================================================================================ SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ------------------------ FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 November 9, 2000 Date of Report (Date of earliest event reported) DURA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 000-19809 95-3645543 (State or other jurisdiction of (Commission file number) (I.R.S. Employer incorporation or organization) Identification No.) 7475 Lusk Boulevard, San Diego, California 92121 (Address of principal executive offices) (858) 457-2553 (Registrant's telephone number, including area code) Not Applicable (Former name or former address, if changed since last report) ================================================================================ Item 1. Change in Control of Registrant Effective on November 9, 2000, Carbon Acquisition Corp., a Delaware corporation and a wholly-owned subsidiary of Elan (as defined below) ("Acquisition Sub"), merged with and into Dura Pharmaceuticals, Inc. ("Dura"), with Dura surviving the merger (the "Merger"), pursuant to an Agreement and Plan of Merger, dated as of September 10, 2000, by and among Elan Corporation, plc, a public limited liability company organized under the laws of Ireland ("Elan"), Acquisition Sub and Dura (the "Merger Agreement"). As a result of the Merger, Dura became a wholly owned subsidiary of Elan. Pursuant to the Merger, each share of Dura's common stock, par value $.001 per share, was converted into 0.6715 of an Elan American depositary share (an "Elan ADS"). Each Elan ADS represents one Elan ordinary share, par value 5 Euro cents, and is evidenced by one Elan American depositary receipt. Dura's stockholders adopted the Merger Agreement at a special meeting of stockholders held on November 9, 2000. On November 10, 2000 Elan issued a press release announcing the completion of the Merger and other matters (the "Press Release"). Each of the Press Release and the Merger Agreement is an exhibit hereto and is incorporated by reference herein. Item 7. Exhibits. (c) Exhibits: Exhibit No. Description 2.1 Agreement and Plan of Merger, dated as of September 10, 2000, by and among Elan Corporation, plc, Carbon Acquisition Corp. and Dura Pharmaceuticals, Inc. (incorporated by reference to Annex A to the Proxy Statement/Prospectus included as part of the Registration Statement on Form F-4 of Elan filed with the Securities and Exchange Commission (the "SEC") on October 10, 2000 (No. 333-127567)) 99 Press Release of Elan, dated November 10, 2000 (incorporated by reference to the Report of Foreign Issuer on Form 6-K of Elan for the period ended November 10, 2000, filled with the SEC on November 13, 2000) 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. Dated: November 22, 2000 DURA PHARMACEUTICALS, INC. By: /s/ Mitchell R. Woodbury ----------------------------------------- Mitchell R. Woodbury Senior Vice President and General Counsel -2- EXHIBIT INDEX Exhibit No. Description 2.1 Agreement and Plan of Merger, dated as of September 10, 2000, by and among Elan Corporation, plc, Carbon Acquisition Corp. and Dura Pharmaceuticals, Inc. (incorporated by reference to Annex A to the Proxy Statement/Prospectus included as part of the Registration statement on Form F-4 of Elan filed with the Securities and Exchange Commission (the "SEC") on October 10, 2000 (No. 333-127567)) 99 Press Release of Elan, dated November 10, 2000 (incorporated by reference to the Report of Foreign Issuer on Form 6-K of Elan for the period ended November 10, 2000, filled with the SEC on November 13, 2000)

DECEMBER 31, JUNE 30, 1998 1999 2000 --------- --------- --------- (UNAUDITED) ASSETS CURRENT ASSETS: Cash and cash equivalents $ 20,535 $ 13,325 $ 15,167 Short-term investments 103,069 57,718 24,184 Other current assets 192 96 75 --------- --------- --------- Total current assets 123,796 71,139 39,426 --------- --------- --------- TOTAL $ 123,796 $ 71,139 $ 39,426 ========= ========= ========= LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Payable to Dura Pharmaceuticals, Inc. $ 4,597 $ 6,720 $ 5,697 Accrued liabilities 281 173 484 --------- --------- --------- Total current liabilities 4,878 6,893 6,181 --------- --------- --------- COMMITMENTS AND CONTINGENCIES (Note 5) STOCKHOLDERS' EQUITY: Special common stock, par value $1.00, 1,000 shares authorized, issued and outstanding 1 1 1 Callable common stock, par value $.001, 7,500,000 shares authorized; 6,325,000 shares issued and outstanding 6 6 6 Additional paid-in capital 169,404 170,191 170,517 Accumulated other comprehensive income (loss) 224 (171) (66) Accumulated deficit (50,717) (105,781) (137,213) --------- --------- --------- Total stockholders' equity 118,918 64,246 33,245 --------- --------- --------- TOTAL $123,796 $ 71,139 $ 39,426 ========= ========= =========

