EMISPHERE TECHNOLOGIES, INC. 15 SKYLINE DRIVE HAWTHORNE, NEW YORK 10532 December 12, 1995 Securities and Exchange Commission Washington, D.C. 20549 Gentlemen: Pursuant to the requirments of the Securities Exchange Act of 1934, we are transmitting herewith the attahced Form 10-Q. Sincerely, Emisphere Technologies, Inc. Joseph D. Povemomo Joseph D. Poveromo, Chief Accounting Officer FORM 10-Q SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 --------------------------- (Mark One) [ X ] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarter period ended October 31, 1995 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 [NO FEE REQUIRED] For the transition period from ______________ to __________________ Commission file number 1-10615 EMISPHERE TECHNOLOGIES, INC. (Exact name of registrant as specified in its charter) DELAWARE 13-3306985 (State or jurisdiction (I.R.S. Employer of incorporation or Identification Number) organization) 15 Skyline Drive Hawthorne, New York 10532 (Address of principal (Zip Code) executive offices) (914) 347-2220 (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 files by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that registrant was required to file such reports) and (2) has been subject to such filing requirements for at least the past 90 days. Yes X No ____. APPLICABLE ONLY TO CORPORATE ISSUERS As of November 30, 1995 there were 8,323,159 Shares of common stock, $.01 par value, of the registrant outstanding. EMISPHERE TECHNOLOGIES, INC. TABLE OF CONTENTS October 31, 1995 Part I. FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS -------------------- Condensed Balance Sheets Condensed Statements of Operations Condensed Statement of Stockholders' Equity Condensed Statements of Cash Flows Condensed Notes to Financial Statements ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF -------------------------------------- FINANCIAL CONDITION AND RESULTS OF OPERATIONS --------------------------------------------- Part II. OTHER INFORMATION ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K -------------------------------- EMISPHERE TECHNOLOGIES, INC. CONDENSED BALANCE SHEETS (UNAUDITED) ASSETS July 31, October 31, 1995 1995 ---------- ----------- Current assets: Cash and cash equivalents $2,226,156 $11,173,363 Marketable securities 3,393,395 3,297,267 Prepaid expenses and other current assets 148,469 134,650 ---------- ----------- Total current assets 5,768,020 14,605,280 Equipment and leasehold improvements, at cost, net of accumulated depreciation and amortization 1,704,309 1,583,588 Restricted cash equivalents 10,000 10,000 Other assets 66,243 66,243 ---------- ----------- Total assets $7,548,572 $16,265,111 ========== ============ Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 234,917 $ 235,649 Accrued compensation 203,145 144,599 Accrued expenses 156,711 197,629 Deposit from Elan plc 3,000,000 ---------- ----------- Total current liabilities 594,773 3,577,877 Deferred lease liability 55,100 52,531 ---------- ----------- Total liabilities 649,873 3,630,408 ---------- ----------- Stockholders' equity: Preferred stock, $.01 par value; 1,000,000 shares authorized, none issued and outstanding Common stock, $.01 par value; 20,000,000 shares authorized; 7,687,304 shares issued (7,643,804 outstanding) at July 31, 1995; 8,366,659 shares issued (8,323,159 outstanding) at October 31, 1995 76,873 83,667 Additional paid-in capital 43,626,657 51,262,518 Accumulated deficit (36,628,209) (38,567,400) Net unrealized gain on marketable securities 16,191 48,731 ----------- ------------ 7,091,512 12,821,516 Less, common stock held in treasury, at cost; 43,500 shares (192,813) (192,813) ----------- ----------- Total stockholders' equity 6,898,699 12,634,703 ----------- ----------- Total liabilities and stockholders' equity $7,548,572 $16,265,111 ========== =========== See accompanying notes to financial statements. The July 31, 1995 Condensed Balance Sheet data was derived from audited financial statements, but does not include all disclosures required by generally accepted accounting principles. EMISPHERE TECHNOLOGIES, INC. CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) Three Months ended October 31, 1994 1995 ---------- ----------- Revenues: Research and development - - Cost and expenses: General and administrative expenses $ 553,552 $ 615,900 Research and development 1,386,664 1,383,409 ----------- ------------ Total operating expenses 1,940,216 1,999,309 ----------- ------------ Operating loss (1,940,216) (1,999,309) ----------- ------------ Other income: Investment income 42,036 60,118 ----------- ------------ Total other income 42,036 60,118 ----------- ------------ Net loss (1,898,180) (1,939,191) =========== ============ Net loss per share ($ .25) ($ .25) =========== ============ Weighted average number of share's outstanding 7,574,867 7,746,457 =========== ============ See accompanying notes to the financial statements EMISPHERE TECHNOLOGIES, INC. CONDENSED STATEMENT OF STOCKHOLDERS' EQUITY (UNAUDITED) For the three months ended October 31, 1995 