-----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, Mmus5aactEnPDNI/o0f+8iywK8Rh2hSqfuzhHhNYwJgL+08QekSRALMBDmAWj5YJ vsChXec5adWZBX+gRFamxQ== 0001104659-10-010433.txt : 20100301 0001104659-10-010433.hdr.sgml : 20100301 20100301070031 ACCESSION NUMBER: 0001104659-10-010433 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20100301 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100301 DATE AS OF CHANGE: 20100301 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AMAG PHARMACEUTICALS 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: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-10865 FILM NUMBER: 10641944 BUSINESS ADDRESS: STREET 1: 100 HAYDEN AVENUE CITY: LEXINGTON STATE: MA ZIP: 02140 BUSINESS PHONE: 6174972070 MAIL ADDRESS: STREET 1: 100 HAYDEN AVENUE CITY: LEXINGTON STATE: MA ZIP: 02140 FORMER COMPANY: FORMER CONFORMED NAME: ADVANCED MAGNETICS INC DATE OF NAME CHANGE: 19920703 8-K 1 a10-3270_28k.htm 8-K

 

 

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): March 1, 2010

 

AMAG PHARMACEUTICALS, 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.)

 

 

 

100 Hayden Avenue

 

 

Lexington, Massachusetts

 

02421

(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, 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, except as expressly set forth by specific reference in such filing.

 

On March 1, 2010, AMAG Pharmaceuticals, Inc., or the Company, issued a press release regarding its operating results and revenues for the quarter and year ended December 31, 2009 and its intention to hold a conference call regarding such financial results, business highlights, commercial plans and development programs. A copy of the Company’s press release is furnished herewith as Exhibit 99.1.

 

Item 9.01.  Financial Statements and Exhibits.

 

(d)  Exhibits.

 

The Company hereby furnishes the following exhibit:

 

99.1

 

Press Release dated March 1, 2010.

 

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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.

 

 

 

AMAG PHARMACEUTICALS, INC.

 

 

 

 

 

By:

/s/ Joseph L. Farmer

 

 

Joseph L. Farmer

 

 

General Counsel and Senior Vice

 

 

President of Legal Affairs

 

 

 

 

 

 

 

Date: March 1, 2010

 

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EXHIBIT INDEX

 

Exhibit  Number

 

Description

99.1

 

Press Release dated March 1, 2010.

 

4


EX-99.1 2 a10-3270_2ex99d1.htm EX-99.1

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

AMAG Pharmaceuticals Announces Fourth Quarter and Year End 2009 Financial Results

 

LEXINGTON, MA (March 1, 2010) — AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2009.

 

Business Highlights

 

·                  AMAG reported fourth quarter 2009 Feraheme® net product revenues of $12.8 million, including $1.3 million of the $11.5 million in previously deferred product revenues.

·                  To date, more than 1,300 providers have purchased Feraheme® (ferumoxytol) Injection; collectively, these providers purchased approximately 240,000 grams of all forms of IV iron over the past 52 weeks(1).

·                  Of the providers that have purchased Feraheme to date, more than 1,100 are treating non-dialysis dependent chronic kidney disease patients and more than 60 percent have purchased on a repeat basis.

·                  AMAG estimates that more than half of Feraheme provider demand in 2009 was outside of the dialysis setting.

 

“We are very pleased with the progress made by AMAG in 2009,” said Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG Pharmaceuticals, Inc.  “In addition to receiving marketing approval for our first therapeutic product in the U.S., we launched Feraheme within two weeks of approval, and ended the year with a strong foundation from which to grow.”

 

Dr. Pereira continued, “We enter 2010 with ambitious plans to continue the successful launch of Feraheme for the treatment of iron deficiency anemia in adult chronic kidney disease patients in the U.S.; expand the development of Feraheme to IDA patients, with and without CKD around the world; advance our ferumoxytol imaging program; and secure a commercial partner for Feraheme in the E.U.”

 

1



 

As of December 31, 2009, the Company’s cash, cash equivalents, investments and settlement rights associated with certain auction rate securities totaled $129.5 million. In January 2010, AMAG successfully completed a follow-on offering of 3.6 million shares of common stock, with net proceeds to the Company of approximately $165.6 million. Revenues for the quarter ended December 31, 2009 were $13.1 million as compared to revenues of $0.6 million for the same period in 2008.  Revenues for the year ended December 31, 2009 were $17.2 million as compared to $1.9 million for the same period in 2008. The increases in revenues in 2009 over the comparable 2008 periods were attributable to Feraheme product sales following its approval and subsequent launch in July 2009.

 

Total operating costs and expenses for the quarter ended December 31, 2009 were $33.3 million as compared to $23.8 million for the same period in 2008.  Total operating costs and expenses for the year ended December 31, 2009 were $115.1 million as compared to $81.5 million for the same period in 2008. The increases in operating costs and expenses in 2009 over the comparable 2008 periods were primarily due to increased selling, general and administrative expenses associated with the commercialization of Feraheme.

 

The Company reported a net loss of $18.4 million, or a loss of $1.07 per basic and diluted share, for the quarter ended December 31, 2009, as compared to a net loss of $21.8 million, or a loss of $1.28 per basic and diluted share, for the same period in 2008.  Net loss for the year ended December 31, 2009 was $93.4 million, or a loss of $5.46 per basic and diluted share, as compared to a net loss of $71.6 million, or a loss of $4.22 per basic and diluted share for the same period in 2008.

 

Conference Call and Webcast Access

 

AMAG Pharmaceuticals, Inc. will host a webcast with slides and conference call today at 8:00 a.m. ET to discuss the Company’s financial results, business highlights, commercial plans and development programs.