SEPTEMBER 23, SEPTEMBER 23, 1997 1997 (DATE OF (DATE OF INCORPORATION) INCORPORATION) THROUGH YEAR ENDED YEAR ENDED THROUGH DECEMBER 31, DECEMBER 31, DECEMBER 31, DECEMBER 31, 1997 1998 1999 1999 -------------- ------------ ------------ -------------- EXPENSES (with related party, Note 5): Research and development $ 7,040 $ 50,799 $ 59,211 $ 117,050 General and administrative 106 1,026 1,194 2,326 ---------- --------- --------- ----------- Operating loss 7,146 51,825 60,405 119,376 ---------- --------- --------- ----------- Interest income 222 8,239 5,341 13,802 ---------- --------- --------- ----------- LOSS BEFORE INCOME TAXES (6,924) (43,586) (55,064) (105,574) PROVISION FOR INCOME TAXES 207 207 ---------- --------- --------- ----------- NET LOSS $ (6,924) $ (43,793) $ (55,064) $ (105,781) ========== ========= ========= =========== NET LOSS PER SHARE: Basic and diluted $ (1.09) $ (6.92) $ (8.71) $ (16.72) ========== ========= ========= =========== WEIGHTED AVERAGE NUMBER OF COMMON SHARES: Basic and diluted 6,325 6,325 6,325 6,325 SEPTEMBER 23, 1997 (DATE OF SIX MONTHS SIX MONTHS INCORPORATION) ENDED ENDED THROUGH JUNE 30, JUNE 30, JUNE 30, 1999 2000 2000 ---------- ------------- -------------- (UNAUDITED) (UNAUDITED) (UNAUDITED) EXPENSES (with related party, Note 5): Research and development $ 26,608 $ 31,143 $ 148,193 General and administrative 556 1,856 4,182 -------- --------- ----------- Operating loss 27,164 32,999 152,375 -------- --------- ----------- Interest income 2,997 1,567 15,369 -------- --------- ----------- LOSS BEFORE INCOME TAXES (24,167) (31,432) (137,006) PROVISION FOR INCOME TAXES 207 -------- --------- ----------- NET LOSS $(24,167) $(31,432) $ (137,213) ======== ======== =========== NET LOSS PER SHARE: Basic and diluted $ (3.82) $ (4.97) $ (21.69) ======== ======== =========== WEIGHTED AVERAGE NUMBER OF COMMON SHARES: Basic and diluted 6,325 6,325 6,325

