-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, GsgijaPPtBtRmd3HJKkdnS0lnNDv5BzI3Gydv89ibfmFFlN1bJKhgZH6nC6R+Trg cZZgxLNOiST/Bwfo9OiB6g== 0000725058-02-000007.txt : 20020514 0000725058-02-000007.hdr.sgml : 20020514 ACCESSION NUMBER: 0000725058-02-000007 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20020331 FILED AS OF DATE: 20020514 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CYTOGEN CORP CENTRAL INDEX KEY: 0000725058 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 222322400 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-14879 FILM NUMBER: 02646232 BUSINESS ADDRESS: STREET 1: 600 COLLEGE RD EAST CN 5308 CITY: PRINCETON STATE: NJ ZIP: 08540 BUSINESS PHONE: 6099878200 MAIL ADDRESS: STREET 1: 600 COLLEGE RD EAST CN 5308 STREET 2: 600 COLLEGE RD EAST CN 5308 CITY: PRINCETON STATE: NJ ZIP: 08540 10-Q 1 final10q_q1-2002.txt CYTOGEN 1ST QUARTER FORM 10-Q SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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 March 31, 2002 -------------- 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 000-14879 Cytogen Corporation ------------------- (Exact name of Registrant as specified in its charter) Delaware 22-2322400 - ------------------------------- ---------------------- (State or Other Jurisdiction of (I.R.S. Employer Incorporation or Organization) Identification Number) 600 College Road East, CN 5308, Princeton, NJ 08540-5308 -------------------------------------------------------- (Address of Principal Executive Offices and Zip Code) Registrant's telephone number, including area code (609) 750-8200 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: Class Outstanding at May 1, 2002 - ---------------------------- --------------------------- Common Stock, $.01 par value 82,513,215 PART I - FINANCIAL INFORMATION - ------------------------------- Item 1 - Consolidated Financial Statements CYTOGEN CORPORATION AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (All amounts in thousands, except share data) (Unaudited)
March 31, December 31, 2002 2001 ---------- ------------ ASSETS: Current Assets: Cash and cash equivalents.............................................. $ 16,843 $ 11,309 Marketable securities.................................................. 1,060 1,376 Receivable on income tax benefit sold.................................. - 1,103 Accounts receivable, net .............................................. 1,763 1,621 Inventories ........................................................... 1,689 1,889 Other current assets .................................................. 829 508 --------- --------- Total current assets ................................................ 22,184 17,806 Property and Equipment, net ............................................. 1,748 1,831 Other Assets............................................................. 1,345 1,855 --------- --------- $ 25,277 $ 21,492 ========= ========= LIABILITIES AND STOCKHOLDERS' EQUITY: Current Liabilities: Current portion of long-term debt...................................... $ 125 $ 77 Accounts payable and accrued liabilities............................... 3,670 5,315 Accrued stock liability ............................................... 2,000 - Deferred revenue ...................................................... 385 534 --------- --------- Total current liabilities............................................ 6,180 5,926 --------- --------- Long-Term Debt........................................................... 2,444 2,291 --------- --------- Deferred Revenue ........................................................ 1,996 2,061 --------- --------- Stockholders' Equity: Preferred stock, $.01 par value, 5,400,000 shares authorized - Series C Junior Participating Preferred Stock, $.01 par value, 200,000 shares authorized, none issued and outstanding............... - - Common stock, $.01 par value, 250,000,000 shares authorized, 82,015,000 and 78,937,000 shares issued and outstanding at March 31, 2002 and December 31, 2001, respectively ............... 820 789 Additional paid-in capital ............................................ 359,498 350,867 Deferred compensation ................................................. (526) (621) Accumulated other comprehensive income................................. 544 860 Accumulated deficit ................................................... (345,679) (340,681) --------- --------- Total stockholders' equity........................................... 14,657 11,214 --------- --------- $ 25,277 $ 21,492 ========= =========
The accompanying notes are an integral part of these statements. 2 CYTOGEN CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS (All amounts in thousands, except per share data) (Unaudited)
Three Months Ended March 31, ---------------------------- 2002 2001 ----------- ----------- Revenues: Product related: ProstaScint .............................................. $ 2,076 $ 2,244 BrachySeed ............................................... 452 34 OncoScint ................................................ 54 80 -------- -------- Total product sales .............................. 2,582 2,358 Quadramet royalties ...................................... 499 441 -------- -------- Total product related ............................ 3,081 2,799 License revenue .......................................... 215 215 -------- -------- Total revenues ................................... 3,296 3,014 -------- -------- Operating Expenses: Cost of product ............................................ 1,054 1,175 Research and development ................................... 3,799 1,739 Equity loss in PSMA LLC .................................... 513 - Selling and marketing ...................................... 1,453 1,754 General and administrative ................................. 1,510 1,172 -------- -------- Total operating expenses ......................... 8,329 5,840 -------- -------- Operating loss ................................... (5,033) (2,826) Interest income ............................................. 77 220 Interest expense ............................................. (42) (48) -------- -------- Net loss ..................................................... $ (4,998) $ (2,654) ======== ======== Basic and diluted net loss per share ......................... $ (0.06) $ (0.03) ======== ======== Weighted average common shares outstanding ................... 81,222 76,244 ======== ========
The accompanying notes are an integral part of these statements. 3 CYTOGEN CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (All amounts in thousands) (Unaudited)
