- -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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 March 31, 1999. [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File number 000-19809 DURA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) DELAWARE 95-3645543 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number) 7475 LUSK BLVD., SAN DIEGO, CALIFORNIA 92121 (Address of principal executive offices) (Zip Code) REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE IS (619) 457-2553 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. [X] Yes [ ] No The number of shares of the Registrant's Common Stock outstanding as of March 31, 1999 was 44,104,851. - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- PART I - FINANCIAL INFORMATION Item 1. Financial Statements DURA PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS In thousands, except share amounts March 31, December 31, 1999 1998 --------- ------------ ASSETS (unaudited) Current assets: Cash and cash equivalents $ 57,575 $ 31,113 Short-term investments 218,620 238,299 Accounts and other receivables 33,616 24,627 Inventory 11,827 9,006 --------- --------- Total current assets 321,638 303,045 License agreements and product rights 366,539 377,250 Property 87,533 85,374 Other assets 65,869 59,790 --------- --------- Total $ 841,579 $ 825,459 --------- --------- --------- --------- LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 8,801 $ 8,893 Accrued liabilities 57,697 46,557 Current portion of long-term obligations 5,846 6,798 --------- --------- Total current liabilities 72,344 62,248 Convertible subordinated notes 287,500 287,500 Other long-term obligations 62,862 65,339 --------- --------- Total liabilities 422,706 415,087 --------- --------- Shareholders' equity: Preferred stock, par value $.001, shares authorized - 5,000,000; no shares issued or outstanding Common stock, par value $.001, shares authorized - 200,000,000; issued and outstanding - 44,104,851 and 44,083,652, respectively 44 44 Additional paid-in capital 607,667 607,436 Accumulated other comprehensive income 227 454 Warrant subscriptions receivable (8,654) (9,385) Accumulated deficit (153,185) (160,951) Treasury stock, at cost; shares outstanding - 2,327,500 (27,226) (27,226) --------- --------- Total shareholders' equity 418,873 410,372 --------- --------- Total $ 841,579 $ 825,459 --------- --------- --------- --------- See accompanying notes to consolidated financial statements. 2 DURA PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS In thousands, except per share amounts (Unaudited) Three months ended March 31, -------------------- 1999 1998 Revenues: Sales $ 55,081 $ 35,885 Contract 16,166 12,881 -------- -------- Total revenues 71,247 48,766 Operating costs and expenses: Cost of sales 10,491 8,093 Clinical, development and regulatory 11,491 9,590 Selling, general and administrative 37,290 22,514 -------- -------- Total operating costs and expenses 59,272 40,197 -------- -------- Operating income 11,975 8,569 -------- -------- Other: Interest income 4,303 5,417 Interest expense (4,064) (3,142) Other - net (228) 13 -------- -------- Total other 11 2,288 -------- -------- Income before income taxes 11,986 10,857 Provision for income taxes 4,220 3,693 -------- -------- Net income $ 7,766 $ 7,164 -------- -------- -------- -------- Net income per share: Basic $ 0.18 $ 0.16 Diluted $ 0.17 $ 0.15 Weighted average number of common shares: Basic 44,100 45,975 Diluted 45,686 48,523 See accompanying notes to consolidated financial statements. 3 DURA PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS In thousands (Unaudited) Three months ended March 31, ------------------ 1999 1998 -------- --------- Net cash provided by operating activities $ 19,179 $ 14,514 -------- --------- Investing activities: Purchases of short-term investments (69,454) (102,211) Sales and maturities of short-term investments 88,907 111,351 Capital expenditures (4,172) (5,768) Product acquisitions (3,679) Other (4,280) (449) -------- --------- Net cash provided by investing activities 7,322 2,923 -------- --------- Financing activities: Issuance of common stock and warrants - net 961 2,194 Principal payments on long-term obligations (1,000) -------- --------- Net cash provided by (used for) financing activities (39) 2,194 -------- --------- Net increase in cash and cash equivalents 26,462 19,631 Cash and cash equivalents at beginning of period 31,113 72,003 -------- --------- Cash and cash equivalents at end of period $ 57,575 $ 91,634 -------- --------- -------- --------- Supplemental disclosure of cash flow information: Cash paid during the period for: Interest (net of amounts capitalized) $ 6,494 $ 5,272 Income taxes $ 281 $ 370 See accompanying notes to consolidated financial statements. 