CAMBRIDGE, Mass., April 25 /PRNewswire-FirstCall/ -- Advanced Magnetics, Inc. , a biopharmaceutical company engaged in the development and commercialization of therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today reported unaudited financial results for the second fiscal quarter and six months ended March 31, 2007.
As of March 31, 2007, Advanced Magnetics’ cash, cash equivalents, short- term and long-term investments totaled $145.7 million. Revenues for the quarter ended March 31, 2007 were $0.9 million as compared to revenues of $0.7 million for the same quarter in fiscal 2006. Revenues for the six months ended March 31, 2007 were $1.5 million as compared to revenues of $1.4 million for the same period in fiscal 2006.
Total costs and operating expenses for the quarter ended March 31, 2007 were $9.1 million as compared to $6.1 million for the same quarter in fiscal 2006, an increase of $3.0 million. Total costs and operating expenses for the six months ended March 31, 2007 were $18.0 million as compared to $11.2 million for the same period in fiscal 2006, an increase of $6.8 million. The increases in costs and operating expenses during both the quarter and six- month period were primarily due to increased expenses associated with the Phase III clinical development program for ferumoxytol as an intravenous (IV) iron replacement therapeutic, as well as increased selling, general and administrative expenses.
The company reported a net loss of $10.2 million, or $0.72 per basic and diluted share for the quarter ended March 31, 2007, as compared to a net loss of $5.1 million, or $0.50 per basic and diluted share for the same quarter in fiscal 2006. Net loss for the six months ended March 31, 2007 was $17.6 million, or $1.33 per basic and diluted share, as compared to a net loss of $9.3 million, or $0.92 per basic and diluted share for the same period in fiscal 2006. The increases in net loss for both the quarter and six-month period were partially attributable to a $4.0 million expense associated with the February 2007 settlement of the company’s litigation with Cytogen Corporation, whereby the company reacquired the U.S. marketing rights to Combidex(R). Also contributing to the increase in net loss during both periods was the increase in total costs and operating expenses, partially offset by an increase in interest income.
Corporate Highlights Accomplishments realized in the past three months of 2007 include: -- Settlement of the company’s lawsuit with Cytogen Corporation in February, whereby Advanced Magnetics re-acquired the U.S. marketing rights to Combidex, the company’s investigational functional molecular imaging agent for use in conjunction with magnetic resonance imaging (MRI) to aid in the differentiation of cancerous from normal lymph nodes. -- Fifth and final review of the ferumoxytol Phase III intravenous iron replacement therapy clinical development program by an independent Data Monitoring Committee (DMC) in March. -- The DMC informed the company that it carefully reviewed the cumulative safety data from over 1,610 subjects in the Phase III program, identified no safety concerns, and recommended continuation of the ferumoxytol Phase III studies with no modifications. -- Completion of enrollment in March of the fourth and final planned multi-center clinical study (protocol 62,475-5) in the company’s Phase III development program for ferumoxytol as an IV iron replacement therapeutic. This study enrolled 230 dialysis-dependent chronic kidney disease (CKD) patients. -- Presentation of positive results from the Phase III development program for ferumoxytol as an IV replacement therapeutic at the National Kidney Foundation meeting on April 11. -- Key management appointments including David Arkowitz as Chief Financial Officer and Chief Business Officer.
In addition, in April the company announced the retirement of Jerome Goldstein, the Executive Chairman of the Board of Directors and founder of the company, effective May 1, 2007. Mr. Goldstein founded Advanced Magnetics in November 1981 and completed its initial public offering in June 1986. Under Mr. Goldstein’s guidance and leadership over the past 25 years the company has developed and commercialized two products, Feridex I.V.(R) and GastroMARK(R) and has advanced two product candidates, Combidex(R) and ferumoxytol, to late- stage clinical development. Mark Skaletsky, a member of the Board of Directors, has been appointed Chairman of the Board, effective May 1, 2007.
“Over the past three months, we have made key additions to our management team, re-acquired U.S. marketing rights to Combidex and announced encouraging efficacy and safety results from the ferumoxytol Phase III clinical trials,” commented Brian J.G. Pereira, M.D., President and Chief Executive Officer of Advanced Magnetics. “We are pleased with this progress as we advance toward our goal of an NDA filing for our lead product candidate, ferumoxytol, as an IV iron replacement therapeutic in chronic kidney disease, during the fourth calendar quarter of 2007.”
