SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 __________________ FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2000 OR [_] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 0-27150 __________________ PathoGenesis Corporation (Exact name of Registrant as specified in its charter) Delaware 91-1542150 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number) 201 Elliott Avenue West, Seattle, Washington 98119 (Address of Principal Executive Offices) (Zip Code) Registrant's telephone number, including area code: (206) 467-8100 __________________ 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 _______ ------- On May 10, 2000, the registrant had an aggregate of 16,558,762 shares of Common Stock issued and outstanding. PART I FINANCIAL INFORMATION Item 1. Financial statements PathoGenesis Corporation Condensed Consolidated Balance Sheets(Unaudited) March 31, 2000 December 31, 1999 --------------- ------------------ ASSETS Current assets: Cash and cash equivalents.................................................... $ 6,548,321 $ 10,456,031 Investment securities........................................................ 33,009,487 34,549,738 Accounts receivable, net..................................................... 8,426,607 6,038,299 Interest receivable.......................................................... 399,513 442,676 Inventories.................................................................. 13,686,372 14,613,385 Other........................................................................ 2,075,890 2,110,610 ------------- ------------- Total current assets.................................................... 64,146,190 68,210,739 ------------- ------------- Property and equipment, at cost: Land......................................................................... 2,994,188 3,030,938 Building and improvements.................................................... 1,437,210 1,454,850 Leasehold improvements....................................................... 9,926,435 9,735,242 Furniture and equipment...................................................... 17,437,221 16,948,235 ------------- ------------- 31,795,054 31,169,265 Less accumulated depreciation and amortization............................... 13,925,434 12,957,926 ------------- ------------- Net property and equipment.............................................. 17,869,620 18,211,339 ------------- ------------- License rights, net............................................................ 13,348,618 13,591,321 Other assets................................................................... 3,320,443 823,519 ------------- ------------- Total assets................................................................. $ 98,684,871 $ 100,836,918 ============= ============= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable............................................................. $ 501,665 $ 1,668,775 Compensation and benefits.................................................... 2,580,082 2,524,184 Clinical development costs................................................... 907,464 1,391,383 Accrued royalties............................................................ 464,651 906,629 Other accrued expenses....................................................... 2,058,422 2,781,644 Current portion of long-term liability....................................... 5,259,939 5,149,847 ------------- ------------- Total current liabilities............................................... 11,772,223 14,422,462 ------------- ------------- Stockholders' equity: Preferred stock, $0.01 par value. Authorized 1,000,000 shares; none issued and outstanding............................... -- -- Common stock, $0.001 par value. Authorized 60,000,000 shares; 16,517,893 shares and 16,451,530 shares issued and outstanding at March 31, 2000 and December 31, 1999, respectively 16,518 16,452 Additional paid-in capital................................................... 195,440,629 194,641,919 Deferred compensation........................................................ (410,959) (526,199) Accumulated other comprehensive loss......................................... (629,519) (582,036) Accumulated deficit.......................................................... (107,504,021) (107,135,680) ------------- ------------- Total stockholders' equity................................................... 86,912,648 86,414,456 ------------- ------------- Total liabilities and stockholders' equity................................... $ 98,684,871 $ 100,836,918 ============= ============= See accompanying notes. 1 PathoGenesis Corporation Condensed Consolidated Statements of Operations (Unaudited) Three Months Ended March 31, --------------------------------------- 2000 1999 ----------- ----------- Revenues: Sales......................................... $19,374,747 $10,056,135 Grants and royalties.......................... 173,684 204,263 ----------- ----------- Total revenues........................... 19,548,431 10,260,398 Operating expenses: Cost of sales................................. 3,445,899 2,202,061 Research and development...................... 8,559,860 6,840,469 Selling, general and administrative........... 8,347,802 6,537,571 ----------- ----------- Total operating expenses................. 