-----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, URAIIlgVZwffsaMM1Af3V2jJjfS9grKM5/U/qrLn05xfRUYJefTpnw+Se5MKLgtP BzY7ANQLMDQOOvAMNrF/FA== 0001157523-07-010980.txt : 20071108 0001157523-07-010980.hdr.sgml : 20071108 20071108084217 ACCESSION NUMBER: 0001157523-07-010980 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20071108 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071108 DATE AS OF CHANGE: 20071108 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEOPHARM INC CENTRAL INDEX KEY: 0000942788 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 510327886 STATE OF INCORPORATION: DE FISCAL YEAR END: 0907 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12493 FILM NUMBER: 071223530 BUSINESS ADDRESS: STREET 1: 1850 LAKESIDE DRIVE CITY: WAUKEGAN STATE: IL ZIP: 60085 BUSINESS PHONE: 8472958678 MAIL ADDRESS: STREET 1: C/O WILSON SONSIN GOODRICH & ROSETI STREET 2: 650 PAGE MILL ROAD CITY: PALO ALTO STATE: CA ZIP: 94304 8-K 1 a5541029.txt NEOPHARM, INC. 8-K ================================================================================ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) November 8, 2007 NEOPHARM, Inc. (Exact name of registrant as specified in its charter) Delaware 33-90516 51-0327886 (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 1850 Lakeside Drive, Waukegan, IL 60085 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (847) 887-0800 (Former name or former address, if changed since last report.) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: |_| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |_| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |_| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) ================================================================================ Item 2.02. Results of Operations and Financial Condition On November 8, 2007, NEOPHARM, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2007. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. In accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02, including Exhibit 99.1, shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing. Item 9.01. Financial Statements and Exhibits (d) Exhibits Exhibit Press Release dated November 8, 2007 announcing NEOPHARM's 99.1 financial results for the third quarter ended September 30, 2007 2 - -------------------------------------------------------------------------------- SIGNATURE PAGE -------------- 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. Dated: November 8, 2007 /s/ Laurence P. Birch ------------------------------ Laurence P. Birch President and Chief Executive Officer (Principal Executive Officer) and Acting Chief Financial Officer (Principal Financial Officer) 3 EX-99.1 2 a5541029ex991.txt EXHIBIT 99.1 Exhibit 99.1 NEOPHARM, Inc. Announces Third Quarter 2007 Financial Results Restructuring Complete and Drug Pipeline Progress on Schedule WAUKEGAN, Ill.--(BUSINESS WIRE)--Nov. 8, 2007--NEOPHARM, Inc. (NASDAQ: NEOL), today announced its third quarter 2007 financial results. For the third quarter ended September 30, 2007, NEOPHARM reported a net loss of $881,000, or ($0.03) per basic and diluted share, as compared to a loss of $8.0 million, or ($0.29) per share, for the same period last year. The net loss for the quarter includes a one-time credit of other income of $2.0 million, or $0.07 per diluted share, related to the termination of the Nippon-Kayaku contract. Adjusting for this one-time credit, the loss for the third quarter would have been $2.9 million, or ($0.10) per share, which represents a 64% reduction year-over-year. Sequentially, the net loss for the third quarter, absent the one-time credit related to Nippon-Kayaku, favorably compared to the $3.6 million net loss incurred in the second quarter ending June 30, 2007, representing a reduction of $734,000, or 20%. For the nine months ended September 30, 2007, NEOPHARM reported a net loss of $9.9 million, or ($0.35) per basic and diluted share, which includes the one-time credit related to the Nippon-Kayaku contract, as compared to a loss of $25.5 million, or ($0.92) per share, for the same period last year. The decline in the Company's net loss can be primarily attributed to the aggressive cost reduction initiatives in both personnel and non-personnel related expenses as a result of the Company's restructuring efforts to optimize its drug development activities. Based on the progress to date, NEOPHARM believes that most of its restructuring initiatives are now complete. "During the quarter, we continued to remain focused on achieving an optimal cost structure, while concurrently taking the necessary steps to reach the targets we announced in August of this year. The significant reduction in our cash consumption level clearly reflects our on-going commitment to driving value from our drug portfolio while utilizing the resources we currently have available," commented Laurence Birch, President and Chief Executive Officer of NEOPHARM. "I believe that the intellectual property NEOPHARM has developed to date, as well as the additional indications that may be developed in the future with our current compounds, have the ability to propel the Company to the next phase of its business life cycle. While I recognize that there is a lot of work ahead of us, I am confident that the team we have in place has the ability and experience to progress a number of our drug candidates to the next stage of development." During the quarter, the Company allocated $2.2 million in cash to its operations versus $3.1 million in the second quarter, which represents a decrease of 29%. While NEOPHARM anticipates future cash consumption levels to be in-line with spending during the third quarter, obligations related to previous drug product candidates' trials are likely to be incurred in the coming quarters. Despite these anticipated disbursements, with $23.5 million in cash and available for sale securities at