Three Months Ended March 31, ---------------------------- 2002 2001 ----------- ----------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss....................................................... $ (4,998) $ (2,654) --------- --------- Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization............................ 194 302 Imputed interest......................................... - (22) Stock-based compensation expenses........................ 376 96 Warrants, stock and stock option grants.................. 125 - Amortization of deferred revenue ........................ (215) (215) Stock-based milestone ................................... 2,000 - Changes in assets and liabilites: Accounts receivable, net............................... 961 (292) Inventories............................................ 200 (114) Other assets........................................... 189 797 Accounts payable and accrued liabilities............... (1,380) (2,051) Other liabilities...................................... 39 39 --------- --------- Total adjustments.............................. 2,489 (1,460) --------- --------- Net cash used in operating activities.................... (2,509) (4,114) --------- --------- CASH FLOWS FROM INVESTING ACTIVITIES: Net proceeds from sale of equipment............................ 100 - Purchases of property and equipment............................ (24) (95) --------- --------- Net cash provided by (used in) investing activities ..... 76 (95) --------- --------- CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of common stock......................... 7,991 6,536 Payment of long-term liabilities ............................ (24) (49) --------- --------- Net cash provided by financing activities................ 7,967 6,487 --------- --------- Net increase in cash and cash equivalents...................... 5,534 2,278 Cash and cash equivalents, beginning of period................. 11,309 11,993 --------- --------- Cash and cash equivalents, end of period....................... $ 16,843 $ 14,271 ========= =========
The accompanying notes are an integral part of these statements. 4 CYTOGEN CORPORATION AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. THE COMPANY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: The Company Cytogen Corporation ("Cytogen" or the "Company") is a biopharmaceutical company with an established and growing product line in prostate cancer and other areas of oncology. FDA-approved products include ProstaScint(R) (a monoclonal antibody-based imaging agent used to image the extent and spread of prostate cancer); BrachySeed(TM) I-125 and Pd-103, (uniquely designed, next-generation radioactive seed implants for the treatment of localized prostate cancer); and Quadramet(R) (a therapeutic agent marketed for the relief of bone pain in prostate and other types of cancer). Cytogen is evolving a pipeline of oncology product candidates by developing its prostate specific membrane antigen, or PSMA technologies, which are exclusively licensed from Memorial Sloan-Kettering Cancer Center. AxCell Biosciences Corporation, a subsidiary of Cytogen Corporation, is engaged in the research and development of novel biopharmaceutical products using its growing portfolio of functional proteomics solutions and collection of proprietary signal transduction pathway information. Through the systematic and industrialized measurement of protein-to-protein interactions, AxCell is assembling ProChart(TM), a proprietary database of signal transduction pathway information that is relevant in a number of therapeutically important classes of molecules including growth factors, receptors and other potential protein therapeutics or drug targets. AxCell's database content and functional proteomics tools are available on a non-exclusive basis to biotechnology, pharmaceutical and academic researchers. AxCell is expanding its research activities to further elucidate the role of novel proteins through both external collaborations and data mining. Basis of Consolidation The consolidated financial statements include the accounts of Cytogen and its subsidiaries. Intercompany balances and transactions have been eliminated in consolidation. Basis of Presentation The consolidated financial statements and notes thereto of Cytogen are unaudited and include all adjustments, which in the opinion of management, are necessary to present fairly the financial condition and results of operations as of and for the periods set forth in the Consolidated Balance Sheets, Consolidated Statements of Operations and Consolidated Statements of Cash Flows. All such accounting adjustments are of a normal, recurring nature. The consolidated financial statements do not include all of the information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles and should be read in 5 conjunction with the consolidated financial statements and notes thereto included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission, which includes financial statements as of and for the year ended December 31, 2001. The results of the Company's operations for any interim period are not necessarily indicative of the results of the Company's operations for any other interim period or for a full year. Cash and Cash Equivalents Cash and cash equivalents include cash on hand, cash in banks and all highly-liquid investments with a maturity of three months or less at the time of purchase. Marketable Securities In connection with the acquisition of Prostagen Inc. in June 1999, the Company received 275,350 shares of Northwest Biotherapeutics, Inc. common stock. The Company has classified this investment as available-for-sale securities in accordance with Statement of Financial Accounting Standards ("SFAS") No. 115, "Accounting for Certain Investments in Debt and Equity Securities." Available-for-sale securities are carried at fair value, based on quoted market prices, with unrealized gains or losses reported as a separate component of stockholders' equity. As of March 31, 2002 and December 31, 2001, the Company had an unrealized gain of $544,000 and $860,000 related to this investment, respectively. There is no assurance, however that the Company can sell these securities within a reasonable amount of time without negatively effecting the price of the stock since the daily trading volume has been low. Inventories The Company's inventories are primarily related to ProstaScint and OncoScint CR/OV. Inventories are stated at the lower of cost or market using the first-in, first-out method and consisted of the following: March 31, December 31, 2002 2001 ------------- -------------- Raw materials................. $ 506,000 $ 506,000 Work-in process............... 681,000 1,371,000 Finished goods................ 502,000 12,000 ---------- ---------- $1,689,000 $1,889,000 ========== ========== Other Comprehensive Income (Loss) Other comprehensive income (loss) consists of unrealized gains or losses on marketable securities. As of March 31, 2002, the fair market value of these securities decreased $316,000, and as a result, the comprehensive loss for the three months ended March 31, 2002 was $5,314,000. There were no marketable securities outstanding during the first quarter of 2001 and therefore no other comprehensive gains or losses. 6 Accrued Stock Liability In connection with the acquisition of Prostagen Inc. in June 1999, the Company agreed to issue up to an additional $4.0 million worth of Cytogen common stock if certain milestones are achieved in the dendritic cell therapy and PSMA development programs. Based on the progress of the dendritic cell prostate cancer clinical trials at Northwest Biotherapeutics Inc., management believes that the initial milestone was met in the first quarter of 2002 and has accrued $2.0 million of expenses, which are recorded as research and development in the accompanying statement of operations. The actual number of shares to be issued will be based on the fair market value of Cytogen common stock on the date to be determined by the parties to the Prostagen Agreement and the Company. Net Loss Per Share Basic net loss per share is based upon the weighted average common shares outstanding during each period. Diluted net loss per share is the same as basic net loss per share, as the inclusion of common stock equivalents would be antidilutive. Reclassifications Certain reclassifications have been made to the 2001 financial statements to conform with the 2002 presentation. 