 

To access the conference call via telephone, please dial (877) 412-6083 from the United States or (702) 495-1202 for international access.  A telephone replay will be available from approximately 11:00 a.m. ET on March 1, 2010 through midnight March 3, 2010.  To access a replay of the conference call, dial (800) 642-1687 from the United States or (706) 645-9291 for international access.  The passcode for the live call and the replay is 54914959.

 

The call will be webcast with slides and accessible through the Investors section of the Company’s website at www.amagpharma.com.  The webcast replay will be available from approximately 11:00 a.m. ET on March 1, 2010 through midnight April 1, 2010.

 

About AMAG Pharmaceuticals, Inc.

 

AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia

 

2



 

and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.  On June 30, 2009, AMAG received approval from the U.S. Food and Drug Administration to market Feraheme® (ferumoxytol) Injection for intravenous (IV) use for the treatment of iron deficiency anemia in adult chronic kidney disease patients.  For additional company and product information, please visit www.amagpharma.com.

 

Forward Looking Statements

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding our plans to continue the successful launch of Feraheme for the treatment of iron deficiency anemia in chronic kidney disease patients in the U.S.; expand the development of Feraheme to IDA patients, with and without CKD around the world; advance our ferumoxytol imaging program; and secure a commercial partner for Feraheme in the E.U. are forward looking statements which 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: (1) uncertainties regarding our ability to successfully compete in the intravenous iron replacement market, (2) the fact that we have limited experience developing and commercializing a pharmaceutical product on our own, particularly outside of the U.S., (3) uncertainties regarding our ability to ensure favorable coverage, pricing and reimbursement for Feraheme, (4) uncertainties regarding our ability to manufacture Feraheme, (5) uncertainties relating to our patents and proprietary rights, and (6) other risks identified in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2009. We caution you 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.

 

Important Safety Information about Feraheme

 

Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.

 

In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects receiving Feraheme, including three patients with serious hypotensive reactions.  Serious hypersensitivity reactions were reported in 0.2% (3/1726) of patients. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and the drug should only be administered when treatment for hypersensitivity reactions is readily available.  Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy.  As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging but will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.   In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients were diarrhea, nausea, dizziness, hypotension, constipation and peripheral edema.

 

3



 

AMAG Pharmaceuticals, Inc.

 

Condensed Consolidated Statements of Operations

 

(unaudited, amounts in thousands, except for per share data)

 

 

 

Three Months Ended
December 31,

 

Twelve Months Ended
December 31,

 

 

 

2009

 

2008

 

2009

 

2008

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

$

13,146

 

$

580

 

$

17,178

 

$

1,938

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses (1):

 

 

 

 

 

 

 

 

 

Cost of product sales

 

824

 

214

 

1,013

 

292

 

Research and development expenses

 

8,978

 

9,563

 

36,273

 

31,716

 

Selling, general and administrative expenses

 

23,460

 

13,997

 

77,829

 

49,536

 

Total operating costs and expenses

 

33,262

 

23,774

 

115,115

 

81,544

 

 

 

 

 

 

 

 

 

 

 

Operating Loss

 

(20,116

)

(23,194

)

(97,937

)

(79,606

)

 

 

 

 

 

 

 

 

 

 

Interest and dividend income, net

 

612

 

1,653

 

3,154

 

9,139

 

Other income (expense)

 

3

 

(221

)

164

 

(1,458

)

 

 

 

 

 

 

 

 

 

 

Net loss before income taxes

 

(19,501

)

(21,762

)

(94,619

)

(71,925

)

 

 

 

 

 

 

 

 

 

 

Income tax benefit

 

1,089

 

 

1,268

 

278

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(18,412

)

$

(21,762

)

$

(93,351

)

$

(71,647

)

 

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted:

 

$

(1.07

)

$

(1.28

)

$

(5.46

)

$

(4.22

)

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding used to compute net loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

17,258

 

17,007

 

17,109

 

16,993

 

 


(1) Stock-based compensation included in operating costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of product sales

 

$

43

 

$

 

$

43

 

$

 

Research and development

 

948

 

1,119

 

4,446

 

3,760

 

Selling, general and administrative

 

2,798

 

(2,845

)

10,932

 

4,277

 

 

4



 

AMAG Pharmaceuticals, Inc.

 

Condensed Consolidated Balance Sheets

 

(unaudited, amounts in thousands)

 

 

 

December 31,
2009

 

December 31,
2008

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

50,126

 

$

64,182

 

Short-term investments and settlement rights

 

30,366

 

94,914

 

Accounts receivable, net

 

27,350

 

408

 

Inventories

 

9,415

 

96

 

Other current assets

 

5,472

 

4,710

 

Total current assets

 

122,729

 

164,310

 

 

 

 

 

 

 

Net property, plant & equipment

 

12,417

 

11,223

 

Long-term investments and settlement rights

 

49,013

 

55,901

 

Other assets

 

460

 

521

 

 

 

 

 

 

 

Total assets

 

$

184,619

 

$

231,955

 

 

 

 

 

 

 

Accounts payable

 

$

5,432

 

$

2,305

 

Accrued expenses

 

21,931

 

11,571

 

Deferred revenues

 

10,198

 

516

 

Total current liabilities

 

37,561

 

14,392

 

 

 

 

 

 

 

Long-term liabilities

 

4,081

 

4,149

 

 

 

 

 

 

 

Total stockholders’ equity

 

142,977

 

213,414

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

184,619

 

$

231,955

 

 

Feraheme is a registered trademark of AMAG Pharmaceuticals, Inc.

 


(1)IMS Health DDD derived annual grams for the period ending February 12, 2010.

 

AMAG Pharmaceuticals, Inc. Contacts
Amy Sullivan, 617-498-3303
Carol Miceli, 617-498-3361

 

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