SPECIAL CALLABLE COMMON STOCK COMMON STOCK ADDITIONAL ------------------- ---------------------- PAID-IN SHARES AMOUNT SHARES AMOUNT CAPITAL ------------------- ---------------------- ----------- BALANCE, SEPTEMBER 23, 1997 (Date of Incorporation) Sale of special common stock 1 $ 1 Sale of callable common stock $ 6,325 $ 6 $ 93,961 Contribution from Dura Pharmaceuticals, Inc. 75,000 Compensation expense for stock options granted 16 Comprehensive loss: Net loss Unrealized gain on investments Comprehensive loss ----- ------ ------- ------- ---------- BALANCE, DECEMBER 31, 1997 1 1 6,325 6 168,977 ----- ------ ------- ------- ---------- Additional issuance costs on sale of callable common stock (71) Compensation expense for stock options granted 498 Comprehensive loss: Net loss Unrealized gain on investments Comprehensive loss ----- ------ ------- ------- ---------- BALANCE, DECEMBER 31, 1998 1 1 6,325 6 169,404 ----- ------ ------- ------- ---------- Compensation expense for stock options granted 787 Comprehensive loss: Net loss Unrealized loss on investment Comprehensive loss ----- ------ ------- ------- ---------- BALANCE, DECEMBER 31, 1999 1 $ 1 6,325 $ 6 $ 170,191 ----- ------ ------- ------- ---------- UNAUDITED: Compensation expense for stock options granted 326 Comprehensive loss: Net loss Unrealized gain on investments Comprehensive loss ----- ------ ------- ------- ---------- BALANCE, JUNE 30, 2000 1 $ 1 6,325 $ 6 $ 170,517 ----- ------ ------- ------- ---------- ACCUMULATED COMPREHENSIVE OTHER COMP. ACCUMULATED LOSS INCOME DEFICIT TOTAL ----------------- --------------- --------------- ------------- BALANCE, SEPTEMBER 23, 1997 (Date of Incorporation) Sale of special common stock $ 1 Sale of callable common stock 93,967 Contribution from Dura Pharmaceuticals, Inc. 75,000 Compensation expense for stock options granted 16 Comprehensive loss: Net loss $ (6,924) $ (6,924) (6,924) Unrealized gain on investments 21 $ 21 21 ----------- Comprehensive loss (6,903) =========== -------- ----------- ---------- BALANCE, DECEMBER 31, 1997 21 (6,924) 162,081 -------- ----------- ---------- Additional issuance costs on sale of callable common stock (71) Compensation expense for stock options granted 498 Comprehensive loss: Net loss (43,793) (43,793) (43,793) Unrealized gain on investments 203 203 203 ----------- Comprehensive loss (43,590) =========== -------- ----------- ---------- BALANCE, DECEMBER 31, 1998 224 (50,717) 118,918 -------- ----------- ---------- Compensation expense for stock options granted 787 Comprehensive loss: Net loss (55,064) (55,064) (55,064) Unrealized loss on investments (395) (395) (395) ------------ Comprehensive loss $ (55,459) ============ -------- ----------- ---------- BALANCE, DECEMBER 31, 1999 $ (171) $ (105,781) $ 64,246 ========= =========== ========== UNAUDITED: Compensation expense for stock options granted 326 Comprehensive loss: Net loss (31,432) (31,432) (31,432) Unrealized gain on investments 105 105 105 ------------ Comprehensive loss $ (31,327) ============ -------- ----------- ---------- BALANCE, JUNE 30, 2000 $ (66) $ (137,213) $ 33,245 ======== =========== ==========

