-----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, NJrSYsrh1+3h3g/wU9dlbnmoSB4HAe6u68Cfg4kf9+A8SBC1KTx59kYqeyf3EPMp 00WFvJuu20G4RNNzABee4g== 0000908737-06-000833.txt : 20061120 0000908737-06-000833.hdr.sgml : 20061120 20061120160321 ACCESSION NUMBER: 0000908737-06-000833 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20061117 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: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061120 DATE AS OF CHANGE: 20061120 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: 061229960 BUSINESS ADDRESS: STREET 1: 125 CAMBRIDGEPARK DRIVE, 6TH FLOOR CITY: CAMBRIDGE STATE: MA ZIP: 02140 BUSINESS PHONE: 6174972070 MAIL ADDRESS: STREET 1: 125 CAMBRIDGEPARK DRIVE, 6TH FLOOR CITY: CAMBRIDGE STATE: MA ZIP: 02140 8-K 1 ami_8k.htm AMI 8K NOVEMBER 20, 2006 AMI 8K November 20, 2006
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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 17, 2006
 
ADVANCED MAGNETICS, INC.
(Exact Name of Registrant as Specified in Its Charter)
 
Delaware
(State or Other Jurisdiction of Incorporation)
 
0-14732
04-2742593
(Commission File Number)
 
(IRS Employer Identification No.)
 
125 CambridgePark Drive, 6th Floor
 
Cambridge, Massachusetts
02140
(Address of principal executive offices)
(Zip Code)

(617) 498-3300
(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:
 
¨ 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.
 
The following information and the Exhibit 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 20, 2006, Advanced Magnetics, Inc. (the “Company”) issued a press release regarding its operating results and revenues for the fourth fiscal quarter and year ended September 30, 2006 and its intention to hold a conference call regarding such financial results. A copy of the Company’s press release is furnished herewith as Exhibit 99.1.
 
ITEM 5.02. DEPARTURE OF DIRECTORS OR PRINCIPAL OFFICERS, ELECTION OF DIRECTORS, APPOINTMENT OF PRINCIPAL OFFICERS; COMPENSATORY ARRANGEMENTS OF CERTAIN OFFICERS.
 
On November 13, 2006, the Company filed a Current Report on Form 8-K describing the bonus structure of Dr. Brian Pereira, the Company’s President and Chief Executive Officer. The Report stated that Dr. Pereira will be eligible to receive a bonus of up to fifty percent (50%) of his annual base salary at the discretion of the Company’s Compensation Committee, based on the achievement of set performance goals for the fiscal year ended September 30, 2007. Dr. Pereira’s maximum bonus opportunity if he exceeds the performance goals established can actually equal up to seventy-five percent (75%) of his annual base salary. The specific terms of Dr. Pereira’s performance goals are not being disclosed because they involve confidential commercial and business information, the disclosure of which would cause competitive harm to the Company.
 
ITEM 7.01. REGULATION FD DISCLOSURE.
 
On November 17, 2006, the Company issued a press release announcing results from a Phase III clinical trial of ferumoxytol as an intravenous (IV) iron replacement therapeutic and the completion of enrollment in its second multi-center Phase III clinical studies of ferumoxytol as an intravenous (IV) iron replacement therapeutic for the treatment of anemia in chronic kidney disease patients, whether or not on dialysis. A copy of the Company’s press release is furnished herewith as Exhibit 99.2.
 
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.

(d) Exhibits.

The Company hereby furnishes the following exhibits:

 
99.1
Press release dated November 20, 2006.
 
99.2
Press release dated November 17, 2006.





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 thereunto duly authorized.
 

 
ADVANCED MAGNETICS, INC.
   
 
By: /s/ Joseph L. Farmer
Joseph L. Farmer
General Counsel and Vice President of Legal Affairs


 
Date: November 20, 2006
 




EXHIBIT INDEX

Exhibit Number
 
Description
99.1
 
Press release dated November 20, 2006.
99.2
 
Press release dated November 17, 2006.

