-----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, H5BZspBXW2qXwWG8WOO3Ej9TjWXiUOI3GZl4ysSJIiqfSa+d3MuFPEwivPdifGoO ZI7JRTjRJb4JBKegBJe/TA== 0001157523-05-006910.txt : 20050803 0001157523-05-006910.hdr.sgml : 20050803 20050803075725 ACCESSION NUMBER: 0001157523-05-006910 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050803 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050803 DATE AS OF CHANGE: 20050803 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AVANT IMMUNOTHERAPEUTICS INC CENTRAL INDEX KEY: 0000744218 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 133191702 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-15006 FILM NUMBER: 05993781 BUSINESS ADDRESS: STREET 1: 119 FOURTH AVE CITY: NEEDHAM STATE: MA ZIP: 02494 BUSINESS PHONE: 7814330771 MAIL ADDRESS: STREET 1: 119 FOURTH AVE CITY: NEEDHAM STATE: MA ZIP: 021942725 FORMER COMPANY: FORMER CONFORMED NAME: T CELL SCIENCES INC DATE OF NAME CHANGE: 19920703 8-K 1 a4944716.txt AVANT IMMUNOTHERAPEUTICS, INC., 8-K ================================================================================ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): August 3, 2005 Commission file number 0-15006 AVANT Immunotherapeutics, Inc. (Exact name of registrant as specified in its charter) -------------------- Delaware 13-3191702 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 119 Fourth Avenue Needham, Massachusetts 02494 (Address of principal executive offices, including zip code) (781) 433-0771 (Registrant's telephone number, including area code) (Former name, 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 August 3, 2005, AVANT Immunotherapeutics, Inc. issued a press release announcing its financial results for the second quarter of 2005. The full text of the press release is furnished as Exhibit 99.1 hereto is incorporated by reference herein. Item 9.01. Financial Statements and Exhibits. - ------- ----- 99.1 Press Release of AVANT Immunotherapeutics, Inc. dated August 3, 2005. [Remainder of page left blank intentionally] SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be filed on its behalf by the undersigned hereunto duly authorized. AVANT Immunotherapeutics, Inc. Dated: August 3, 2005 By: /s/ Avery W. Catlin --------------------------------------- Avery W. Catlin Senior Vice President and Chief Financial Officer Exhibit Index 99.1 Press Release of AVANT Immunotherapeutics, Inc. dated August 3, 2005. EX-99.1 2 a4944716ex99_1.txt EXHIBIT 99.1 Exhibit 99.1 AVANT Immunotherapeutics Reports Second Quarter and Six Month Financial Results NEEDHAM, Mass.--(BUSINESS WIRE)--Aug. 3, 2005--AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) today reported financial results for the second quarter and six months ended June 30, 2005. The company reported a net loss of $4.7 million, or $.06 per share, for the second quarter of 2005 compared to a net loss of $3.9 million, or $.05 per share, for the second quarter of 2004. For the six months ended June 30, 2005, the company reported a net loss of $9.6 million, or $.13 per share, compared to a net loss of $5.8 million, or $.08 per share, for the six months ended June 30, 2004. AVANT reported cash and cash equivalents of $27 million, including a $5 million upfront payment received from Paul Royalty Fund, at June 30, 2005. The increased loss for the second quarter of 2005 compared to the same period in 2004 primarily reflected a decrease in revenues combined with an increase in operating expense. The decrease in revenues of $255,849 primarily reflected lower billing levels to DynPort Vaccine Company LLC ("DVC") for the anthrax/plague vaccine contract during the second quarter of 2005. The increase in operating expense of $654,572 is primarily due to increased clinical trial costs associated with the ongoing TP10 Phase IIb study in women undergoing cardiac bypass surgery and operating expenses of the Fall River manufacturing facility, offset by a reduction in TP10 contract manufacturing costs incurred for process development and scale-up work. The increase in operating expenses further resulted from an increase in general and administrative expenses primarily due to increases in personnel-related expenses, legal and professional services and consultancy costs. The six-month results for 2005 reflect an increase in net loss compared to the same period in 2004. This increase in net loss primarily reflected a decrease in revenue and an increase in operating expense, offset in part by an increase