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): February 13, 2017

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.)

1100 Winter St.
Waltham, Massachusetts	02451
(Address of principal executive offices)	(Zip Code)

(617) 498-3300

(Registrant’s telephone number, including area code)

(Former address, if changed since last report)

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 1.01 Entry into a Material Definitive Agreement

On February 13, 2017, AMAG Pharmaceuticals, Inc. (“AMAG”) and Endoceutics, Inc. (“Endoceutics”) entered into a license agreement (the “License Agreement”) pursuant to which Endoceutics has agreed to grant to AMAG rights to Intrarosa^TM (prasterone), an FDA-approved product for the treatment of moderate-to-severe dyspareunia (pain during sexual intercourse). The License Agreement grants AMAG the right to develop and commercialize pharmaceutical products containing dehydroepiandrosterone (“DHEA”), including Intrarosa, at dosage strengths of 13 mg or less per dose and formulated for intravaginal delivery (the “Product”), excluding any dosage strengths over 13 mg per dose and combinations with other active pharmaceutical ingredients, in the United States for the treatment and prevention of vulvar and vaginal atrophy (“VVA”) and female sexual dysfunction (“FSD”) (the “Field”). The closing of the transactions contemplated by the License Agreement (the “Effective Date”) is subject to clearance under the Hart-Scott-Rodino Act and other customary closing conditions.

Subject to the terms of the License Agreement, Endoceutics has agreed to conduct clinical studies for use of the Product in FSD to support an application for regulatory approval for the Product for use in FSD in the United States. AMAG and Endoceutics have agreed to share the direct costs related to such studies based upon a negotiated allocation with AMAG funding up to $20.0 million. AMAG may, with Endoceutics’ consent (not to be unreasonably withheld, conditioned or delayed), conduct any other studies of the Product in the Field anywhere in the world for the purpose of obtaining or maintaining regulatory approval of or commercializing the Product in the Field in the United States. All data generated in connection with the above described studies would be owned by Endoceutics and licensed to AMAG pursuant to the License Agreement.

AMAG will be granted the exclusive right to commercialize the Product in the Field in the United States, subject to the terms of the License Agreement, including having final decision making authority with respect to commercial strategy, pricing and reimbursement and other commercialization matters. AMAG has agreed to use commercially reasonable efforts to market, promote and otherwise commercialize the Product in the Field in the United States. Endoceutics has the right to directly conduct, itself or through its affiliates or subcontractors, additional commercialization activities for the Product in the Field in the United States, which scope of activities will be agreed to by the parties acting reasonably and in good faith, and has the right to conduct activities related generally to the field of intracinology, in each case, subject to AMAG’s right to withhold approval in certain instances.

Pursuant to the terms of the License Agreement, promptly following the Effective Date, AMAG has agreed to make an upfront cash payment of $50.0 million, and (subject to certain conditions) has agreed to issue 600,000 shares of unregistered common stock, to Endoceutics, 300,000 of which will be subject to a 180-day lock-up provision, and the other 300,000 of which will be subject to a one-year lock-up provision. AMAG has also agreed to make a payment of $10.0 million to Endoceutics on the first anniversary of the Effective Date and up to $10.0 million upon the delivery of launch quantities of the Product. AMAG has also agreed to pay tiered royalties to Endoceutics equal to a percentage of net sales of the Product in the United States ranging from mid-teens (for calendar year net sales up to $150 million) to mid twenty percent (for any calendar year net sales that exceed $1 billion) (such royalty rate to be dependent on the aggregate net sales of the Products) for the commercial life of the Product, with deductions after the later of (i) the expiration date of the last to expire of a licensed patent containing a valid patent claim or (ii) ten years after the first commercial sale of the Product in the Field in the United States, generic competition and third party payments. Endoceutics is also eligible to receive certain sales milestone payments, including a first sales milestone payment of $15.0 million, which would be triggered when Intrarosa annual net U.S. sales exceed $150.0 million, and a second milestone payment of $30.0 million, which would be triggered when annual net U.S. sales exceed $300.0 million. If annual net U.S. sales exceed $500.0 million, there are additional sales milestone payments totaling up to $850 million, which would be triggered at various sales thresholds.

In connection with the License Agreement, AMAG and Endoceutics have agreed to enter into a commercial supply agreement on or about the Effective Date, pursuant to which Endoceutics, itself or through affiliates or contract manufacturers, would agree to manufacture and supply the Product to AMAG (the “Supply Agreement”) and would be AMAG’s exclusive supplier of the Product in the United States, subject to certain rights for AMAG to manufacture and supply the Product in the event of a cessation notice or supply failure (as such terms are defined in the Supply Agreement). Under the Supply Agreement, Endoceutics would maintain at all times a second source supplier for the manufacture of DHEA and the drug product and identify and validate and transfer manufacturing intellectual property to the second source supplier within two years of the Effective Date. The Supply Agreement remains in effect until the termination of the License Agreement, unless terminated earlier by either party for an uncured material breach or insolvency of the other party, or by AMAG if it exercises its rights to manufacture and supply the Product following a cessa

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tion notice or supply failure.

Under the License Agreement, except as permitted under the License Agreement or the Supply Agreement, and except for any compounds or products affecting the melanocortin receptor pathway, including without limitation, bremelanotide (collectively, “Excluded Product”), AMAG will not be permitted to research, develop, manufacture, or commercialize (i) DHEA for delivery by any route of administration anywhere in world, (ii) any compound (including DHEA) or product for use in VVA anywhere in the world, or (iii) commencing on the date of an approval of the Product for the treatment of FSD in the United States and continuing for the remainder of the term of the License Agreement, any compound (including DHEA) for use in FSD (each, a “Competing Product”). Any compound or product for use in FSD that would be a Competing Product in the United States but that (i) does not contain DHEA and (ii) was acquired or licensed or for which the research, development, manufacture or commercialization of such compound or product is initiated by AMAG or its affiliates, in each case, prior to the date of an approval of the Product for the treatment of FSD in the United States, will be an Excluded Product and will not be subject to the exclusivity obligations under the License Agreement in the treatment of FSD, subject to certain restrictions in the License Agreement. These noncompete restrictions are subject to certain exclusions relating to the acquisition of competing programs.