20,353,561 15,580,101 ----------- ----------- Operating loss........................... (805,130) (5,319,703) ----------- ----------- Other income (expense): Investment income, net........................ 671,752 827,200 Interest expense.............................. (110,339) (218,380) Other expense................................. (124,624) (26,780) ----------- ----------- Net other income......................... 436,789 582,040 ----------- ----------- Net loss................................. $ (368,341) $(4,737,663) =========== =========== Loss per common share - basic and diluted....... $ (0.02) $ (0.29) =========== =========== Weighted average common shares outstanding - basic and diluted............................. 16,488,100 16,378,828 See accompanying notes. 2 PathoGenesis Corporation Condensed Consolidated Statements of Cash Flows (Unaudited) Three Months Ended March 31, -------------------------------- 2000 1999 ----------- ------------ Cash flows from operating activities: Net loss.......................................................................... $ (368,341) $ (4,737,663) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization................................................... 972,620 825,302 Amortization of license rights.................................................. 242,702 242,702 Amortization of discount on long-term liability................................. 110,092 211,094 Compensation expense from stock options......................................... 190,240 115,240 Change in certain assets and liabilities: Accounts receivable........................................................... (2,389,202) 6,034,764 Interest receivable........................................................... 43,163 (88,393) Inventories................................................................... 926,796 (2,510,177) Other current assets.......................................................... 38,686 1,590,503 Other assets.................................................................. 43,183 (838,729) Accounts payable.............................................................. (1,172,017) (334,370) Compensation and benefits..................................................... 55,898 (1,348,244) Clinical development costs.................................................... (482,894) 326,960 Accrued royalties............................................................. (441,978) (566,765) License payable............................................................... -- (2,000,000) Other accrued expenses........................................................ (720,492) (375,790) ----------- ------------ Net cash used in operating activities........................................ (2,951,544) (3,453,566) ----------- ------------ Cash flows from investing activities: Purchases of investment securities................................................ (7,248,894) (13,437,697) Sales of investment securities.................................................... 8,759,859 10,942,724 Purchase of property and equipment................................................ (692,707) (1,020,935) Investment in AeroGen, Inc........................................................ (2,500,000) -- ----------- ------------ Net cash used in investing activities........................................ (1,681,742) (3,515,908) ----------- ------------ Cash flows from financing activities: Proceeds from issuance of common stock in connection with employee stock purchase plan............................................. 119,560 325,876 Stock option and warrant exercises................................................ 604,216 418,348 ----------- ------------ Total cash provided by financing activities.................................. 723,776 744,224 ----------- ------------ Effect of exchange rate changes on cash............................................. 1,800 -- ----------- ------------ Net decrease in cash and cash equivalents.................................... (3,907,710) (6,225,250) Cash and cash equivalents at beginning of period.................................... 10,456,031 8,139,153 ----------- ------------ Cash and cash equivalents at end of period.......................................... $ 6,548,321 $ 1,913,903 =========== ============ See accompanying notes. 3 PathoGenesis Corporation NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) MARCH 31, 2000 AND 1999 (1) BASIS OF PRESENTATION We have prepared the accompanying condensed consolidated financial statements of PathoGenesis Corporation and subsidiaries and these notes in accordance with Securities and Exchange Commission rules and regulations for interim financial statements. As permitted by those rules and regulations, we have condensed or omitted certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles. You should read the accompanying condensed consolidated financial statements and these notes in conjunction with our audited consolidated financial statements for 1999 included in our annual report on Form 10-K. The information furnished reflects, in the opinion of our management, all adjustments, consisting only of normal recurring items, necessary for a fair presentation