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): May 1, 2012

AMAG PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction of incorporation)

001-10865	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:

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

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

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

oPre-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, 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 May 1, 2012, AMAG Pharmaceuticals, Inc., or the Company, issued a press release regarding its operating results and revenues for the quarter ended March 31, 2012 and its intention to hold a conference call to discuss the Company’s financial results, commercial progress 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 exhibits:

99.1Press Release dated May 1, 2012.

99.2Copy of presentation slides of the Company during May 1, 2012 conference call.

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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
	Chief Administrative Officer and General Counsel
Date: May 1, 2012

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EXHIBIT INDEX

Exhibit Number	Description
99.1	Press Release dated May 1, 2012.
99.2	Copy of presentation slides of the Company during May 1, 2012 conference call.

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EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

AMAG Pharmaceuticals Announces First Quarter 2012 Financial Results

Achieves Record Quarterly Provider Demand for Feraheme®

LEXINGTON, MA (May 1, 2012) — AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a specialty pharmaceutical company focused on the development and commercialization of Feraheme® (ferumoxytol) Injection for intravenous (IV) use to treat iron deficiency anemia (IDA), today reported unaudited consolidated financial results for the first quarter ended March 31, 2012. As of March 31, 2012, the company’s cash, cash equivalents and investments totaled approximately $218 million.

Business Update

·Total revenues for the quarter ended March 31, 2012 were $15.5 million, of which $13.6 million were net product revenues from Feraheme.

·Total Feraheme provider demand for the first quarter of 2012 was approximately 26,600 grams(1), representing a 30% increase in provider demand as compared to the first quarter of 2011 and a 10% increase as compared to the fourth quarter of 2011.

·Positive data from IDA-302, a phase III clinical trial evaluating Feraheme compared to IV iron sucrose in patients with IDA regardless of the underlying cause, was released in March. Feraheme achieved both primary efficacy endpoints in this study.

·Enrollment completed in IDA-301, a phase III clinical trial evaluating Feraheme against placebo in patients with IDA regardless of the underlying cause. Data from IDA-301 and IDA-302 will be the basis for the supplemental new drug application (sNDA) to the U.S. Food and Drug Administration to expand the label for Feraheme to include this broader patient population.

·In April, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the approval of ferumoxytol for the treatment of IDA in adult patients with CKD. EU Commission approval and launch are expected in the second half of 2012, and would trigger $30 million in milestone payments to AMAG. Ferumoxytol will be marketed in Europe as Rienso® by AMAG’s partner, Takeda Pharmaceutical Company Limited.

“The record provider demand for Feraheme in the first quarter is a testament to the progress that we are making in driving organic growth of the brand,” said Frank Thomas, interim president and chief

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executive officer of AMAG. “We believe that the commercial initiatives that we continue to implement in the U.S. this year and the growth potential of Feraheme through geographic expansion will position us for success in 2012 and beyond. Our decision late last year to realign our expense structure has resulted in a 22% decline in operating expenses as compared to the first quarter of 2011, and, we believe, sets us on a course to profitability.”

First Quarter 2012 Financial Results (unaudited)

Total revenues for the quarter ended March 31, 2012 were $15.5 million as compared to $13.4 million for the same period in 2011. Net Feraheme product revenues for the first quarter of 2012 were $13.6 million, as compared to $10.9 million in the first quarter of 2011.

Total operating costs and expenses, including costs of goods sold, for the quarter ended March 31, 2012 were $28.3 million as compared to $36.2 million for the same period in 2011. The decrease in operating costs and expenses in the first quarter of 2012 versus the first quarter of 2011 was primarily due to the cost reduction efforts implemented by the company associated with the restructuring announced in the fourth quarter of 2011.

The company reported a net loss of $12.4 million, or a loss of $0.58 per share, for the quarter ended March 31, 2012, as compared to a net loss of $22.3 million, or a loss of $1.05 per share, for the same period in 2011.

2012 Financial Guidance

The company reiterates its financial guidance to manage the business to achieve cash flow breakeven in 2012 based on the following guidance:

·Net Feraheme product revenues of $53 — $57 million, excluding any royalties from sales outside the U.S.;

·Milestones received totaling $33 million associated with potential regulatory approvals and commercial launches in the EU and Canada;

·Cost of goods sold (COGS) of approximately 14% — 18% of total product sales;

·Total operating expenses, excluding COGS, of $90 — $95 million, of which $40 — $45 million are expected to be research and development expenses and $50 — $55 million are expected to be selling, general and administrative expenses; and

·A 2012 year-end cash and investments balance of $225 — $230 million.