AMAG and Endoceutics have made customary representations and warranties and have agreed to certain customary covenants. The License Agreement expires on the date of expiration of all royalty obligations due thereunder unless earlier terminated in accordance with the License Agreement. The License Agreement may be terminated by either Party if the Effective Date has not occurred within 180 days following the execution date or such date as the parties may mutually agree. The License Agreement may be terminated by either Party for material breach that is either uncured after a 90-day notice period, or if such breach cannot be cured within such 90-day period, if the breaching party does not commence appropriate and material actions to cure such breach within the notice period and continue to diligently cure such breach for a period not to exceed 90 days, in either case, subject to tolling or determination of the arbitrators, if dispute resolution procedures are initiated within 30 days’ of the termination notice. AMAG has the ability to elect not to terminate the License Agreement in the case of a material breach, in which case future milestone and royalty payments owed to Endoceutics would be reduced by a negotiated percentage or by an amount determined by arbitration. Either party may terminate under certain situations relating to the bankruptcy or insolvency of the other party. AMAG may terminate the License Agreement for a valid business reason upon 365 days’ prior written notice to Endoceutics; or upon 60 days’ written notice in the event AMAG reasonably determines in good faith, after due inquiry and after discussions with Endoceutics, that AMAG cannot reasonably continue to develop or commercialize any Product as a result of a safety issue regarding the use of the Product. AMAG may also terminate the License Agreement upon 180 days’ notice if there is a change of control of AMAG and the acquiring entity (alone or with its affiliates) is engaged in a competing program (as defined in the Licensed Agreement) in the United States or in at least three countries within the European Union.

Endoceutics has represented that the historical research and development costs incurred to date by Endoceutics and its affiliates (including any third party costs and expenses) in connection with the Product are approximately CAD $19.6 million (approximately USD $15.0 million) since January 1, 2014, including (i) CAD $10,127,220 (approximately USD $7.7 million) during the twelve months ended December 31, 2014, (ii) CAD $4,896,520 (approximately USD $3.8 million) during the twelve months ended December 31, 2015, and (iii) CAD $4,559,816 (approximately USD $3.5 million) during the twelve months ended December 31, 2016. AMAG is not assuming any liabilities (including contingent liabilities), acquiring any physical assets, or hiring or acquiring any employees from Endoceutics in connection with the License Agreement.

The foregoing summary is qualified in its entirety by reference to the License Agreement and Supply Agreement, each of which AMAG expects to file as an exhibit to its Quarterly Report on Form 10-Q for the quarter in which such agreement is entered, if not earlier on a Current Report on Form 8-K. AMAG intends to seek confidential treatment for certain portions of the License Agreement and the Supply Agreement.

Item 2.02. Results of Operations and Financial Condition.

The following information and Exhibit 99.1 and Exhibit 99.2 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 they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), except as expressly set forth by specific reference in such filing.

On February 14, 2017 AMAG issued a press release entitled “AMAG Reports Fourth Quarter and Full Year 2016 Financial Results” regarding its operating results for the quarter and year ended December 31, 2016 and its intention to

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hold a conference call to discuss AMAG’s financial results and provide a business update. A copy of AMAG’s press release is furnished herewith as Exhibit 99.1 and a copy of the presentation slides to be used during the conference call is furnished herewith as Exhibit 99.2.

Item 3.02 Unregistered Sales of Equity Securities.

Pursuant to the License Agreement described in Item 1.01 of this Current Report on Form 8-K, which description is incorporated herein by reference, and subject to the occurrence of the Effective Date and certain other conditions, including there being a valid exception from registration under the Securities Act, AMAG expects to issue 600,000 shares of unregistered AMAG common stock to Endoceutics within five days of the Effective Date. The issuance of these shares to Endoceutics will not be registered under the Securities Act in reliance upon an exception from registration pursuant to Regulation S promulgated under the Securities Act.

Item 7.01. Regulation FD Disclosure

The following information and Exhibit 99.3 attached hereto shall not be deemed “filed” for purposes of Section 18 of 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, except as expressly set forth by specific reference in such filing.

On February 14, 2017, AMAG issued a press release, entitled “AMAG And Endoceutics Enter Into An Exclusive U.S. License Agreement For Intrarosa^TM (Prasterone)” announcing that it had executed the License Agreement and its intention to hold a conference call to present further details regarding the License Agreement. A copy of such press release is furnished as Exhibit 99.3 hereto.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

AMAG hereby furnishes the following exhibits:

Exhibit Number	Description
99.1	Press release entitled “AMAG Reports Fourth Quarter and Full Year 2016 Financial Results” issued by AMAG Pharmaceuticals, Inc. on February 14, 2017.
99.2	Copy of AMAG Pharmaceuticals, Inc.’s presentation slides dated February 14, 2017.
99.3	Press release entitled “AMAG And Endoceutics Enter Into An Exclusive U.S. License Agreement For IntrarosaTM (Prasterone)” issued by AMAG Pharmaceuticals, Inc. on February 14, 2017.

Forward Looking Statements

This Current Report on Form 8-K and the materials furnished herewith contains forward-looking information about AMAG within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein and therein which do not describe historical facts, including, among others, statements regarding each party’s respective performance of its obligations under the License Agreement and the Supply Agreement, including with respect to funding additional clinical trials and conducting commercialization activities; anticipated clinical development plans and costs for Intrarosa to support regulatory approval of FSD; expected timing for the closing of the transaction under the License Agreement; the timing and amounts of future milestone and royalty payments; and expected investment amounts by AMAG in the potential FSD label expansion and those statements in the materials furnished herewith that are designated as “forward-looking statements” 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, among others, (1) the possibility that the closing conditions set forth in the License Agreement, including, those related to antitrust clearance, will not be met and that the parties will be unable to consummate the proposed transactions; (2) the possibility that AMAG will not realize the expected benefits of the transaction, including the anticipated market opportunity and the ability of its current or expanded sales force to successfully commercialize Intrarosa; (3) the possibility that significant safety or drug interaction problems could arise with respect to Intrarosa; (4) the ability of AMAG to drive awareness of dyspareunia and the potential benefits of Intrarosa; (5) uncertainties regarding the manufacture of Intrarosa; (6) uncertainties relating to patents and proprietary

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rights associated with Intrarosa in the United States; (7) that the cost of the transaction to AMAG will be more than planned and/or will not provide the intended positive financial results; (8) that AMAG or Endoceutics will fail to fully perform their respective obligations under the License Agreement or the Supply Agreement; (9) uncertainty regarding AMAG’s ability to compete in the dyspareunia market in the United States; and (10) other risks identified in AMAG’s Securities and Exchange Commission (“SEC”) filings, including its Annual Report on Form 10-K for the year ended December 31, 2015, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016, June 30, 2016 and September 30, 2016 and subsequent filings with the SEC, including its Current Report on Form 8-K filed with the SEC on January 9, 2017 and February 3, 2017, as well as in its upcoming Annual Report on Form 10-K for the year ended December 31, 2016. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AMAG disclaims 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.