4 DURA PHARMACEUTICALS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 1. BASIS OF PRESENTATION The accompanying unaudited consolidated financial statements have been prepared by Dura Pharmaceuticals, Inc. ("Dura" or the "Company") in accordance with the instructions to Form 10-Q. The consolidated financial statements reflect all adjustments, consisting of only normal recurring accruals, which are, in the opinion of management, necessary for a fair statement of the results of the interim periods presented. These consolidated financial statements and notes thereto should be read in conjunction with the audited financial statements and notes thereto included in the Company's annual report on Form 10-K for the year ended December 31, 1998. The results of operations for the interim periods are not necessarily indicative of results to be expected for any other interim period or for the year as a whole. The consolidated financial statements include the accounts of Dura and its wholly owned subsidiaries. All intercompany transactions and balances are eliminated in consolidation. Certain reclassifications have been made to amounts included in the prior year's financial statements to conform to the financial statement presentation for the three months ended March 31, 1999. The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect amounts reported in the consolidated financial statements and related notes. Changes in those estimates may affect amounts reported in future periods. 2. REPORTING COMPREHENSIVE INCOME Statement of Financial Accounting Standards No. 130, "Reporting Comprehensive Income" ("SFAS 130") requires reporting and displaying comprehensive income and its components which, for Dura, includes net income and unrealized gains and losses on investments. In accordance with SFAS 130, the accumulated balance of other comprehensive income is disclosed as a separate component of shareholders' equity. For the three months ended March 31, 1999 and 1998, comprehensive income consisted of (in thousands): 1999 1998 ------- ------- Net income $ 7,766 $ 7,164 Other comprehensive income: Unrealized gain(loss) on investments (227) 84 ------- ------- Comprehensive income $ 7,539 $ 7,248 ------- ------- ------- ------- 5 3. LICENSE AGREEMENTS AND PRODUCT RIGHTS On December 31, 1998, the Company acquired from Bristol-Myers Squibb Company the exclusive U.S. distribution rights for the patented hospital antibiotic products Maxipime-R- (cefepime hydrochloride) for Injection and Azactam-R- (aztreonam) for Injection. The Company began selling these products effective January 1, 1999. The purchase price consisted of $60 million paid in cash at closing, payments totaling $4 million due in 1999 and a payment of $70 million due in 2003, plus additional contingent payments due from 1999 through 2003 based on sales of Maxipime and Azactam during that period. Based on historical sales data, the Company estimates that such future contingent payments could approximate $90 million. 4. COMMITMENTS AND CONTINGENCIES TERMINATION OF MERGER AGREEMENT WITH SCANDIPHARM, INC. - On December 1, 1997, the Company terminated a merger agreement with Scandipharm, Inc. ("Scandipharm") entered into on October 20, 1997. On January 16, 1998, Scandipharm filed suit against the Company for breach of contract. On January 20, 1998, the Company filed suit against Scandipharm seeking a declaratory judgment that Dura's termination of the merger agreement did not breach the agreement and for damages against Scandipharm. The Company believes that it had the right to terminate the merger agreement, that Scandipharm's claims in its lawsuit and its claims for damages are without merit, and the outcome of this matter will not have a material adverse effect on the Company's financial condition or operations. SHAREHOLDER CLASS ACTION LITIGATION - Commencing on January 27, 1999, several class action suits were filed against the Company, various current or former officers and directors of the Company, and one of the Company's investment bankers in the United States District Court for the Southern District of California. The lawsuits allege violations of the federal securities laws, and purport to seek damages on behalf of a class of shareholders who purchased Dura common stock during a defined period. The Company believes that the claims in the lawsuits are without merit and intends to defend against them vigorously. 5. SEGMENT INFORMATION The Company operates in two business segments: (1) Pharmaceutical Products and (2) Research and Development. The Pharmaceutical Products segment markets prescription pharmaceutical products for the treatment of respiratory ailments. The Research and Development segment manages the development of Spiros-R-, the Company's proprietary dry powder delivery technology. Each of the Company's segments operates solely within the United States. Three wholesale customers accounted for 12%, 14%, and 16% of sales, respectively, for the first quarter of 1999, while one wholesale customer accounted for 10% of sales for the first quarter of 1998. 