in investment income. The decrease in revenue in 2005 resulted primarily from the one-time recognition in 2004 of $1 million in revenue from DVC for rPA clinical materials and the onetime recognition of an upfront license fee of $1 million from AdProTech, Ltd. The increase in operating expense were primarily a result of an increase in research and development expenses due to an increase in TP10 contract manufacturing costs and laboratory supplies incurred for process development and scale-up work and operating expenses of the Fall River manufacturing facility. The increase in general and administrative expenses was primarily due to increases in personnel-related expenses, legal and professional services and consultancy costs. The increase in investment income reflected higher interest rates between periods. Una S. Ryan, Ph.D., AVANT's President and Chief Executive Officer, said, "We were very pleased to report an important strategic transaction in May with the Paul Royalty Fund that provided AVANT with non-dilutive financial resources for furthering our product development programs. Additionally, our overall financial results for the quarter were consistent with our expectations." "Our development programs also continue to progress as planned," Dr. Ryan continued. "Moreover, we were pleased last week to announce the preliminary results of the infant and children portions of our Phase II study of CholeraGarde(R) in Bangladesh, which reinforces the strong safety and immunogenicity results reported last year in adults receiving this experimental vaccine. We will now be working with Harvard University to apply our VitriLife(R) technology for vaccine thermostability to this product, under a grant also announced recently from the National Institutes of Health." Transaction with Paul Royalty Fund On May 18, AVANT announced a transaction with Paul Royalty Fund II, L.P. (PRF) that enables AVANT to receive a considerable amount of the future royalty stream now from future sales by GlaxoSmithKline (GSK) of its vaccine against rotavirus disease, Rotarix(R). At the same time, the agreement allows AVANT to retain significant upside in future royalty revenues depending on sales of that product. The company announced that an affiliate of PRF would purchase, for up to $61 million, an interest in the net royalties AVANT is due to receive on worldwide sales of Rotarix(R). AVANT expects to receive $50 million of this funding within the next 12 months, with a guaranteed $10 million to be received this year ($5 million received at signing and $5 million on December 1, 2005). The remainder will be received as a $40 million payment on European launch of Rotarix(R), currently expected for the first half of 2006. AVANT expects to receive between $11 and $9 million on product launch in the United States, depending on the date of that launch. AVANT also retains substantial upside participation in future royalties from Rotarix(R) depending on its commercial success. Under the agreement with PRF, AVANT will continue to retain half of up to $5.5 million in future gross milestones payable by GSK. We will keep 92.5% of royalties above the first $27.5 million in any year, which goes to PRF. Once PRF receives a return on its investment of 2.45 times its cash payments, AVANT will receive 92.5% of all future royalties. If GSK does not launch Rotarix(R) in the United States by the end of 2009, either PRF or AVANT can opt out of the related milestone, and AVANT will retain all royalties on U.S. sales. GSK now reports having achieved approval of Rotarix(R) in seven countries outside the United States. "While these initial approvals do not represent large financial markets for Rotarix(R)," said Dr. Ryan, "they represent important gains for human health on a global basis and provide additional clinical experience with this new vaccine." Clinical Development Programs AVANT announced on July 27, results in children and infants from a randomized, Phase II double blind, placebo-controlled study of its single-dose, oral cholera vaccine, CholeraGarde(R), conducted in Bangladesh by the International Centre for Diarrhoeal Disease Research, Bangladesh in collaboration with the International Vaccine Institute (IVI). The researchers found the vaccine to be immunogenic and well tolerated in the vaccinated children. Over 84% of children and 70% of infants vaccinated with the effective dose responded with a favorable immune response. If the results in children aged from 9 months