AMAG Pharmaceuticals^® is a registered trademark of AMAG Pharmaceuticals, Inc. Intrarosa^TM is a registered trademark of Endoceutics.

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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 hereunto duly authorized.

AMAG PHARMACEUTICALS, INC.
By:	/s/ Joseph D. Vittiglio
	Joseph D. Vittiglio General Counsel and Senior Vice President of Legal Affairs
Date: February 14, 2017

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EXHIBIT INDEX

Exhibit Number	Description
99.1*		Press release entitled “AMAG Reports Fourth Quarter and Full Year 2016 Financial Results” issued by AMAG Pharmaceuticals, Inc. on February 14, 2017.
99.2*		Copy of AMAG Pharmaceuticals, Inc.’s presentation slides dated February 14, 2017.
99.3*		Press release entitled “AMAG And Endoceutics Enter Into An Exclusive U.S. License Agreement For IntrarosaTM (Prasterone)” issued by AMAG Pharmaceuticals, Inc. on February 14, 2017.

* Furnished herewith

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EX-99.1

FOR IMMEDIATE RELEASE

AMAG Reports Fourth Quarter and Full Year 2016 Financial Results

2016 GAAP revenue increased 27% over 2015

Achieved record quarterly and annual net sales for Makena® and Feraheme®

Conference call scheduled for 8:00 a.m. ET today

WALTHAM, Mass., (February 14, 2017) - AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited consolidated financial results for the fourth quarter and full year ended December 31, 2016.

Total GAAP revenue for the full year of 2016 increased approximately 27% to $532.1 million, primarily driven by record sales for both Makena® (hydroxyprogesterone caproate injection) and Feraheme® (ferumoxytol) and the recognition of a full year of service revenues from Cord Blood Registry® (CBR), which AMAG acquired in August 2015. The company reported operating income of $78.9 million in 2016. Non-GAAP adjusted EBITDA increased approximately 24% to $265.7 million in 2016.¹

“We drove significant top- and bottom-line growth in 2016, building an even stronger base to grow and expand upon in 2017,” said William Heiden, AMAG’s chief executive officer. “We achieved our 2016 financial goals with strong performance across each of our products, generated significant cash flows, and advanced our next-generation development programs. In addition to the revenue growth announced today from our current marketed product portfolio, we recently expanded our women's health portfolio, acquiring rights to Rekynda^TM and Intrarosa^TM, two important products with long-term growth potential. In 2017, we expect to continue to drive growth across our portfolio, execute well on upcoming new product launches, and continue to expand our product portfolio through additional business development transactions."

2016 Highlights:

Makena

• Successfully launched single-dose, preservative-free formulation and strengthened an important relationship with a large home health services provider

• Increased GAAP net sales by 33% to $334.1 million

• Successfully completed pharmacokinetic (PK) study comparing bioavailability between subcutaneous and intramuscular (IM) injections

Feraheme

• Completed enrollment in 2,000 patient, Phase 3 clinical trial evaluating the safety of Feraheme compared to Injectafer® (ferric carboxymaltose injection) in adults with iron deficiency anemia (IDA)

• Accelerated potential approval time line for IDA label expansion by approximately six months through rapid enrollment of Phase 3 clinical study

• Maintained market share in competitive and growing intravenous iron market

¹ See summaries of GAAP to non-GAAP adjustments at the conclusion of this press release.

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CBR

• Successfully implemented pricing strategy that increased revenue per consumer by 8.5% over 2015

• Added more than 40,000 stored units of cord blood and cord tissue

• Began implementation of enhanced messaging to capitalize on generational shift

Financial

• Achieved record net sales of Makena and Feraheme

• Generated GAAP operating income of $78.9 million and non-GAAP adjusted EBITDA of $265.7 million¹ 

• Ended 2016 with $579.1 million of cash and investments, an increase of $112.8 million, net of debt principal payments, stock repurchases and a $100 million milestone payment to former shareholders of Lumara Health, which AMAG acquired in 2014

Recent 2017 Business Highlights:

• Expanded portfolio into women’s health segment through two recently-executed license agreements:

◦ Rekynda, an investigational product designed for on-demand treatment of hypoactive sexual desire disorder (HSDD) that successfully met its co-primary endpoints in two Phase 3 clinical trials, which closed in February 2017

◦ Intrarosa, the only FDA-approved, vaginally administered, daily, non-estrogen product for the treatment of moderate-to-severe dyspareunia (pain during intercourse), a common symptom of vulvar and vaginal atrophy, due to menopause, which we anticipate will close in the first half of 2017

• Announced topline PK data for Makena subcutaneous auto-injector program and confirmed plans to submit sNDA in the second quarter of 2017, with an anticipated FDA decision and product launch in the fourth quarter of 2017

Fourth Quarter Financial Results Ended December 31, 2016 (unaudited)

GAAP Fourth Quarter Financial Results

Total GAAP revenues for the fourth quarter of 2016 were $151.6 million, compared with $108.7 million for the same period in 2015. In the fourth quarter of 2016, sales of Makena increased 44% to $97.2 million, compared with $67.4 million in the same period last year; sales of Feraheme and MuGard increased 13% to $26.6 million, compared with $23.5 million in the same period last year; and service revenue from CBR increased 64% to $27.7 million, compared with $17.0 million in the same period last year. The growth in CBR service revenue was positively impacted by a purchase accounting adjustment to deferred revenue, which reduced the GAAP revenue recorded in 2015.

Total costs and expenses, including costs of product sales and services, totaled $137.0 million for the fourth quarter of 2016, compared with $86.1 million for the same period in 2015. The increase in total costs and expenses in the fourth quarter of 2016 was related to (i) higher cost of products sold due to an increase in amortization expense recorded for the Makena intangible asset, (ii) an impairment charge of a $3.7 million related to the CBR tradename intangible asset (iii) higher R&D expenses associated with the company's Makena and Feraheme next-generation development programs, and (iv) higher expenses in selling, general and administrative primarily due to an increase in the Makena contingent consideration expense to reflect the estimated fair value of future milestone payments.