2. EQUITY LOSS IN PSMA DEVELOPMENT CO. LLC: In June 1999, Cytogen entered into a joint venture called the PSMA Development Co. LLC (the "Joint Venture"), with Progenics Pharmaceuticals Inc. ("Progenics"), to develop vaccine and antibody-based immunotherapeutic products utilizing Cytogen's proprietary PSMA technology. The Joint Venture is owned equally by Cytogen and Progenics. The Company accounts for the Joint Venture using the equity method of accounting. Progenics was obligated to fund the initial $3.0 million of development costs of the Joint Venture. Beginning in December 2001, the Company and Progenics began to equally share the costs of the Joint Venture. Since December 2001, Cytogen has recognized 50% of the Joint Venture's operating results in its consolidated statement of operations. Selected financial statement information of the Joint Venture is as follows: Statement of Operations Data: Three Months Ended March 31, ---------------------------------- 2002 2001 ------------ ----------- Total revenue $ - $ 14,000 Total expenses 1,027,000 441,000 ----------- ---------- Net loss $(1,027,000) $ (427,000) ============ =========== 7 3. SALES OF CYTOGEN COMMON STOCK: In January 2002, the Company sold 2,970,665 shares of Cytogen common stock to the State of Wisconsin Investment Board ("SWIB") for an aggregate purchase price of $8.0 million or $2.69 per share pursuant to a January 2002 Share Purchase Agreement between SWIB and the Company. In connection with such sale and issuance to SWIB as well as the Company's previous sale and issuance of its common stock to SWIB in June 2001, the Company agreed not to enter into equity line arrangements in the future, issue certain securities at less than fair market value or undertake certain other securities issuances without requisite stockholder approval. 8 Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations The following discussion contains historical information as well as forward looking statements that involve a number of risks and uncertainties. Statements contained or incorporated by reference in this Quarterly Report on Form 10-Q that are not based on historical facts are "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Generally, forward looking statements can be identified by the use of phrases like "believe", "expect", "anticipate", "plan", "may", "will", "could", "estimate", "potential", "opportunity" and "project" and similar terms. The Company's actual results could differ materially from the Company's historical results of operations and those discussed in the forward looking statements. Factors that could cause actual results to differ materially, include, but are not limited to those identified in the Company's Annual Report on Form 10-K for the year ended December 31, 2001 under the caption "Additional Factors That May Affect Future Results". Investors are cautioned not to put undue reliance on any forward looking statement. Cautionary Statement In addition to the risks discussed under the caption referred to above, among other factors that could cause actual results to differ materially from expected results are the following: (i) the Company's ability to access the capital markets in the near term and in the future for continued funding of its operations including existing projects and for the pursuit of new projects; (ii) the ability to attract and retain personnel needed for business operations and strategic plans; (iii) the timing and results of clinical studies, and regulatory approvals; (iv) market acceptance of the Company's products, including programs designed to facilitate use of the products, such as the Partners in Excellence or PIE Program; (v) demonstration over time of the efficacy and safety of the Company's products; (vi) the degree of competition from existing or new products; (vii) the decision by the majority of public and private insurance carriers on whether to reimburse patients for the Company's products; (viii) the ability of the Company and its partners to comply with applicable governmental regulations and changes thereto; (ix) the profitability of its products; (x) the ability to attract, and the ultimate success of, strategic partnering arrangements, collaborations, and acquisition candidates; (xi) the ability of the Company and its partners to identify new products as a result of those collaborations that are capable of achieving FDA approval, that are cost-effective alternatives to existing products and that are ultimately accepted by the key users of the product; (xii) the success of the Company in obtaining marketing approvals for its products in Canada and Europe; (xiii) the ability of the Company to protect its proprietary technology, trade secrets or know-how under the patent and other intellectual property laws of the United States and other countries; and (xiv) the ability of Advanced Magnetics Inc. to satisfy the conditions specified by the FDA regarding approval to market Combidex in the United States. The following discussion and analysis should be read in conjunction with the Financial Statements and related notes thereto contained elsewhere herein, as well as the Company's Annual Report on Form 10-K for the year ended December 31, 2001 and from time to time the Company's other filings with the Securities and Exchange Commission. 9 Significant Events in 2002 During 2002, the Company received regulatory approval in Canada for ProstaScint(R), the Company's radio-labeled monoclonal antibody prostate cancer imaging agent. ProstaScint was approved for marketing in the United States in 1996. In both Canada and United States, ProstaScint is indicated for use in patients newly diagnosed with prostate cancer who are at risk for lymph node metastases and for patients with recurrent prostate cancer following a radical prostatectomy who are suspected of having occult metastatic disease. In Canada, ProstaScint is also indicated for use in identifying those patients with recurrent prostate cancer who are likely to benefit from receiving local salvage radiation therapy. The Company plans to launch both ProstaScint and Quadramet in Canada, alone or with a partner during 2002. The Company also expects to introduce, during the first half of 2002, the palladium version of BrachySeed(TM), a uniquely designed next generation radioactive seed implant for treatment of localized prostate cancer. The iodine version of BrachySeed was introduced in 2001. The Company is utilizing its existing oncology sales force to market BrachySeed. There can be no assurance, however, regarding the timing of launch for ProstaScint and Quadramet in Canada and the palladium version of BrachySeed in the United States, the market acceptance of these products and whether these products will significantly increase the revenues of the Company. Results of Operations Three Months Ended March 31, 2002 and 2001 Revenues. Total revenues for the first quarter of 2002 were $3.3 million compared to $3.0 million for the same period in 2001. The increase from the prior year period is due to higher product related revenues. Product related revenues, which included product sales and royalties, accounted for 93% of total revenues in both 2001 and 2002. License revenues accounted for the remainder of revenues. Product related revenues for the first quarter of 2002 were $3.1 million compared to $2.8 million for the same period in 2001. Sales of ProstaScint accounted for 67% and 80% of product related revenues in the first quarters of 2002 and 2001, respectively, while Quadramet