1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q X Quarterly report pursuant to Section 13 or 15(d) of the Securities --- Exchange Act of 1934. For the quarterly period ended June 30, 2000 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 19777 10 1 ALLOS THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) DELAWARE 54-1655029 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 7000 NORTH BROADWAY, SUITE 400 DENVER, COLORADO 80221 (303) 426-6262 (Address, including zip code, and telephone number, including area code, of principal executive offices) 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 June 30, 2000, there were 22,838,655 shares of the Registrant's Common Stock outstanding, par value $0.001 per share. This quarterly report on Form 10-Q, including exhibits, consists of 14 pages. The exhibit index is located on page 14 2 ALLOS THERAPEUTICS, INC. FORM 10-Q INDEX PAGE NUMBER ------ PART I. Financial Information ITEM 1. Financial Statements ......................................................... 3 Balance Sheet -- as of June 30, 2000 (unaudited) and December 31, 1999 .................... 3 Statement of Operations (unaudited) -- for the three and six months ended June 30, 2000 and 1999 and the period from inception (September 1, 1992) through June 30, 2000 ................. 4 Statement of Cash Flows (unaudited) -- for the six months ended June 30, 2000 and 1999 and the period from inception (September 1, 1992) through June 30, 2000 ...................... 5 Notes to Financial Statements (unaudited) .................................... 6 ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations ................................................................... 7 PART II. Other Information ....................................................................12 ITEM 1. Legal Proceedings ............................................................12 ITEM 2. Changes in Securities and Use of Proceeds ....................................12 ITEM 3. Defaults Upon Senior Securities ..............................................12 ITEM 4. Submission of Matters to a Vote of Security Holders ..........................12 ITEM 5. Other Information ............................................................12 ITEM 6. Exhibits and Reports on Form 8-K .............................................12 SIGNATURES .....................................................................................13 Page 2 of 14 3 PART I. FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS ALLOS THERAPEUTICS, INC. (A DEVELOPMENT STAGE COMPANY) BALANCE SHEET JUNE 30, DECEMBER 31, ASSETS 2000 1999 ------------- ------------- (unaudited) Current assets: Cash and cash equivalents $ 1,158,500 $ 2,597,884 Short-term investments 43,935,775 6,877,303 Prepaid expenses - research 677,934 223,117 Prepaid expenses - other 90,244 45,311 Other assets 6,176 185,898 ------------- ------------- Total current assets 45,868,629 9,929,513 ------------- ------------- Marketable securities 43,743,353 -- Property and equipment (net of accumulated depreciation of $386,613 and $322,227, respectively) 235,945 230,360 Other assets 23,979 45,641 ------------- ------------- Total assets $ 89,871,906 $ 10,205,514 ============= ============= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable - related parties $ 5,072 $ 8,087 Accrued expenses - research 1,071,648 768,592 Accounts payable - trade 199,805 65,123 Accrued compensation and employee benefits 177,325 224,379 Current portion of capital lease obligations 66,590 79,042 ------------- ------------- Total current liabilities 1,520,440 1,145,223 Long-term portion of capital lease obligations 37,728 69,320 ------------- ------------- Total liabilities 1,558,168 1,214,543 Stockholders' equity: Convertible preferred stock, Series A: $0.001 par value, 0 and 5,000,000 shares authorized, issued and outstanding at June 30, 2000 and December 31, 1999, respectively (liquidation value: $6,718,107 at December 31, 1999) -- 5,000 Convertible preferred stock, Series B: $0.001 par value, 0 and 5,050,000 shares authorized at June 30, 2000 and December 31, 1999, respectively; 0 and 5,032,500 shares issued and outstanding at June 30, 2000 and December 31, 1999, respectively (liquidation value: $10,191,261 at December 31, 1999) -- 5,033 Convertible preferred stock, Series C: $0.001 par value, 0 and 16,610,000 shares authorized at June 30, 2000 and December 31, 1999, respectively; 0 and 15,255,786 shares issued and outstanding at June 30, 2000 and December 31, 1999, respectively (liquidation value: $30,161,846 at December 31, 1999) -- 15,256 Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2000, no shares issued or outstanding -- -- Common stock, $0.001 par value; 75,000,000 and 31,000,000 shares authorized at June 30, 2000 and December 31, 1999, respectively; 22,838,655 and 2,022,138 shares issued and outstanding at June 30, 2000 and December 31, 1999, respectively 22,839 2,022 Additional paid-in capital preferred stock -- 49,873,495 Additional paid-in capital common stock 156,521,815 7,020,291 Notes receivable - related parties (49,687) (139,687) Accumulated deficit (58,154,258) (43,348,145) Deferred compensation related to grant of options (10,026,971) (4,442,294) ------------- ------------- Total stockholders' equity 88,313,738 8,990,971 ------------- ------------- Total liabilities and stockholders' equity $ 89,871,906 $ 10,205,514 ============= ============= The accompanying notes are an integral part of these financial statements. Page 3 of 14 4 ALLOS THERAPEUTICS, INC. (A DEVELOPMENT STAGE COMPANY) STATEMENT OF OPERATIONS (UNAUDITED) CUMULATIVE PERIOD FROM SEPTEMBER 1, 1992 (INCEPTION) THREE MONTHS ENDED SIX MONTHS ENDED THROUGH JUNE 30, JUNE 30, JUNE 30, 2000 1999 2000 1999 2000 ------------ ------------ ------------ ------------ ----------------- Operating expenses: Research and development $ 2,033,409 $ 2,401,676 $ 5,880,026 $ 4,378,983 $ 28,825,913 Clinical manufacturing 801,866 268,157 1,146,844 676,331 6,311,677 General and administrative 1,960,520 360,455 9,361,026 788,222 16,531,759 ------------ ------------ ------------ ------------ ------------ Total operating expenses 4,795,795 3,030,288 16,387,896 5,843,536 51,669,349 Loss from operations (4,795,795) (3,030,288) (16,387,896) (5,843,536) (51,669,349) Interest and other income, net 1,466,430 60,382 1,581,783 155,478 3,128,066 ------------ ------------ ------------ ------------ ------------ Net loss (3,329,365) (2,969,906) (14,806,113) (5,688,058) (48,541,283) Dividend related to beneficial conversion feature of preferred stock -- -- -- -- (9,612,975) ------------ ------------ ------------ ------------ ------------ Net loss attributable to common stockholders $ (3,329,365) $ (2,969,906) $(14,806,113) $ (5,688,058) $(58,154,258) ============ ============ ============ ============ ============ Net loss per common share: Basic and diluted $ (0.15) $ (1.49) $ (1.13) $ (2.86) ============ ============ ============ ============ Weighted average common shares - basic and diluted 22,837,154 1,989,347 13,053,937 1,985,570 ============ ============ ============ ============ The accompanying notes are an integral part of these financial statements. Page 4 of 14 5 ALLOS THERAPEUTICS, INC. (A DEVELOPMENT STAGE COMPANY) STATEMENT OF CASH FLOWS (UNAUDITED) CUMULATIVE PERIOD FROM SEPTEMBER 1, 1992 SIX MONTHS ENDED (INCEPTION) THROUGH JUNE 30, JUNE 30, 2000 1999 2000 ------------- ------------- -------------------- Cash Flows From Operating Activities Net loss $ (14,806,113) $ (5,688,058) $ (48,541,283) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 64,386 72,460 416,408 Stock-based compensation expense 11,378,141 -- 13,746,902 Other -- -- 52,406 Changes in operating assets and liabilities: Decrease (increase) in prepaids and other assets (298,366) 201,425 (798,333) (Increase) decrease in interest receivable on short-term investments (1,422,230) 60,142 (1,516,722) Increase (decrease) in accounts payable - related parties (3,015) (109,472) 5,072 Increase (decrease) in accounts payable - research 303,056 226,389 1,071,648 Increase (decrease) in accounts payable - trade 134,682 (66,628) 199,805 Increase (decrease) in accrued compensation and employee benefits (47,054) 13,294 177,325 ------------- ------------- ------------- Net cash used in operating activities (4,696,513) (5,290,448) (35,186,772) ------------- ------------- ------------- Cash Flows From Investing Activities Acquisition of property and equipment (69,971) (13,645) (363,163) Purchase of investments (86,184,509) (3,941,734) (134,121,687) Proceeds from maturities of investments 6,804,914 9,810,297 47,959,281 ------------- ------------- ------------- Net cash provided by (used in) investing activities (79,449,566) 5,854,918 (86,525,569) ------------- ------------- ------------- Cash Flows From Financing Activities Principal payments under capital leases (44,044) (57,051) (317,770) Proceeds from sale leaseback -- -- 120,492 Proceeds from stockholder loan -- -- 12,000 Repayment of stockholder loan -- -- (12,000) Proceeds from issuance of convertible preferred stock, net of issuance