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Higher costs and expenses in the fourth quarter 2016 resulted in a decrease in operating income, as compared to the prior year period, of $8.1 million to $14.6 million. The company reported a net loss of $10.6 million, or $0.31 per basic and diluted share for the fourth quarter of 2016, compared with net income of $7.2 million, or $0.21 per basic share and $0.20 per diluted share, for the same period in 2015.

Non-GAAP Fourth Quarter Financial Results¹ 

Non-GAAP revenue totaled $153.0 million in the fourth quarter of 2016, up from $120.6 million in same period last year. Non-GAAP CBR service revenue totaled $29.1million in the fourth quarter of 2016, compared with $28.8 million in the fourth quarter of 2015. The difference between GAAP and non-GAAP revenue for CBR represents purchase accounting adjustments related to deferred revenue.

Total costs and expenses on a non-GAAP basis totaled $75.6 million, resulting in an adjusted EBITDA margin of 51% in the fourth quarter of 2016. This compares to costs and expenses of $59.2 million, resulting in an adjusted EBITDA margin of 51% in the same period of 2015. Non-GAAP adjusted EBITDA totaled $77.4 million in the fourth quarter of 2016, an increase of 26% from the $61.3 million recorded in the fourth quarter of 2015.

Full Year Financial Results Ended December 31, 2016 (unaudited)

GAAP Full Year Financial Results

Total GAAP revenues in 2016 increased 27% to $532.1 million, compared with $418.3 million in 2015. This increase is primarily related to record annual net sales of Makena and the recognition of a full year of service revenues from CBR, partially offset by the recognition of $52.3 million of collaboration revenue in 2015 related to the termination of the company’s ex-US ferumoxytol marketing agreement. In 2016, net sales of Makena increased 33% to $334.1 million, compared with $251.6 million in 2015; sales of Feraheme and MuGard increased 9% to $98.1 million, compared with $90.2 million in 2015; and service revenues from CBR, which AMAG acquired in August 2015, were $99.6 million, compared with $24.1 million in 2015. The results for CBR were included from the date of closing of the acquisition by AMAG in August 2015.

Total costs and expenses, including costs of product sales and services, totaled $453.2 million in 2016, compared with $307.1 million in 2015. The increase in total costs and expenses in 2016 was primarily related to (i) higher expenses to account for a full year of CBR ownership, (ii) higher amortization expense of the Makena intangible asset, (iii) impairment charges recorded in 2016 of $15.7 million and $3.7 million related to MuGard and CBR intangible assets, respectively, (iv) higher R&D expenses related to the company's Makena and Feraheme next generation development programs, and (v) an increase in the Makena contingent consideration expense to reflect the estimated value of future milestone payments.

Higher costs and expenses in 2016 resulted in a $32.4 million decrease in operating income to $78.9 million, compared with $111.2 million in 2015. The company reported a net loss of $2.5 million, or $0.07 per basic and diluted share in 2016. This compares with net income of $32.8 million, or $1.04 per basic share and $0.93 per diluted share, in 2015.

Non-GAAP Full Year Financial Results¹ 

Non-GAAP revenues increased 38% to $549.1 million in 2016, compared with $397.4 million in 2015. Non-GAAP CBR service revenue totaled $116.6 million in 2016, compared with non-GAAP CBR service revenue of $43.3 million in 2015. Non-GAAP, pro forma CBR service revenue totaled $118.6 million in 2015, as if AMAG had acquired CBR at the beginning of the period.

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Total costs and expenses on a non-GAAP basis totaled $283.4 million, resulting in an adjusted EBITDA margin of 48% in 2016. This compares to costs and expenses of $184.0 million in 2015, resulting in an adjusted EBITDA margin of 54%. Non-GAAP adjusted EBITDA totaled $265.7 million in 2016, compared with $213.4 million in 2015.

Balance Sheet Highlights

As of December 31, 2016, the company’s cash, cash equivalents and investments increased by $112.8 million to approximately $579.1 million, net of $20.0 million utilized to repurchase the company’s common stock, $17.5 million to repay debt and a $100.0 million milestone payment to former Lumara Health shareholders, which was payable when Makena annual net sales reached $300 million.

"We are pleased to confirm today that we achieved our key financial goals in 2016. Specifically, we reported adjusted EBITDA of $265.7 million, even after accelerating approximately $10 million of R&D costs from 2017 into 2016 due to the faster-than-expected enrollment in our Feraheme IDA trial," said Ted Myles, AMAG's chief financial officer. "Our demonstrated ability to execute against our plan gives us confidence as we enter 2017 with another set of aggressive growth targets. The licensing transaction that we announced this morning will impact our 2017 guidance, and we'll update the market after we close this transaction and have additional visibility on launch timing, costs and overall plans. Meanwhile, our strong cash position and our ability to generate cash through operations allows us to pursue additional portfolio expansion opportunities."

Conference Call and Webcast Access

AMAG Pharmaceuticals, Inc. will host a conference call and webcast today at 8:00 a.m. ET to discuss the company's fourth quarter and full year 2016 financial results and recent developments, including its exclusive U.S. license agreement for Intrarosa, which was announced today in a separate news release.

Dial-in Number

U.S./Canada Dial-in Number: (877) 412-6083

International Dial-in Number: (702) 495-1202

Conference ID: 65936323

Replay Dial-in Number: (855) 859-2056

Replay International Dial-in Number: (404) 537-3406

Conference ID: 65936323

A telephone replay will be available from approximately 11:00 a.m. ET on February 14, 2017 through midnight on February 21, 2017.

The webcast with slides will be accessible through the Investors section of AMAG’s website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.

Use of Non-GAAP Financial Measures

AMAG has presented certain non-GAAP financial measures, including non-GAAP revenue, non-GAAP costs and expenses, non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization) and adjusted EBITDA margin. These non-GAAP financial measures exclude certain amounts, revenue, expenses or

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income, from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP). Management believes this non-GAAP information is useful for investors, taken in conjunction with AMAG’s GAAP financial statements, because it provides greater transparency regarding AMAG’s operating performance. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of AMAG’s operating results as reported under GAAP, not as a substitute for GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

About AMAG

AMAG is a biopharmaceutical company focused on developing and delivering important therapeutics, conducting clinical research in areas of unmet need and creating education and support programs for the patients and families we serve. Our currently marketed products support the health of patients in the areas of women's health, anemia management and cancer supportive care. Through CBR®, we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders, and have the potential to play a valuable role in the ongoing development of regenerative medicine. For additional company information, please visit www.amagpharma.com. 