to 5 years are grouped together, the responder frequency was 77%. These results were consistent with results in adults receiving vaccination with CholeraGarde(R) in an earlier reported Phase of this study, which showed a response rate of 70%. The enrollment rate in the company's Phase IIb study of TP10 in women undergoing cardiac bypass surgery improved during the quarter as a result of steps taken to increase enrollment including the addition of new study sites. AVANT now expects to complete enrollment in this trial by year-end. The aim of the trial is to augment the safety data for TP10 and further define its effect in women before advancing to a Phase III study. AVANT is seeking to partner the TP10 program prior to starting a Phase III trial. AVANT also completed all of the validation at its Fall River manufacturing facility required to start vaccine production of the plague component of its oral combination anthrax and plague vaccine. The company plans to begin production of that vaccine during the third quarter of 2005. AVANT also recently reported that it and Harvard Medical School would receive approximately $500,000 from the National Institutes of Health to apply AVANT's VitriLife(R) formulation to CholeraGarde(R). In the future, AVANT plans to utilize VitriLife(R), a proprietary technology that confers thermostability to live bacterial vaccines, at the Fall River facility for each of AVANT's bacterial vaccines and potentially other products. Webcast and Conference Call Dr. Ryan and Mr. Catlin will host a conference call at 11:00 AM EDT on Wednesday, August 3, 2005 to discuss AVANT's Second Quarter 2005 financial results. To access the conference call, dial 800-510- 9691 (within the United States), or 617-614-3453 (if calling from outside the U.S.). The passcode for participants is 60970651. An audio replay will be available approximately two hours after the call for approximately one week and can be accessed by dialing 888-286-8010 (within the U.S.), or 617-801-6888 (if calling from outside the U.S.). The passcode I.D. number is 47416229. A live webcast of the conference call, together with this press release, can be accessed through the company's web site www.avantimmune.com in the Investor Information section. In order to access the webcast, your PC must have a sound card, speakers and Windows Media Player software. It is recommended that you configure your PC in advance of the webcast as the software download and installation can take several minutes. In addition, the call and webcast will be archived and can be accessed through the same link. Additionally, a copy of this press release is available by contacting Investor Relations at (781) 433-0771. About AVANT Immunotherapeutics, Inc. AVANT Immunotherapeutics, Inc. discovers and develops innovative vaccines and therapeutics that harness the human immune system to prevent and treat disease. Six of AVANT's products are in clinical development, including a treatment to reduce complement-mediated tissue damage associated with cardiac bypass surgery and a novel vaccine for cholesterol management. AVANT is also developing a pipeline of bacteria-fighting products for biodefense, travelers' vaccines, and global health needs based on AVANT'S rapid-protecting, single-dose, oral and temperature stable vaccine technology. Additional information on AVANT Immunotherapeutics, Inc. can be obtained through our site on the World Wide Web: http://www.avantimmune.com. Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements which reflect AVANT's current views with respect to future events and financial performance. These forward-looking statements are based on management's beliefs and assumptions and information currently available. The words "believe", "expect", "anticipate", "intend", "estimate", "project" and similar expressions which do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: (1) the integration of multiple technologies and programs; (2) the ability to adapt AVANT's vectoring systems to develop new, safe and effective orally administered vaccines against anthrax and plague or other bioterrorism threats or emerging health care threats; (3) the ability to successfully complete development and commercialization of TP10, CETi-1, CholeraGarde(R) (Peru-15), Ty800 and other products; (4) the cost, timing, scope and results of ongoing safety and efficacy trials of TP10, CETi-1, CholeraGarde(R) (Peru-15), Ty800 and other preclinical and clinical testing; (5) the