costs (2,503) (28,788) 40,283,306 Proceeds from issuance of common stock, net of issuance costs 82,753,242 569 82,784,813 ------------- ------------- ------------- Net cash provided by (used in) investing activities 82,706,695 (85,270) 122,870,841 ------------- ------------- ------------- Net increase (decrease) in cash (1,439,384) 479,200 1,158,500 Cash and cash equivalents, beginning of period 2,597,884 1,656,546 -- ------------- ------------- ------------- Cash and cash equivalents, end of period $ 1,158,500 $ 2,135,746 $ 1,158,500 ============= ============= ============= Supplemental Schedule of Noncash Operating and Financing Activities: Cash paid for interest 27,890 -- 37,890 Issuance of stock in exchange for license agreement -- -- 40,000 Capital lease obligations incurred for purchase of property and equipment -- 2,105 422,088 Issuance of stock in exchange for notes receivable -- -- 139,687 The accompanying notes are an integral part of these financial statements. Page 5 of 14 6 ALLOS THERAPEUTICS, INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO FINANCIAL STATEMENTS (UNAUDITED) 1. BASIS OF PRESENTATION The accompanying unaudited financial statements of Allos Therapeutics, Inc., referred to herein as the Company, we, us or our, have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"). Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. The unaudited financial statements included herein have been prepared on the same basis as the annual financial statements and reflect all adjustments, which include only normal recurring adjustments necessary for a fair presentation in accordance with generally accepted accounting principles. The results for the six-month period ended June 30, 2000 are not necessarily indicative of the results expected for the full fiscal year. These financial statements should be read in conjunction with the December 31, 1999 audited financial statements and the notes thereto included in the Company's Form S-1 filed with the SEC on March 27, 2000. The Company has not generated any revenue to date and its activities have consisted primarily of developing products, raising capital and recruiting personnel. Accordingly, the Company is considered to be in the development stage at June 30, 2000 as defined in Statement of Financial Accounting Standards No. 7, "Accounting and Reporting by Development Stage Enterprises". 2. EARNINGS PER COMMON SHARE Basic earnings per common share is computed using the weighted average number of common shares outstanding during the period. Diluted earnings per common share is computed using the weighted average number of common and potential common shares outstanding during the period. Potential common shares consist of stock options and warrants and have been excluded from the computation of diluted earnings per common share because their effect was anti-dilutive. Page 6 of 14 7 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following Management's Discussion and Analysis of Financial Condition and Results of Operations as well as information contained elsewhere in this report, contains statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You can identify these statements by forward-looking words such as "may," "will," "expect," "intend," "anticipate," "believe," "estimate," "plan," "could," "should" and "continue" or similar words. Actual results could differ materially from those anticipated in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those mentioned in the discussion below and those described in the "Risk Factors" discussion of our Registration Statement on Form S-1 filed with the Securities and Exchange Commission. As a result, you should not place undue reliance on these forward-looking statements. We do not intend to update or revise these forward-looking statements to reflect future events or developments. OVERVIEW We are a pharmaceutical company focused on developing and commercializing innovative small molecule drugs initially for improving cancer treatments. Our lead product candidate is RSR13. RSR13 is a synthetic small molecule that increases the release of oxygen from hemoglobin, the oxygen carrying protein contained within red blood cells. We believe RSR13 can be used to improve existing treatments for cancer and treat many diseases attributed to or aggravated by tissue oxygen deprivation. To date, we have devoted substantially all of our resources to research and clinical development. We have not derived any commercial revenues from product sales, and we do not expect to receive product revenues for at