About Makena® (hydroxyprogesterone caproate injection)

Makena® is a progestin indicated to reduce the risk of preterm birth in women pregnant with a single baby who have a history of singleton spontaneous preterm birth.

The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.

Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to the current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure. Before patients receive Makena, they should tell their healthcare provider if they have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.

In one clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth

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(fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in the urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).

Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of the skin and the whites of the eyes. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.

For additional product information, including full prescribing information, please visit www.makena.com.

About Feraheme® (ferumoxytol)

Feraheme received marketing approval from the FDA on June 30, 2009 for the treatment of IDA in adult CKD patients and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol is protected in the U.S. by six issued patents covering the composition and dosage form of the product. Each issued patent is listed in the FDA’s Orange Book, the last of which expires in June 2023.

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. Feraheme is contraindicated in patients with a known hypersensitivity to Feraheme or any of its components, or a history of allergic reaction to any intravenous iron product.

For additional product information, please see full Prescribing Information, including Boxed Warning, available at www.feraheme.com.

About Cord Blood Registry® (CBR)

CBR is the world’s largest private newborn stem cell company. Founded in 1992, CBR is entrusted by parents with storing more than 670,000 umbilical cord blood and cord tissue units. CBR is dedicated to advancing the clinical application of newborn stem cells by partnering with reputable research institutions on FDA-regulated clinical trials for conditions that have no cure today. For more information, visit www.cordblood.com.

About Rekynda^TM (bremelanotide)

Rekynda (bremelanotide), an investigational product, is thought to possess a novel mechanism of action, activating endogenous melanocortin pathways involved in sexual desire and response.

The two Phase 3 studies for HSDD in pre-menopausal women consisted of double-blind placebo-controlled, randomized parallel group studies comparing a subcutaneous dose of 1.75 mg of Rekynda delivered via an auto-injector pen to placebo. Each trial consisted of more than 600 patients randomized in a 1:1 ratio to either the treatment arm or placebo with a 24 week evaluation period. In both clinical trials, Rekynda met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire as measured using validated patient-reported outcome instruments.

Women in the trials had the option, after completion of the trial, to continue in an ongoing open-label safety extension study for an additional 12 months. Nearly 80% of patients elected to remain in the open-label portion of the study, and all of these patients will continue to receive Rekynda.

6

In both Phase 2 and Phase 3 clinical trials, the most frequent adverse events were nausea, flushing, and headache, which were generally mild-to-moderate in severity.

Rekynda has no known alcohol interactions.

About Intrarosa^TM (Prasterone)

Intrarosa is the only FDA-approved, vaginally administered, daily non-estrogen steroid for the treatment of moderate-to-severe dyspareunia (pain during intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa contains prasterone, also known as dehydroepiandrosterone (DHEA). Prasterone is an inactive endogenous steroid, which is converted locally into androgens and/or estrogens to help restore the vaginal tissue as indicated by improvements in the percentage of superficial cells, parabasal cells, and pH. The mechanism of action is not fully established.

In two primary 12-week placebo-controlled efficacy trials, women taking Intrarosa experienced a significant reduction in dyspareunia, as well as significant improvements in the percentage of vaginal superficial cells and parabasal cells, as well as vaginal pH. In clinical trials, the most common adverse reactions were vaginal discharge and abnormal pap smear. Patients with current or prior history of breast cancer should talk to their healthcare providers before using Intrarosa.

Forward-Looking Statements

This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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, among others, AMAG’s beliefs regarding the long-term growth potential of Rekynda and Intrarosa; expectations that AMAG will continue to drive growth across its portfolio, execute well on upcoming new product launches and continue its expansion strategy by entering into additional transactions, AMAG’s anticipated expansion in women’s health through the licensing transaction with Endoceutics, Inc., including the expected timing for the closing of Intrarosa transaction, expectations regarding timing for the submission of the Makena auto-injector sNDA (including expected timing for an FDA decision on the sNDA and product launch, if approved); expected 2016 fourth quarter and full year financial results, including revenues and year end cash, cash equivalents and investments balances; AMAG’s beliefs regarding its 2017 growth targets and ability to pursue potential portfolio expansion opportunities; and beliefs that newborn stem cells have the potential to play a valuable role in the development of regenerative medicine 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, among others, (1) the possibility that the closing conditions set forth in the Intrarosa license agreement, including, those related to antitrust clearance, will not be met and that the parties will be unable to consummate the proposed transactions; (2) the possibility that AMAG will not realize the expected benefits of the Intrarosa transaction, including the anticipated market opportunity and the ability of its current or expanded sales force to successfully commercialize Intrarosa; (3) the possibility that significant safety or drug interaction problems could arise with respect to Intrarosa; (4) the ability of AMAG to drive awareness of dyspareunia and the potential benefits of Intrarosa; (5) uncertainties regarding the manufacture of Intrarosa; (6) uncertainties relating to patents and proprietary rights associated with Intrarosa in the United States; (7) that the cost of the transaction to AMAG will be more than planned and/or will not provide the intended positive financial results; (8) that AMAG or Endoceutics will fail to fully perform their respective obligations under the

7

Intrarosa license agreement or the Intrarosa supply agreement; (9) uncertainty regarding AMAG’s ability to compete in the dyspareunia market in the United States; and (10) other risks identified in AMAG’s Securities and Exchange Commission (“SEC”) filings, including its Annual Report on Form 10-K for the year ended December 31, 2015, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016, June 30, 2016 and September 30, 2016 and subsequent filings with the SEC, including its Current Reports on Form 8-K filed with the SEC on January 9, 2017 and February 3, 2017, as well as in its upcoming Annual Report on Form 10-K for the year ended December 31, 2016. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AMAG disclaims 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.

AMAG disclaims 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.

AMAG Pharmaceuticals® and Feraheme® are registered trademark of AMAG Pharmaceuticals, Inc. MuGard® is a registered trademark of Abeona Therapeutics, Inc. Makena® is a registered trademark of AMAG Pharmaceuticals IP, Ltd. Cord Blood Registry® and CBR® are registered trademarks of CBR Systems, Inc. Rekynda^TM is a trademark of Palatin Technologies, Inc. Intrarosa^TM is a trademark of Endoceutics, Inc.