SEPTEMBER 23, 1997 (DATE OF INCORPORATION) THROUGH YEAR ENDED DECEMBER 31, DECEMBER 31, 1997 1998 ------------------ ------------ OPERATING ACTIVITIES: Net loss $ (6,924) $ (43,793) Adjustments to reconcile net loss to net cash provided by operating activities: Compensation expense for stock options granted 16 498 Changes in assets and liabilities: Other current assets (192) Payable to Dura Pharmaceuticals, Inc. 7,110 (2,513) Accrued liabilities 26 255 ----------- ----------- Net cash provided by (used in) operating activities 228 (45,745) ----------- ----------- INVESTING ACTIVITIES: Purchases of short-term investments (31,450) (142,908) Sales and maturities of short-term investments 71,513 ----------- ----------- Net cash provided by (used in) investing activities (31,450) (71,395) ----------- ----------- FINANCING ACTIVITIES: Net proceeds from issuance of special common and callable common stock 93,968 (71) Contribution from Dura Pharmaceuticals, Inc. for purchase option 75,000 Increase (decrease) in payable to Dura Pharmaceuticals, Inc. for issuance costs 1,289 (1,289) ----------- ----------- Net cash provided by (used in) financing activities 170,257 (1,360) ----------- ----------- NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 139,035 (118,500) CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 139,035 ----------- ----------- CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 139,035 $ 20,535 =========== =========== SEPTEMBER 23,1997 (DATE OF INCORPORATION) YEAR ENDED THROUGH DECEMBER 31, DECEMBER 31, 1999 1999 ------------ --------------- OPERATING ACTIVITIES: Net loss $(55,064) $ (105,781) Adjustments to reconcile net loss to net cash provided by operating activities: Compensation expense for stock options granted 787 1,301 Changes in assets and liabilities: Other current assets 96 (96) Payable to Dura Pharmaceuticals, Inc. 2,123 6,720 Accrued liabilities (108) 173 -------- ----------- Net cash provided by (used in) operating activities (52,166) (97,683) -------- ----------- INVESTING ACTIVITIES: Purchases of short-term investments (29,559) (203,917) Sales and maturities of short-term investments 74,515 146,028 -------- ----------- Net cash provided by (used in) investing activities 44,956 (57,889) -------- ----------- FINANCING ACTIVITIES: Net proceeds from issuance of special common and callable common stock 93,897 Contribution from Dura Pharmaceuticals, Inc. for purchase option 75,000 Increase (decrease) in payable to Dura Pharmaceuticals, Inc. for issuance costs -------- ----------- Net cash provided by (used in) financing activities 168,897 -------- ----------- NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (7,210) 13,325 CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 20,535 -------- ----------- CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 13,325 $ 13,325 ======== ===========

SEPTEMBER 23,1997 (DATE OF SIX MONTHS SIX MONTHS INCORPORATION) ENDED ENDED THROUGH JUNE 30, JUNE 30, JUNE 30, 1999 2000 2000 --------------- -------------- -------------------- (UNAUDITED) (UNAUDITED) (UNAUDITED) OPERATING ACTIVITIES: Net loss $ (24,167) $ (31,432) $ (137,213) Adjustments to reconcile net loss to net cash provided by operating activities: Compensation expense for stock options granted 484 326 1,627 Changes in assets and liabilities: Other current assets 48 20 (76) Payable to Dura Pharmaceuticals, Inc. 372 (1,022) 5,698 Accrued liabilities (106) 311 484 ---------- ---------- ------------ Net cash provided by (used in) operating activities (23,369) (31,797) (129,480) ---------- ---------- ------------ INVESTING ACTIVITIES: Purchases of short-term investments (20,431) (203,917) Sales and maturities of short-term investments 49,652 33,639 179,667 ---------- ---------- ------------ Net cash provided by (used in) investing activities 29,221 33,639 (24,250) ---------- ---------- ------------ FINANCING ACTIVITIES: Net proceeds from issuance of special common and callable common stock 93,897 Contribution from Dura Pharmaceuticals, Inc. for purchase option 75,000 Increase (decrease) in payable to Dura Pharmaceuticals, Inc. for issuance costs ---------- ---------- ------------ Net cash provided by (used in) financing activities 168,897 ---------- ---------- ------------ NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 5,852 1,842 15,167 CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 20,535 13,325 ---------- ---------- ------------ CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 26,387 $ 15,167 $ 15,167 ========== ========== ============

UNREALIZED ESTIMATED COST GAINS (LOSSES) FAIR VALUE December 31, 1998: U.S. government securities $ 5,127 $ 6 $ 5,133 U.S. corporate debt securities 97,718 218 97,936 -------- ----- -------- Total $102,845 $ 224 $103,069 ======== ===== ======== December 31, 1999: U.S. corporate debt securities $ 57,889 $(171) $ 57,718 ======== ===== ========

ESTIMATED COST FAIR VALUE Due in one year or less $ 46,702 $ 46,727 Due after one year through two years 11,187 10,991 ---------- --------- Total $ 57,889 $ 57,718 ========== =========

