-----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, CJbwcjpm4T1dvgaObuoAGZ6YM3l2huXElmZo64fV7B5yja4X0jBxxJRy8Rrlg5fp 5ulccZwRPGNT9la9Y5rKhQ== 0000908737-05-000826.txt : 20051116 0000908737-05-000826.hdr.sgml : 20051116 20051116161720 ACCESSION NUMBER: 0000908737-05-000826 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20051115 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051116 DATE AS OF CHANGE: 20051116 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ADVANCED MAGNETICS INC CENTRAL INDEX KEY: 0000792977 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 042742593 STATE OF INCORPORATION: DE FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-14732 FILM NUMBER: 051210098 BUSINESS ADDRESS: STREET 1: 61 MOONEY ST CITY: CAMBRIDGE STATE: MA ZIP: 02138 BUSINESS PHONE: 6174972070 MAIL ADDRESS: STREET 1: 61 MOONEY ST CITY: CAMBRIDGE STATE: MA ZIP: 02138 8-K 1 ami8k_nov16.htm

 

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 15, 2005

 

ADVANCED MAGNETICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

(State or other jurisdiction

of incorporation)

 

 

0-14732
(Commission File No.)

04-2742593
(IRS Employer Identification No.)

 

 

 

61 Mooney Street

Cambridge, Massachusetts

(Address of Principal Executive Offices)

 

02138

(Zip Code)

 

(617) 497-2070
(Registrant’s Telephone Number, Including Area Code)

 

 

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:

 

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o 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.

The following information and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

On November 16, 2005 Advanced Magnetics, Inc. (the “Company”) issued a press release setting forth the Company’s results of operations and financial condition for the quarter and fiscal year ended September 30, 2005. The Company's press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

Item 5.02.     Departure Of Directors Or Principal Officers; Election Of Directors; Appointment Of Principal Officers.

On November 15, 2005, Dr. Brian J.G. Pereira was appointed the Company’s President. In order to vacate the position, Jerome Goldstein resigned as the Company’s President. Mr. Goldstein will continue to serve as the Chairman of the Company’s Board of Directors, Chief Executive Officer and Treasurer.

Brian J.G. Pereira, M.D., age 47, has been a director of the Company since July 2004. Dr. Pereira served as President and Chief Executive Officer of the New England Health Care Foundation at Tufts-New England Medical Center from October 2001 to November 2005, and held various other positions at Tufts-New England Medical Center from 1993 to 2001. He is a Professor of Medicine at Tufts University School of Medicine and at the Sackler School of Biomedical Sciences of Tufts University. Dr. Pereira served as President of the National Kidney Foundation from 2002 to 2004, and has served on the editorial board of twelve scientific journals. He also serves as a director of the National Kidney Foundation, Aksys, Inc., Kidney Care Partners, Wellbound Inc., and Satellite Health Care Inc. In addition, Dr. Pereira is a member of the advisory boards of Amgen, Inc. and Sigma-Tau Pharmaceuticals, Inc. along with several other organizations.

On July 12, 2005, the Company and Dr. Pereira also entered into a consulting agreement pursuant to which Dr. Pereira provides advice and consultation to the Company in the areas of business development, product marketing, medical affairs, Data and Safety Monitoring Board and Scientific Advisory Board recruitment.

 

Item 9.01.     Financial Statements and Exhibits.

(d)     Exhibits.

The Company hereby furnishes the following exhibit:

99.1

Press release dated November 16, 2005

The Company hereby files the following exhibit:

99.2

Press release dated November 15, 2005

 

 

 



 

 

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 hereunto duly authorized.

 

ADVANCED MAGNETICS, INC.

 

 

By: /s/ Michael N. Avallone

Name: Michael N. Avallone

Title: Chief Financial Officer

 

 

Date: November 16, 2005

 

 

 

 

 

 



EXHIBIT INDEX

99.1   Press release dated November 16, 2005.

99.2   Press release dated November 15, 2005.


EX-99.1 2 ex99-1.htm

 

EXHIBIT 99.1

 

Contact:

Lisa Gordon

VP of Business Development

Advanced Magnetics, Inc.

(617) 497-2070

lgordon@advancedmagnetics.com

 

For Immediate Release

 

ADVANCED MAGNETICS, INC. REPORTS FOURTH FISCAL QUARTER AND YEAR END RESULTS

 

CAMBRIDGE, MA (November 16, 2005) — Advanced Magnetics, Inc. (AMEX: AVM) today announced operating results and revenues for the fourth fiscal quarter and year ended September 30, 2005. Revenues for the quarter were $407,452 as compared to revenues of $883,598 for the same period in fiscal 2004. The company reported a net loss of ($3,576,536), or ($0.36) per share, for the fourth quarter of fiscal 2005 compared to a net loss of ($2,210,812), or ($0.28) per share, for the same period in fiscal 2004. Cash, cash equivalents, and short-term investments, consisting entirely of U.S. Treasury bills and notes, totaled approximately $23.7 million at September 30, 2005.