6 The following table summarizes information about the Company's operating segments for the three months ended March 31, 1999 and 1998 (in thousands): Pharmaceutical Research and Products Development Consolidated Total revenues 1999 $ 55,668 $ 15,579 $ 71,247 1998 $ 35,885 $ 12,881 $ 48,766 Operating income 1999 $ 9,442 $ 2,533 $ 11,975 1998 $ 6,176 $ 2,393 $ 8,569 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following information should be read in conjunction with the consolidated financial statements and the accompanying notes included in Item 1 of this quarterly report and the audited financial statements and accompanying notes and Management's Discussion and Analysis of Financial Condition and Results of Operations for the year ended December 31, 1998 contained in our 1998 annual report on Form 10-K. See "Risks and Uncertainties" below for trends and uncertainties known to us that could cause reported financial information not to be necessarily indicative of future results. RECENT DEVELOPMENTS On December 31, 1998, we acquired from Bristol-Myers Squibb Company the exclusive U.S. distribution rights for the patented hospital antibiotic products Maxipime-R- (cefepime hydrochloride) for Injection and Azactam-R(aztreonam) for Injection. The Company began selling these products effective January 1, 1999. The purchase price consisted of $60 million paid in cash at closing, payments totaling $4 million due in 1999 and a payment of $70 million due in 2003, plus additional contingent payments due from 1999 through 2003 based on sales of Maxipime and Azactam during that period. Based on historical sales data, we estimate that such future contingent payments could approximate $90 million. RESULTS OF OPERATIONS Total revenues for the three months ended March 31, 1999 were $71.2 million, an increase of $22.5 million, or 46%, over the same period in 1998. Net income for the three months ended March 31, 1999 was $7.8 million, or $0.17 per diluted share, as compared to $7.2 million, or $0.15 per diluted share, for the same period in 1998. The principal factors causing these results are discussed below. 7 Pharmaceutical sales for the three months ended March 31, 1999 were $55.1 million, an increase of $19.2 million, or 53%, over 1998. This increase is due primarily to sales of Maxipime and Azactam (acquired in December 1998) and Myambutol (acquired in August 1998) and increases in sales of Ceclor-R- CD, Nasarel-R- and Nasalide-R- resulting from increased prescription volumes for those products. Gross profit (pharmaceutical sales less cost of sales) for the three months ended March 31, 1999 was $44.6 million, an increase of $16.8 million, or 60%, over 1998. This increase is due primarily to the increase in pharmaceutical sales discussed above. Gross profit as a percentage of sales was 81% for the three months ended March 31, 1999 as compared to 77% for the same period in 1998. The increase in the gross profit percentage is due to differences in product mix for the first quarter of 1999 as compared to the same period in 1998. Contract revenue relates primarily to amounts received by us for the development of our Spiros-R- system. Under agreements with several companies, we conduct feasibility testing and development work on various compounds for use with Spiros. Contract revenues include payment for feasibility and development work performed by us as well as milestone and technology access payments. Contract revenue for the three months ended March 31, 1999 was $16.2 million, an increase of $3.3 million, or 26%, over 1998. This increase is due to increased development activity conducted on behalf of Spiros Development Corporation II, Inc. and Eli Lilly and Company. Contract revenue totaled $12.2 million from Spiros Corp. II for the three months ended March 31, 1998 as compared to $10.4 million for the same period in 1998. Contract revenue may fluctuate from period to period based on the level of research funding as well as the achievement of milestones and receipt of technology access payments from partners. Clinical, development and regulatory expenses for the three months ended March 31, 1999 were $11.5 million, an increase of $1.9 million, or 20%, over 1998. The increase reflects additional expenses incurred by us under feasibility and development agreements covering the use of various compounds with Spiros as discussed above. Selling, general and administrative expenses for the three months ended March 31, 1999 were $37.3 million, an increase of $14.8 million, or 66%, over 1998. These expenses increased as a percentage of total revenues to 52% for the three months ended March 31, 1999 as compared to 46% for 1998. The dollar and percentage increases are primarily due to costs incurred to support the expansion of our sales organization from approximately 270 field sales representatives in the first quarter of 1998 to approximately 400 in the first quarter of 1999 (increase of $7.8 million) and to promote the newly acquired products, Maxipime and Azactam (increase of $5.7 million). We anticipate that our selling, general and administrative expenses will increase during fiscal 1999 as we establish our hospital-based sales force of approximately 120 representatives and associated field management. Interest income for the three months ended March 31, 1999 was $4.3 million, a decrease of $1.1 million, or 21%, from 1998. The decrease is due to lower balances of cash and short-term investments resulting from the acquisition of product rights and the repurchase of shares of our common stock in the second half of 1998. 