Net Unrealized Additional Gain on Common Stock Common Stock Paid-in Accumulated Marketable Held in Treasury Shares Amount Capital Deficit Securities Shares Amount Total --------- ------ ------------ ------------ ----------- ------- ---------- ---------- Balance, July 31, 1995 7,687,304 $76,873 $ 43,626,657 $ (36,628,209) $ 16,191 43,500 $ (192,813) $6,898,699 Sale of common stock under employee stock purchase plans 79,355 794 178,861 179,655 Issuance of common stock to Elan International Services Ltd., net of expenses 600,000 6,000 7,457,000 7,463,000 Unrealized gain 32,541 32,541 Net loss for the three months ended October 31, 1995 (1,939,191) (1,939,191) --------- ------- ----------- ------------ ----------- ------ ----------- ----------- Balance, October 31, 1995 8,366,659 $83,667 $51,262,518 $(38,567,400) $ 48,732 43,500 $ (192,813) $12,643,704 ========= ======= =========== ============ =========== ====== =========== =========== See accompanying notes to financial statements EMISPHERE TECHNOLOGIES, INC. CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) Three Months ended October 31, -------------------- 1994 1995 ----------- --------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $(1,898,180) $(1,939,191) ------------ ------------ Adjustments to reconcile net loss to net cash (used in) provided by operating activities: Depreciation and amortization 136,428 134,799 Increase (decrease) in deferred lease liability 618 ( 2,569) Realized loss(gain) on sales of marketable securities 27,528 ( 335) Change in Assets and Liabilities: Prepaid expenses and other current assets 18,146 13,819 Accounts payable and accrued expenses 139,826 ( 16,897) Deposit from Elan plc 3,000,000 ----------- ----------- Total adjustments 322,546 3,128,817 ---------- ---------- Net cash (used in) provided by operating activities (1,575,634) 1,189,626 ----------- ---------- CASH FLOWS FROM INVESTING ACTIVITIES: Capital expenditures ( 33,406) ( 14,078) Purchase of marketable securities (1,141,844) Proceeds from sales of marketable securities 2,638,264 129,004 ----------- ---------- Net cash provided by investing activities 1,463,014 114,926 ----------- ---------- CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from issuance of common stock and warrants to Elan International Services ltd. - 7,463,000 Proceeds from exercise of options and warrants, and employee stock purchases 179,655 Purchase of treasury stock ( 123,438) ----------- ----------- Net cash (used in) provided by financing activities ( 123,438) 7,642,655 ----------- ----------- Net (decrease)increase in cash and cash equivalents ( 236,058) 8,947,207 CASH AND CASH EQUIVALENTS, beginning of period 272,607 2,226,156 ----------- ----------- CASH AND CASH EQUIVALENTS, end of period $ 36,549 $ 11,173,363 =========== ============ See accompanying notes to financial statements EMISPHERE TECHNOLOGIES, INC. CONDENSED NOTES TO FINANCIAL STATEMENTS 1. Interim Financial Statements: The interim Condensed Statements of Operations and Condensed Statements of Cash Flows for the three months ended October 31, 1994 and 1995, and the Condensed Balance Sheets as of July 31, and October 31, 1995, of Emisphere Technologies, Inc. (the "Company"), have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all information and disclosures Necessary for a presentation of the Company's financial position, results of operations and cash flows in conformity with generally accepted accounting principles. In the opinion of management, these financial statements reflect all adjustments, consisting only of normal recurring accruals, necessary for a fair presentation of the Company's financial position, results of operations and cash flows for such periods. The results of operations for any interim period are not necessarily indicative of the results for the full year. These financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company`s Annual Report on Form 10-K for the fiscal year ended July 31, 1995. 2. Marketable Securities: The following table summarizes the aggregate fair value of marketable securities, gross unrealized holding gains and losses, and the amortized cost basis of marketable securities at October 31, 1995. Amortized Fair Unrealized Holding Cost Basis Value Gains Losses Net Maturities within one year: U.S. Government securities $ 2,649,732 $ 2,686,381 $ 37,098 $( 449) $ 36,649 Maturities between one and two years: U.S. Government securities 598,804 610,886 12,082 12,082 ----------- ----------- -------- -------- --------- $ 3,248,536 $ 3,297,267 $ 49,180 $( 449) $ 48,731 =========== =========== ======== ======== ========= The aggregate net unrealized gain of $48,732 has been included as an addition to stockholders' equity at October 31, 1995. 