the end of the third quarter, the Company reaffirmed its estimate that it has adequate resources to fund its operations into 2009. NEOPHARM also announced that it remains optimistic regarding its ability to achieve a number of milestones related to its drug candidates as announced in August 2007. Currently Projected Milestone Events for Drug Candidate Portfolio -- LE-DT, liposomal docetaxel - Potential alternative therapy for patients allergic or less responsive to Taxotere(R). Possible indications for breast, ovarian, prostate, and non-small cell lung cancers. -- IND submission anticipated in late 2007 -- Phase I patient enrollment expected in mid-2008 -- LEP-ETU, liposomal paclitaxel - an anti-cancer agent designed to treat breast, ovarian, and non-small cell lung cancers. -- Phase II patient enrollment projected in early 2008 -- LE-rafAON - designed and developed to inhibit activated c-raf-1 gene, which has been associated with radiation and chemotherapy resistance. c-raf gene-specific antisense. -- IND submission anticipated in early 2008 -- LE-SN38, liposomal SN38 - for the treatment of colorectal cancer. Other possible indications for breast, ovarian, prostate, and non-small cell lung cancers. -- Phase II patient enrollment anticipated in late 2008 -- IL13-PE38, or Cintredekin Besudotox, for the treatment of Idiopathic Pulmonary Fibrosis. -- IND submission expected in mid-2008 -- Phase I patient enrollment expected in late 2008 -- The Company continues to pursue partnership opportunities for IL13-PE38, or Cintredekin Besudotox, for the treatment of Recurrent Glioblastoma Multiforme, or GBM. About NEOPHARM, Inc. NEOPHARM, Inc., based in Waukegan, Illinois, is a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative cancer and other drugs for therapeutic applications. Additional information can be obtained by visiting NEOPHARM's Web site at www.neopharm.com. Forward Looking Statements - This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to, any statements relating to the Company's strategic review of projects and operations, the Company's drug development programs, the initiation, progress and outcomes of clinical trials of the Company's drug product candidates, projections regarding cash used in operations, financial projections, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in financing, development, testing, regulatory approval, production, and marketing of the Company's drug and non-drug compounds including, but not limited to the Company's ability to pursue additional testing of its tumor targeting and NeoLipid drug product candidates, uncertainty regarding the outcomes of ongoing or proposed FDA studies, the Company's financial guidance and projections, the Company's ability to evaluate the strategic alternatives available to the Company and to cut back on its funding of certain of its development projects in order to conserve its cash resources, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug and non-drug compounds, including, but not limited to, its tumor targeting and NeoLipid drug product candidates, that could slow or prevent products coming to market, uncertainty regarding the Company's ability to market its drug and non-drug products, including, but not limited to, its tumor targeting and NeoLipid drug product candidates, the uncertainty of patent protection for the Company's intellectual property or trade secrets, and other risks detailed from time to time in filings the Company makes with the Securities and Exchange Commission. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release, and in the Company's most recent annual report on Form 10-K for the calendar year ended December 31, 2006, as updated in its quarterly reports on Form 10-Q. Accordingly, you should not rely on these forward-looking statements as a prediction of actual future results. NEOPHARM, INC. Condensed Consolidated Statements of Operations Three and Nine Months Ended September 30, 2007 and September 30, 2006 Three Months Ended Nine Months Ended ------------------------- --------------------------- (unaudited) (unaudited) September September September 30, September 30, 30, 2007 30, 2006 2007 2006 ------------ ------------ ------------- ------------- Product revenue $- $1,000 $- $11,000 ------------ ------------ ------------- ------------- Total revenue - 1,000 - 11,000 Expenses: Cost of product revenue - - - 1,000 Research and development 1,668,000 4,319,000 6,175,000 16,200,000 Selling, general, and administrative 1,265,000 3,702,000 6,097,000 10,808,000 Employee termination costs - 293,000 555,000 1,298,000 Change in fair value of derivative financial instruments (11,000) (98,000) (64,000) (1,269,000) Facility consolidation costs 296,000 428,000 296,000 428,000 ------------ ------------ ------------- ------------- Total Expenses 3,218,000 8,644,000 13,059,000 27,466,000 ------------ ------------ ------------- ------------- Loss from operations (3,218,000) (8,643,000) (13,059,000) (27,455,000) Other income 2,000,000 - 2,000,000 - Interest income 337,000 639,000 1,110,000 1,981,000 ------------ ------------ ------------- ------------- Net loss $(881,000) $(8,004,000) $(9,949,000) $(25,474,000) ============ ============ ============= ============= Net loss per share - basic and diluted $(0.03) $(0.29) $(0.35) $(0.92) Weighted average shares outstanding - basic and diluted 28,377,120 27,934,702 28,189,815 27,685,928 ============ ============ ============= ============= Selected Balance Sheet data September 30, December 31, 2007 2006 ------------- ------------- (unaudited) Cash and available for sale securities 23,496,000 38,587,000 Total assets 24,599,000 40,689,000 Total current liabilities 5,288,000 9,577,000 Accumulated deficit (271,182,000) (261,233,000) Total stockholders' equity 19,175,000 28,871,000 CONTACT: NEOPHARM, Inc. Laurence P. Birch President & CEO 847-887-0800 lbirch@neopharm.com -----END PRIVACY-ENHANCED MESSAGE-----