8 Interest expense for the three months ended March 31, 1999 was $4.1 million, an increase of $922,000, or 29%, over 1998. The increase is primarily due to the amortization of the discounts recorded in connection with the acquisitions of Myambutol-R-, Maxipime and Azactam in the second half of 1998. The Company records interim provisions for income taxes based on the estimated effective combined tax rate to be applicable for the fiscal year. This estimate is reevaluated by management each quarter based on forecasts of income before income taxes for the year as well as anticipated adjustments from statutory federal and state tax rates. The Company's effective tax rate for the three months ended March 31, 1999 was 35%, as compared to 34% for the same period in 1998. LIQUIDITY AND CAPITAL RESOURCES Cash, cash equivalents and short-term investments totaled $276.2 million at March 31, 1999 as compared to $269.4 million at December 31, 1998. Working capital increased by $8.5 million from $240.8 million at December 31, 1998 to $249.3 million at March 31, 1999. In the third quarter of 1997, we issued $287.5 million principal amount of notes due July 15, 2002 with interest payable semiannually at a coupon rate of 3.5%. The notes are convertible, at the option of the holder, into shares of common stock at any time prior to maturity or redemption at a conversion price of $50.635 per share. In addition to the notes, as of March 31, 1999, we had outstanding an aggregate of $68.7 million in current and other long-term obligations, of which $5.8 million is to be paid during the next 12 months. As of March 31, 1999, additional future contingent obligations existed relating to product acquisitions. Payments totaling approximately $135 million, estimated based on historical sales levels of the related products, are contingent upon the levels of future sales of certain products, and approximately $80 million are contingent upon the continued absence of competing formulations of certain products as defined in the respective agreements. Such contingent amounts are payable through 2004, including approximately $35 million contingently due within the next 12 months. We have entered into a loan agreement which provides for the borrowing of up to $50 million, subject to maintaining certain financial ratios, through August 1, 1999. As of March 31, 1999, no borrowings have been or were outstanding under this agreement. We anticipate that our existing capital resources, cash generated from operations and available bank borrowings will be sufficient to finance our operations through at least the next 12 months. Product or company acquisitions or in-licensing opportunities, however, may require significant additional resources. Such additional resources may not be available when needed or on terms acceptable to us. We are actively pursuing the acquisition of rights to products and/or companies which may require the use of substantial capital resources; however, there are no present agreements or commitments for such acquisitions. 9 YEAR 2000 We utilize computer systems throughout our business to carry out our day-to-day operations. Beginning in 1997, we implemented a program designed to enable our computer operating systems to process data having dates on or after January 1, 2000. The program assesses our information technology systems as well as technology systems embedded in our facilities and equipment. The first phase in our year 2000 program was to identify the systems with year 2000 exposure. This phase was completed during 1998. Substantially all the hardware and software comprising our information technology systems were replaced in 1997 with systems that are year 2000 compliant. Accordingly, no further evaluation or testing of these systems is required. We are currently evaluating our other systems to assess whether they are year 2000 compliant or, if not, whether the systems will be impacted by the change in year. When the evaluation phase is complete, we will assess if any remediation to these other systems will be necessary. We have contacted our significant suppliers, customers, and key business partners to determine if our business may be affected if these parties fail to address their year 2000 issues. We intend to monitor the progress made by these parties and to address any risks arising from their failure to adequately prepare for the year 2000. In addition, we will test key interfacing data systems with our business partners to ensure that all measures taken to become year 2000 compliant are effective. We are developing a contingency plan to address any year 2000 exposures from internal and third-party systems that may not be adequately remediated or replaced. While it is difficult to identify all potential year 2000 exposures, the greatest risks to us are our inability to receive and process orders from our customers and our vendors' inability to supply product inventory. If necessary, our contingency plan will address these risks by identifying alternative suppliers, stocking additional inventory, and developing back-up systems to process sales orders. We expect to complete our year 2000 evaluation, testing and contingency planning by September 30, 1999. We estimate that the aggregate costs of our year 2000 program will be less than $1 million, including costs