Conference Call and Webcast Access

AMAG Pharmaceuticals, Inc. will host a conference call and webcast with slides at 4:30 p.m. ET during which management will discuss the company’s financial results, commercial progress 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 7:30 p.m. ET

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on May 1, 2012 through midnight May 8, 2012.  To access a replay of the conference call, dial (855) 859-2056 from the United States or (404) 537-3406 for international access.  The pass code for the live call and the replay is 73223897.

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 7:30 p.m. ET on May 1, 2012 through midnight June 1, 2012.

About Feraheme

In the United States, Feraheme® (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients.  Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol received marketing approval in Canada in December 2011 and a positive recommendation for approval from the Committee for Medicinal Products for Human Use of the European Medicines Agency in April 2012. Ferumoxytol will be marketed in Canada as Feraheme and in the European Union as Rienso® by AMAG’s partner, Takeda Pharmaceutical Company Limited. For additional product information, please visit www.feraheme.com.

About AMAG Pharmaceuticals, Inc.

AMAG Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia. AMAG manufactures and sells Feraheme® (ferumoxytol) Injection for intravenous use. 

For additional company or product information, please visit www.amagpharma.com or http://feraheme.com.

AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc.

Rienso is a registered trademark of Takeda Pharmaceutical Company Limited.

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AMAG Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

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

	Three Months Ended March 31,
	2012			2011
Revenues:
Product sales, net	$	13,708		$	11,022
License fee, collaboration and royalty revenues	1,772			2,363
Total revenues	15,480			13,385
Operating costs and expenses (1):
Cost of product sales	2,646			3,041
Research and development expenses	12,462			13,566
Selling, general and administrative expenses	13,181			19,634
Total operating costs and expenses	28,289			36,241
Operating Loss	(12,809		)	(22,856		)
Interest and dividend income, net	393			560
Other income (expense)	—			1
Net loss	$	(12,416	)	$	(22,295	)
Net loss per share - basic and diluted:	$	(0.58	)	$	(1.05	)
Weighted average shares outstanding used to compute net loss per share:
Basic and diluted	21,349			21,144

(1) Stock-based compensation included in operating costs and expenses:
Cost of product sales	$	78	$	195
Research and development	$	422	$	642
Selling, general and administrative	$	1,185	$	3,638

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AMAG Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(unaudited, amounts in thousands)

	March 31, 2012		December 31, 2011
Cash and cash equivalents	$	37,619	$	63,474
Short-term investments	162,833		148,703
Accounts receivable, net	6,278		5,932
Inventories	14,255		15,206
Receivable from collaboration	370		428
Other current assets	5,740		6,288
Total current assets	227,095		240,031
Property, plant & equipment, net	8,702		9,206
Long-term investments	17,409		17,527
Other assets	460		460
Total assets	$	253,666	$	267,224
Accounts payable	$	3,398	$	3,732
Accrued expenses	27,986		28,916
Deferred revenues	6,346		6,346
Total current liabilities	37,730		38,994
Deferred revenues	43,672		45,196
Other long-term liabilities	2,341		2,438
Total long-term liabilities	46,013		47,634
Total stockholders’ equity	169,923		180,596
Total liabilities and stockholders’ equity	$	253,666	$	267,224

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: the statement that the data from our IDA-301 and IDA-302 studies will be the basis for the sNDA for Feraheme in the broader IDA patient population; our plan to achieve cash flow breakeven status in 2012; our expectation regarding EU Commission approval and subsequent commercial launch of Rienso(R) in the EU, the expected timing thereof, and the milestone payments we expect to receive from Takeda in connection therewith; the statement that our commercial initiatives we are implementing, together with Feraheme geographic expansion will position us for success; statements that our decline in operating expenses will drive the company to profitability; statements regarding our 2012 financial guidance, including our expected 2012 net Feraheme product revenues, our expected 2012 operating expenses, including expected research and development and selling, general and administrative expenses, our expected cost of goods sold, and

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our expected 2012 year-end cash and investments balance; and any potential milestone payments we expect to receive, 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 and Takeda’s ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme in the broader IDA indication and in territories outside of the U.S., including the European Union, (3) the fact that significant safety or drug interaction problems could arise with respect to Feraheme, (4) uncertainties regarding our ability to manufacture Feraheme, (5) uncertainties relating to our patents and proprietary rights, (6) the risk that ferumoxytol/Rienso(R) does not receive final marketing approval in the EU from the EU Commission, and (7) other risks identified in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2011. 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.