royalties accounted for 16% of product related revenues in each such quarter. Sales of ProstaScint were $2.1 million in the first quarter of 2002, which were slightly below the $2.2 million recorded in the first quarter of 2001. Future growth of ProstaScint is dependent upon increased marketing and sales initiatives by Cytogen's in-house sales force, entry in additional markets and the implementation of new product applications, such as using ProstaScint scans to guide the placement of brachytherapy seeds and/or external beam radiation. There can be no assurance, however, that the Company's new sales initiatives will significantly increase the sales of ProstaScint. Sales of BrachySeed during the first quarter of 2002 were $452,000 and accounted for 15% of product related revenues, compared to $34,000 recorded in the same period of 2001. Since the market introduction of BrachySeed I-125 in February 2001, the Company has increased its market penetration of the brachytherapy iodine market, which has contributed to consistent quarter-over-quarter growth since launch. The Company plans to utilize Cytogen's 10 sales and marketing organization for the launch of the palladium version of BrachySeed during the first half of 2002. There can be no assurance, however, as to the timing of launch or market acceptance of the BrachySeed palladium product or whether the sale of the iodine and palladium products will significantly increase the revenues of the Company. Sales of OncoScint CR/OV during the first quarter of 2002 were $54,000 compared to $80,000 in the same period of 2001. The market for OncoScint CR/OV for colorectal cancer diagnosis has been negatively affected by positron emission tomography or "PET" scans which have shown the same or higher sensitivity than OncoScint CR/OV. Accordingly, the Company is decreasing its emphasis on OncoScint in order to focus on its prostate cancer products. Quadramet royalties for the first quarter of 2002 increased to $499,000 from $441,000 in the same period of 2001. Quadramet is currently marketed by the Company's marketing partner, Berlex Laboratories ("Berlex"). Although Cytogen believes that Berlex is an advantageous partner, there can be no assurance that Quadramet will achieve greater market penetration on a timely basis or result in significant revenues for Cytogen. License revenues were $215,000 for both 2002 and 2001. As a result of the adoption of Securities and Exchange Commission's Staff Accounting Bulletin No.101, license revenues include the recognition of deferred revenues from certain up-front, non-refundable license fees previously recognized in prior years. Operating Expenses. Total operating expenses for the first quarter of 2002 were $8.3 million compared to $5.8 million recorded in the same quarter of 2001. The increase from the prior year period is attributable primarily to a one-time, non-cash milestone accrual of $2.0 million related to the progress of dendritic cell prostate cancer clinical trials at Northwest Biotherapeutics, Inc. and increased development costs associated with the PSMA Development Company LLC (see Notes 1 and 2 to Consolidated Financial Statements). Cost of product for the first quarter of 2002 was $1.1 million compared to $1.2 million recorded in the same period of 2001. The decrease from the prior year period is primarily due to lower facility related costs associated with the manufacturing of ProstaScint, but partially offset by increased costs as a result of increased BrachySeed sales. Research and development expenses for the first quarter of 2002 were $3.8 million compared to $1.7 million recorded in the same period of 2001. The increase from the prior year period is attributable primarily to a one-time, non-cash milestone accrual of $2.0 million related to the progress of dendritic cell prostate cancer clinical trials at Northwest Biotherapeutics, Inc., increased funding for AxCell's signal transduction inhibitors and increased costs associated with the development of a new manufacturing and purification process for ProstaScint. During the first quarters of 2002 and 2001, the Company invested $1.3 million and $1.1 million, respectively, in AxCell's signal transduction research activities, and $231,000 and $44,000, respectively, in the development of a new manufacturing process for ProstaScint. The Company anticipates that funding for these two programs will continue at the current level over the remainder of this year. 11 The Company's share in the equity loss in the PSMA Development LLC, our joint venture with Progenics Pharmaceuticals, Inc., was $513,000 for the first quarter of 2002 and represented 50% of the Joint Venture's operating results. The Joint Venture is equally owned by Cytogen and Progenics. The Company accounts for the Joint Venture using the equity method of accounting. Progenics was obligated to fund the initial $3.0 million of development costs of the Joint Venture. Beginning in December 2001, the Company and Progenics began to equally share the costs of the Joint Venture. The Company expects to incur significant costs going forward to fund its share of the development costs from the Joint Venture (see Note 2 to the Consolidated Financial Statements). Selling and marketing expenses were $1.5 million for the first quarter of 2002 compared to $1.8 million for the same period of 2001. The decrease from the prior year period is primarily due to costs associated with the 2001 launch of BrachySeed I-125 and timing of certain expenses related to various marketing functions which will be held at a later time than last year. General and administrative expenses for the first quarter of 2002 were $1.5 million compared to $1.2 million for the comparable period in 2001. The increase from the prior year period is due primarily to a charge related to stock based compensation for a key employee. Interest Income/Expense. Interest income for the first quarter of 2002 was $77,000 compared to $220,000 recorded in the same period of 2001. The decrease from the prior year period is due to a lower average yield on investments during 2002. Interest expense for the first quarter of 2002 was $42,000 compared to $48,000 recorded in the same period of 2001. The interest expenses included finance charges related with various equipment leases. Net Loss. Net loss for the first quarter of 2002 was $5.0 million compared to $2.7 million recorded in the same period of 2001. The net loss per share for the first quarter of 2002 was $0.06 based on average common shares outstanding of 81.2 million compared to a net loss per share of $0.03 based on average common shares outstanding of 76.2 million for the same period in 2001. The 2002 net loss included a one-time, non-cash milestone accrual of $2.0 million related to the progress of dendritic cell prostate cancer clinical trials at Northwest Biotherapeutics, Inc. as described above. Liquidity and Capital Resources The Company's cash and cash equivalents were $16.8 million as of March 31, 2002, compared to $11.3 million as of December 31, 2001. The cash used for operating activities for the three months ended March 31, 2002 was $2.5 million compared to $4.1 million in the same period of 2001. The decrease from the prior year period is due primarily to the improved working capital management and a milestone payment to Draximage Inc. related to the 2001 launch of the iodine version of BrachySeed. Historically, the Company's primary sources of cash have been proceeds from the issuance and sale of its stock through public offerings and private placements, product related revenues, revenues from contract manufacturing and research services, fees paid under license agreements and interest earned on cash and short-term investments. 