incurred to date. This estimate excludes the cost of the information technology systems implemented in 1997 as the implementation was not in response to the year 2000 issue. The majority of the costs are not expected to be incremental expenses but rather an allocation of existing resources. The estimated impact, cost, and timing of our year 2000 program are based on our best estimates using information currently available. These estimates may not be achieved, and actual results could differ materially from our plans. RISKS AND UNCERTAINTIES FORWARD-LOOKING STATEMENTS. We caution readers that the statements in this quarterly report that are not descriptions of historical facts may be forward-looking statements that are subject to risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors, including those identified below. 10 SPIROS-R- REQUIRES SIGNIFICANT ADDITIONAL DEVELOPMENT WHICH IS COSTLY, TIME-CONSUMING AND MAY NEVER BE COMMERCIALLY SUCCESSFUL. Spiros, our proprietary dry powder pulmonary drug delivery system, will require significant additional development efforts as well as clinical testing. This work is very costly and time consuming. Even after spending significant amounts of money and time, the development and commercialization, if any, of any Spiros product may not be successful. BEFORE WE CAN MARKET ANY SPIROS PRODUCT, WE WILL HAVE TO OBTAIN REQUIRED GOVERNMENTAL APPROVALS, WHICH IS NOT ASSURED; FAILURE TO OBTAIN SUCH APPROVALS WOULD HAVE AN ADVERSE EFFECT ON OUR BUSINESS. The development, testing, manufacturing and marketing of pharmaceutical products are subject to extensive regulation by governmental authorities, including the FDA. Each Spiros product will have to obtain approval from the FDA before that product can be manufactured or marketed. The review and approval process mandated by the FDA is very rigorous, requiring extensive preclinical and clinical testing as well determining manufacturing capability and product performance. None of the products currently in development by Dura or in collaboration with third parties may ever be approved by the FDA. Failure to obtain such approvals would have an adverse effect on our business and results of operations. OUR REGULATORY APPLICATION SUBMITTED TO THE FDA FOR ALBUTEROL SPIROSTM WILL NOT BE APPROVED WITHOUT ADDITIONAL CLINICAL TRIALS, WHICH WILL DELAY THE COMMERCIALIZATION OF ALBUTEROL SPIROS. On November 4, 1998 Dura and Spiros Corp. II announced the receipt of a complete response letter from the FDA. The letter indicated that the new drug application submitted by Dura on behalf of Spiros Corp. II for Albuterol Spiros will not be approved unless certain deficiencies are addressed. The FDA requested that additional clinical trials on the Spiros inhaler be completed to ensure the inhaler is reliable and to replicate clinical outcomes of the initial trials. The FDA also requested that several chemistry, manufacturing and control issues, as well as certain electromechanical reliability issues be resolved. As a result of a series of meetings with the FDA, Dura and Spiros Corp. II have determined the requirements to address these issues to support the resubmission of the new drug application for Albuterol Spiros. Dura, on behalf of Spiros Corp. II, expects to initiate clinical trials for both Albuterol Spiros and Beclomethasone SpirosTM in the fourth quarter of 1999 and to commercialize these products in 2001, pending successful development and FDA approval. We cannot predict or assure the successful outcome of additional trials to support the resubmission of the new drug application, or if the FDA will ever approve this new drug application. WE WILL NEED TO SIGNIFICANTLY EXPAND OUR MANUFACTURING CAPABILITY AND COMPLY WITH GOVERNMENT REGULATIONS BEFORE WE CAN MANUFACTURE OUR SPIROS PRODUCT. We will need to significantly expand our current manufacturing operations and comply with current good manufacturing practices and other regulations prescribed by various regulatory agencies in the U.S. and other countries to achieve the quality and required levels of production of such products to obtain marketing approval. In addition, our manufacturing facility must be registered with and licensed by various regulatory authorities and must comply with current good manufacturing practice requirements prescribed by the FDA and the State of California. We intend to utilize third parties to produce components of and assemble the Spiros inhaler. Such third parties have only produced limited 11 quantities of components and assembled limited numbers of inhalers. These third parties will be required to significantly scale up their activities and to produce components which meet applicable specifications on a timely and consistent basis. Such third parties may not be successful in attaining acceptable service levels or meeting regulatory requirements which would have an adverse effect on our ability to commercialize the Spiros products. WE INTEND TO CONTINUE TO PURSUE OUR STRATEGY OF ACQUIRING COMPLEMENTARY PRODUCTS AND TECHNOLOGIES WHICH COULD RESULT IN SIGNIFICANT CHARGES TO EARNINGS AND REQUIRE THE USE OF CAPITAL RESOURCES. As part of our business strategy, we intend to continue