3. Strategic Alliance Elan plc: During October 1995, the Company entered into a letter of intent with Elan plc ("Elan") which, among other things, provides for a strategic alliance with the Company for the development of the oral formulation of a specific drug. The term and provisions of the strategic alliance are presently being negotiated. The Company recieved $3 million from Elan which has been recorded as a deposit until such time as the terms of the strategic alliance are finalized. In connection with the letter of intent, the Company entered into a Purchase Agreement with Elan International Services Ltd., an affiliate of Elan. The terms of the Purchase Agreement provided for the Company to sell 6000,000 shares of its common stock, and issue 250,000 warrants to purchase shares of the Company's common stock at $16.25 per share, in consideration for $7.5 million. The warrants contain antidilutive provisions, are exercisable upon issuance, and expire on October 18, 2000. 4. Impact of the Future Adoption of Recently Issue Accounting Standard: The Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 123, "Accounting for Stock-Based Compensation" ("FAS 123") in October 1995. The Company will be required to adopt the provisions of FAS 123 at the beginning of the year ending July 31, 1997. FAS 123 requires companies to estimate the fair value of common stock, stock options, or other equity instruments ("Equity Instruments") issued to employees using pricing models which take into account various factors such as current price of the common stock, volatility and expected life of the Equity Instrument. FAS 123 permits companies to either provide pro forma note disclosure or adjust operating results for the amortization of the estimated value of the Equity Instument, as compensation expense, over the vesting period of the Equity Instrument. The Company has not fully evaluated the impact that the future adoption of FAS 123 will have on its financial position or results of operations at this time. ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS. General Emisphere Technologies, Inc. is a drug delivery company engaged in the research and development of its proprietary technologies with the goal of commercializing its drug delivery technologies. Results of Operations: The Company has since its inception generated significant losses from operations. The Company does not expect to achieve sustained profitability for the foreseeable future. Profitability in the long term will depend on the Company's ability to attract pharmaceutical companies willing to enter into agreements with the Company to produce and market their drugs utilizing the Company's drug delivery technologies. There can be no assurance that any pharmaceutical company will be willing to undertake the clinical testing and other product development activities necessary to develop a marketable product or enter into an agreement acceptable to the Company or that the agreements, if entered into, will result in the ultimate profitability of the Company. The ability of the Company to reduce its operating losses in the near term will be dependent upon, among other things, its ability to attract new pharmaceutical and non-pharmaceutical companies who are willing to provide funding to the Company for a portion of the Company's research and development with respect to specific projects. While the Company is consistently engaged in discussions with pharmaceutical and non-pharmaceutical companies, there can be no assurance that the Company will enter into any additional agreements or that the agreements will provide research and development revenues to the Company. Three Months Ended October 31, 1995 vs. Three Months Ended October 31, 1994: For the three months ended October 31, 1995, and October 31, 1994, the Company had no research and development revenues. Total operating expenses for the fiscal quarter ended October 31, 1995, increased by approximately $59,000, or 3%, as compared to the fiscal quarter ended October 31, 1994. The details of this increase are as follows: General and administrative expenses increased by approximately $62,000, or 11%, in the fiscal quarter ended October 31, 1995, as compared to the fiscal quarter ended October 31, 1994. This increase is primarily the result of legal and professional fees incurred in connection with , among other things the settlement of a class action lawsuit and the cmpletion of the letter of intent with Elan plc ("Elan"). Research and development costs decreased by approximately $3,000, or less than 1%, in the fiscal quarter ended October 31, 1995, as compared to the fiscal quarter ended October 31, 1994. The reduced cost is attributable to decreased funding of outside consultants and universities engaged to conduct studies to help advance the Company's scientific research efforts and a decrease in usage of laboratory supplies as a result of a reduction in the number of projects on which the Company is actively working. The Company also experienced a decrease in personnel and related expenses due, in part, to a staff reduction in May 1995. These lower costs were offset by an increase in costs related to the Company's clinical development program for heparin. The Company believes that this level of research and development spending will continue for the foreseeable future and may increase if operations are expanded. The Company's other