 
 
 
 
 
 
 
 
 
 
 


EX-99.1 2 ex99-1.htm EX99-1 ex99-1
EXHIBIT 99.1



Contact:
Lynn Kettleson
Clarke Communications Group
lkettleson@clarkecommgroup.com
(617) 587-8705


ADVANCED MAGNETICS, INC. REPORTS RESULTS FOR THE FOURTH FISCAL QUARTER AND YEAR
ENDED SEPTEMBER 30, 2006

CAMBRIDGE, MA, (November 20, 2006) -- Advanced Magnetics, Inc. (NASDAQ: AMAG) today announced operating results and revenues for the fourth fiscal quarter and year ended September 30, 2006. Revenues for the quarter were $350,834 compared to revenues of $407,452 for the same period in fiscal 2005. The company reported a net loss of ($9,346,940), or ($0.78) per share, for the fourth quarter of fiscal 2006 compared to a net loss of ($3,576,536), or ($0.36) per share, for the same period in fiscal 2005. The decrease in revenues for the quarter compared to the same quarter in fiscal 2005 was largely due to decreases in both product sales revenue and royalties received from the company’s marketing partners. The increase in expenses in the quarter compared to the same quarter in fiscal 2005 was due to an increase in external research and development expenses related to the Phase III development program for ferumoxytol as an intravenous iron replacement therapeutic and an increase in general and administrative expenses. Contributing to the increase in the loss for the quarter compared to the same quarter in fiscal 2005 was a non-cash charge of approximately $783,000 associated with the company’s adoption in fiscal year 2006 of Statement of Financial Accounting Standards No. 123R “Share-Based Payment” and related pronouncements relative to accounting for stock-based compensation (SFAS 123R), combined with an increase in expenses. Costs and expenses associated with the same quarter last year do not include, and have not been restated to reflect, non-cash accounting charges of approximately $323,000 for the quarter ended September 30, 2005 associated with employee stock-based compensation.

Revenues for the fiscal year ended September 30, 2006 were $2,673,387 compared to revenues of $2,445,168 in fiscal 2005. The net loss in the fiscal year was ($25,364,988), or ($2.31) per share, compared to a net loss of ($12,714,615), or ($1.47) per share, in fiscal 2005. The increase in revenues for the fiscal year ended September 30, 2006 compared to fiscal 2005 was largely due to an increase in both product sales revenue and royalties received from the company’s marketing partners, partially offset by a decrease in the recognition of deferred license fee revenue under a license and marketing agreement covering Combidex®. The increase in expenses in the fiscal year ended September 30, 2006 compared to fiscal 2005 was primarily due to an increase in external research and development expenses related to the Phase III development program for ferumoxytol as an intravenous iron replacement therapeutic and an increase in selling, general and administrative expenses. Contributing to the increase in the loss for fiscal 2006 compared to fiscal 2005 was a non-cash charge of approximately $4,003,000 associated with the company’s adoption in fiscal year 2006 of SFAS 123R, combined with an increase in expenses. Costs and

- more -

 
 

 

expenses associated with fiscal 2005 do not include, and have not been restated to reflect, non-cash accounting charges of approximately $1,263,000 for the fiscal year ended September 30, 2005 associated with employee stock-based compensation.

At September 30, 2006, cash, cash equivalents and short-term investments (the latter consisting entirely of one U.S. Treasury Bill), totaled approximately $42.1 million.

Ferumoxytol, the company’s key product candidate, is in Phase III multi-center clinical trials for use as an iron replacement therapeutic in chronic kidney disease patients, whether or not on dialysis.

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 magnetic resonance imaging, or MRI, to aid in the differentiation of cancerous from normal lymph nodes.