Conference Call and Webcast Access
Advanced Magnetics will host a webcast and conference call today at 4:30 pm ET to discuss the company’s second fiscal quarter financial results, business highlights and development programs.
An audio webcast of the earnings call will be available through the Investors section of the company’s website at www.advancedmagnetics.com. The webcast will also be available as a replay, starting approximately one hour after the call is completed, through May 25, 2007.
To access the conference call via telephone, please dial (800) 819-9193 from the United States or (913) 981-4911 for international access. A telephone replay will be available from approximately 7:30 p.m. ET on April 25 through April 27. To access a replay of the conference call, dial (888) 203- 1112 from the United States or (719) 457-0820 for international access. The passcode for both replay numbers is 5320343.
About Advanced Magnetics
Advanced Magnetics, Inc. is a biopharmaceutical company engaged in the development and commercialization of therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, utilizing its proprietary nanoparticle technology.
Ferumoxytol, the company’s key product candidate, is being developed for use as an intravenous iron replacement therapeutic for the treatment of iron deficiency anemia in chronic kidney disease. The company plans to file a New Drug Application for marketing approval of ferumoxytol with the U.S. Food and Drug Administration during the fourth calendar quarter of 2007.
Combidex, the company’s other product under development, is an investigational functional molecular imaging agent consisting of iron oxide nanoparticles for use in conjunction with MRI to aid in the differentiation of cancerous from normal lymph nodes. In March 2005, the company received an approvable letter from the FDA with respect to Combidex, subject to certain conditions.
This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and federal securities laws. Any statements contained in this press release that do not describe historical facts, including but not limited to, statements regarding our plan to file an NDA for ferumoxytol with the FDA during the fourth quarter of 2007, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include the following: (1) the possibility that we may not be able to successfully complete the development of ferumoxytol, or may not be able to complete the development in a timely or cost-effective manner, due to deficiencies in the design or oversight by us of these trials, the failure of our trials to demonstrate that ferumoxytol is safe and efficacious, unexpected results from our clinical sites, inadequate performance by third-party service providers, or any other factor causing an increase in expenses, a delay and/or a negative effect on the results of the clinical studies for ferumoxytol; (2) the possibility that we may not be able to obtain the necessary regulatory approvals in order to market and sell ferumoxytol, or we may not obtain such approvals in a timely manner; (3) the possibility that the results of past ferumoxytol studies may not be replicated in future studies; (4) the fact that we have limited sales and marketing expertise; (5) the possibility that we may not be able to timely or cost-effectively resolve the questions raised by the FDA and satisfy the conditions specified for approval of Combidex, including the provision of additional data or the conduct of additional clinical trials to demonstrate the efficacy of Combidex; (6) the possibility that we may not be able to raise additional capital on terms and on a timeframe acceptable to us, if at all; (7) uncertainties relating to our patents and proprietary rights; and (8) other risks identified in our Securities and Exchange Commission filings. We caution readers not to place undue reliance on any forward-looking statements which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Contact: Kristen Galfetti kgalfetti@advancedmagnetics.com (617) 498-3362 ADVANCED MAGNETICS, INC. (IN THOUSANDS, EXCEPT PER SHARE DATA) CONDENSED STATEMENT OF OPERATIONS (unaudited) Three Months Ended Six Months Ended March 31, March 31, 2007 2006 2007 2006 Revenues $913 $714 $1,531 $1,378 Costs and expenses (9,088) (6,104) (17,966) (11,158) Interest income 1,973 256 2,791 430 Litigation settlement (4,000) (4,000) Net loss (10,203) (5,134) (17,644) (9,349) Net loss per share -- basic and diluted $(0.72) $(0.50) $(1.33) $(0.92) Weighted average shares outstanding used to compute basic and diluted net loss per share 14,160 10,334 13,262 10,108 CONDENSED BALANCE SHEETS (unaudited) March 31, September 30, 2007 2006 Cash, cash equivalents, short-term and long-term investments* $145,653 $42,073 Working capital $132,996 $33,623 Total assets $152,332 $47,371 Stockholders’ equity $144,939 $36,075 * Investments at March 31, 2007 consisted of various securities with maturity dates ranging from 4/02/07 to 1/30/09 The short-term investment at September 30, 2006 consisted of a U.S. Treasury Bill which matured on 11/16/06
Advanced Magnetics, Inc.
CONTACT: Kristen Galfetti of Advanced Magnetics, Inc., +1-617-498-3362,kgalfetti@advancedmagnetics.com
Web site: http://www.advancedmagnetics.com/