income in the quarter ended October 31, 1995 increased by approximately $18,000 from that of the fiscal quarter ended October 31, 1994. The increase was due to better returns on the Company's smaller investment portfolio plus losses on the sale of investment securtities which the Company realized in the quarted ended October 31, 1994 did not occur during the quarter ended October 3, 1995. Based on the above factors, the Company sustained a net loss for the first quarter of fiscal 1996 of $1,939,191, a 2% increase from $1,898,180 net loss of the 1995 fiscal first quarter. Liquidity and Capital Resources As of October 31, 1995, the Company had working capital of approximately $11,027,000 as compared with approximately $5,173,000 at July, 31, 1995. Cash and cash equivalents and marketable securities were approximately $14,471,000 as of October 31, 1995, compared to approximately $5,620,000 at July 31, 1995. The increase in the Company's cash and cash equivalents and marketable securities is a result of the letter of intent entered into by Company with Elan which provides for the development of an oral formulation of heparin. The termns of the letter of intent initially require Elan to finance $7.5 million the development work of heparin. It is anticipated that subsequent financing needs for the development work will be shared equally by the Company and Elan. In connection with the letter of intent, the Company entered into a Purchase Agreement with Elan International Services Ltd., an affiliate of Elan. The terms of the Purchase Agreement provided for the Company to sell 600,000 shares of its common stock and issue 250,000 warrants to purchase shares of the Company's common stock at $16.25 per share, in consideration for $7.5 million. The Company expects to incur substantial research and development expenses associated with development of the Company's oral drug delivery system. As the result of the ongoing research and development efforts of the Company, management believes that the Company will continue to incur operating losses and that, potentially, such losses could increase. The Company expects that cash, cash equivalents and marketable securities will, under the Company's present operating assumptions, be adequate to meet its liquidity and capital requirements at least through the end of the second quarter of fiscal 1998. While the Company does not currently foresee any major capital expenditures, the Company expects to need substantial resources to continue its research and development efforts. Should circumstances warrant it, the Company would seek additional funds primarily in the public and private equity markets, and to the extent necessary and available, through debt financing. The Company has no firm agreements with respect to any additional financing and there can be no assurance that the Company would be able to obtain adequate funds on acceptable terms. If adequate funds were not available, the Company would be required to delay, scale back, or eliminate one or more of its research or development programs, or obtain funds, if available, through arrangements with collaborative partners or others that may require the Company to relinquish rights to certain of its technologies, product candidates, or products that the Company would not otherwise relinquish. The Company does not maintain any credit lines with financial institutions. Part II. OTHER INFORMATION Item 6. Exhibits and Reports on Form 8-k (a) Exhibits 11. Statement of computation of per share data 27. Financial Data Schedule (b) Reports No reports on form 8-k were filed by the Registrant during the quarter ended October 31, 1994. Exhibit 11 EMISPHERE TECHNOLOGIES, INC. STATEMENT OF COMPUTATION OF PER SHARE DATA Three months ended --------------------------------------------------------- October 31, 1994 October 31, 1995 --------------------------- -------------------------- Primary Fully Diluted Primary Fully Diluted Net loss ($1,898,180) ($1,898,180) ($1,939,191) ($1,939,191) ============ ============ ============ ============ Weighted average number of shares 7,574,867 7,574,867 7,746,457 7,746,457 Shares issuable upon exercise of options and warrants (A) 349,669 Shares assumed to be repurchased under the treasury stock method 201,871 ------------ ------------ ------------ ------------ 7,574,867 7,574,867 7,76,457 7,894,255 ============ ============ ============ ============ NET LOSS PER SHARE ($.25) ($.25) ($.25) ($.25) =========== ============ ============ ============ (A) As of, and for the quarter ended October 31, 1994 all previously issued and outstanding options had exercise prices above the current fair market value of the common stock. SIGNATURE Pursuant to the requirement 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. Emisphere Technologies, Inc. Dated: December 12, 1995 Michael M. Goldberg, M.D. ------------------------- Michael M. Goldberg, M.D. Chairman, and Chief Executive Officer Joseph D. Poveromo, C.P.A. -------------------------- Joseoh D. Poveromo, C.P.A. Controller (Principal Financial and Accounting Officer)