SHARES WEIGHTED --------------------------------- AVERAGE OPTIONS EXERCISE OPTIONS AVAILABLE FOR PRICE PER OUTSTANDING GRANT SHARE ----------- ------------- --------- Balance, September 23, 1997 (date of incorporation) Options authorized 700,000 Options granted 548,000 (548,000) $ 14.00 ---------- --------- ------- Balance, December 31, 1997 548,000 152,000 $ 14.00 Options authorized 248,750 Options granted 272,000 (272,000) $ 14.35 ---------- --------- ------- Balance, December 31, 1998 820,000 128,750 $ 14.12 Options granted 12,500 (12,500) $ 14.00 Options cancelled (78,000) 78,000 $ 14.01 ---------- --------- ------- Balance, December 31, 1999 754,500 194,250 $ 14.13 ========== ========= =======

WEIGHTED AVERAGE REMAINING WEIGHTED CONTRACTUAL AVERAGE RANGE OF NUMBER LIFE EXERCISE EXERCISE PRICES OUTSTANDING (YEARS) PRICE --------------- ----------- ----------- --------- $14.00 - $15.88 754,500 8.2 $14.13

1997 1998 1999 ---- ---- ---- Expected dividend yield............................... None None None Expected stock price volatility....................... 30% 30% 30% Risk-free interest rate............................... 5.7% 4.4-5.7% 5% Expected life of options.............................. 4 years 3.1-3.9 years 1.6-1.8 years

PRO FORMA CONSOLIDATED BALANCE SHEET (UNAUDITED) JUNE 30, 2000 IN THOUSANDS SPIROS PRO FORMA PRO FORMA DURA CORP. II ADJUSTMENTS CONSOLIDATED ------------- ------------ -------------- --------------- ASSETS Current assets: Cash and cash equivalents $ 137,172 $ 15,167 $ (90,201) (2b) $ 62,138 Short-term investments 157,910 24,184 182,094 Accounts and other receivables 48,675 (5,697) (2a) 42,978 Inventory 14,481 14,481 Other current assets 5,052 75 5,127 --------- -------- --------- --------- Total current assets 363,290 39,426 (95,898) 306,818 License agreements and product rights 413,102 413,102 Property 92,288 92,288 Other assets 57,562 57,562 --------- -------- --------- --------- TOTAL $ 926,242 $ 39,426 $ (95,898) $ 869,770 ========= ======== ========= ========= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 14,947 $ 5,697 $ (5,697) (2a) $ 14,947 Accrued liabilities 86,359 484 86,843 Current portion of long-term obligations 1,931 1,931 --------- -------- --------- --------- Total current liabilities 103,237 6,181 (5,697) 103,721 Convertible subordinated notes 287,500 287,500 Other long-term obligations 68,288 68,288 --------- -------- --------- --------- Total liabilities 459,025 6,181 (5,697) 459,509 Stockholders' equity: Common stock 44 7 (7) (2b) 44 Additional paid-in capital 581,538 170,517 (150,150) (2b) 601,905 Accumulated other comprehensive income (loss) (1,056) (66) 66 (2b) (1,056) Warrant subscriptions receivable (4,261) 4,261 (2b) - Accumulated deficit (109,048) (137,213) 55,629 (2b) (190,632) --------- -------- --------- --------- Total stockholders' equity 467,217 33,245 (90,201) 410,261 --------- -------- --------- --------- TOTAL $ 926,242 $ 39,426 $ (95,898) $ 869,770 ========= ======== ========= =========