12 The Company filed a shelf Registration Statement on Form S-3 to register 10,000,000 shares of its common stock in October 2001. Such Registration Statement was declared effective by the Securities and Exchange Commission in November 2001. The Company may issue such registered shares of common stock from time to time and may use the proceeds thereof for general corporate purposes, including, but not limited to, continued development and commercialization of its proteomics technologies, research and development of additional products and expansion of its sales and marketing capabilities. In January 2002, the Company sold 2,970,665 shares of Cytogen common stock to the State of Wisconsin Investment Board ("SWIB") for an aggregate purchase price of $8.0 million or $2.69 per share. In connection with such sale and issuance to SWIB as well as the Company's previous sale and issuance of its common stock to SWIB in June 2001, we agreed not to enter into equity line arrangements in the future, issue certain securities at less than fair market value or undertake certain other securities issuances without requisite stockholder approval. In order to effect such restrictions that have not already been incorporated into the Company's By-Laws and Stock Option Plans, the Company has submitted certain amendments to its By-Laws, 1995 Stock Option Plan and 1999 Non-Employee Director Plan for approval by the stockholders of the Company at the Company's Annual Meeting of Stockholders to be held on June 18, 2002. In January 2002, the Company received cash of $1.1 million relating to the December 2001 sale of New Jersey State net operating losses and research and development credits. Under the current legislation, the Company may be able to sell a minimum $634,000 of its remaining approved $2.4 million of tax benefits in 2002 assuming the State of New Jersey continues to fund this program. The actual amount of net operating losses and tax credits the Company may sell will also depend upon the allocation among qualifying companies of an annual pool established by the State of New Jersey. In connection with the acquisition of Prostagen Inc. in June 1999, the Company agreed to issue up to an additional $4.0 million worth of Cytogen common stock if certain milestones are achieved in the dendritic cell therapy and PSMA development programs. Based on the progress of the dendritic cell prostate cancer clinical trials at Northwest Biotherapeutics Inc., the Company believes that the initial milestone was met in the first quarter of 2002 and has, accordingly, accrued $2.0 million of expenses, which were recorded as research and development expenses. The recognition of the remaining $2.0 million of expenses, and the resulting additional issuance of Cytogen common stock, will be made if and when the remaining milestones are achieved. Beginning in December 2001, the Cytogen and Progenics began to equally share the costs of the Joint Venture. Since that date, Cytogen has recognized 50% of the Joint Venture's operating results, which, during the first quarter of 2002 was a loss of $513,000. The Company expects its share of losses in the PSMA Development Co. LLC to continue at even higher levels in subsequent periods. The Company's capital and operating requirements may change depending upon various factors, including: (i) whether the Company and its strategic partners achieve success in manufacturing, marketing and commercialization of its products; (ii) the amount of resources which the Company devotes to clinical 13 evaluations and the expansion of marketing and sales capabilities; (iii) results of clinical trials and research and development activities; and (iv) competitive and technological developments, in particular, the Company expects to incur significant costs for the development of its proteomics and PSMA technologies. The Company's financial objectives are to meet its capital and operating requirements through revenues from existing products and licensing arrangements. To achieve its strategic objectives, the Company may enter into research and development partnerships and acquire, in-license and develop other technologies, products or services. Certain of these strategies may require payments by the Company in either cash or stock in addition to the costs associated with developing and marketing a product or technology. There can be no assurance as to the success of such strategies or that resulting funds will be sufficient to meet cash requirements until such time as product revenues are sufficient to cover operating expenses, if ever. To fund these strategic and operating activities, the Company may sell assets, equity or debt securities as market conditions permit or enter into credit facilities. The Company has incurred negative cash flows from operations since its inception, and has expended, and expects to continue to expend in the future, substantial funds to implement its planned product development efforts, including acquisition of products and complementary technologies, research and development, clinical studies and regulatory activities, and to further its marketing and sales programs. The Company expects that its existing capital resources should be adequate to fund the Company's operations for the foreseeable future. The Company cannot assure you that its business or operations will not change in a manner that would consume available resources more rapidly than anticipated. The Company expects that it will have additional requirements for debt or equity capital, irrespective of whether and when it reaches profitability, for further product development costs, product and technology acquisition costs, and working capital. The Company's future capital requirements and the adequacy of available funds will depend on numerous factors, including the successful commercialization of its products, the costs associated with the acquisition of complementary products and technologies, progress in its product development efforts, the magnitude and scope of such efforts, progress with clinical trials, progress with regulatory affairs activities, the cost of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights, competing technological and market developments, and the expansion of strategic alliances for the sales, marketing, manufacturing and distribution of its products. To the extent that the currently available funds and revenues are insufficient to meet current or planned operating requirements, the Company will be required to obtain additional funds through asset sales, equity or debt financing, strategic alliances with corporate partners and others, or through other sources. There can be no assurance that the financial sources described above will be available when needed or at terms commercially acceptable to the Company. If adequate funds are not available, the Company may be required to delay, further scale back or eliminate certain aspects of its operations or attempt to obtain funds through arrangements with collaborative partners or others that may require the Company to relinquish rights to certain of its technologies, product candidates, products or potential markets. If adequate funds are not available, the Company's business, financial condition and results of operations will be materially and adversely affected. 