The important safety information below is based on the United States prescribing information.

Important Safety Information About Feraheme

Indication and contraindications

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components.

Warnings and precautions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme.  Observe patients for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration.  Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Anaphylactic type reactions, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience.In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in3.7% (63/1,726) of subjects.

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Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Monitor for signs and symptoms of hypotension following each Feraheme injection. 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, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.

Adverse reactions

In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in > 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.

Post-marketing safety experience

The following adverse reactions have been identified during post-approval use of Feraheme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic-type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme injection. Reactions have occurred following the first dose or subsequent doses of Feraheme.

For full prescribing information, please visit www.feraheme.com.

(1)IMS Health data.

AMAG Pharmaceuticals, Inc. Contact

Amy Sullivan, 617-498-3303

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EX-99.2

Exhibit 99.2

1Q 2012 Financial Results May 1, 2012 1

Forward Looking Statements This presentation 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: the potential size of the addressable market for Feraheme and the potential size of the broad IDA market; the potential incremental Feraheme sales potential from geographic and label expansion; our expectations regarding EU Commission approval and subsequent commercial launch of Rienso(R) in the EU, the expected timing thereof, the expected timing of Feraheme's commercial launch in Canada, and the milestone payments we expect to receive from Takeda in connection therewith; the expected timing of our sNDA filing for the broad IDA indication for Feraheme; statements regarding our 2012 financial guidance, including our expected 2012 net Feraheme product revenues, our expected 2012 operating expenses, including expected research and development and selling, general and administrative expenses, our expected cost of goods sold, and our expected 2012 year-end cash and investments balance, and any potential milestone payments we expect to receive; our expectation to operate at cash flow break even in 2012; our expectations regarding the 2012 market growth in the hematology/oncology and hospital segments and our targeted 2012 Feraheme market share in those segments; our expectation regarding the growth of Feraheme provider demand in 2012 as compared to 2011; 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 and Takeda's ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme in the broader IDA indication and in territories outside of the U.S., including the European Union, (3) the fact that significant safety or drug interaction problems could arise with respect to Feraheme, (4) uncertainties regarding our ability to manufacture Feraheme, (5) uncertainties relating to our patents and proprietary rights, (6) the risk that ferumoxytol/Rienso(R) does not receive final marketing approval in the EU from the EMA, and (7) other risks identified in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2011. 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. 2

Agenda Topic Speaker Introduction and Overview Frank Thomas, interim CEO Feraheme US CKD Business Broad IDA Opportunity John Tucker, VP of Commercial Operations Financial Highlights and Outlook Scott Holmes, VP of Finance Closing Remarks Frank Thomas, interim CEO

FRANK THOMAS, CHIEF OPERATING OFFICER AND INTERIM CEO 4

Leveraging Core Assets to Create Long-term Stockholder Value 5 Working with advisors to evaluate all strategic options to enhance stockholder value and leverage AMAG’s core assets Reigniting top-line growth of Feraheme with realigned expense structure ensures our balance sheet remains strong

US CKD business returns to growth Record Feraheme provider demand in 1Q12 40% period-over-period non-dialysis provider demand growth 10% sequential quarter growth Feraheme growth exceeded market growth tenfold International expansion milestones Canadian launch planned by Takeda in 2Q12; triggers $3 million milestone Positive recommendation received from CHMP; European approval and launch expected in 2H12 and triggers $30 million in milestones Label expansion efforts on track IDA phase III program completed enrollment IDA-302 data released; Feraheme achieved primary efficacy endpoints; no new safety signals were observed sNDA filing by end of 2012 Reiterating financial guidance Realizing positive financial impact of 2011 restructuring Operating expenses down 22% compared to 1Q11 6 2012 Year-to-Date Highlights

FERAHEME US CKD BUSINESS JOHN TUCKER, VP COMMERCIAL OPERATIONS

8 1Q12 – Record-Breaking Quarter for Feraheme -Historic results based on IMS Health data. Feraheme Grams Record non-dialysis provider demand 40% period-over-period growth 10% sequential quarter growth Average weekly customers topped 700 for the first time since launch Average weekly demand topped 2,000 grams for the first time since launch Non-Dialysis Provider Demand Record Weekly Average Customers and Demand Buyers Feraheme Grams

