UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 1996 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number 0-24424 CIMA LABS INC. (Exact name of registrant as specified in its charter) Delaware 41-1569769 - --------------------------------- ---------------------------------- (State or other jurisdiction of (I.R.S. Employer Identification No.) incorporation or organization) 10000 Valley View Road, Eden Prairie, Minnesota 55344-9361 (Address of principal executive offices including zip code) (612) 947-8700 (Registrant's telephone number, including area code) ------------------------------------------------------ (Former name, former address and former fiscal year, if changed since last report) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No ___ Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date. Common Stock $.01 par value 9,411,589 shares --------------------------- -------------------------------- (Class) (Outstanding at November 1, 1996) CIMA LABS INC. TABLE OF CONTENTS PAGE NUMBER ---------- COVER PAGE 1 TABLE OF CONTENTS 2 PART I. FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS. Condensed Balance Sheets as of September 30, 1996 and December 31, 1995 3 Condensed Statements of Operations for the three- and nine-month periods ended September 30, 1996 and 1995 and the period from December 12, 1986 (inception) to September 30, 1996 4 Condensed Statements of Cash Flows for the nine-month periods ended September 30, 1996 and 1995 and the period from December 12, 1986 (inception) to September 30, 1996 5 Notes to Condensed Financial Statements 6 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. 7 PART II. OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS. 11 ITEM 2. CHANGES IN SECURITIES. 11 ITEM 3. DEFAULTS UPON SENIOR SECURITIES. 11 ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS. 11 ITEM 5. OTHER INFORMATION. 12 ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K. 12 SIGNATURE 13 2 PART I - FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS CIMA LABS INC. (A DEVELOPMENT STAGE COMPANY) CONDENSED BALANCE SHEETS (UNAUDITED) September 30, December 31, 1996 1995 ------------- ------------ (Note) ASSETS Current assets: Cash and cash equivalents $ 11,934,051 $3,558,743 Accounts receivable 439,732 212,971 Inventories -- Note B 349,783 324,610 Prepaid expenses 112,252 287,279 ------------- ------------ Total current assets 12,835,818 4,383,603 Property, plant and equipment 13,466,102 13,061,836 Less accumulated depreciation (2,839,166) (2,479,688) ------------- ------------ Other assets: 10,626,936 10,582,148 Lease deposits 290,651 290,650 Patents and trademarks, net of amortization 261,308 262,244 ------------- ------------ 551,959 552,894 ------------- ------------ Total assets $ 24,014,713 $15,518,645 ------------- ------------ ------------- ------------ Liabilities and stockholders' equity Current liabilities: Accounts payable $ 143,292 $291,868 Accrued expenses 988,936 695,127 Advance royalties 250,000 250,000 ------------- ------------ Total current liabilities 1,382,228 1,236,995 Commitments and contingencies Stockholders' equity Convertible Preferred Stock, $.01 par value: Authorized shares - 5,000,000; issued and outstanding shares - none Common Stock, $.01 par value: 94,111 78,201 Authorized shares - 20,000,000; issued and outstanding shares - [ 9,411,171] - September 30, 1996; 7,821,974 - December 31, 1995 Additional paid-in capital 56,584,670 43,462,921 Deficit accumulated during the development stage (34,046,296) (29,259,472) ------------- ------------ Total stockholders' equity 22,632,485 14,281,650 ------------- ------------ Total liabilities and stockholders' equity $ 24,014,713 $15,518,645 ------------- ------------ ------------- ------------ Note: The balance sheet at December 31, 1995 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. See notes to condensed financial statements. 3 CIMA LABS INC. (A DEVELOPMENT STAGE COMPANY) CONDENSED STATEMENTS OF OPERATIONS Three Months Ended Nine Months Ended Period from September 30, September 30, December 12, 1986 -------------------------- ---------------------- (Inception) to September 30, 1996 1995 1996 1995 1996 ------------- ----------- ----------- ----------- ---------------- Revenues: Net sales $ 0 $ 0 $ 0 $ 151,074 $ 13,750,884 Research, development and licensing revenues 504,425 200,761 1,171,560 447,569 5,046,291 ----------- ----------- ----------- ----------- ---------------- Total Revenues 504,425 200,761 1,171,560 598,643 18,797,175 Costs and Expenses: Cost of goods sold 0 0 0 240,038 17,831,415 Research and product development 1,228,632 1,119,694 3,903,428 5,348,044 19,023,719 Selling, general and administrative 782,544 717,058 2,363,303 2,665,027 17,098,337 ----------- ----------- ----------- ----------- ---------------- Total costs and expenses 2,011,176 1,836,752 6,266,731 8,253,109 53,953,471 ----------- ----------- ----------- ----------- ---------------- Other income (expense): Interest income, net 200,096 80,160 367,574 378,355 989,440 Other income (expense) (1,876) 3,244 (4,700) 12,207 269,068 ----------- ----------- ----------- ----------- ---------------- Total other income 198,220 83,404 362,874 390,562 1,258,508 ----------- ----------- ----------- ----------- ---------------- Net loss and deficit accumulated