of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year. (2) INVENTORIES Inventories are stated at the lower of cost, as determined by the first- in, first-out method, or market. Inventories consisted of the following: March 31, 2000 December 31, 1999 -------------- ----------------- Finished goods $ 1,982,383 $ 2,433,718 Work in progress 3,397,703 2,907,128 Raw materials and supplies 8,306,286 9,272,539 -------------- ---------------- $ 13,686,372 $ 14,613,385 ============== ================ (3) LOSS PER COMMON SHARE We have not included options and warrants to purchase 3,907,839 and 2,960,357 shares of common stock that were outstanding during the first quarters of 2000 and 1999, respectively, in the computation of diluted loss per share because the representative share increments would be antidilutive. (4) COMPREHENSIVE LOSS Total comprehensive loss amounted to $415,824 for the first quarter of 2000 and $4,870,059 for the first quarter of 1999. Our other comprehensive income (loss) is comprised of unrealized gains and losses on available-for-sale investment securities and foreign currency translation adjustments. (5) BUSINESS SEGMENTS In 1998, we adopted Statement of Financial Accounting Standards (SFAS) No. 131, Disclosures about Segments of an Enterprise and Related Information. SFAS No. 131 requires an enterprise to report segment information based on how management internally evaluates the operating performance of its business units (segments). Our operations are confined to one business segment, the development of drugs to treat chronic infectious diseases. 4 (6) COLLABORATION AND INVESTMENT AGREEMENTS In January 2000, we entered into a collaboration with Chiron Corporation to discover and develop new antibiotics. The collaboration combines Chiron's combinatorial chemistry library and expertise in high-throughput screening with our strengths in bacterial target discovery and antibiotic development, as well as our knowledge of the Pseudomonas aeruginosa genome. The focus of this collaboration is on the discovery of novel treatments for infectious diseases, specifically antibiotics with new mechanisms of action to address serious medical needs, such as antibiotic resistance. In March 2000, we entered into an agreement with AeroGen, Inc. to collaborate on the development and registration of a product combining TOBI and AeroGen's hand-held, portable AeroDose/(TM)/ Inhaler. Our goal is to reduce TOBI's delivery time from 15-20 minutes to 5-10 minutes or less. Under the development and supply agreement, we will reimburse AeroGen for costs incurred in developing the AeroDose Inhaler and will obtain worldwide exclusive distribution rights to the product. AeroGen will receive royalties on all product sales. Under a separate agreement, we invested $2.5 million in convertible preferred stock of privately held AeroGen. This investment is included in other assets and accounted for under the cost method. (7) LEGAL PROCEEDINGS On February 18, 2000, the United States District Court for the Western District of Washington dismissed with prejudice all eight consolidated putative class action lawsuits that had been filed in March and April 1999 against PathoGenesis Corporation, our chief executive officer and our chief financial officer. The eight consolidated lawsuits purported to allege claims on behalf of all purchasers of PathoGenesis common stock during the period January 15, 1999 to March 22, 1999. Plaintiffs had claimed that the company and the officers violated certain provisions of the federal securities laws by making statements in early 1999 regarding the company's 1998 financial results. The court's order dismissed the consolidated cases and bars plaintiffs from filing another lawsuit on the matter. Plaintiffs have appealed the dismissal order to the United States Court of Appeals for the Ninth Circuit. We intend to defend the appeal vigorously. Although we cannot ascertain the ultimate outcome of the appeal at this time or predict with certainty the results of legal proceedings, we currently believe that the resolution of the appeal will not have a material adverse effect on our financial position or results of operations. 5 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations In addition to historical information, this quarterly report on Form 10-Q contains forward-looking statements. You may identify these forward-looking statements by the use of such words as "believe," "anticipate," "expect," "plan" and "intend," among others. Since these statements are based on factors that involve risks and uncertainties, they do not necessarily indicate what our actual future results will be, and results may vary from quarter to quarter. Important factors that could cause or contribute to material differences between our actual results and the results expressed or implied by the forward-looking statements include, but are not limited to, those discussed in "Item 1. Business," "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" of our annual report on Form 10-K for 1999, and in Exhibit 99.1 to the Form 10-K. These factors include, but are not limited to, uncertainties related to the fact that PathoGenesis only began commercial operations in 1998, its dependence on TOBI (tobramycin solution for inhalation), the degree of penetration of