Increasing Demand and Share in Two Largest Market Segments Source: IMS Monthly Data. 9 Feraheme in Hematology/Oncology Segment Feraheme in Hospital Segment Market Data Hematology/Oncology Segment ~206,000 IV iron grams in 2011 ~26% of total non-dialysis IV iron use Expect market growth of 7% (’12/’11) 2012 Feraheme target share: 26% Hospital Segment ~513,000 IV iron grams in 2011 ~65% of total non-dialysis IV iron use Expect market growth of 6% (’12/’11) 2012 Feraheme target share: 7% Feraheme focused on outpatient business

2012 Commercial Priorities Implement targeted account call plan for sales representatives Feraheme segmentation messaging and patient profiling for all target audiences Leverage relationships with hematology/oncology GPOs to drive access in hard to see accounts and build awareness of Feraheme and the prevalence of CKD in IDA patients Pricing strategy to improve net effective price per gram 5% WAC price increase effective May 2012 Increase in net effective price anticipated in 2H12 10

11 Feraheme — On Track to Meet Forecasted Growth -Historic results based on IMS Monthly Data, IMS Weekly Data and Wholesaler Shipment Data. Feraheme Grams ~40% Growth in Feraheme Provider Demand from 2010 - 2011 >15% Growth in Feraheme Provider Demand Estimated from 2011 - 2012

 BROAD IDA OPPORTUNITY JOHN TUCKER, VP COMMERCIAL OPERATIONS

Source: IMS Health DDD Data MAT Dec11 and AMAG company estimates. IV Iron Grams CKD1 CKD1 IDA Treated Today1 CKD1 IDA Potential1 Two-Step Approach to Capturing Broad IDA Market with Expanded Label Step One: Take Share IDA Treated Today1 ~$600 million assuming a 5% increase in IV iron treatment rates for broader non-CKD patients with IDA U.S. Market Opportunity at $500/gram ~$400 million current U.S. CKD and IDA market ~$200 million current U.S. CKD market Step Two: Expand Market 13

FINANCIAL OVERVIEW SCOTT HOLMES, VP OF FINANCE 14

First Quarter Financial Highlights ($ in millions, except per share ) 1Q-2012 1Q-2011 Total Revenues $15.3 $13.4 Net Feraheme Product Revenues 13.6 10.9 Cost of Product Sales 2.6 3.0 R&D Expenses 12.5 13.6 SG&A Expenses 13.2 19.6 Net Loss (12.4) (22.3) Loss Per Share (0.58) (1.05) 15 Balance Sheet $218 million in cash and investments as of March 31, 2012 Results of operations (1Q 2012 vs. 1Q 2011) 40% growth in Feraheme non-dialysis provider demand Inventory down ~750 grams 23% increase in net Feraheme product revenues Operating expenses down 22% Net loss nearly cut in half

Strong Financial Profile 16 GAAP Revenue Operating Expenses (excluding COGS) ($ in millions) ($ in millions) $53 – $57 million in Feraheme net product revenue >15% growth in grams $33 million of cash milestones to be received COGS assumed to be 14-18% of net product sales $90 – $95 million in total operating expenses $40 – $45 million in R&D $50 – $55 million in SG&A Committed to managing business to cash flow breakeven End 2012 with $225 – $230 million 2012 Financial Outlook *Represents $3.0 million reversal in Medicaid reserves in the third quarter of 2011.

CLOSING REMARKS FRANK THOMAS, CHIEF OPERATING OFFICER AND INTERIM CEO 17

Focus on Performance During Time of Uncertainty 18

AMAG: Well Positioned for Growth in 2012 and Beyond Clinical and regulatory Complete enrollment of broad IDA phase 3 registration program Regulatory decisions in international markets on CKD filings Positive opinion received from EMA Present/publish IDA program data IDA-302 achieved both primary efficacy endpoints Submit sNDA in US for broad IDA indication Commercial and business Complete strategic alternatives process Support international launches of Feraheme in Europe and Canada Deliver on financial guidance for 2012 1Q 2012 meets or exceeds AMAG forecast 19

Q&A 20 INVESTOR RELATIONS CONTACT: 617-498-3303