during the development stage $(1,308,531) $(1,552,587) $(4,732,297) $(7,263,904) $(33,897,788) ----------- ----------- ----------- ----------- ---------------- ----------- ----------- ----------- ----------- ---------------- Net loss per share: Primary $(.14) $(.20) $(.55) $(.96) $ (12.23) Full diluted $(.14) $(.20) $(.55) $(.96) $ (8.22) Weighted average number of shares outstanding: Primary 9,405,846 7,687,551 8,633,939 7,599,329 2,772,537 Fully diluted 9,405,846 7,687,551 8,633,939 7,599,329 4,124,224 4 CIMA LABS INC. (A DEVELOPMENT STAGE COMPANY) CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) Nine Months Ended September 30, Period from December 12, ---------------------- 1986 (Inception) to 1996 1995 September 30, 1996 ------------- ----------- ------------------------ OPERATING ACTIVITIES Net Loss $ (4,732,297) $ (7,263,904) $(33,897,788) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 442,374 437,097 3,856,598 Preferred Stock issued for accrued interest 0 0 141,448 Gain on sale of property, plant and equipment 0 (396,816) (53,270) Changes in operating assets and liabilities: Account receivable (226,761) 233,534 (439,732) Inventories (25,173) (18,237) (349,783) Other current assets 175,028 34,979 (112,251) Accounts payable (148,575) (530,038) 143,288 Accrued expenses 293,809 (250,146) 988,936 Advance royalties 0 0 250,000 ------------- ----------- ------------------------ Net cash used in operating activities (4,221,595) (7,753,531) (29,472,554) Investing activities: Purchase of and deposits on property, plant and equipment (404,268) (983,163) (14,550,328) Purchase of short-term investments 0 (6,819,276) (18,547,140) Proceeds from sale of property, plant and equipment 0 0 471,883 Proceeds from maturities of short-term investments 0 16,500,000 18,547,140 Patents and trademarks (81,959) (49,185) (593,702) ------------- ----------- ------------------------ Net cash provided by (used in) investing activities (486,227) 8,648,376 (14,672,147) Financing activities: Proceeds from issuance of stock: Common Stock 13,083,130 651,238 30,829,882 Preferred Stock 0 0 25,458,690 Borrowing under line of credit 0 0 0 Payment on line of credit 0 0 0 Lease financing of equipment 0 0 2,441,650 Security deposits on leases 0 0 (290,651) Proceeds from issuance of notes payable and warrants 0 0 1,923,951 Payments on notes payable 0 0 (1,823,700) Payments on capital leases 0 0 (2,441,650) Organization costs 0 0 (19,420) ------------- ----------- ------------------------ Net cash provided by financing activities 13,083,130 651,238 56,078,752 ------------- ----------- ------------------------ Increases (decreases) in cash equivalents 8,375,308 1,546,083 11,934,051 Cash and cash equivalents at beginning of period 3,558,743 2,912,150 - ------------- ----------- ------------------------ Cash and cash equivalents at end of period 11,934,051 4,458,233 11,934,051 ------------- ----------- ------------------------ Supplemental schedule of noncash investing and financing activities: Note payable exchanged for issuance $ 1,517,500 Common Stock issued for note receivable 50,000 See notes to condensed financial statements. 5 CIMA LABS INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO CONDENSED FINANCIAL STATEMENTS SEPTEMBER 30, 1996 (UNAUDITED) NOTE A - BASIS OF PRESENTATION The accompanying unaudited condensed financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three-month and nine-month periods ended September 30, 1996 are not necessarily indicative of the results that may be expected for the year ended December 31, 1996. For further information, refer to the financial statements and footnotes thereto included in the Company's annual report on Form 10-K for the year ended December 31, 1995. NOTE B - INVENTORIES September 30, December 31, 1996 1995 ------------- ------------- Raw materials $ 349,783 $ 324,610 Work in process -- -- Finished products -- -- ------------- ------------- $ 349,783 $ 324,610 NOTE C - INITIAL PUBLIC OFFERING The Company completed its initial public offering ("IPO") of its Common Stock in August 1994. Outstanding shares of Series A, B, C, D and E Preferred Stock were automatically converted on a one-for-one basis to shares of Common Stock on the closing date of August 4, 1994. NOTE D - LOSS PER SHARE The primary loss per share is based on the weighted average Common shares outstanding during the period. The fully diluted loss per share assumes the conversion of the preferred shares to common shares as of the beginning of the period, or from the date of issuance if later. The loss per share for periods prior to August 4, 1994, the closing date of the IPO, also gives effect to the requirements of Staff Accounting Bulletin No. 83 (SAB 83). 