The company will host a conference call at 4:15 pm ET today to discuss the company’s financial results and quarterly highlights and the status of the company’s development programs, including the ferumoxytol development program. To listen to this conference call via audio webcast, please visit 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 finished, through December 20, 2006. Alternatively, to access the call via live telephone, please dial (800) 810-0924. Internationally, the call may be accessed by dialing (913) 981-4900.

In addition to the webcast replay, a telephone replay will be available from approximately 7:15 pm (ET) on November 20, 2006 through December 4, 2006. To access the replay please call (800) 203-1112 and use the passcode of 4233167. The replay is also available internationally at (719) 457-0820 using the same passcode.

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 cancer and cardiovascular disease. 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.



- financial table follows -


 
 

 




ADVANCED MAGNETICS, INC.
CONDENSED INCOME STATEMENT FOR THE THREE-MONTH
AND TWELVE-MONTH PERIODS ENDED SEPTEMBER 30, 2006
(unaudited)


   
Three Months
Ended September 30,
 
Twelve Months
Ended September 30,
 
   
2006
 
 
2005
 
 
 2006
 
 
2005
 
 
 
Revenues
 
$
350,834
 
$
407,452
 
$
2,673,387
 
$
2,445,168
 
 
Costs and expenses
   
(10,258,386
)
 
(4,170,694
)
 
(29,613,346
)
 
(15,579,218
)
 
Interest income
   
560,612
   
186,706
   
1,574,971
   
419,435
 
 
Net loss
 
$
(9,346,940
)
$
(3,576,536
)
$
(25,364,988
)
$
(12,714,615
)
Loss per share, basic and diluted
 
$
(0.78
)
$
(0.36
)
$
(2.31
)
$
(1.47
)
Weighted average shares outstanding, basic and diluted
   
11,918,006
   
9,866,446
   
10,964,412
   
8,633,827
 





Balance Sheet Data
   
 
9/30/06
 
 
9/30/05
 
 
Cash, cash equivalents and short-term investments*
 
$
42,073,046
 
$
23,727,298
 
 
Working capital
 
$
33,622,792
 
$
21,211,412
 
 
Total assets
 
$
47,370,564
 
$
28,291,982
 
 
Shareholders' equity
 
$
36,074,522
 
$
22,379,159
 

*
Short-term investment at 9/30/06 consists of one U.S. Treasury Bill with a maturity date of November 16, 2006. Short-term investments at 9/30/05 consist 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.

 
 
 
 

 
 
EX-99.2 3 ex99-2.htm EX99-2 ex99-2

EXHIBIT 99.2
For Immediate Release


Contact:
Lisa Gordon, VP of Business Development
and Strategy
Advanced Magnetics, Inc.
(617) 498-3321
lgordon@advancedmagnetics.com


ADVANCED MAGNETICS ANNOUNCES POSITIVE RESULTS FROM PHASE III STUDY OF FERUMOXYTOL
AS AN INTRAVENOUS IRON REPLACEMENT THERAPEUTIC
- Company Provides Update on Phase III Program -

CAMBRIDGE, MA (November 17, 2006) - Advanced Magnetics (NASDAQ: AMAG) today announced positive results from a Phase III clinical trial of ferumoxytol as an intravenous (IV) iron replacement therapeutic that is being presented at the American Society of Nephrology’s Renal Week 2006 Annual Meeting in San Diego, CA. A poster entitled “Ferumoxytol as Intravenous Iron Replacement Therapy in Chronic Kidney Disease (CKD) Patients Not on Dialysis - Evaluation of Safety and Efficacy in Two Phase III Studies” is being presented today at 10:00 am PT. The study enrolled 304 non dialysis-dependent chronic kidney disease patients (NDD-CKD) who were randomized to receive either two 510 mg doses of ferumoxytol within one week or 200 mg of oral iron daily for three weeks. The study demonstrated a statistically significant achievement of all the primary and secondary endpoints. Additionally, all primary and secondary endpoints were statistically significant in both patients on erythropoiesis stimulating proteins (ESP) and those not on ESPs.