ability to successfully complete product research and further development, including animal, pre-clinical and clinical studies of TP10, CETi-1, CholeraGarde(R) (Peru-15), Ty800and other products; (6) the ability of the Company to manage multiple late stage clinical trials for a variety of product candidates; (7) the volume and profitability of product sales of Megan(R)Vac 1, Megan(R)Egg and other future products; (8) the process of obtaining regulatory approval for the sale of Rotarix (R) in major commercial markets, as well as the timing and success of worldwide commercialization of Rotarix (R) by our partner, GlaxoSmithKline; (9)GSK's strategy and business plans to launch and supply Rotarix (R) worldwide, including in the US and other major markets;(10) changes in existing and potential relationships with corporate collaborators; (11) the availability, cost, delivery and quality of clinical and commercial grade materials supplied by contract manufacturers; (12) the timing, cost and uncertainty of obtaining regulatory approvals to use TP10, CETi-1, CholeraGarde(R) (Peru-15) and Ty800, among other purposes, for adults undergoing cardiac surgery, to raise serum HDL cholesterol levels and to protect travelers and people in endemic regions from diarrhea causing diseases, respectively; (13) the ability to obtain substantial additional funding; (14) the ability to develop and commercialize products before competitors and that are superior to the alternatives developed by competitors; (15) the ability to retain certain members of management; and (16) other factors detailed from time to time in filings with the Securities and Exchange Commission. We expressly disclaim any responsibility to update forward-looking statements. AVANT IMMUNOTHERAPEUTICS, INC. CONSOLIDATED Quarter Year to Date STATEMENTS Ended June 30, Ended June 30, OF OPERATIONS DATA - ---------------------------------------------------------------------- 2005 2004 2005 2004 (Unaudited) (Unaudited) REVENUE Product Development and Licensing Agreements $59,060 $124,419 $130,517 $2,248,838 Government Contracts and Grants 522,963 714,638 1,389,050 1,594,546 Product Royalties 55,138 53,953 88,146 80,323 - ---------------------------------------------------------------------- Total Revenue 637,161 893,010 1,607,713 3,923,707 - ---------------------------------------------------------------------- OPERATING EXPENSE Research and Development 3,430,992 3,367,804 7,461,610 6,821,003 General and Administrative 1,861,095 1,269,711 3,571,879 2,561,846 Amortization of Acquired Intangible Assets 248,778 248,778 497,556 497,556 - ---------------------------------------------------------------------- Total Operating Expense 5,540,865 4,886,293 11,531,045 9,880,405 - ---------------------------------------------------------------------- Operating Loss (4,903,704) (3,993,283) (9,923,332) (5,956,698) Investment Income, Net 169,764 94,546 320,894 148,549 - ---------------------------------------------------------------------- Net Loss $(4,733,940) $(3,898,737) $(9,602,438) $(5,808,149) - ---------------------------------------------------------------------- Basic and Diluted Net Loss per Common Share $(0.06) $(0.05) $(0.13) $(0.08) - ---------------------------------------------------------------------- Weighted Average Common Shares Outstanding 74,132,829 74,091,599 74,132,416 71,655,099 - ---------------------------------------------------------------------- CONDENSED CONSOLIDATED BALANCE SHEETS June 30, December 31, - ---------------------------------------------------------------------- 2005 2004 (Unaudited) ASSETS Cash and Cash Equivalents $27,028,598 $31,741,494 Other Current Assets 6,060,212 2,798,266 Property and Equipment, net 4,788,560 4,164,292 Intangible and Other Assets, net 6,600,914 7,099,470 ------------ ------------ Total Assets $44,478,284 $45,803,522 ============ ============ LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities $3,576,729 $5,450,948 Long-Term Liabilities $11,851,886 1,944,948 Stockholders' Equity 29,049,669 38,407,626 ------------ ------------ Total Liabilities and Stockholders' Equity $44,478,284 $45,803,522 ============ ============ CONTACT: AVANT Immunotherapeutics, Inc. Una S. Ryan, Ph.D., 781-433-0771 President and CEO or AVANT Immunotherapeutics, Inc. Avery W. Catlin, 781-433-0771 Chief Financial Officer info@avantimmune.com or Kureczka/Martin Associates Joan Kureczka, 415-821-2413 jkureczka@comcast.net -----END PRIVACY-ENHANCED MESSAGE-----