6 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS EXCEPT FOR THE HISTORICAL INFORMATION CONTAINED HEREIN, THE FOLLOWING DISCUSSION CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE RISKS AND UNCERTAINTIES. THE COMPANY'S ACTUAL RESULTS COULD DIFFER MATERIALLY FROM THOSE DISCUSSED HEREIN. FACTORS THAT COULD CAUSE OR CONTRIBUTE TO SUCH DIFFERENCES INCLUDE, BUT ARE NOT LIMITED TO, THOSE DISCUSSED IN THIS SECTION AS WELL AS THOSE DISCUSSED IN THE COMPANY'S PROSPECTUS, DATED MAY 10, 1996, FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. GENERAL CIMA LABS INC. ("CIMA" or the "Company") was founded in 1986 to develop effervescent drug delivery technologies and focused initially on contract manufacturing of liquid effervescents. CIMA continues to be a development stage company. CIMA's business focus has evolved over the last several years with the development and patenting of OraSolv-Registered Trademark-, an oral dosage form which incorporate microencapsulated drug ingredients into a tablet that dissolves quickly in the mouth without chewing or water and which effectively masks the taste of the medication being delivered. In 1993, following issuance of the U.S. patent covering OraSolv-Registered Trademark-, the Company began to emphasize and focus on the development of OraSolv-Registered Trademark- products and currently focuses primarily on such products. At September 30, 1996, the Company had accumulated net losses of approximately $34,046,000. The Company's revenues have been from product sales using the Company's AutoLution-Registered Trademark- (a liquid effervescent) technology, license fees paid by corporate partners in consideration of the transfer of rights under collaboration agreements, and research and development fees paid by corporate partners to fund the Company's research and development efforts for products developed under such agreements. To date, such revenues have been derived primarily from manufacturing agreements with third parties for liquid effervescent and other products, and to a lesser extent from research and development fees and licensing arrangements, the latter generated primarily in the last five years. In 1996, there have not been any revenues from manufacturing liquid effervescent products. This is a result of the Company's decision to discontinue manufacturing those products and focus on developing its OraSolv-Registered Trademark- technology. The last revenues for manufacturing liquid effervescent products were recognized in 1995. In addition to revenues from such manufacturing, research and development and licensing, the Company has funded operations from private sales of equity securities, realizing net proceeds of approximately $25,963,000. In July 1994 the Company completed an initial public offering of shares of its Common Stock realizing net proceeds of approximately $16,379,000, and in May 1996 completed an additional public offering of its Common Stock realizing net proceeds of approximately $12,145,000. The Company expects that losses will continue at least through 1997. Research and development expenses and general and administrative expenses are expected to remain relatively stable as the majority of the necessary personnel for these functions have already been hired. As CIMA prepares for the commercialization of its OraSolv-Registered Trademark- technology, it is expected that additional manufacturing personnel will be added, and that operating expenses will increase prior to a product launch by one of CIMA's corporate partners. 7 The Company's ability to generate revenues is dependent upon its ability to enter into and be successful in collaborative arrangements with pharmaceutical and other healthcare companies for the development and manufacture of OraSolv- Registered Trademark- products to be marketed by these corporate partners. The Company is highly dependent upon the efforts of the corporate partners to successfully market OraSolv-Registered Trademark- products. Although the Company believes these partners will have an economic motivation to market these products vigorously, the amount and timing of resources to be devoted to marketing are not within the control of the Company. These partners independently could make material marketing and other commercialization decisions which could adversely affect the Company's future revenues. Moreover, certain of the Company's products are seasonal in nature and the Company's revenues could vary materially from quarter to quarter depending on which of such products, if any, are then being marketed. Since the Company's initial public offering in 1994, the Company has put in place a substantially new management team. This new management team was responsible for the build out and validation of the Company's Eden Prairie manufacturing facility. RESULTS OF OPERATIONS THREE MONTHS AND NINE MONTHS ENDED SEPTEMBER 30, 1995 AND 1996 The Company's results of operations for the three- and nine-month periods ended September 30, 1996 reflect increased emphasis on development of OraSolv- Registered Trademark- products. Product sales declined to zero product sales in the first nine months of 1996 from $0 and $151,074 in the three- and nine-month periods ended September 30, 1995 respectively, as the Company ceased to manufacture liquid effervescent and other products. The Company does not intend to manufacture liquid effervescent products in the future. Research and development fees and licensing revenues were $200,761 and $447,569 for the three- and nine-month periods ended September 30, 1995, respectively, compared to $504,425 and $1,171,560, respectively, in the comparable periods of 1996. These increased research and development fees and licensing revenues reflect the progress of license option and development agreements with multinational pharmaceutical companies that provide for licensing fees, milestone payments, royalties and manufacturing