PRO FORMA CONSOLIDATED STATEMENT OF OPERATIONS (UNAUDITED) FOR THE YEAR ENDED DECEMBER 31, 1999 IN THOUSANDS, EXCEPT PER SHARE DATA SPIROS PRO FORMA PRO FORMA DURA CORP. II ADJUSTMENTS CONSOLIDATED ------------- ------------ ------------------------------------ REVENUES: Sales $ 231,776 $ 231,776 Contract 69,650 $ (55,496) (3a) 14,154 ----------- --------- ---------- Total revenues 301,426 (55,496) 245,930 ----------- --------- ---------- OPERATING COSTS AND EXPENSES: Cost of sales 45,839 45,839 Clinical, development and regulatory 52,977 $ 59,211 (58,423) (3b) 53,765 Selling, general and administrative 133,311 1,194 (400) (3b) 134,105 Product rights amortization 20,242 20,242 ----------- -------- --------- ---------- Total operating costs and expenses 252,369 60,405 (58,823) 253,951 ----------- -------- --------- ---------- OPERATING INCOME (LOSS) 49,057 (60,405) 3,327 (8,021) ----------- -------- --------- ---------- OTHER: Interest income 17,363 5,341 22,704 Interest expense (18,175) (18,175) Other (net) (3,797) (3,797) ----------- -------- ---------- Total other (4,609) 5,341 732 ----------- -------- ---------- INCOME (LOSS) BEFORE INCOME TAXES 44,448 (55,064) 3,327 (7,289) PROVISION (BENEFIT) FOR INCOME TAXES 14,444 (14,444) (3c) ----------- -------- --------- ---------- NET INCOME (LOSS) $ 30,004 $(55,064) $ 17,771 $ (7,289) =========== ======== ========= ========== NET INCOME PER SHARE - BASIC $ 0.68 $ (0.17) =========== ========== WEIGHTED AVERAGE NUMBER OF COMMON SHARES - BASIC 44,132 44,132 =========== ========== NET INCOME PER SHARE - DILUTED $ 0.66 $ (0.17) =========== ========== WEIGHTED AVERAGE NUMBER OF COMMON SHARES - DILUTED 45,672 44,132 =========== ==========

PRO FORMA CONSOLIDATED STATEMENT OF OPERATIONS (UNAUDITED) FOR THE SIX MONTHS ENDED JUNE 30, 2000 IN THOUSANDS, EXCEPT PER SHARE DATA SPIROS PRO FORMA PRO FORMA DURA CORP. II ADJUSTMENTS CONSOLIDATED ------------- ------------ ------------------------------------ REVENUES: Sales $ 128,206 $ 128,206 Contract 39,103 $ (29,221) (3a) 9,882 ----------- --------- ---------- Total revenues 167,309 (29,221) 138,088 ----------- --------- ---------- OPERATING COSTS AND EXPENSES: Cost of sales 26,076 26,076 Clinical, development and regulatory 30,811 $ 31,143 (30,817) (3b) 31,137 Selling, general and administrative 72,956 1,856 (200) (3b) 74,612 Product rights amortization 10,916 10,916 ----------- -------- --------- ---------- Total operating costs and expenses 140,759 32,999 (31,017) 142,741 ----------- -------- --------- ---------- OPERATING INCOME (LOSS) 26,550 (32,999) 1,796 (4,653) ----------- -------- --------- ---------- OTHER: Interest income 9,895 1,567 11,462 Interest expense (8,624) (8,624) Other (net) 3,450 3,450 ----------- -------- ---------- Total other 4,721 1,567 6,288 ----------- -------- ---------- INCOME (LOSS) BEFORE INCOME TAXES 31,271 (31,432) 1,796 1,635 PROVISION (BENEFIT) FOR INCOME TAXES 9,373 (8,882) (3c) 491 ----------- -------- --------- ---------- NET INCOME (LOSS) $ 21,898 $(31,432) $ 10,678 $ 1,144 =========== ======== ========= ========== NET INCOME PER SHARE - BASIC $ 0.49 $ 0.03 =========== ========== WEIGHTED AVERAGE NUMBER OF COMMON SHARES - BASIC 44,389 44,389 =========== ========== NET INCOME (LOSS) PER SHARE - DILUTED $ 0.48 $ 0.02 =========== ========== WEIGHTED AVERAGE NUMBER OF COMMON SHARES - DILUTED 46,002 46,002 =========== ==========

Year Ended Six Months Ended December 31, 1999 June 30, 2000 ----------------- ------------- Contract revenue.... $55,496 $29,221

Year Ended Six Months Ended December 31, June 30, 1999 2000 ------------ ----------------- Clinical, development and regulatory..... $58,423 $30,817 General and administrative............... 400 200

Year Ended Six Months Ended December 31, 1999 June 30, 2000 ----------------- ------------- Provision for income tax........ $14,444 $8,882

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