its markets and frequency of TOBI's use by patients, risks associated with marketing TOBI in international markets, third party reimbursement and product pricing, seasonal impacts on hospitalizations or exacerbations experienced by patients, variability in wholesaler ordering patterns, drug development and clinical trials, uncertain outcome of the U.S. and international drug approval process, competition and alternative therapies. We cannot assure you that TOBI -- which is currently our only product -- will penetrate markets as planned, that our development of TOBI for other uses will succeed or occur within anticipated time frames, or that we will develop any of our other drug candidates successfully. Results of Operations Revenues. Revenues in the first quarter of 2000 totaled $19.5 million, including $19.4 million from TOBI sales. Revenues for the corresponding period in 1999 were $10.3 million, with $10.1 million resulting from sales of TOBI. TOBI sales volume varies from quarter to quarter depending on a number of factors, including underlying demand and wholesaler inventory management practices. Our analysis suggests that sales in the first quarter of 1999 were lower as a result of increased patient demand and wholesaler purchases in the fourth quarter of 1998 and lower than anticipated demand and purchases in the first quarter of 1999. We do not believe such factors negatively affected sales in the first quarter of 2000. Operating Expenses. We incurred total operating expenses of $20.4 million in the first quarter of 2000, an increase of $4.8 million from $15.6 million in the first quarter of 1999. Cost of sales was $3.4 million for the first quarter of 2000, up $1.2 million from $2.2 million for the corresponding period in 1999. The increase in cost of sales is directly related to the corresponding increase in sales. However, cost of sales as a percentage of sales declined as sales volumes increased. Research and development expense for the first quarter of 2000 increased by $1.8 million to $8.6 million from $6.8 million for the first quarter of 1999, as we invested in a number of programs. These include preclinical studies on PA-1806, which is expected to enter Phase I clinical trials later in 2000. In addition, we have begun a program to develop the next- generation TOBI, with the goal of improving convenience and significantly shortening the time required for a treatment. In the second quarter of 2000, we intend to begin a clinical trial of TOBI to be administered using a portable inhaler made by AeroGen, Inc. We expect our research and development expenses to increase over the next several quarters as our efforts in these areas progress, and as we initiate additional clinical trials of TOBI in cystic fibrosis and other patients. Selling, general and administrative expenses increased to $8.3 million for the first quarter of 2000 from $6.5 million for the corresponding period in 1999. This increase is primarily attributable to an increase in sales and marketing costs. We have expanded our U.S. sales force and strengthened our marketing efforts in order to further penetrate the domestic cystic fibrosis market. In addition, we have made significant investments in establishing sales and marketing capabilities in international markets, including Europe and Canada. We expect our selling, general and administrative expenses to increase over the next several quarters as we continue to expand TOBI's markets. 6 Net Loss. We had an operating loss of $805,000 in the first quarter of 2000, a decrease of $4.5 million from the operating loss of $5.3 million in the first quarter of 1999. This decrease in operating loss was due to improved TOBI sales in the first quarter of 2000. Including net other income (primarily income from investment securities), our net loss for the first quarter of 2000 was $368,000, compared to a net loss of $4.7 million for the first quarter of 1999. In the first quarter of 2000, net investment income decreased by $155,000 to $672,000 from $827,000 for the corresponding period in 1999. The decrease was primarily due to lower average invested cash balances. Interest expense, most of which represents the amortization of the discount on the remaining installment of our obligation to the Cystic Fibrosis Foundation, totaled $110,000 and $218,000 in the first quarters of 2000 and 1999, respectively. Liquidity and Capital Resources Our combined cash, cash equivalents and investment securities totaled $39.6 million at March 31, 2000, a decrease of $5.4 million from the balance of $45.0 million at December 31, 1999. We expect that these funds, in combination with expected revenues from sales of TOBI, should be sufficient to meet our operating expenses and capital requirements for the foreseeable future. In addition, we have a $10.0 million revolving line of credit from Harris Trust and Savings Bank. Net cash used in operating activities totaled $3.0 million for the three months ended March 31, 2000, compared to $3.5 million for the three months ended March 31, 1999. We incurred a $368,000 net loss for the three months ended March 31, 2000, compared to a net loss of $4.7 million for the corresponding period in the prior year. Significant changes in working capital components included a $2.4 million