14 CRITICAL ACCOUNTING POLICIES Financial Reporting Release No. 60, which was recently released by the Securities and Exchange Commission, requires all companies to include a discussion of critical accounting policies or methods used in the preparation of financial statements. Note 1 to our Consolidated Financial Statements in this Quarterly Report on Form 10-Q and Note 1 to our Consolidated Financial Statements in the Company's Annual Report on Form 10-K for the year ended December 31, 2001, include a summary of our significant accounting policies and methods used in the preparation of our Consolidated Financial Statements. The following is a brief discussion of the more significant accounting policies and methods used by us. The preparation of our Consolidated Financial Statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Our actual results could differ from those estimates. Revenue Recognition We recognize revenue from the sale of our products upon shipment. We do not grant price protection to customers. Quadramet royalties are recognized when earned. The Securities and Exchange Commission has issued Staff Accounting Bulletin (SAB) No. 101, "Revenue Recognition", which provides guidance on the recognition of up-front, non-refundable license fees. Accordingly, we defer up-front license fees and recognize them over the estimated performance period of the related agreement. Since the term of the performance periods is subject to management's estimates, future revenues to be recognized could be affected by changes in such estimates. Accounts Receivable Our accounts receivable balances are net of an estimated allowance for uncollectible accounts. We continuously monitor collections and payments from our customers and maintain an allowance for uncollectible accounts based upon our historical experience and any specific customer collection issues that we have identified. While we believe our reserve estimate to be appropriate, we may find it necessary to adjust our allowance for doubtful accounts if our future bad debt expense exceeds our estimated reserve. We are subject to concentration risks as a limited number of our customers provide a high percent of total revenues, and corresponding receivables. Inventories Inventories are stated at the lower of cost or market, as determined using the first-in, first-out method, which most closely reflects the physical flow of our inventories. Our products and raw materials are subject to expiration dating. We regularly review quantities on hand to determine the need for reserves for excess and obsolete inventories based primarily on our estimated forecast of our product sales. Our estimate of future product demand may prove to be inaccurate, in which case we may have understated or overstated our reserve for excess and obsolete inventories. 15 Carrying Value of Fixed and Intangible Assets Our fixed assets and certain of our acquired rights to market our products have been recorded at cost and are being amortized on a straight-line basis over the estimated useful life of those assets. In accordance with SFAS No. 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed of," if indicators of impairment exist, we assess the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. If impairment is indicated, we measure the amount of such impairment by comparing the carrying value of the assets to the present value of the expected future cash flows associated with the use of the asset. Adverse changes regarding future cash flows to be received from long-lived assets could indicate that an impairment exists, and would require the write down of the carrying value of the impaired asset at that time. Item 3 - Quantitative and Qualitative Disclosures About Market Risk The Company does not have operations subject to risks of foreign currency fluctuations, nor does it use derivative financial instruments in its operations or investment portfolio. The Company does not have exposure to market risks associated with changes in interest rates, as it has no variable interest rate debt outstanding. The Company does not believe it has any other material exposure to market risks associated with interest rates. 16 PART II - OTHER INFORMATION Item 6 - Exhibits and Reports on Form 8-K (a) Exhibits: 10.1 Amendment No. 1 to Limited Liability Company Agreement of PSMA Development Company LLC by and between Cytogen Corporation, Progenics Pharmaceuticals, Inc. and PSMA Development Company LLC dated as of March 22, 2002. Filed herewith. (b) Reports on Form 8-K: On January 24, 2002, we filed a Current Report on Form 8-K relating to the issuance and sale of 2,970,665 shares of our Common Stock to the State of Wisconsin Investment Board for an aggregate purchase price of approximately $8.0 million pursuant to a share purchase agreement dated January 18, 2002. 17 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. CYTOGEN CORPORATION Date May 14, 2002 By /s/ H. Joseph Reiser ----------------- -------------------------------------------- H. Joseph Reiser President and Chief Executive Officer Date May 14, 2002 By /s/ Lawrence R. Hoffman ----------------- -------------------------------------------- Lawrence R. Hoffman Vice President and Chief Financial Officer (Principal Financial and Accounting Officer) 18 EX-10.1 MATERIAL CON 3 llc_amendment1.txt AMEND. #1 PSMA DEVELOPMENT COMPANY LLC EXHIBIT 10.1 AMENDMENT NUMBER 1 TO LIMITED LIABILITY COMPANY AGREEMENT OF PSMA DEVELOPMENT COMPANY LLC This Amendment Number 1 is made this 22nd day of March, 2002 by and between Progenics Pharmaceuticals, Inc., a Delaware corporation ("Progenics"), CYTOGEN Corporation, a Delaware corporation ("CYTOGEN") and PSMA Development Company LLC, a Delaware Limited Liability company (the "Company"), and amends the Limited Liability Company Agreement, dated June 15, 1999 (the "Agreement"), among Progenics, CYTOGEN and the Company. Unless otherwise defined herein, capitalized terms used in this Amendment Number 1 shall have the respective meanings ascribed to such terms in the Agreement. WHEREAS, the parties to the Agreement desire to amend, clarify and supplement the provisions of the Agreement; NOW, THEREFORE, Progenics, CYTOGEN and the Company hereby agree as follows: 1. Section 2.2(c)(i)of the Agreement is hereby amended to read as follows: (c) (i) The Management Committee may from time to time, in connection with preparing the Budget (as defined hereinafter) or otherwise, call for the Members to make additional capital contributions (the "Additional Capital Contributions"), in which event the Management Committee shall give notice to each Member of: (A) the total amount of the Additional Capital Contribution being called; (B) the reason the Additional Capital Contribution is being called; (C) each Member's proportionate share of the total Additional Capital Contribution (determined in accordance with this Section 2.2(c); and (D) the date the Additional Capital Contribution is due and payable, which date shall not, without the written consent of the Members, be less than 30 nor more than 90 calendar days after the notice has been given. A Member's share of the total Additional Capital Contribution shall be equal to the product obtained by multiplying the Member's Percentage and the total Additional Capital Contribution required. A Member's share shall be payable in cash, by certified check or wire transfer. No Additional Capital Contribution by any Member may be made or required to be made on an in-kind or any other non-cash basis unless consented to in writing by each of the Members. Upon payment of the