to pursue the acquisition of complementary product rights and technologies. Such acquisitions could result in significant charges to earnings as well as require the use of a large amount of our available capital resources. Depending on the acquisition opportunities available and our use of existing funds to fund existing capital and operating needs, Dura may need to raise additional funds to finance such transactions. If adequate funds are not available when needed on terms acceptable to us, our ability to complete acquisitions could be limited. Further, there can be no assurance that reimbursement will be available to enable us to achieve market acceptance of our products or to maintain price levels sufficient to realize an appropriate return on our investment in product acquisition, in-licensing and development. THE PHARMACEUTICAL INDUSTRY IS EXTREMELY COMPETITIVE. Many companies, including large pharmaceutical firms with financial and marketing resources and development capabilities substantially greater than those of Dura, are engaged in developing, marketing and selling products that compete with those offered or planned to be offered by Dura. The selling prices of such products typically decline as competition increases. Further, other products now in use or under development by others may be more effective than our current or future products. The industry is characterized by rapid technological change, and competitors may develop their products more rapidly than we are able. Competitors may also be able to complete the regulatory process sooner, and therefore, may begin to market their products in advance of our products. Our failure to effectively respond to the competitive pressures of our industry would have an adverse effect on our business and results of operations. WE NEED TO BUILD A HOSPITAL-BASED FIELD SALES FORCE BY THE END OF 1999 TO BE ABLE TO EFFECTIVELY MARKET OUR NEWLY ACQUIRED PRODUCTS, MAXIPIME AND AZACTAM. Effective January 1, 1999, we acquired the rights to two hospital-based products, Maxipime-R- (cefepime hydrochloride) for Injection and Azactam-R-(aztreonam) for Injection. In the first quarter of 1999 we built our acute care sales and marketing management team, and by the end of 1999 we expect to have an additional 120 field sales representatives and associated field management who will be fully dedicated to the hospital-based products. We may not be able to hire qualified field sales representatives with the necessary experience selling to hospitals. Even if we are successful in identifying and hiring such representatives, we may not be able to hire the numbers needed in the appropriate time frame. Our success with these products is dependent upon effectively building this sales and marketing capability. 12 WE COMPETE WITH MANY COMPANIES FOR THE ACQUISITION OF PRODUCT RIGHTS; FAILURE TO ACQUIRE PRODUCT RIGHTS COULD HAVE AN ADVERSE EFFECT ON OUR BUSINESS. Our strategy for growth is dependent, in part, on our ability to continue to acquire product rights. Other companies, including those with substantially greater resources, are competing with us for the rights to such products. We may not be able to acquire, in-license or co-promote additional pharmaceuticals on acceptable terms, or at all. The failure to acquire, in-license, co-promote, develop or market commercially successful pharmaceuticals would have an adverse effect on our ability to achieve our targeted growth rates. GROSS MARGINS ON PHARMACEUTICAL PRODUCTS MAY DECREASE AS A RESULT OF A NUMBER OF FACTORS OUTSIDE OUR CONTROL, WHICH WOULD HAVE AN ADVERSE EFFECT ON OUR BUSINESS. We do not have proprietary protection for several of the products we sell and substitutes for such products are sold by other pharmaceutical companies. In addition, the average selling prices for many of our products may decline over time due to competitive and reimbursement pressures. We may not be successful in any efforts we take to mitigate the effect of a decline in average selling prices. Our commercial success will depend in part on the price that third-party healthcare payors, such as government and private health insurers and managed care organizations, are willing to pay for our products. Third-party payors continually challenge the pricing of medical products and services. Many managed care organizations limit the number of pharmaceutical products they approve for reimbursement. The competition between pharmaceutical companies to get their products approved for reimbursement may also result in downward pricing pressure in the industry. Any of these factors causing a decline in average selling prices would also reduce the gross margins we achieve. ALTERNATIVE SUPPLIERS TO OUR THIRD-PARTY MANUFACTURERS MAY NOT BE AVAILABLE ON A TIMELY BASIS WHICH WOULD HAVE AN ADVERSE EFFECT ON OUR BUSINESS. We do not have the capability to manufacture the pharmaceutical products we currently sell. As a result, we are dependent on third-party contract manufacturers for the supply of our products. These products are supplied under short-term and long-term supply agreements. If these manufacturers were unable to supply product, it could be difficult for us to secure alternative