least the next several years. We have incurred significant operating losses since our inception in 1992 and, as of June 30, 2000, had an accumulated deficit of $58,154,258. There can be no assurance if or when we will become profitable. We expect to continue to incur significant operating losses over the next several years as we continue to incur increasing research and development costs, in addition to costs related to clinical trials and manufacturing activities. We expect that losses will fluctuate from quarter to quarter and that such fluctuations may be substantial. Our achieving profitability depends upon our ability, alone or with others, to successfully complete the development of our product candidates, and obtain required regulatory clearances and successfully manufacture and market our future products. RESULTS OF OPERATIONS Expenses Research and Development Research and development expenses were $2,033,000 for the three months ended June 30, 2000 compared to $2,402,000 for the three months ended June 30, 1999, which represents a $369,000, or 15% decrease. For the six months ended June 30, 2000 and 1999, research and Page 7 of 14 8 development expenses were $5,880,000 and $4,379,000, respectively. Excluding the impact of the non-cash charges comprising amortization of deferred compensation expense and stock compensation expense (see "Non-cash Charges" below for discussion of stock compensation expense allocated to research and development), research and development expenses decreased $1,879,000, or 43%. The decrease in both periods was primarily due to lower clinical trial costs resulting from the completion of several Phase II clinical trials in oncology and cardiopulmonary bypass and the Phase III oncology trial just commencing. Clinical Manufacturing Clinical manufacturing expenses include the cost of manufacturing RSR13 for use in clinical trials and costs associated with the scale-up of manufacturing to support commercial requirements. Clinical manufacturing expenses increased to $802,000 for the three months ended June 30, 2000 from $268,000 for the three months ended June 30, 1999, which represents a $534,000, or 199% increase. For the six months ended June 30, 2000 and 1999, clinical manufacturing expenses were $1,147,000 and $676,000, respectively, which represents a $471,000 increase, or 70%. The increase in both periods was primarily related to purchasing additional drug to meet expected clinical trial requirements associated with our Phase III oncology trial and increased personnel cost. General and Administrative General and administrative expenses increased to $1,961,000, or 445% for the three months ended June 30, 2000, from $360,000 for the three months ended June 30, 1999. Excluding the impact of the non-cash charges (see "Non-cash Charges" below for discussion of stock compensation expense allocated to general and administrative), general and administrative expenses increased $484,000, or 134%. For the six months ended June 30, 2000 and 1999, general administrative expenses were $9,361,000 and $788,000, respectively. Excluding the impact of the non-cash charges, general and administrative expenses increased $649,000, or 82%. The increase in both periods was the result of an increase in headcount and additional expenses associated with becoming a public company. Non-cash Charges For the three months and six months ended June 30, 2000, we recorded amortization of deferred stock compensation of $1,753,000 and $3,671,000, respectively. The compensation charge resulted from granting of certain options to employees prior to our March 2000 initial public offering with exercise prices below the fair market value of our common stock on their respective grant dates. Of the $1,753,000 recorded for the three months ended June 30, 2000, $1,116,000 related to general and administrative, $573,000 related to research and development and the remaining $64,000 related to clinical manufacturing. For the six months ended June 30, 2000, $2,422,000 related to general and administrative, $1,145,000 related to research and development and $104,000 was clinical manufacturing. For the six months ended June 30, 2000, we recorded $7,617,000 in stock compensation expense in connection with the forgiveness of the 1996 Notes (as defined below) in the first Page 8 of 14 9 quarter of 2000. Of this amount, $5,417,000 related to general and administrative and the remaining $2,200,000 related to research and development. This compensation charge is a result of obtaining recourse notes receivable in March 1996 (the "1996 Notes") from two officers in the amount of $90,000 upon the officers' exercise of 558,000 stock options. The 1996 Notes accrued interest at 8% annually with interest and principal originally due March 1998. In December 1997, the maturity dates for the 1996 Notes were extended by two years and extended by an additional year in January 2000. Upon forgiveness of the notes in March 2000, we recorded stock compensation expense based on the difference between the fair market value of the underlying common stock and option exercise price. Interest and Other Income, Net Interest income, net of interest expense, was $1,466,000 and $60,000 for the three months ended June 30, 2000 and 1999, respectively, representing an increase of $1,406,000, or 2,343%. For the six months ended June 30, 2000 and 1999, net interest income was $1,582,000 and $155,000, respectively, representing an increase of $1,427,000, or 917%. These increases were primarily attributable to increased earnings from higher investment balances resulting from the proceeds of our initial public offering of common stock completed in March 2000. LIQUIDITY AND CAPITAL RESOURCES Our principal source of working capital has been private and public equity financings as well as grant revenues and interest income. As of June 30, 2000, we had approximately $88,838,000 in cash, cash equivalents and investments. Net cash used in operating activities of $4,697,000 during the six months ended June 30, 2000 resulted primarily from the net loss for the period and a reduction in accounts payable. Net cash used in operating activities of $5,290,000 during the six months ended June 30, 1999 resulted primarily from the net loss for the period. Net cash used in investing activities of $79,450,000 for the six months ended June 30, 2000, consisted primarily of purchases of investments net of proceeds. Net cash provided by investing activities of $5,855,000 for the six months ended June 30, 1999, consisted primarily of proceeds from the sale of investments, net of purchases. Net cash provided by financing activities of $82,707,000 for the six months ended June 30, 2000 primarily resulted from the sale of common stock which was offset by payments under our capital lease obligations. Net cash used in financing activities of $85,000 for the six months ended June 30, 1999, consisted of payments under our capital lease obligations. Based upon the current status of our product development and commercialization plans, we believe cash, cash equivalents and investments will be adequate to satisfy our capital needs through at least the calendar year 2002. However, our actual capital requirements will depend on many factors, including the status of product development; the time and cost involved in conducting clinical trials and obtaining regulatory approvals; filing, prosecuting and enforcing patent claims; competing technological and market developments; and our ability to market and distribute our future products and establish new collaborative and licensing arrangements. Page 9 of 14 10 Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. The factors described above will impact our future capital requirements and the adequacy of our available funds. We may be required to raise additional funds through public or private financings, collaborative relationships or other arrangements. There can be no assurance that such additional funding, if needed, will be available on terms attractive to us, or at all. Furthermore, any additional equity financing may be dilutive to existing stockholders and debt financing, if available, may involve restrictive covenants. Collaborative arrangements, if necessary to raise additional funds, may require us to relinquish rights to certain of our technologies, products or marketing territories. Our failure to raise capital when needed could have a material adverse effect on our business, financial condition and results of operations. MARKET RISK We are exposed to certain market risks, primarily changes in interest rates. Uncertainties that are either nonfinancial or nonquantifiable, such as political, economic, tax, other regulatory, or credit risks, are not included in the following assessment of our market risks. Investments, including cash equivalents, short-term investments and long-term marketable securities, consist of commercial paper and corporate bonds, with maturities of up to 24 months. All investments are classified as held-to-maturity as defined in SFAS No. 115, "Accounting for Certain Investments in Debt and Equity Securities," and