EX-99.1 2 a09-32342_1ex99d1.htm EX-99.1

Exhibit 99.1

 

GRAPHIC

 

AMAG Pharmaceuticals, Inc. Reports Financial Results

for the Third Quarter Ended September 30, 2009

 

LEXINGTON, MA, October 29, 2009 — AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today reported unaudited consolidated financial results for the third quarter and nine months ended September 30, 2009.

 

Business Highlights

 

·                  The Company commenced the U.S. commercial launch of Feraheme™ (ferumoxytol) Injection on July 13, 2009, within two weeks of receipt of FDA approval. The Company reported $3.0 million of total revenues for the third quarter of 2009, of which $2.9 million was related to the sale of Feraheme. An additional $11.5 million was recorded as deferred revenue as of September 30, 2009. This deferred revenue was primarily associated with a launch incentive program implemented to advance the adoption of Feraheme by dialysis organizations.

·                  More than 500 customers have purchased Feraheme; collectively, these customers used 140,000 grams of all forms of IV iron over the past 52 weeks(1).

·                  Approximately 65 percent of Feraheme provider demand in the third quarter was outside of the dialysis setting. The Company views non-dialysis chronic kidney disease as a significant market opportunity for a safe and effective IV iron with the dosing profile of Feraheme.

 

“During the third quarter, years of hard work by AMAG employees culminated in the launch of Feraheme, which completed the transformation of AMAG into a commercial biopharmaceutical company,” commented Brian J.G. Pereira, M.D., President and Chief Executive Officer of AMAG Pharmaceuticals, Inc.  “We are now focused on making Feraheme a commercial success in the chronic kidney disease market in the United States and unlocking the value of this asset for iron deficiency anemia patients, with or without chronic kidney disease, around the world.”

 

As of September 30, 2009, the Company’s cash, cash equivalents, investments and settlement rights associated with certain auction rate securities totaled $151.8 million.  Total revenues for the quarter ended September 30, 2009 were $3.0 million as compared to total revenues of $0.3 million for the same period in 2008.  Total revenues for the nine month period ended September 30, 2009 were $4.0 million as compared to $1.4 million for the same period in 2008.

 

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100 Hayden Avenue, Lexington, MA 02421

(617) 498-3300

 


 

Total operating costs and expenses for the quarter ended September 30, 2009 were $25.6 million as compared to $24.8 million for the same period in 2008.  Total operating costs and expenses for the nine month period ended September 30, 2009 were $81.9 million as compared to $57.8 million for the same period in 2008.  The increase in operating costs and expenses over the comparable nine month periods was primarily due to increased selling, general and administrative expenses associated with the commercialization of Feraheme.

 

The Company reported a net loss of $22.1 million, or a loss of $1.29 per basic and diluted share, for the quarter ended September 30, 2009, as compared to a net loss of $23.6 million, or a loss of $1.39 per basic and diluted share, for the same period in 2008.  Net loss for the nine months ended September 30, 2009 was $74.9 million, or a loss of $4.39 per basic and diluted share, as compared to a net loss of $49.9 million, or a loss of $2.94 per basic and diluted share for the same period in 2008.

 

Conference Call and Webcast Access

 

AMAG Pharmaceuticals, Inc. will host a webcast and conference call today at 8:30 a.m. ET to discuss the Company’s financial results and condition, 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 10:00 a.m. ET on October 29, 2009 through midnight November 2, 2009.  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 36056615.

 

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 10:00 a.m. ET on October 29, 2009 through midnight November 12, 2009.

 

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 and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.  AMAG recently received approval from the U.S. Food and Drug Administration to market Feraheme for the treatment of iron deficiency anemia in adult chronic kidney disease patients.  For additional company and product information, please visit www.amagpharma.com.

 

Feraheme™ is a trademark of AMAG Pharmaceuticals, Inc.

 

Forward Looking Statement

 

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 the significance of the pre-dialysis market opportunity for Feraheme, 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

 

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ability to manufacture Feraheme, (2) the fact that we have limited experience commercializing a pharmaceutical product on our own, (3) uncertainties regarding our ability to successfully compete in the intravenous iron replacement market, (4) uncertainties regarding our ability to obtain favorable coverage, pricing and reimbursement for Feraheme, (5) uncertainties relating to our patents and proprietary rights, and (6) other risks identified in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 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.

 

(1) IMS Health DDD derived annual grams for the 12 month period ending September 2009.

 

AMAG Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

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

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2009

 

2008

 

2009

 

2008

 

Total revenues

 

$

 3,021

 

$

 260

 

$

 4,032

 

$

 1,358

 

Operating costs and expenses (1):

 

 

 

 

 

 

 

 

 

Cost of product sales

 

128

 

3

 

189

 

78

 

Research and development expenses

 

6,109

 

10,269

 

27,295

 

22,153

 

Selling, general and administrative expenses

 

19,351

 

14,543

 

54,369

 

35,539

 

Total operating costs and expenses

 

25,588

 

24,815

 

81,853

 

57,770

 

Operating Loss

 

(22,567

)

(24,555

)

(77,821

)

(56,412

)

Interest and dividend income, net

 

503

 

2,021

 

2,542

 

7,486

 

Other income (expense)

 

2

 

(1,321

)

161

 

(1,237

)

Net loss before income taxes

 

(22,062

)

(23,855

)

(75,118

)

(50,163

)

Income tax benefit

 

—

 

278

 

179

 

278

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(22,062

)

$

(23,577

)

$

(74,939

)

$

(49,885

)

 

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted:

 

$

 (1.29

)

$

 (1.39

)

$

 (4.39

)

$

 (2.94

)

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

 

 

 

 

 

 

 

 

 

Basic and diluted

 

17,117

 

17,001

 

17,059

 

16,989

 

 

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

 

 

 

 

 

 

 

 

 

Research and development

 

1,162

 

1,049

 

3,498

 

2,641

 

Selling, general and administrative

 

2,845

 

2,826

 

8,134

 

7,122

 

 

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AMAG Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(unaudited, amounts in thousands)

 

 

 

September 30, 2009

 

December 31, 2008

 

Cash and cash equivalents

 

$

 62,302

 

$

 64,182

 

Short-term investments and settlement rights

 

39,840

 

94,914

 

Accounts receivable

 

16,454

 

408

 

Inventories

 

5,532

 

96

 

Other current assets

 

4,035

 

4,710

 

Total current assets

 

128,163

 

164,310

 

Net property, plant & equipment

 

11,231

 

11,223

 

Long-term investments and settlement rights

 

49,701

 

55,901

 

Other assets

 

460

 

521

 

Total assets

 

$

 189,555

 

$

 231,955

 

 

 

 

 

 

 

Accounts payable

 

$

 1,960

 

$

 2,305

 

Accrued expenses and other short term liabilities

 

15,871

 

11,571

 

Deferred revenues - short term

 

11,450

 

516

 

Total current liabilities

 

29,281

 

14,392

 

Long term liabilities

 

4,141

 

4,149

 

Total stockholders’ equity

 

156,133

 

213,414

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

 189,555

 

$

 231,955

 

 

AMAG Pharmaceuticals Contacts:

Amy Sullivan, 617-498-3303

Kristen Galfetti, 617-498-3362

Carol Miceli, 617-498-3361

 

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