increase in accounts receivable and a $927,000 decrease in inventories, compared to a $6.0 million decrease in accounts receivable and $2.5 million increase in inventories for the same period a year ago. Also, in the first quarter of 2000, we invested $2.5 million in convertible preferred stock of privately held AeroGen, Inc. AeroGen is the developer of the hand- held, portable AeroDose(TM) Inhaler, which is being developed to administer our next-generation TOBI. At March 31, 2000, our working capital was $52.4 million and current ratio was 5.45 to 1. We plan to continue our policy of investing excess funds in government securities and investment grade, interest-bearing securities, primarily those with an expected maturity of one-and-one-half years or less. Quantitative and Qualitative Disclosures about Market Risk We are exposed to the impact of interest rate changes and changes in the market values of our investments, in addition to changes in foreign currency exchange rates. Our exposure to market rate risk for changes in interest rates relates primarily to debt securities included in our investment portfolio. We do not hold any derivative financial instruments. We invest in government securities and high-quality corporate obligations. Investments in both fixed rate and floating rate interest-earning instruments carry a degree of interest rate risk. Fixed rate securities may decline in fair market value due to a rise in prevailing interest rates, while floating rate securities may produce less income than expected if prevailing interest rates fall. Due in part to these factors, our future investment income may fall short of expectations due to changes in interest rates, or we may suffer losses in principal if forced to sell securities which have declined in market value due to changes in interest rates. At March 31, 2000, we owned $3.2 million in government debt instruments and $29.8 million in corporate debt securities. Our exposure to losses as a result of interest rate changes is managed through investing in securities predominantly with maturities of one-and-one-half years or less. Substantially all the revenue and operating expenses of our subsidiaries are denominated in local foreign currencies and translated into U.S. dollars at rates of exchange approximating those existing at the date of the transactions. Foreign currency translation primarily impacts revenue and operating expenses as a result of exchange rate fluctuations. Because our inventories are manufactured in the U.S., foreign currency fluctuations generally do not affect our cost of sales. Our foreign currency transaction risk is primarily limited to amounts receivable from our subsidiaries and distributors, which are denominated in local foreign currencies. We do not currently utilize foreign currency hedging contracts. If the U.S. dollar uniformly increases in strength by 10% in 2000 relative to the currencies in which our sales are denominated, results of operations would not be significantly impacted. 7 PART II OTHER INFORMATION Item 1 Legal Proceedings On February 18, 2000, the United States District Court for the Western District of Washington dismissed with prejudice all eight consolidated putative class action lawsuits that had been filed in March and April 1999 against PathoGenesis Corporation, our chief executive officer and our chief financial officer. The eight consolidated lawsuits purported to allege claims on behalf of all purchasers of PathoGenesis common stock during the period January 15, 1999 to March 22, 1999. Plaintiffs had claimed that the company and the officers violated certain provisions of the federal securities laws by making statements in early 1999 regarding the company's 1998 financial results. The court's order dismissed the consolidated cases and bars plaintiffs from filing another lawsuit on the matter. Plaintiffs have appealed the dismissal order to the United States Court of Appeals for the Ninth Circuit. We intend to defend the appeal vigorously. Although we cannot ascertain the ultimate outcome of the appeal at this time or predict with certainty the results of legal proceedings, we currently believe that the resolution of the appeal will not have a material adverse effect on our financial position or results of operations. Item 2 Changes in Securities On January 26, 2000, PathoGenesis issued 10,379 shares of its common stock upon cashless exercise of outstanding warrants at an exercise price of $14.40 per share. Such shares were issued without registration under the Securities Act of 1933, as amended, in reliance on Section 4(2) of said Act. Item 3 Defaults Upon Senior Securities NONE Item 4 Submission of Matters to a Vote of Security-Holders NONE Item 5 Other Information NONE Item 6. Exhibits and Reports on Form 8-K (a) EXHIBITS Exhibit Number Description of Exhibit -------------- ---------------------- 27.1 Financial Data Schedule. (b) REPORTS ON FORM 8-K NONE 8 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, on May 15, 2000. PathoGenesis Corporation By: /s/ Wilbur H. Gantz ------------------------------------- Wilbur H. Gantz Chairman and Chief Executive Officer By: /s/ Alan R. Meyer ------------------------------------- Alan R. Meyer Executive Vice President and Chief Financial Officer 9