accordingly are carried at amortized costs. Changes in interest rates could impact our anticipated interest income. We prepared sensitivity analyses of our interest rate exposures and its exposure from anticipated investment for fiscal 2000 and 2001 to assess the impact of hypothetical changes in interest rates. Based on the results of these analyses, a 10% adverse change in interest rates from the 1999 fiscal year-end rates would not have a material adverse effect of the fair value of investments and would not materially impact our results of operations, cash flows, or financial condition for the next twelve months. RISK FACTORS In addition to the other information contained in this report, we caution stockholders and potential investors that the following important factors, among others, in some cases have affected, and in the future could affect, our actual results of operations and could cause our actual results to differ materially from those expressed in any forward-looking statements made by, on, or on behalf of us. The following information is not intended to limit in any way the characterization of other statements or information under other captions as cautionary statements for such purpose. These factors include: o Delay, difficulty, or failure to obtain regulatory approval or clearance to market our product candidates; including delays or difficulties in development because of insufficient proof of safety or efficacy. o Our limited experience in conducting and managing clinical trials; failure to conduct clinical trials in compliance with applicable regulations and at an acceptable cost. Page 10 of 14 11 o The ability to obtain, maintain and enforce intellectual property rights; the cost of acquiring in-process technology and other intellectual property rights, either by license, collaboration or purchase of another entity; the cost of enforcing or defending our intellectual property rights. o Failure of third party collaborators to conduct research and development activities, including drug discovery and clinical testing; conflicts of interest or priorities that may arise between us and such third party collaborators. o Dependence upon third parties to manufacture RSR13 bulk drug substance and formulated drug product; failure of third parties to manufacture RSR13 bulk drug substance or formulated drug product in compliance with regulatory requirements and at an acceptable cost; failure of third parties to supply sufficient quantities of RSR13 bulk drug substance or formulated drug product for preclinical, clinical or commercial purposes; failure to establish alternative sources of supply of RSR13 bulk drug substance or formulated drug product. o The ability to create sales, marketing and distribution capabilities for our product candidates, or enter into agreements with third parties to perform these functions; o The ability to obtain acceptable prices or adequate levels of reimbursement for our products from third party payors, including government and health administration authorities and private health insurers. o Difficulties or high cost of obtaining adequate financing to fund future research, development and commercialization of product candidates. o Competitive or market factors that may limit the use or broad acceptance of our product candidates. o The ability to attract and retain highly qualified management and scientific personnel. Page 11 of 14 12 PART II. OTHER INFORMATION Item 1. Legal Proceedings None Item 2. Changes in Securities and Use of Proceeds None Report of Use of Proceeds from Initial Public Offering in March 2000: Aggregate offering price $ 90,000,000 Expenses incurred in connection with offering 7,300,000 ------------- Net offering proceeds to issuer 82,700,000 Investment in marketable securities 82,700,000 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 (b) Reports on Form 8-K 27 (Financial Data Schedule) None Page 12 of 14 13 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, (the "Exchange Act") the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Date: July 26, 2000 ALLOS THERAPEUTICS, INC. /s/ Stephen J. Hoffman ------------------------------------- Stephen J. Hoffman, PhD, MD President and Chief Executive Officer /s/ Michael E. Hart ------------------------------------- Michael E. Hart Chief Financial Officer and Sr. Vice President, Operations /s/ Paulette M. Wilson ------------------------------------- Paulette M. Wilson Controller Page 13 of 14 14 EXHIBIT INDEX EXHIBIT NUMBER DESCRIPTION - ------ ----------- 27 FINANCIAL DATA SCHEDULE Page 14 of 14