Efficacy results in the intent to treat (ITT) and efficacy evaluable (EE) populations were similar. In the ITT population, ferumoxytol significantly outperformed oral iron for the primary endpoint of change in hemoglobin at Day 35 (ferumoxytol 0.81 ± 1.24 g/dl vs. oral iron 0.21 ± 1.04 g/dl, p=0.0002).
 
The results from the EE population analysis are as follows:
 
 
·
At Day 35, patients receiving ferumoxytol had a significantly greater mean increase in hemoglobin compared to patients in the oral iron group (ferumoxytol 0.86 ± 1.23 g/dl vs. oral iron 0.06 ± 1.08 g/dl, p<0.0001).
 
 
·
Ferumoxytol was more likely to increase baseline hemoglobin by ≥ 1 g/dl compared to oral iron (ferumoxytol 42.3% vs. oral iron 16.1%, p=0.0004).
 
 
·
Increase in serum ferritin was significantly greater in the ferumoxytol group compared to the oral iron group at Day 21 (ferumoxytol 551.0 ± 301.7 ng/ml vs. oral iron 8.9 ± 52.2 ng/ml, p<0.0001).
 
 
·
Stratifying by ESP use, there was a significant difference in hemoglobin increase for ferumoxytol compared to oral iron in both patients who were on ESP and those who were not.
 
 
·
At Day 35, mean hemoglobin increase in the group on a stable ESP dose was 1.20 ± 1.54 g/dl for ferumoxytol compared to -0.12 ± 1.27 g/dl for oral iron (p=0.0015).
 
- more -
 

 
 

 

 
·
Similarly, at Day 35, mean hemoglobin increase in the group not on ESPs was 0.70 ± 1.01 g/dl for ferumoxytol compared to 0.15 ± 0.99 g/dl for oral iron (p=0.0038).
 
 
·
ESP use in combination with ferumoxytol resulted in 61.0% of patients achieving an increase in hemoglobin of at least 1 g/dl compared to 16.7% of patients on ESP and oral iron (p=0.001).
 
Ferumoxytol was well tolerated with repeated dosing (2 x 510 mg). Adverse events occurred in 52.0% of oral iron patients compared to 35.5% of ferumoxytol patients. Similarly, drug-related adverse events occurred in 24.0% of oral iron patients compared to 10.6% of ferumoxytol patients. Serious adverse events were higher in the oral iron group compared to the ferumoxytol group (oral iron 9.3% vs. ferumoxytol 4.6%). There were no drug-related serious adverse events in either group.

A copy of the company’s poster presentation is available on the Investors section of the company’s web site.

“We are pleased with the results we are presenting today at this prestigious nephrology meeting,” stated Brian J.G. Pereira, MD, President and CEO of Advanced Magnetics. “This is an exciting milestone for the company. These early results are encouraging, and we will continue our efforts to successfully complete the Phase III development program for ferumoxytol.”

The company also announced today the completion of enrollment in its second multi-center study in NDD-CKD patients. With the completion of this study, three of the four pivotal Phase III clinical studies in the iron therapy program are done. The company currently expects to complete enrollment in its last remaining Phase III study, a multi-center study in hemodialysis-dependent chronic kidney disease (HD-CKD) patients, by the end of the first quarter of calendar 2007. Based on the company’s current estimates of the timing of completion of the HD-CKD study and its efforts to prepare and finalize the submission of the New Drug Application (NDA) for ferumoxytol, the company currently plans to submit the NDA during the second half of calendar 2007.

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 cancer and cardiovascular disease. 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 expected date for completion of enrollment in the last remaining clinical trial for ferumoxytol, our efforts to successfully complete the Phase III development program for ferumoxytol, and the timing of the planned submission of the NDA for ferumoxytol 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

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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 failure of our trials to demonstrate that ferumoxytol is safe and efficacious, 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 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 fact that we lack sales and marketing expertise; (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) uncertainties relating to our patents and proprietary rights; and (7) 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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