1 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark one) [X] Quarterly Report Under Section 13 or 15 (d) Of the Securities Exchange Act of 1934 For Quarterly Period Ended March 31, 1998 [ ] Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act 1934 for the period from ___ to ___. HOLLIS-EDEN PHARMACEUTICALS, INC (Exact name of registrant as specified in its charter) DELAWARE (State or other jurisdiction of incorporation) 000-24672 13-3697002 (Commission File No.) (I.R.S. Employer Identification No.) 9333 Genesee Ave., Suite 110 SAN DIEGO, CALIFORNIA 92121 (Address of principal executive offices and zip code) Registrant's telephone number, including area code: (619) 587-9333 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 As of April 16, 1998 there were 6,801,315 shares of registrant's Common Stock, $.01 par value, outstanding. 2 HOLLIS-EDEN PHARMACEUTICALS, INC. Form 10-Q FOR THE QUARTER ENDED MARCH 31, 1998 INDEX PART I FINANCIAL INFORMATION PAGE ITEM 1 Financial Statements..........................................................................3 Balance Sheet - March 31, 1998 and December 31, 1997..........................................3 Statements Of Operations for the Three-Month Periods Ended March 31, 1997 and 1998 and Period from August 15, 1994 to March 31, 1998...................................4 Statements Of Cash Flows for the Fiscal Years Ended March 31, 1997 and 1998 and Period from August 15, 1994 to March 31, 1998.............................................5 Notes To Financial Statements.................................................................6 ITEM 2 Management's Discussion and Analysis of Results of Operations and Financial Condition.....................................................................................6 PART II OTHER INFORMATION. ITEM 1 Legal Proceedings.............................................................................9 ITEM 2 Changes in Securities.........................................................................9 ITEM 3 Defaults Upon Senior Securities...............................................................9 ITEM 3 Submission of Matters to a Vote of Security Holders...........................................9 ITEM 4 Other Information.............................................................................9 ITEM 6 Exhibits and Reports on Form 8-K..............................................................9 2 3 PART I. FINANCIAL INFORMATION ITEM I. FINANCIAL STATEMENTS HOLLIS-EDEN PHARMACEUTICALS, INC. (A DEVELOPMENT STAGE COMPANY) BALANCE SHEETS (UNAUDITED) 1998 1997 ------------ ------------ ASSETS: Current assets: Cash and cash equivalents .......................... $ 6,053,007 $ 7,102,620 Prepaid expenses .................................... 405,853 53,009 Deposits ............................................ 9,163 9,163 Other receivable - tax refund ....................... 105,436 105,436 Other receivable from related party ................. 46,679 46,679 ------------ ------------ Total current assets ........................... 6,620,138 7,316,907 Property and equipment, net of accumulated depreciation of $11,295 and $6,602 ................ 81,271 82,941 ------------ ------------ Total assets ................................... $ 6,701,409 $ 7,399,848 ============ ============ LIABILITIES AND STOCKHOLDERS' EQUITY: Current liabilities: Accounts payable and accrued expenses ............... $ 114,024 $ 128,631 R & D fees payable to related party ................. 250,000 338,000 ------------ ------------ Total liabilities .............................. 364,024 466,631 Commitments and contingencies Stockholders' equity: Preferred stock, no par value, 10,000,000 shares authorized; no shares issued or outstanding ..... -- -- Common stock, $01 par value, 30,000,000 shares authorized; 6,801,315 and 6,772,023 shares issued and outstanding ......... 68,013 67,720 Paid-in capital ................................... 16,835,520 16,325,338 Deferred compensation-stock options, net of accumulated amortization of $359,000 and $282,000 (1,489,000) (1,566,000) Deficit accumulated during development stage ...... (9,077,148) (7,893,841) ------------ ------------ Total stockholders' equity ...................... 6,337,385 6,933,217 ------------ ------------ Total liabilities and stockholders' equity ...... $ 6,701,409 $ 7,399,848 ============ ============ The accompanying notes are an integral part of these financial statements. 3 4 HOLLIS-EDEN PHARMACEUTICALS, INC. (A DEVELOPMENT STAGE COMPANY) STATEMENTS OF OPERATIONS (UNAUDITED) PERIOD FROM INCEPTION (AUG.15,1994) TO 3 MONTHS ENDED MARCH 31, MARCH 31, 1997 1998 1998 ----------- ----------- ----------- Operating expenses: Research and development . $ 1,573,680 $ 556,047 $ 5,858,443 General and administrative 793,344 712,395 3,541,561 ----------- ----------- ----------- Total operating expenses .. 2,367,024 1,268,442 9,400,004 Other income (expense): Interest income .......... 1,372 85,135 370,679 Interest expense ......... -- -- (47,823) ----------- ----------- ----------- Total other income ........ 1,372 85,135 322,856 ----------- ----------- ----------- Net loss .................. $(2,365,652) $(1,183,307) $(9,077,148) =========== =========== =========== Net loss per share ........ $ (0.48) $ (0.17) Weighted average number of common shares outstanding 4,959,583 6,796,485 The accompanying notes are an integral part of these financial statements. 4 5 HOLLIS-EDEN PHARMACEUTICALS, INC. (A DEVELOPMENT STAGE COMPANY) STATEMENTS OF CASH FLOWS (UNAUDITED) PERIOD FROM INCEPTION (AUG. 15, 1994) TO 3 MONTHS ENDED MARCH 31, MARCH 31, 1997 1998 1998 ------------ ------------ ------------ Cash flows from operating activities: Net loss ........................................... $ (2,365,652) $ (1,183,307) $ (9,077,148) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation ................................... 254 4,873 11,475 Common stock issued as consideration for amendments to the license agreements ...... -- -- 32,540 Common stock issued as consideration for termination of a finance agreement ........ -- -- 33,962 Expense related to options and warrants issued as consideration to consultants ........ 2,006 104,006 118,047 Expense related to warrants issued to director for successful closure of merger ..... 570,000 -- 570,000 Deferred compensation expense related to options issued ............................. -- 77,000 359,000 Changes in assets and liabilities: Prepaid expenses ................................... 93,937 (48,850) (91,831) Deposits ........................................... 100,000 -- (9,163) Other receivable - tax refund ...................... -- -- (105,436) Other receivable from related party ................ (43,944) -- (46,679) Accounts payable and accrued expenses .............. 173,066 (14,607) 114,024 Wages payable ...................................... 40,625 -- -- R & D fees payable to related party ................ 1,500,000 (88,000) 250,000 Income taxes payable ............................... 110,114 -- -- ------------ ------------ ------------ Net cash provided (used) in operating activities 180,406 (1,148,885) (7,841,209) Cash flow provided by investing activities: Purchase of property and equipment ................. -- (4,924) (94,467) ------------ ------------ ------------ Net cash used in investing activities .......... -- (4,924) (94,467) Cash flows from financing activities: Borrowings from related party ...................... 92,000 -- 342,000 Payments on note payable to related party .......... (92,000) -- (342,000) Contributions from stockholder ..................... -- -- 103,564 Net proceeds from sale of common stock ............. -- 102,475 1,611,974 Proceeds from issuance of debt ..................... -- -- 371,164 Net proceeds from recapitalization ................. 6,270,782 -- 6,270,782 Net proceeds from warrants exercised ............... -- -- 5,629,478 ------------ ------------ ------------ Net cash from financing activities ............. 6,270,782 102,475 13,986,962 Net increase (decrease) in cash ...................... 6,451,188 (1,051,334) 6,051,286 Cash at beginning of period .......................... 17,917 7,102,620 -- ------------ ------------ ------------ Cash at end of period ................................ $ 6,469,105 $ 6,051,286 $ 6,051,286 ============ ============ ============ Supplemental disclosure cash flow information: 1) The Company issued warrants for services in lieu of cash with an estimated value of $408,000. The accompanying notes are an integral part of these financial statements. 5 6 HOLLIS-EDEN PHARMACEUTICALS, INC. (a corporation in the development stage) NOTES TO FINANCIAL STATEMENTS (UNAUDITED) 1. BASIS OF PRESENTATION The information at March 31, 1998, and for the three-month periods ended March 31, 1998 and 1997, is unaudited. In the opinion of management, these financial statements include all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented. Interim results are not necessarily indicative of results for a full year. These financial statements should be read in conjunction with Hollis-Eden Pharmaceuticals (the "Company") Annual Report on Form 10-K for the year ended December 31, 1997, which was filed with the United States Securities and Exchange Commission on March 31, 1998. 2. ISSUANCE OF WARRANTS During February 1998, the Company entered into an agreement with an investors relations firm, which expires on December 31, 1998. The Company agreed to issue as part of the compensation for services, 150,000 warrants with an exercise price of $14.75 per share and an expiration date of December 31, 1998. The warrants were estimated to have a value of $408,000, which amount will be expensed $102,000 per quarter during 1998. ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION The forward-looking comments contained in the following discussion involve risks and uncertainties. The Company's actual results may differ materially from those discussed here. Factors that could cause or contribute to such differences can be found in the following discussion, as well as in the Company's Annual Report on Form 10-K for the year ended December 31, 1997. While management believes that the discussion and analysis in this report is adequate for a fair presentation of the information, management recommends that this discussion and analysis be read in conjunction with Management's Discussion and Analysis of Results of Operations and Financial Condition included in the Company's Annual Report on Form 10-K for the year ended December 31, 1997 which was filed with the United States Securities and Exchange Commission on March 31, 1998. GENERAL Hollis-Eden Pharmaceuticals, a development-stage pharmaceutical company, is engaged in the discovery, development and commercialization of products for the treatment of a number of targeted disease states caused by viral, bacterial, parasitic or fungal infections, including HIV/AIDS, hepatitis B and C, and malaria. The Company has three technology platforms, one based on cellular energy regulation, the second on a unique immune system modulation technology, and the third on biochemical synthesis regulators. The Company believes that certain of its drug candidates may provide the first long-term treatment for HIV without the development of viral strain resistance to the drugs' effectiveness, significant toxicity or severe side effects. The Company has not yet generated any operating revenues. The Company has experienced significant operating losses due to substantial expenses incurred to acquire and fund development of its drug candidates and, as of March 31, 1998, had an accumulated deficit of $9.1 million. 6 7 When and if any of the Company's drug candidates have been approved for commercial sale, the Company plans to market them in the United States. For international markets, the Company intends to develop strategic alliances with major pharmaceutical companies that have foreign regulatory expertise and established distribution channels, and will also consider corporate strategic partnerships and co-marketing agreements. No assurances can be given that any of the Company's drug candidates will be approved for commercial sale or that any of the foregoing proposed arrangements will be implemented or prove to be successful. The Company has been unprofitable since inception and expects to incur substantial additional operating losses for at least the next few years as it increases expenditures on research and development and begins to allocate significant and increasing resources to its clinical testing and other activities. In addition, during the next few years, the Company will have to meet the substantial new challenge of developing the capability to market products. Accordingly, the Company's activities to date are not as broad in depth or scope as the activities it must undertake in the future, and the Company's historical operations and financial information are not indicative of the Company's future operating results or financial condition or its ability to operate profitably as a commercial enterprise when and if it succeeds in bringing any drug candidate to market. During March 1997, Hollis-Eden, Inc. ("Hollis-Eden"), a Delaware corporation, was merged with and into the Company (then known as Initial Acquisition Corp. ("IAC")). Upon the consummation of the merger, Hollis-Eden ceased to exist, and IAC changed its name to Hollis-Eden Pharmaceuticals. For accounting and financial reporting purposes, the merger was treated as a recapitalization of Hollis-Eden. As used herein, unless otherwise indicated, for periods prior to March 1997 the terms "Company" and "Hollis-Eden Pharmaceuticals" shall refer to Hollis-Eden, not IAC. RESULTS OF OPERATIONS The Company has not generated any revenues for the period from August 15, 1994 (inception of Hollis-Eden) through March 31, 1998. The Company has devoted substantially all its resources to the payment of licensing fees and research and development fees plus expenses related to the startup of its business. From inception until March 31, 1998, the Company incurred expenses of approximately $5.9 million in research and development fees, $3.5 million in general and administrative expenses, and $300,000 in net interest income resulting in a loss of $9.1 million for the period. Research and Development expenses totaled $556,000 for the three months ended March 31, 1998, compared to $1.6 million for the comparable period in 1997. The 1997 research and development expenses were significantly larger than 1998 due to a $1.5 million expense to Edenland, Inc., a related party, as funding to continue the development of the Company's second drug candidate, REVERSIONEX. The 1998 research and development expenses relate primarily to the ongoing development of the Company's first drug candidate, INACTIVIN. General and administrative expenses totaled $712,000 for the three month's ended March 31, 1998, compared to $793,000 for the comparable period in 1997. During 1997, general and administrative expenses included one time charges associated with the merger with IAC, including a $570,000 charge relating to the issuance of warrants to a certain director and former officer. The 1998 general and administrative expenses included (i) the non-cash charges for the issuance of warrants to an investors relations group (described above) and (ii) increased expenses as a public company such as legal fees, filing and reporting fees, and directors and officers insurance. Net interest income totaled $85,000 for the three months ended March 31, 1998, compared to $1,000 for the comparable period in 1997. The increase in net interest income in 1998 from 1997 is due to high balances in cash and cash equivalents. 