fees. Research and development fees and licensing revenues will tend to fluctuate on a quarter to quarter basis. Cost of goods sold decreased to zero in the first nine months of 1996 from $0 and $240,038 in the three- and nine-month periods ended September 30, 1995, respectively. Costs of goods sold are not expected to increase until such time as the Company begins commercial production and sales of OraSolv-Registered Trademark- products. Research and product development expenses increased from $1,119,694 in the three months ending September 30, 1995, to $1,228,632 for the same period ending September 30, 1996. This increase is due to additional expenditures for development work for our corporate partners. Research and product development decreased from $5,348,044 to $3,903,428 for the nine month period ending September 30, 1995, compared to September 30, 1996. The decrease was the result of a product development/optimization charge in the first half of 1995 of approximately $1,659,000, of which approximately $591,000 was taken in the second quarter of 1995, from an independent consultant for improving product taste and packaging of OraSolv-Registered Trademark- products. Selling, general and administrative expenses decreased due to downsizing from $2,665,027 in the nine-month period ended September 30, 1995, to $2,363,303 in the nine-month period ended September 30, 1996. Selling, general and administrative expenses increased from $717,058 for the three month period ending September 30, 1995, to $782,544 for the three month period ending September 30, 1996, due to expenses related to hiring the Chief Financial Officer, and consumer testing of OraSolv-Registered Trademark-. Net interest income is dependent upon the cash position of the Company. Net interest income shows a slight decrease from $378,355 to $367,504 for the nine month periods ending September 30, 1995, and 1996, respectively, but shows an increase from $80,160 to $200,096 for the three month periods ending September 30, 1995, and 1996, respectively. Other income (expense) decreased from $3,244 and $12,207 in the three- and nine-month periods ended September 30, 1995, respectively, to $(1,876) and $(4,700) in the three-and nine-month periods ended September 30, 1996, respectively. 8 LIQUIDITY AND CAPITAL RESOURCES The Company has financed its operations to date primarily through private and public sales of its equity securities and revenues from manufacturing agreements. Through September 30, 1996, CIMA had received net offering proceeds from such private and public sales of approximately $54,500,000 and had net sales from manufacturing agreements of approximately $13,800,000. Among other things, these funds were used to purchase approximately $14,550,000 of capital equipment, including approximately $7,500,000 in the last two quarters of 1994 in connection with completing the Company's new Eden Prairie manufacturing facility. In July 1994 the Company completed an initial public offering of shares of its Common Stock, realizing net proceeds of approximately $16,400,000, and in May 1996 the Company completed another public offering of shares of its Common Stock, realizing net proceeds of approximately $12,145,000. The funds raised in CIMA's initial public offering have been used to build out the manufacturing facility, purchase and validate the appropriate production equipment, complete the research and development facilities and purchase the necessary equipment for that facility. The Company expects to use the funds raised in its May 1996 public offering primarily to begin commercial production in its new manufacturing facility and to fund research and development (including preclinical and clinical testing) for the application of the OraSolv- Registered Trademark- technology to pharmaceutical products, and that the balance of such funds will be used for working capital and other general corporate purposes. The Company's long-term capital requirements will depend upon numerous factors, including the status of the Company's collaborative arrangements, the progress of the Company's research and development programs and receipt of revenues from sales of the Company's products. Cash and cash equivalents, were approximately $11,934,000 at September 30, 1996. The Company believes that its currently available funds, excluding any license fees that may be received in the future, will meet its needs at least through the second quarter of 1997. There can be no assurance that, prior to such time the Company will not need to raise additional funds through public or private financings, including equity financing which may be dilutive to stockholders. There can be no assurance that the Company will be able to raise additional funds if its capital resources are exhausted, or that funds will be available on terms attractive to the Company. The Company has not generated taxable income through September 1996. At December 31, 1995, the net operating losses available to offset future taxable income were approximately $29,664,000. Because the Company has experienced ownership changes, pursuant to Internal Revenue Code regulations, future utilization of the operating loss carryforwards will be limited in any one fiscal year. The carryforwards expire beginning in 2001. As a result of the annual limitation, a