-----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, VrG+ht4Mx6tF2Q8U7LFXqdboxgYXzvvNEtEVSaXglMKM3S+3nbFGmaYBPwteYR5Y nWYO1N2sle7DnP8SofgcEQ== 0001104659-05-016984.txt : 20050419 0001104659-05-016984.hdr.sgml : 20050419 20050419103234 ACCESSION NUMBER: 0001104659-05-016984 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050419 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050419 DATE AS OF CHANGE: 20050419 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: 05758310 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 a05-6929_18k.htm 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):  April 19, 2005

 

ADVANCED MAGNETICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

(State or other jurisdiction

of incorporation)

 

Commission File No. 0-14732

 

04-2742593

 

 

(IRS Employer
Identification No.)

 

 

 

61 Mooney Street
Cambridge, Massachusetts

 

02138

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (617) 497-2070

 

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.

 

On April 19, 2005, Advanced Magnetics, Inc. (the “Company”) issued a press release setting forth the Company’s results of operations and financial condition for the quarter ended March 31, 2005.  A copy of the Company’s press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01.  Financial Statements and Exhibits.

 

(c) Exhibits.

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release dated April 19, 2005.

 

2



 

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: April 19, 2005

 

 

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release dated April 19, 2005.

 

4


EX-99.1 2 a05-6929_1ex99d1.htm EX-99.1

Exhibit 99.1

 

For Immediate Release

 

Contact:

Mike Avallone, CFO

(617) 497-2070 (x3013)

or Lisa Gordon, VP of Business Development

Advanced Magnetics, Inc.

(617) 497-2070 (x3024)

 

 

ADVANCED MAGNETICS, INC. REPORTS RESULTS FOR THE SECOND FISCAL
QUARTER AND SIX MONTHS ENDED MARCH 31, 2005

 

Cambridge, MA (April 19, 2005) — Advanced Magnetics, Inc. (AMEX:AVM) today announced operating results and revenues for the second fiscal quarter and six-month period ended March 31, 2005.  Revenues for the quarter were $612,491 as compared to revenues of $766,530 for the same period in fiscal 2004.  The company recorded a net loss of ($3,335,835) or ($0.42) per share compared to a net loss of ($566,001) or ($0.07) per share for the same period in fiscal 2004. Revenues for the six-month period ended March 31, 2005 were $1,634,755 as compared to revenues of $1,398,494 for the same period in fiscal 2004.  The company recorded a net loss of ($5,884,947) or ($0.73) per share in the six-month period ended March 31, 2005 compared to a net loss of ($1,506,701) or ($0.19) per share for the same period in fiscal 2004. The increase in the loss in both the quarter and the six-month period ended March 31, 2005, as compared to the same respective periods in fiscal 2004, resulted primarily from an increase in research and development expenses.  Cash, cash equivalents, and short-term investments, the latter consisting entirely of U.S. Treasury Notes, totaled approximately $13.3 million at March 31, 2005.

 

“We continue to work toward our corporate goals,” stated Jerome Goldstein, Chairman, President and CEO of Advanced Magnetics.  “We have formally requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss next steps in the regulatory process for Combidex® and we continue to move forward our clinical development program for ferumoxytol in iron replacement therapy.”

 

In March, Advanced Magnetics received an approvable letter from the FDA regarding Combidex, its investigational functional molecular imaging agent.  Combidex (ferumoxtran-10) consists of iron oxide nanoparticles for use in conjunction with magnetic resonance imaging (MRI) to aid in the differentiation of cancerous from normal lymph nodes.

 

Phase III clinical trials for ferumoxytol in iron replacement therapy for chronic kidney disease patients whether or not on dialysis are currently ongoing and the company expects to submit a New Drug Application to the FDA in mid-2006.

 

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 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 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, one of our two products currently under development, or may not be able to complete the development in a timely 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 studies, or any other factor causing a delay in or negatively affecting the results of the clinical studies for ferumoxytol;(2) the possibility that we may not be able to raise additional needed capital on terms and on a timeframe acceptable to us, if at all;(3) the possibility that the results of past ferumoxytol studies may not be replicated in future studies; (4) uncertainties surrounding the timing and results of FDA interactions regarding the clinical development of ferumoxytol; (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) uncertainties surrounding our ability to resolve final labeling for Combidex with the FDA; (7) uncertainties regarding market acceptance of Combidex; (8) uncertainties relating to third-party reimbursements to us or our partners for Combidex when patients are prescribed Combidex; (9) our reliance on a limited number of customers and our dependence on our collaborative relationships;   (10) the timing of recognition of deferred revenue which is affected by the performance of our obligations under our license agreements;(11) uncertainties relating to the cyclical nature of our product sales cycles;(12) uneven demand for our products by end users;(13) 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; (14) uncertainties relating to patents and proprietary rights and 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 follows -

 



 

ADVANCED MAGNETICS, INC.

CONDENSED INCOME STATEMENT FOR THE THREE-MONTH AND SIX-MONTH
PERIODS ENDED MARCH 31, 2005

(unaudited)

 

 

 

 

Three Months 
Ended March 31,

 

Six Months 
Ended March 31,

 

 

 

2005

 

2004

 

2005

 

2004

 

Revenues

 

$

612,491

 

$

766,530

 

$

1,634,755

 

$

1,398,494

 

Costs and expenses

 

(4,017,268

)

(1,382,375

)

(7,651,462

)

(2,965,124

)

Other income*

 

68,942

 

49,844

 

131,760

 

59,929

 

Net income (loss)

 

$

(3,335,835

)

$

(566,001

)

$

(5,884,947

)

$

(1,506,701

)

Earnings (loss) per share, Basic and diluted

 

$

(0.42

)

$

(0.07

)

$

(0.73

)

$

(0.19

)

Weighted average shares outstanding, basic and diluted

 

8,028,954

 

7,793,161

 

8,006,929

 

7,780,707

 

 


* Other income consists of interest income.

 

BALANCE SHEET DATA

 

 

 

3/31/05

 

9/30/04

 

Cash, cash equivalents and short-term investments*

 

$

13,283,815

 

$

14,334,278

 

Long-term investment**

 

$

 

$

4,768,159

 

Working capital

 

$

11,243,335

 

$

12,313,754

 

Total assets

 

$

18,117,169

 

$

23,810,611

 

Shareholders’ equity

 

$

12,027,771

 

$

17,546,455

 

 


                   Short-term investment at 9/30/04 consists of a U.S. Treasury Bond with a maturity date of January 31, 2005.  Short-term investments at 3/31/05 consist of a U.S. Treasury Bill with a maturity date of May 5, 2005 and a U.S. Treasury Bond with a maturity date of February 15, 2006.

 

**             Long-term investment consists of a U.S. Treasury Bond with a maturity date of February 15, 2006.

 


-----END PRIVACY-ENHANCED MESSAGE-----