sources of supply in a timely manner. This would impair our ability to ship product to our customers and could have an adverse effect on our business and results of operations. OUR EXERCISE OF THE SPIROS CORP. II STOCK PURCHASE OPTION MAY HAVE AN ADVERSE EFFECT ON OUR BUSINESS. We have a purchase option with respect to the outstanding shares of callable common stock of Spiros Corp. II which expires on December 31, 2002. We may or may not exercise this option. If we exercise our stock purchase option, we will be required to make a substantial cash payment or to issue shares of our common stock, or both. A payment in cash would reduce our capital resources. A payment in shares of our common stock would result in a decrease in the percentage ownership of our shareholders at that time and have a dilutive effect on future earnings per share. If we determine to exercise the stock purchase option, it will likely require us to record a significant charge to earnings. If we do not exercise our stock purchase option prior to its expiration in December 2002, our rights in and to Spiros with respect to certain compounds will terminate. 13 WE ALSO HOLD OPTIONS TO PURCHASE FROM SPIROS CORP. II CERTAIN RIGHTS TO ALBUTEROL SPIROS AND RIGHTS TO USE SPIROS WITH AN ADDITIONAL PRODUCT OTHER THAN ALBUTEROL. We may or may not exercise either of these options. If we exercise either of our product options, we will need to make a significant cash payment which could have an adverse effect on our capital resources. Any such cash payment also may result in a significant charge to our earnings in the period we exercise the option. We may not have sufficient capital resources to exercise the product options, which may result in our loss of valuable rights. OUR ABILITY TO OBTAIN PATENTS AND PROTECT OUR PROPRIETARY RIGHTS IS UNCERTAIN AND COULD RESULT IN AN ADVERSE EFFECT ON OUR BUSINESS. Our ability to obtain patents on current or future products or formulations, defend our patents, maintain trade secrets and operate without infringing upon the proprietary rights of others both in the U.S. and abroad is uncertain. Patents may never issue. Even if issued or licensed to us, patents may not be enforceable, provide substantial protection from competition or be of commercial benefit to Dura. Even if all these are true, we may not possess the financial resources necessary to enforce or defend any of our patent rights. Our commercial success will also depend upon avoiding the infringement of patents issued to competitors and upon maintaining the technology licenses upon which certain of our products are based. Litigation, which is costly, may be necessary to enforce our patent and license rights or to determine the scope and validity of proprietary rights of third parties. If any of our products are found to infringe upon patents or other rights owned by third parties, we could be required to obtain a license to continue to manufacture or market such products. Licenses to such patent rights may not be available to us on commercially reasonable terms, if at all. If we do not obtain such licenses, we could encounter delays in marketing affected products or we could find that the development, manufacture or sale of products requiring such licenses is not possible. OUR STOCK PRICE IS VOLATILE. The market prices for securities of emerging companies, including ours, have historically been highly volatile. Future announcements concerning us or our competitors may have a significant impact on the market price of our common stock. Such announcements might include: - financial results, - the results of clinical testing of our or our competitors' products, - regulatory developments, - technological innovations, - new commercial products, - changes to government regulations, - regulatory decisions on commercialization of products, - developments concerning proprietary rights, - litigation or public concern as to safety of our products or - our failure to achieve securities analysts' expectations concerning our earnings per share or revenues. WE ARE INVOLVED IN CERTAIN LAWSUITS AND CANNOT PREDICT THEIR OUTCOME. We are involved in certain lawsuits as described in note 4 of the notes to consolidated financial statements. The outcome of these lawsuits and any other suits we may become involved in cannot be predicted. An adverse outcome could have an adverse effect on our business or results of operations. 14 SEASONALITY AND THE TIMING AND SEVERITY OF THE WINTER COLD AND FLU SEASON CAN HAVE AN ADVERSE EFFECT ON OUR OPERATING RESULTS. Historically, as a result of the winter cold and flu season, industry-wide demand for respiratory products has been stronger in the first and fourth quarters than in the second and third quarters of the year. In addition, variations in the timing and severity of the winter cold and flu season have influenced our results of operations in the past. A PROPOSED NEW ACCOUNTING STANDARD MAY REQUIRE US TO CONSOLIDATE SPIROS CORP. II WHICH WOULD HAVE AN ADVERSE EFFECT ON OUR RESULTS OF OPERATIONS. In February 1999, the Financial Accounting Standards Board issued an exposure draft of a proposed new statement of financial accounting standards entitled "Consolidated Financial Statements: Purpose and Policy." This proposed standard, if adopted, would modify existing standards which govern when entities should be consolidated. During its exposure period, interested parties have the opportunity to comment on the proposed changes and these comments will be considered prior to issuing the standard in its final form, if one is issued at all. If adopted as initially proposed, this standard may require us to consolidate Spiros Corp. II into our financial statements. Such consolidation would have an adverse effect on our results of operations. OUR PRODUCTS MAY CAUSE PRODUCT LIABILITY CLAIMS OR NEED TO BE RECALLED, EITHER OF WHICH WOULD HAVE AN ADVERSE EFFECT ON OUR BUSINESS. We face an inherent business risk of exposure to product liability claims in the event that the use of our technologies or products is alleged to have resulted in adverse effects. The level or breadth of any insurance coverage we currently maintain may not be sufficient to fully cover potential claims. Adequate insurance coverage may not be available in the future at acceptable costs, if at all. CERTAIN OF OUR CHARTER AND OTHER CONTRACTUAL PROVISIONS MAY PREVENT A CHANGE OF CONTROL WHICH COULD BE BENEFICIAL TO OUR SHAREHOLDERS. Certain provisions of our charter documents, outstanding securities, including certain warrants, options and our notes, and our shareholder rights plan may have the effect of delaying, deferring or preventing a change in control. This could deprive you of an opportunity to receive a premium for your shares of common stock. WE MAY NOT ADEQUATELY ADDRESS YEAR 2000 ISSUES WHICH COULD HAVE AN ADVERSE EFFECT ON OUR BUSINESS. We are currently evaluating certain of our systems to assess whether they are year 2000 compliant or, if not, whether the systems will be impacted by the change in year. We will not be able to assess what, if any, remediation to these systems will be necessary until the evaluation phase is complete. We have not yet completed our audit of the compliance efforts of our significant suppliers, customers and key business partners to determine the extent to which our business may be affected if these parties fail to address their year 2000 issues. We estimate that the aggregate costs of our year 2000 program will be less than $1 million, including costs incurred to date. There can be no guarantee that these estimates will be achieved and actual results could differ materially from those plans. Our failure to adequately address our year 2000 risks would have an adverse effect on our business and results of operations. For a more complete description of the initiatives we have implemented with respect to the year 2000 issue, please see "Management's Discussion and Analysis of Financial Condition and Results of Operations - Year 2000." 15 ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK We invest our excess cash and short-term investments in U.S. government and corporate debt securities with high quality credit ratings and maturities of less than two years. These investments are not held for trading or other speculative purposes. Changes in interest rates affect the investment income we earn on our investments and, therefore, impact our cash flows and results of operations. At March 31, 1999, we had outstanding subordinated notes totaling $287.5 million which mature in July 2002. The notes have a fixed interest rate of 3 1/2 percent. Accordingly, while changes in interest rates may affect the fair market value of the notes, they do not impact our cash flows or results of operations. As of March 31, 1999, the notes had a fair market value of $217.8 million. We are not exposed to risks for changes in foreign currency exchange rates, commodity prices, or any other market rates. PART II - OTHER INFORMATION ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K (a) Exhibits Exhibit No. (1)3.1 Certificate of Incorporation (2)3.2 Certificate of Amendment of Certificate of Incorporation, effective May 21, 1998 (2)3.3 Certificate of Designation of Series A Junior Participating Preferred Stock (1)3.4 Bylaws (3)10.1 Distribution Agreement for Maxipime-R- and Azactam-R- between the Company and Bristol-Myers SquIbb Company (with certain confidential portions omitted). (3)10.2 Supply Agreement for Maxipime-R- and Azactam-R- between the Company and Bristol-Myers SquIbb Company (with certain confidential portions omitted). 11 Statements re Computations of Net Income Per Share 27 Financial Data Schedule (1) Incorporated by reference to the Company's Form 10-Q for the quarter ended June 30, 1997. (2) Incorporated by reference to the Company's Registration Statement on Form 8-A filed on May 22, 1998. (3) Incorporated by reference to the Company's Form 8-K, dated January 1, 1999. 16 (b) Reports on Form 8-K On January 15, 1999, the Company filed a current report on Form 8-K dated January 1, 1999, reporting the Company's acquisition of product rights from Bristol-Myers Squibb Company. 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. DURA PHARMACEUTICALS, INC. DATE MAY 3, 1999 /s/ MICHAEL T. BORER ---------------------- (MICHAEL T. BORER) Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) 18