Additional Capital Contributions, the Capital Contributions of each Member shall be adjusted. Without the prior written consent of each Member, which consent may be withheld, with or without reason, in the sole and absolute discretion of each Member, the Management Committee may not call for additional capital contributions in excess of an amount necessary to fund a Budget previously approved by the Management Committee, plus a reasonable reserve. -1- 2. Section 2.4(a) of the Agreement is hereby amended to read as follows: 2.4. Budget. (a) The Management Committee shall promptly prepare a budget for the Company's activities covering such time period as the Management Committee shall deem appropriate. The Budget may include provisions for Additional Capital Contributions to made by the Members. The Management Committee shall meet to review and update the Budget on a semi-annual basis or as it may otherwise determine to be appropriate. Without the prior written consent of each Member, which consent may be withheld, with or without reason, in the sole and absolute discretion of each Member, the Management Committee shall not adopt for any 12-month period a Budget requiring funding by the Members in an amount in the aggregate in excess of twice the funding required by the Members in the Budget relating to the immediately preceding 12-month period. 3. Section 4.1(g)(i)of the Agreement is hereby amended to read as follows: (g) (i) If submission of a Deadlock to the procedures described in Section 4.1(f) does not, within the time periods specified in Section 4.1(f) hereof, result in resolution of the Deadlock, submission of the Deadlock to arbitration or agreement by the Members on an alternative dispute resolution procedure, either party may elect to exercise the buy/sell right contained in this Section 4.1(g) (the "Buy/Sell Right"). The Member electing to exercise the Buy/Sell Right (the "Offeror") shall furnish in writing to the other Member (the "Offeree") the Offeror's irrevocable, unconditional (except as provided herein) and binding offer (such notice being referred to herein as the "Exercise Notice"), at the Offeree's option, to purchase the Offeree's Interest or to sell the Offeror's Interest for a cash purchase price determined in accordance with Section 4.1(g)(ii) hereof (the "Purchase Price"). The Exercise Notice shall set forth an amount expressed in dollars and without contingencies (the "Valuation"), which amount shall be used to calculate, in accordance with Section 4.1(g)(ii) hereof, the Purchase Price. The Valuation is intended to represent the amount that would be payable for 100% of the Interests of the Company. Within 15 calendar days after the Exercise Notice is given, the Offeree may give notice to the Offeror of its irrevocable, unconditional (except as provided herein) and binding election either: (1) to purchase the entire Interest of the Offeror for an amount in cash equal to the Purchase Price; or (2) to sell its entire Interest to the Offeror for an amount in cash equal to the Purchase Price. Failure of the Offeree to give notice of its decision within such applicable time period shall constitute a conclusive election by the Offeree to sell its entire Interest pursuant to this Section 4.1(g)(i). -2- 4. Section 6.1 of the Agreement is hereby amended to read as follows: 6.1 Transfer or Withdrawal Prohibited; Change of Control of a Member. (a) Except as expressly provided herein, no Member may withdraw from the Company or sell, assign, transfer, pledge, hypothecate, mortgage or create a security interest, directly or indirectly, including by a grant of rights with respect to voting, distributions or other economic rights or management ("Transfer"), in all or any portion of its Interest without the prior written consent of the other Member (the "Consent-Required Member"), and such Consent Required Member may, in the exercise of its reasoned business judgment, withhold consent in its sole and absolute discretion. Any purported withdrawal or Transfer of an Interest by a Member without the requisite consent in writing shall be null and void, and the Company and the Consent-Required Member shall be entitled to damages as a result of, and/or injunctive relief with respect to, any attempts to withdraw or Transfer. (b) In the event that the Consent-Required Member consents to a Transfer of a Member's Interest, such consent shall, unless expressly stated otherwise, be deemed a consent only to the assignment of such Member's economic interest in profits, losses and distributions and shall not be deemed a consent to the admission of such assignee as a member of the Company as a substitute for the assignor, and such assignee shall not have any of the rights of a member of the Company, including, without limitation, voting rights, unless otherwise stated in writing by the Consent-Required Member. Except to the extent that the Consent-Required Member has consented to the admission of the assignee as a member in the Company and/or consented to the exercise of voting rights by the assignee, the assigning Member shall retain all voting rights in connection with the transferred Interest. (c) In the event that at any time there occurs a Change of Control (as hereinafter defined) of a Member, such Member's Interest shall automatically convert into an economic interest only in the profits, losses and distributions of the Company, and such Member shall not have any other rights of a Member of the Company, including, without limitation, voting and marketing rights unless such Change of Control is a Qualifying Corporate Transaction (as defined below). For purposes hereof, a "Change in Control" shall be deemed to have occurred: (i) on the sale or other disposition of all or substantially all of the Member's assets to any entity, person or related group of persons; (ii) when there shall be consummated any consolidation, merger, reorganization or similar corporate transaction (a "Corporate Transaction") of the Member (A) in which the Member is not the continuing or surviving entity (other than a consolidation or merger with a wholly owned subsidiary of the Member in which all shares of common stock of such Member outstanding immediately prior to the effectiveness thereof are changed into or exchanged for the same consideration), (B) pursuant to which the common stock of such Member would be converted into cash, securities or other property or (C) any -3- transaction or series of related transactions in which the holders of the common stock of the Member immediately prior to such transaction (or the first of such transactions, if a series) does not hold at least a majority of the total voting power of all classes of capital stock entitled to vote generally in the election of directors of the Member immediately after such transaction (or the last of such transactions, if a series), in each case, other than a Corporate Transaction that is a Qualifying Corporate Transaction; (iii) when any person, or any persons acting together which would constitute a "group" for purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended, together with any affiliates thereof, shall beneficially own (as defined in Rule 13d-3 under the Exchange Act) at least 50% of the total voting power of all classes of capital stock of the Member entitled to vote generally in the election of directors of the Member (unless the "acquisition" is deemed to have occurred indirectly solely as a result of the completion of a Corporate Transaction that is not a Change in Control pursuant to clause (ii) above); (iv) when at any time during any consecutive two-year period, individuals who at the beginning of such period constituted the Board of Directors of the Member (together with any new directors whose election by such Board of Directors or whose nomination for election by the stockholders of the Member was approved by a vote of 75% of the directors then still in office who were either directors at the beginning of such period or whose election or nomination for election was previously so approved) cease for any reason to constitute a majority of the Board of Directors of the Member then in office; or (v) when the Member is liquidated or dissolved or adopts a plan of liquidation or dissolution. A "Qualifying Corporate Transaction" shall be any Corporate Transaction in which the holders of common stock of the Member immediately prior to such Corporate Transaction have, directly or indirectly, at least (i) a majority of the total voting power of all classes of capital stock entitled to vote generally in the election of directors of the continuing or surviving entity immediately after such Corporate Transaction in substantially the same proportion as their ownership of common stock before such transaction or (ii) 25% of the total voting power of all classes of capital stock entitled to vote generally in the election of directors of the continuing or surviving entity immediately after such Corporate Transaction in substantially the same proportion as their ownership of common stock before such transaction and, in the case of this clause (ii), the other Member has given a CIC Approval. A "CIC Approval" shall be given by the other Member if such Member cannot conclude in good faith and in its reasonable judgment after discussions with the parties to the Corporate Transaction that such Corporate Transaction and any resulting change in management or leadership is reasonably likely to disrupt or delay the commercialization of products by the LLC, or fundamentally alter the approach, philosophy or vision of the LLC, giving due regard to the importance of good-faith cooperation and collaboration and single-mindedness of purpose between CYTOGEN and Progenics which has formed the basis for the collaboration initially contemplated by the parties hereto. A CIC Approval may not be unreasonably withheld, and failure of the other Member to give a CIC Approval may be contested in arbitration pursuant to Article 10 hereof. In the event of a Qualifying Corporate Transaction, such acquirer or -4- surviving entity shall have the rights of such Member, including, without limitation, voting and marketing rights. Notwithstanding the foregoing, a Change of Control shall not include any transaction the purpose of which is to reorganize the Member's corporate structure, reincorporate the Member in another jurisdiction or undertake any other action which does not have the purpose or effect of materially affecting the ownership and/or control of the Member at the time of such transaction. (d) The parties desire for the foregoing provisions of this Section 6.1 to be interpreted as necessary to give effect to their intent that no Interest be transferred indirectly, in one or a series of transactions, without giving effect to the ownership consequences described in this Agreement. 5. Section 9.2 of the Agreement is hereby amended to read as follows: 9.2 Diligence Obligations. CYTOGEN shall use diligent efforts to market Licensed Products in the North American Territory ("Diligent Efforts"). For purposes of the foregoing, "Diligent Efforts" shall mean carrying out such obligation in a commercially reasonable and sustained manner consistent with the efforts a commercial enterprise in the pharmaceutical industry would devote to a product of similar market potential, profit potential or strategic value resulting from its own research efforts to which such party has exclusive rights based on conditions then prevailing. Diligent Efforts requires: (i) developing a strategic plan for product launch and subsequent market penetration with defined objectives; (ii) establishing systems and protocols reasonably designed to achieve such objectives; (iii) allocating appropriate resources to support such systems and protocol; (iv) promptly assigning responsibility for executing all phases of the Marketing Plan to specific employees who are held accountable for discharging their assigned responsibilities; and (v) monitoring on an ongoing basis the execution of the Marketing Plan and its success and making such changes as are warranted by market and/or operational conditions. CYTOGEN shall provide the LLC with access to all relevant records and personnel, during normal business hours and with reasonable advance notice, under customary confidentiality conditions, for the purpose of determining the utilization by CYTOGEN of Diligent Efforts to commercialize Licensed Products. 6. Section 9.7 of the Agreement is hereby amended to read as follows: 9.7 Non-Transferability of Rights. The product marketing rights granted by the LLC pursuant to this Agreement are personal in nature to the party to whom they are granted and, except as otherwise provided in Section 6.1, are not transferable or licensable in any manner whatsoever by such party to whom they are granted hereby, nor are such product marketing rights otherwise exercisable by any person or entity other than the party to which such rights have been granted hereby. 7. Section 11.3 of the Agreement is hereby amended to read as follows: -5- 11.3 Entire Agreement; Amendment. This Agreement contains a complete statement of the arrangements among the Members with respect to the Company and supersedes all prior agreements and understandings among them with respect to the Company and may not be amended except by unanimous written agreement of the Members. 8. Section 11.12 of the Agreement is hereby amended to read as follows: 11.12 Assignability. Except as otherwise provided in Section 6.1 hereof, neither this Agreement nor any Interest, including the right, directly or indirectly, to receive distributions or any other economic, voting or management rights or interests , shall be assignable by either Member without the written consent of the other, and any attempted assignment without such consent shall be null and void. This Agreement shall be binding upon the successors and permitted assigns of the Members. Any such successor or permitted assign shall be subject to the same rights and obligations as the original Member hereunder. 9. This Amendment Number 1 to the Agreement shall be deemed an amendment of the Agreement for purposes of Section 11.3 the Agreement. Except as expressly provided in this Amendment Number 1, all provisions of the Agreement remain in full force and effect. 10. This Amendment Number 1 supercedes all prior agreements, discussions and correspondence between Progenics, CYTOGEN and the Company concerning the subject matter of said provisions. IN WITNESS WHEREOF, the parties have executed this Amendment Number 1 as of the date and year first written above. Progenics Pharmaceuticals, Inc. PSMA Development Company LLC By: /s/ Ronald J. Prentki By: /s/ Paul J. Maddon --------------------------- ---------------------------- Ronald J. Prentki Paul J. Maddon President Managing Representative CYTOGEN Corporation By: /s/ H. Joseph Reiser By: /s/ H. Joseph Reiser --------------------------- --------------------------- H. Joseph Reiser H. Joseph Reiser President and CEO Managing Representative -6- -----END PRIVACY-ENHANCED MESSAGE-----