 

Revenues for the twelve-month period ended September 30, 2005 were $2,445,168 as compared to revenues of $3,755,884 for the same period in fiscal 2004. The net loss in the twelve-month period was ($12,714,615), or ($1.47) per share, as compared to a net loss of ($4,495,200), or ($0.57) per share, for the same period in fiscal 2004. The decrease in revenues for the twelve months ended September 30, 2005 is primarily the result of a decrease in the recognition of deferred license fee revenue from the company’s license and marketing agreement covering Combidex®. The company had an increase in costs and expenses in the twelve-month period ended September 30, 2005 resulting from both an increase in research and development expenses associated with the ferumoxytol Phase III iron therapy program as well as an increase in general and administrative expenses during the period.

 

“While fiscal 2005 posed some challenges for our company, the increased spending reflects our stepped-up efforts to bring our products in development to market,” stated Jerome Goldstein, Chairman and CEO of Advanced Magnetics. “We continue to work with the FDA to move both of our product candidates through the regulatory process and look forward to reporting progress on both ferumoxytol and Combidex during fiscal 2006. We are adding important resources, such as recently-appointed President Brian Pereira, to our management team as the first step in our continuing efforts to successfully bring Combidex and ferumoxytol to the patients who will benefit from them. We remain confident that both products have a significant role to play in their respective markets.” Ferumoxytol is in Phase III clinical trials for use as an intravenous iron replacement therapeutic for anemic chronic kidney disease patients, whether or not on dialysis. Combidex (ferumoxtran-10) is an investigational functional molecular imaging agent for use in conjunction with MRI to aid in the differentiation of normal from cancerous lymph nodes. Combidex received an approvable letter, subject to certain conditions, from the U.S. Food and Drug Administration in March 2005.

 

About Advanced Magnetics

Advanced Magnetics, Inc. is a developer of superparamagnetic iron oxide nanoparticles used in

 

- more -

 

 



 

 

pharmaceutical products. As a leader in our field, we are dedicated to the development and commercialization of our proprietary nanoparticle technology for use in therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cardiovascular disease and cancer. For more information about us, please visit our website at http://www.advancedmagnetics.com, the content of which is not part of this press release.

 

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 the development programs and regulatory process for ferumoxytol or Combidex, any progress we may report with respect to these programs and processes, and our belief in the role these products will play in the marketplace, 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 clinical development of ferumoxytol, or may not be able to complete the development in a timely or cost-effective manner, due to the timing of enrollment of patients in the Phase III studies, unexpected results from our clinical sites, inadequate performance by third-party service providers involved in the conduct of the clinical trials, deficiencies in the design or oversight by us of these trials, 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) uncertainties surrounding the timing and results of FDA interactions regarding the clinical development of ferumoxytol and our ability to obtain regulatory approval for ferumoxytol from the FDA; (3) the possibility that the results of past ferumoxytol studies may not be replicated in future studies; (4) 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; (5) the possibility that we may not be able to raise additional capital on terms and on a timeframe acceptable to us, if at all; (6) our reliance on a limited number of customers and our dependence on our collaborative relationships; (7) the timing of recognition of deferred revenue which is affected by the performance of our obligations under our license agreements; (8) uncertainties relating to the cyclical nature of our product sales cycles; (9) uneven demand for our products by end users; (10) uncertainties relating to our ability to continue to operate at commercial scale in compliance with FDA regulations and other applicable manufacturing requirements when producing Combidex or ferumoxytol; and (11) uncertainties relating to patents and proprietary rights and (12) 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.

 

- financial table to follow -

 

 

 



 

 

ADVANCED MAGNETICS, INC.

CONDENSED INCOME STATEMENT FOR THE THREE-MONTH

AND TWELVE-MONTH PERIODS ENDED SEPTEMBER 30, 2005 and 2004

(unaudited)

 

 

 

Three Months

Twelve Months

Ended September 30,

Ended September 30,

 

2005

2004

2005

2004

Revenues

$ 407,452

$ 883,598

$ 2,445,168

$ 3,755,884

Costs and expenses

(4,170,694)

(3,151,587)

(15,579,218)

(8,420,631)

Interest income

186,706

57,177

419,435

169,547

 





Net loss

$ (3,576,536)

$ (2,210,812)

$ (12,714,615)

$ (4,495,200)

 





Loss per share, basic and diluted:

$  (0.36)

$  (0.28)

$  (1.47)

$  (0.57)

Weighted average shares outstanding, basic and diluted:

9,866,446

7,885,664

8,633,827

7,817,918

 

 

BALANCE SHEET

(unaudited)

 

 

9/30/05

9/30/04 

Cash, cash equivalents and short-term investments*

$23,727,298

$14,334,278

Long-term investment**

$--

$4,768,159

Working capital

$21,211,412

$12,313,754

Total assets

$28,291,982

$23,810,611

Shareholders' equity

$22,379,159

$17,546,455

 

*  Short-term investment at 9/30/04 consists of a U.S. Treasury Note with a maturity date of January 31, 2005. Short-term investments at 9/30/05 consists of a U.S. Treasury Note with a maturity date of February 15, 2006, combined with three U.S. Treasury bills having maturity dates of October 27, 2005, November 3, 2005 and January 26, 2006.