-- Tables Follow –

8

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,
	2016			2015			2016			2015
Revenues:
Makena	$	97,226		$	67,356		$	334,050		$	251,615
Feraheme/MuGard	26,619			23,476			98,120			90,201
Cord Blood Registry	27,741			16,955			99,604			24,132
License fee, collaboration and other revenues	4			948			317			52,328
Total revenues	151,590			108,735			532,091			418,276
Operating costs and expenses:
Cost of product sales	30,372			18,716			96,314			78,509
Cost of services	4,870			6,731			20,575			9,992
Research and development expenses	20,505			7,897			66,084			42,878
Selling, general and administrative expenses	77,556			50,255			249,870			160,309
Impairment of intangible assets	3,700			—			19,663			—
Acquisition-related costs	—			80			—			11,232
Restructuring expenses	3			2,383			715			4,136
Total costs and expenses	137,006			86,062			453,221			307,056
Operating income	14,584			22,673			78,870			111,220
Other income (expense):
Interest expense	(18,151)			(18,457		)	(73,153		)	(53,251		)
Loss on debt extinguishment	—			—			—			(10,449		)
Interest and dividend income	830			545			3,149			1,512
Other income (expense)	(7		)	(8		)	189			(9,188		)
Total other income (expense)	(17,328		)	(17,920		)	(69,815		)	(71,376		)
Income (loss) before income taxes	(2,744		)	4,753			9,055			39,844
Income tax expense (benefit)	7,814			(2,448		)	11,538			7,065
Net income (loss)	$	(10,558	)	$	7,201		$	(2,483	)	$	32,779
Net income (loss) per share
Basic	$	(0.31	)	$	0.21		$	(0.07	)	$	1.04
Diluted	$	(0.31	)	$	0.20		$	(0.07	)	$	0.93
Weighted average shares outstanding used to compute net income (loss) per share:
Basic	34,254			34,712			34,346			31,471
Diluted	34,254			42,805			34,346			35,308

9

AMAG Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(unaudited, amounts in thousands)

	December 31, 2016		December 31, 2015
ASSETS
Current assets:
Cash and cash equivalents	$	274,305	$	228,705
Investments	304,781		237,626
Accounts receivable, net	92,375		85,678
Inventories	37,258		40,645
Receivable from collaboration	—		428
Prepaid and other current assets	9,839		13,592
Total current assets	718,558		606,674
Property, plant and equipment, net	24,460		28,725
Goodwill	639,484		639,188
Intangible assets, net	1,092,178		1,196,771
Restricted cash	2,593		2,593
Other long-term assets	1,153		2,259
Total assets	$	2,478,426	$	2,476,210
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	3,684	$	4,906
Accrued expenses	156,008		106,363
Current portion of long-term debt	21,166		17,500
Current portion of acquisition-related contingent consideration	97,068		96,967
Deferred revenues	34,951		20,185
Total current liabilities	312,877		245,921
Long-term liabilities:
Long-term debt, net	785,992		803,669
Convertible 2.5% notes, net	179,363		170,749
Acquisition-related contingent consideration	50,927		125,592
Deferred tax liabilities	197,066		189,145
Deferred revenues	14,850		5,093
Other long-term liabilities	2,962		3,777
Total liabilities	1,544,037		1,543,946
Total stockholders’ equity	934,389		932,264
Total liabilities and stockholders’ equity	$	2,478,426	$	2,476,210

10

AMAG Pharmaceuticals, Inc.

Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations

Three Months Ended December 31,2016

(unaudited, amounts in thousands)

	Revenue		Cost of product sales			Cost of services			Research & development			Selling, general & administrative			Intangible asset impairment charges			Acquisition-related		Restructuring			Operating Income / Adjusted EBITDA
GAAP	$	151,590	$	30,372		$	4,870		$	20,505		$	77,556		$	3,700		$	—	$	3		$	14,584
Purchase accounting adjustments related to CBR deferred revenue	1,378		—			—			—			—			—			—		—
Depreciation and intangible asset amortization	—		(23,554		)	(371		)	(48		)	(5,067		)	—			—		—
Non-cash inventory step-up adjustments	—		(1,024		)	—			—			—			—			—		—
Stock-based compensation	—		(125		)	—			(893		)	(4,719		)	—			—		—
Adjustments to contingent consideration	—		—			—			—			(20,576		)	—			—		—
Impairment charges of intangible assets	—		—			—			—			—			(3,700		)	—		—
Transaction/Acquisition-related costs	—		—			—			—			(1,318		)	—			—		—
Restructuring costs	—		—			—			—			—			—			—		(3		)
Non-GAAP Adjusted	$	152,968	$	5,669		$	4,499		$	19,564		$	45,876		$	—		$	—	$	—		$	77,360

11

AMAG Pharmaceuticals, Inc.

Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations

Three Months Ended December 31,2015

(unaudited, amounts in thousands)

	Revenue		Cost of product sales			Cost of services			Research & development			Selling, general & administrative			Intangible asset impairment charges		Acquisition-related			Restructuring			Operating Income / Adjusted EBITDA
GAAP	$	108,735	$	18,716		$	6,731		$	7,897		$	50,255		$	—	$	80		$	2,383		$	22,673
Purchase accounting adjustments related to CBR deferred revenue	11,815		—			—			—			—			—		—			—
Inventory reserve	—		—			(992		)	—			—			—		—			—
Depreciation and intangible asset amortization	—		(14,008		)	(356		)	(23		)	(2,557		)	—		—			—
Non-cash inventory step-up adjustments	—		(813		)	—			(74		)	—			—		—			—
Stock-based compensation	—		(117		)	—			(921		)	(4,627		)	—		—			—
Adjustments to contingent consideration	—		—			—			—			253			—		—			—
Transaction/Acquisition-related costs	—		—			—			—			(147		)	—		(80		)	—
Restructuring costs	—		—			—			—			—			—		—			(2,383		)
Non-GAAP Adjusted	$	120,550	$	3,778		$	5,383		$	6,879		$	43,177		$	—	$	—		$	—		$	61,333

12

AMAG Pharmaceuticals, Inc.

Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations

Twelve Months Ended December 31,2016

(unaudited, amounts in thousands)

	Revenue		Cost of product sales			Cost of services			Research & development			Selling, general & administrative			Intangible asset impairment charges			Acquisition-related		Restructuring			Operating Income / Adjusted EBITDA
GAAP	$	532,091	$	96,314		$	20,575		$	66,084		$	249,870		$	19,663		$	—	$	715		$	78,870
Purchase accounting adjustments related to CBR deferred revenue	16,977		—			—			—			—			—			—		—
Depreciation and intangible asset amortization	—		(72,463		)	(1,435		)	(145		)	(20,100		)	—			—		—
Non-cash inventory step-up adjustments	—		(4,880		)	—			(861		)	—			—			—		—
Stock-based compensation	—		(511		)	(9		)	(3,476		)	(18,547		)	—			—		—
Adjustments to contingent consideration	—		—			—			—			(25,682		)	—			—		—
Impairment charges of intangible assets	—		—			—			—			—			(19,663		)	—		—
Transaction/Acquisition-related costs	—		—			—			—			(1,318		)	—			—		—
Restructuring costs	—		—			—			—			—			—			—		(715		)
Non-GAAP Adjusted	$	549,068	$	18,460		$	19,131		$	61,602		$	184,223		$	—		$	—	$	—		$	265,652

13

AMAG Pharmaceuticals, Inc.

Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations

Twelve Months Ended December 31,2015

(unaudited, amounts in thousands)

	Revenue			Cost of product sales			Cost of services			Research & development			Selling, general & administrative			Intangible asset impairment charges		Acquisition-related			Restructuring			Operating Income / Adjusted EBITDA
GAAP	$	418,276		$	78,509		$	9,992		$	42,878		$	160,309		$	—	$	11,232		$	4,136		$	111,220
Purchase accounting adjustments related to CBR deferred revenue	19,136			—			—			—			—			—		—			—
Non-cash collaboration revenue	(39,965		)	—			—			—			—			—		—			—
Inventory reserve	—			—			(992		)	—			—			—		—			—
Depreciation and intangible asset amortization	—			(52,521		)	(571		)	(75		)	(4,292		)	—		—			—
Non-cash inventory step-up adjustments	—			(11,644		)	—			(1,192		)	—			—		—			—
Stock-based compensation	—			(371		)	—			(2,991		)	(13,874		)	—		—			—
Adjustments to contingent consideration	—			—			—			—			(4,272		)	—		—			—
Option rights to license orphan drug	—			—			—			(10,000		)	—			—		—			—
Impairment charges of intangible assets	—			—			—			—			—			—		—			—
Transaction/Acquisition-related costs	—			—			—			—			(2,548		)	—		(11,232		)	—
Restructuring costs	—			—			—			—			(2,338		)	—		—			(4,136		)
Non-GAAP Adjusted	$	397,447		$	13,973		$	8,429		$	28,620		$	132,985		$	—	$	—		$	—		$	213,440

14

AMAG Pharmaceuticals, Inc.

Share Count Reconciliation

(unaudited, amounts in millions)

	Three Months Ended December 31,					Twelve Months Ended December 31,
	2016		2015			2016		2015
Weighted average basic shares outstanding	34.3		34.7			34.3		31.5
Employee equity incentive awards	—	1	0.7			—	1	1.4
Convertible notes	—	1	7.4			—	1	—		1
Warrants	—	1	—		1	—	1	2.4
GAAP diluted shares outstanding	34.3		42.8			34.3		35.3
Employee equity incentive awards	0.8	2	—			0.5	2	—
Convertible notes	—		—			—		7.4		2
Effect of bond hedge and warrants	—		(1.2	)	3	—		(3.5	)	3
Non-GAAP diluted shares outstanding	35.1		41.6			34.8		39.2

¹ Employee equity incentive awards, convertible notes and warrants would be anti-dilutive in this period utilizing the “if-converted” method, which adjusts net income for the after-tax interest expense applicable to the convertible notes.

² Reflects the Non-GAAP dilutive impact of employee equity incentive awards and convertible notes.

³ Reflects the impact of the non-GAAP benefit of the bond hedge and warrants.

CONTACT:

Linda Lennox

Vice President, Investor Relations

617-498-2846

15

EX-99.2

AMAG Pharmaceuticals 2016 Financial Results and Intrarosa License Agreement February 14, 2017

Forward-Looking Statements 2 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, statements regarding expected 2016 financial results, including revenues, adjusted EBITDA; AMAG’s anticipated expansion in women’s health through the licensing transaction with Endoceutics, Inc., including the expected timing for the closing of Intrarosa transaction; Makena’s position in the market and future growth drivers for Makena, including its potential market opportunity, filing a supplemental new drug application (sNDA) for the Makena subcutaneous (SC) auto-injector and customer engagement and outreach; beliefs that the current Makena SC auto-injector formulation offers benefits to physicians and patients, including the potential for greater convenience and alternative administration; AMAG’s beliefs that bioavailability is a key parameter and that the PK study demonstrated comparable bioavailability between the SC and intramuscular (IM) arms; expectations regarding timing for the submission of the Makena auto-injector sNDA (including expected timing for an FDA decision on the sNDA and commercial launch, if approved); growth drivers for Cord Blood Registry (CBR), including plans to differentiate CBR offerings and increase engagement and communications in the industry; expected timing for topline data and submission of the sNDA for the expanded Feraheme label (including expected timing for an FDA decision on the sNDA and commercial launch, if approved); growth drivers for Feraheme, including plans to optimize net revenue per gram, grow in key segments and expectations that the size of the addressable market, if the broader indication is approved, would double; expectations regarding the potential benefits, safety profile and commercial opportunity of Intrarosa and its’ strategic fit for AMAG’s women’s health business; the competitive landscape and breadth of the vulvovaginal atrophy (VVA) markets and Intrarosa’s market potential; expectations on timing of Intrarosa launch, AMAG’s ability to leverage existing commercial and medical affairs teams and to expand its current sales force and deploy its digital engagement platform, and Intrarosa label expansion opportunities (including timing of initiation of Phase 3 female sexual dysfunction study); AMAG’s belief that its well-positioned to improve women’s health care and that Intrarosa will build long-term shareholder value; expectations on timing of Rekynda NDA submission (including expected timing for an FDA decision on the sNDA and commercial launch, if approved); and the expected timing of initiation of the Velo Phase 2b/3a study 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, among others, (1) the possibility that the closing conditions set forth in the Intrarosa License Agreement, including, those related to antitrust clearance, will not be met and that the parties will be unable to consummate the proposed transactions; (2) the possibility that AMAG will not realize the expected benefits of the transaction, including the anticipated market opportunity and the ability of its current or expanded sales force to successfully commercialize Intrarosa; (3) the possibility that significant safety or drug interaction problems could arise with respect to Intrarosa; (4) the ability of AMAG to drive awareness of dyspareunia and the potential benefits of Intrarosa; (5) uncertainties regarding the manufacture of Intrarosa; (6) uncertainties relating to patents and proprietary rights associated with Intrarosa in the United States; (7) that the cost of the transaction to AMAG will be more than planned and/or will not provide the intended positive financial results; (8) that AMAG or Endoceutics will fail to fully perform their respective obligations under the Intrarosa License Agreement or the Intrarosa Supply Agreement; (9) uncertainty regarding AMAG’s ability to compete in the dyspareunia market in the United States; and (10) other risks identified in AMAG’s Securities and Exchange Commission (“SEC”) filings, including its Annual Report on Form 10-K for the year ended December 31, 2015, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016, June 30, 2016 and September 30, 2016 and subsequent filings with the SEC, including its Current Reports on Form 8-K filed with the SEC on January 9, 2017 and February 3, 2017, as well as in its upcoming Annual Report on Form 10-K for the year ended December 31, 2016. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AMAG disclaims 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. AMAG Pharmaceuticals® and Feraheme® are registered trademark of AMAG Pharmaceuticals, Inc. MuGard® is a registered trademark of Abeona Therapeutics, Inc. Makena® is a registered trademark of AMAG Pharmaceuticals IP, Ltd. Cord Blood Registry® and CBR® are registered trademarks of CBR Systems, Inc. Rekynda is a trademark of Palatin Technologies, Inc. IntrarosaTM is a trademark of Endoceutics, Inc.