7 8 LIQUIDITY AND CAPITAL RESOURCES The Company has financed its operations since inception through the sale of shares of Common Stock and with loans from the Company's founder, Richard B. Hollis. The Company repaid Mr. Hollis in January 1996. During the year ended December 31, 1995, the Company received cash proceeds of $250,000 from the sale of its securities. In May 1996, the Company completed a private placement of shares of Common Stock, from which it received aggregate gross proceeds of $1.3 million. In March 1997, the Merger of IAC and Hollis-Eden provided the Company with $6.5 million in cash and other receivables. Under its license agreements with Dr. Patrick T. Prendergast, Colthurst and Edenland, the Company is obligated to pay certain minimum license fees to maintain its rights to its drug candidates. Under these agreements, the Company is obligated to pay the licensors an aggregate of two and one-half percent of all such proceeds raised within 24 months of the $350,000 license payment which was made on April 5, 1996. An annual renewal license fee of $500,000 is due when one of the following events occur: the Company raises a predetermined amount of capital; the Company sublicenses the technology received under the Colthurst License Agreement; the Company generates sales; the Company licenses or funds new technologies not covered under the existing agreements; or a predetermined date in the future. As of March 31, 1998, the Company is current on all license fee obligations under these agreements. Under its Research and Development Agreement with Edenland and Dr. Patrick T. Prendergast, the Company is committed to pay $3.0 million for the development costs related to REVERSIONEX. An amount of $1.5 million was recorded as a charge to operations upon the closing of the Merger and was paid in April 1997. An additional $1.2 million was recorded as a charge to operations upon the exercise of the warrants and was paid in May 1997. The remaining $300,000 was accrued as an expense during the fourth quarter of 1997 and is payable by April 28, 1998. In addition, the Company has agreed to commit at least 30% of its annual research and development budget up to a maximum of $50.0 million during the term of the agreement, but a minimum of $2.0 million and maximum of $10.0 million for any given calendar year, to pay development costs for REVERSIONEX or any new product developed under the agreement. In addition, payments made towards the $3.0 million development costs are deductible from the amounts due for the $2.0 million per year of research. Accordingly, with respect to the $2.0 million per year obligation, assuming only such minimum amounts will be due, only $1.0 million will be due in 1998. The Company's operations to date have consumed substantial capital without generating any revenues, and the Company will continue to require substantial and increasing amounts of funds to conduct necessary research and development and preclinical and clinical testing of its drug candidates, and to market any drug candidates that receive regulatory approval. The Company does not expect to generate revenue from operations for the foreseeable future, and the Company's ability to meet its cash obligations as they become due and payable is expected to depend for at least the next several years on its ability to sell securities, borrow funds or some combination thereof. Based upon its current plans, the Company's management believes that its existing capital resources, together with interest thereon, will be sufficient to meet the Company's operating expenses and capital requirements through at least the end of 1998. There can be no assurance, however, that changes in the Company's research and development plans or other events affecting the Company's operating expenses will not result in the expenditure of such cash before that time. No assurance can be given that the Company will be successful in raising necessary funds. The Company's future capital requirements will depend upon many factors, including progress with preclinical testing and clinical trials, the number and breadth of the Company's programs, the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights, the time and costs involved in obtaining regulatory approvals, competing technological and market developments, the ability of the Company to establish collaborative arrangements and effective commercialization and marketing activities and other arrangements. In any event, the Company will continue to incur increasing negative cash flows and net losses for the foreseeable future. 8 9 YEAR 2000 ISSUE The year 2000 computer issue is not expected to have any material affect on the Company's financial statements or operations of the Company. 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 SECURITIES HOLDERS None ITEM 5. OTHER INFORMATION None ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K Exhibits: 27 Financial Data Schedule (filed electronically only) 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 hereunto duly authorized. HOLLIS-EDEN PHARMACEUTICALS, INC. Dated: April 21, 1998 By: /s/ Robert W. Weber -------------------------------- Robert W. Weber Vice President-Controller (Principal Financial and Accounting Officer) INDEX TO EXHIBITS 27 FINANCIAL DATA SCHEDULE (FILED ELECTRONICALLY ONLY) 9