**   Long-term investment at 9/30/04 consists of a U.S. Treasury Note with a maturity date of February 15, 2006.

 

 

EX-99.1 3 ex99-2.htm

EXHIBIT 99.2

 

Contact:

 

Jerome Goldstein, CEO

or Lisa Gordon, VP of Business Development

Advanced Magnetics, Inc.

(617) 497-2070

 

BRIAN J. G. PEREIRA, MD NAMED PRESIDENT OF ADVANCED MAGNETICS

 

Cambridge, MA (November 15, 2005) (Advanced Magnetics, Inc. (Amex: AVM) today announced the appointment of Brian J.G. Pereira, MD as President of the Company. Dr. Pereira joins Advanced Magnetics from his position as President and CEO of NEHCF, Tufts-New England Medical Center and Professor of Medicine at Tufts University. Dr. Pereira is the past-President of the National Kidney Foundation and is a world-renowned researcher and educator in the field of nephrology. He brings his extensive knowledge of the factors affecting nephrology science, treatment and reimbursement to his new post. Dr. Pereira has been a member of the Board of Directors of Advanced Magnetics since 2004. In this new position, Dr. Pereira will be addressing all aspects of Advanced Magnetics’ business, especially focusing on the continuing clinical development of ferumoxytol as an intravenous iron replacement therapy and the commercial introduction of the product to the nephrology community. Ferumoxytol is currently in Phase III multi-center clinical trials for the treatment of anemia in chronic kidney disease (CKD) patients, whether or not on dialysis. Dr. Pereira will continue to serve on Advanced Magnetics’ Board of Directors.

 

“We are very pleased that Dr. Pereira has agreed to join our company in this capacity,” stated Jerome Goldstein, Chairman and Chief Executive Officer. “We are most fortunate to attract an individual of such quality, knowledge and international reputation. This appointment signals our optimism and faith in the potential of this product.”

 

Dr. Pereira added, “I am excited about this opportunity. This is the first in a series of key hires to ensure our successful commercialization and launch of ferumoxytol to the large number of CKD patients who may benefit from its use.”

 

Dr. Pereira was President and CEO of NEHCF, Tufts-New England Medical Center since 2001 and has held various other positions at Tufts-New England Medical Center since 1993. A nationally-recognized expert on kidney disease and nephrology, Dr. Pereira has served on the editorial board of twelve scientific journals, is the Editor of the widely read textbook, “Chronic Kidney Disease, Dialysis and Transplantation”, and has over 200 scientific papers to his credit. He also serves as a director of the National Kidney Foundation, Aksys, Inc., Kidney Care Partners, Satellite Health Care Inc. and Wellbound Inc. In addition, Dr. Pereira is a member of the advisory boards of Amgen and Sigma-Tau Pharmaceuticals along with several other organizations. Dr. Pereira is a graduate of St. John’s Medical College and has an MBA from the Kellogg Business School, Northwestern University.

 

About Advanced Magnetics

Advanced Magnetics, Inc. is a developer of superparamagnetic iron oxide nanoparticles used in pharmaceutical products. As a leader in our field, we are dedicated to the development and

 

- more -

 

 



 

commercialization of our proprietary nanoparticle technology for use in therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cardiovascular disease and cancer. For more information about us, please visit our website at http://www.advancedmagnetics.com, the content of which is not part of this press release.

 

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 optimism and faith in the potential of ferumoxytol, certain key hires we intend to make, and our efforts to commercialize and launch ferumoxytol to CKD patients, 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 clinical development of ferumoxytol, or may not be able to complete the development in a timely or cost-effective manner, due to the timing of enrollment of patients in the Phase III studies, unexpected results from our clinical sites, inadequate performance by third-party service providers involved in the conduct of the clinical trials, deficiencies in the design or oversight by us of these trials, 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) uncertainties surrounding the timing and results of FDA interactions regarding the clinical development of ferumoxytol and our ability to obtain regulatory approval for ferumoxytol from the FDA; (3) the possibility that the results of past ferumoxytol studies may not be replicated in future studies; (4) the possibility that we may not be able to raise additional capital on terms and on a timeframe acceptable to us, if at all; (5) our reliance on a limited number of customers and our dependence on our collaborative relationships; (6) uncertainties relating to the cyclical nature of our product sales cycles; (7) uneven demand for our products by end users; (8) uncertainties relating to our ability to continue to operate at commercial scale in compliance with FDA regulations and other applicable manufacturing requirements when producing ferumoxytol; and (9) uncertainties relating to patents and proprietary rights and (10) 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.

 

 

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