portion of these carryforwards may expire before ultimately becoming available to reduce potential federal income tax liabilities. BUSINESS RISKS The Company is a development stage company and must be evaluated in light of the uncertainties and complications present for any such company and, in particular, a company in the pharmaceutical industry. The Company has accumulated aggregate net losses from inception in December 1986 through September 30, 1996 of approximately $34,046,000. Losses have resulted principally from costs incurred in research and development of the Company's technologies and from general and administrative costs. These costs have exceeded the Company's revenues, which have been derived primarily from the manufacturing of AutoLution-Registered Trademark- (a liquid effervescent) and other non-OraSolv-Registered Trademark- products under agreements with third parties. The Company no longer manufactures such products and no longer derives revenues from their manufacture. The Company expects to continue to incur quarterly losses at least through 1997. Many of the Company's expenditures to date have been non-recurring costs for plant, equipment and product optimization and validation. There can be no assurance, however, that the Company will ever generate substantial revenues or achieve profitability. The Company may need to raise additional funds to operate prior to the end of the first half of 1997 and will need to raise such funds prior to the end of 1997, and is subject to the risks inherent in raising such additional funds. See "-Liquidity and Capital Resources." In addition, the Company is dependent upon its ability to enter into and perform under collaborative arrangements with pharmaceutical companies for the development and commercialization of its products. See "-General." The success of the Company and of its business strategy is also dependent in large part on the ability of the Company to attract and retain key management and operating personnel. Such individuals are in high demand and are often subject to competing offers. In particular, the Company's success will depend, in part, on its ability to attract and retain the services of its executive officers and scientific and technical personnel. The loss of the services of one or more members of management or key employees 9 or the inability to hire additional personnel as needed or replace personnel who have left the Company may have a material adverse affect on the Company. To date no commercial sales of OraSolv-Registered Trademark- products have been made, and the Company has not derived any revenues from sales of OraSolv- Registered Trademark- products. Further, the Company does not expect to derive any such revenues until at least 1997. The Company has not yet manufactured OraSolv-Registered Trademark- products in commercial quantities. To achieve desired levels of production, the Company will be required to increase substantially its manufacturing capabilities. There can be no assurance that manufacturing can be scaled-up in a timely manner to allow production in sufficient quantities to meet the needs of the Company's corporate partners. The foregoing risks reflect the Company's stage of development and the nature of the Company's industry and products. Also inherent in the Company's stage of development is a range of additional risks, including competition, uncertainties regarding the effects of health care reform on the pharmaceutical industry, including pressures exerted on the prices charged for pharmaceutical products, uncertainties regarding protection of patents and proprietary rights, uncertainties relating to government regulation and risks associated with having only one manufacturing line at the sole manufacturing facility. 10 CIMA LABS INC. PART II. OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS. None ITEM 2. CHANGES IN SECURITIES. None 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 Item Description ----- ------------ 10.11 Equity Incentive Plan, as amended and restated. 10.12 1994 Directors' Stock Option Plan, as amended and restated. 10.29 Offer letter between the Company and Keith P. Salenger dated August 8, 1996. 11.1 Statement re Computation of Net Loss Per Share 27 Financial Data Schedule - ------------------------ (b) REPORTS ON FORM 8-K The Company filed no reports on Form 8-K during the quarter ended September 30, 1996. 11 CIMA LABS INC. SIGNATURES Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed in its behalf by the undersigned thereunto duly authorized. CIMA LABS INC. Date: November 14, 1996 By: /s/ John M. Siebert ----------------- --------------------------------- John M. Siebert President and Chief Executive Officer Date: November 14, 1996 By: /s/ Keith P. Salenger ----------------- --------------------------------- Keith P. Salenger Vice President, Finance and Chief Financial Officer (Principal Financial and Accounting Officer) 12 EXHIBIT INDEX NO. OF EXHIBIT DESCRIPTION - -------------- ------------ 10.11 Equity Incentive Plan, as amended and restated. 10.12 1994 Directors' Stock Option Plan, as amended and restated. 10.29 Offer letter between the Company and Keith P. Salenger dated August 8, 1996. 11.1 Statement re Computation of Net Loss Per Share 27 Financial Data Schedule - ------------------------- 13