatement of the Company's Articles of Incorporation effective upon the closing of the initial public offering, eliminating the provisions designating the rights and preferences of the Company's Preferred Stock, increasing the number of authorized shares of the Company's Common Stock and decreasing the authorized number of shares of the Company's Preferred Stock; (iii) the amendment and restatement of the Company's Bylaws adopting certain other shareholder protection measures; (iv) the adoption of the Employee Stock Purchase Plan; (v) the amendment and restatement of the 1992 Stock Option Plan, which was renamed the 1996 Equity Incentive Plan; (vi) the adoption of the 1996 Non-Employee Directors' Stock Option Plan; and (vii) the adoption of a form of Indemnity Agreement, which was entered into by the Company with each of its directors and executive officers. Shareholder approval was solicited by means of a written consent. All shareholders were solicited. The Company received consents voting in favor of each of the proposals above from shareholders holding 5,051,773 shares out of a total of 5,062,726 shares outstanding on June 5, 1996. The Company did not receive any consents voting against any of the proposals above. ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K. (a) Exhibits (11) Net loss per share calculation (27) Financial Data Schedule (b) Reports on Forms 8-K. The Company filed no reports on Form 8-K during the quarter ended June 30, 1996. SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. Dated: August 13, 1996 ARADIGM CORPORATION (Registrant) /s/ Richard P. Thompson Richard P. Thompson President, Chief Executive Officer, Chief Financial Officer and Director (Principal Executive Officer and Chief Accounting Officer) Exhibit (11) Net Loss Per Share Calculation Three Months Ended Six Months Ended June 30, June 30, 1995 1996 1995 1996 Weighted average shares outstanding 936,680 2,146,038 936,680 1,946,272 Weighted average shares outstanding - conversion of preferred stock to common stock - 5,611,910 - 2,805,955 Net effect of dilutive and antidilutive stock options, warrants and convertible preferred stock (Series E) - based on the treasury stock method using average market price 2,687,955 - 2,687,955 - Total shares used in computing net loss 3,624,635 7,757,948 3,624,635 4,752,227 per share Net loss $(1,078,082) $(2,122,120) $(2,197,798) $(3,729,868) Net loss per share $ (0.30) $ (0.27) $ (0.61) $ (0.78)