Today’s Agenda 3 2016 Highlights and Recent Events1 5 Value Drivers and Upcoming Potential Product Launches 4 IntrarosaTM: Further Expansion into Women’s Health 3 2016 Financial Overview 6 Q&A 2 2016 Product Performance and 2017 Growth Drivers

2016 Highlights and Recent Events

2016 Highlights and Recent Events  Makena  Drove 44% quarterly sales growth over 4Q-2015 and 33% growth year over year through: ‒ Successful launch of single-dose, preservative free formulation ‒ Expansion of Makena @Home service, including enhanced agreement with Optum Home Health  Completed Makena pharmacokinetic study and preparing sNDA filing for subcutaneous auto-injector - Feraheme  Achieved record sales  Completed enrollment in broad iron deficiency anemia (IDA) study to support 2017 sNDA filing - Cord Blood Registry (CBR)  Added more than 40,000 stored units of cord blood and cord tissue  Increased revenue per consumer by 8.5% over 2015 Achieved Financial and Business Development Goals  Grew net revenue 27% to $532M  Generated significant cash flow; ended 2016 with $579M of cash and equivalents  Expanded product portfolio 5

Further Expanding AMAG’s Product Portfolio 6 Pregnancy & Birth Wellness Post-Menopausal Health Feraheme Makena Velo Option Cord Blood Registry Used for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) The only FDA-approved therapy to reduce recurrent preterm birth in certain at-risk women World’s largest umbilical cord stem cell collection and storage company At completion of a Phase 2b/3a clinical trial, AMAG has the option to acquire an orphan drug candidate for the treatment of severe preeclampsia Intrarosa1 Recently FDA-approved non-estrogen product to treat moderate-to-severe dyspareunia, and only FDA approved VVA (vulvar and vaginal atrophy) treatment without a boxed warning Recent successful completion of two Phase 3 clinical trials for on- demand treatment of hypoactive sexual desire disorder (HSDD) Rekynda MuGard Prescriptive mucoadhesive for the management of oral mucositis, a common side effect of radiation or chemotherapy Maternal and Women’s Health Hematology/Oncology 1 Announced exclusive U.S. license agreement for Intrarosa on February 14, 2017. The transaction license expected to close in the first half of 2017.

7 $67.4 $97.2 4Q-2015 4Q-2016 Makena: Strong Commercial Execution $251.6 $334.1 2015 2016 Fourth Quarter Revenue ($M) Full Year Revenue ($M) W O M E N ’ S H E A L T H : M A K E N A 2017 Growth Drivers  Continue to take share from compounders  Grow Makena @Home administration  Greater share of voice with target customers  Expand use in late preterm birth segment  Majority of prescriptions flow through Makena Care Connection (~66%)  Launch subcutaneous auto-injector1 2016 Accomplishments  Successfully launched single-dose, preservative free formulation  Increased market share to 42%  Enhanced patient access to Makena  Expanded Optum Home Health Services relationship  Initiated and fully enrolled PK study +44% +33% 1 If regulatory approved is received.

 Makena intramuscular (IM) ‒ Only approved product to lower the risk of preterm birth ‒ Most frequent AE is injection site pain1  Makena exclusivity and patents ‒ IM orphan drug exclusivity through February 2018 ‒ Auto-injector covered by multiple issued Antares patents to 2026 ‒ Additional patent applications pending  Makena subcutaneous formulation offers the potential for: ‒ Greater convenience for healthcare providers • No vials, needle switching or lengthy IM injection ‒ Alternative to IM injection for patients • Smaller concealed needle, rapid auto-injection, can be injected discretely  Makena auto-injector sNDA submission on-track ‒ Company believes PK study results demonstrated comparable bioavailability between SC and IM injections • Bioequivalence met on AUC, a key PK parameter given Makena’s long-acting duration of action ‒ Moving forward with sNDA submission in 2Q-2017 ‒ Anticipate FDA decision in 4Q-2017 Makena: Next Generation Program Update W O M E N ’ S H E A L T H : M A K E N A 1 Meis et al, N Engl J Med 2003; 348:2379-2385, June 12, 2003. 8

9 CBR: Attractive Recurring Revenue Stream W O M E N ’ S H E A L T H : C O R D B L O O D R E G I S T R Y $24.1 $99.6 2015 2016 $118.6 2015 2016 GAAP Full Year Revenue ($M) $116.6 Non-GAAP, Pro Forma Full Year Revenue2,3 ($M) 1 Represents revenues from August 17, 2015 to December 31, 2015. CBR was acquired by AMAG on August 17, 2015. 2 Non-GAAP CBR revenue includes purchase accounting adjustments related to CBR deferred revenue of $1.4M and $17M for the fourth quarter and full year of 2016, respectively. 3 Represents pro forma revenue for 2015. AMAG acquired CBR on August 17, 2015. 1 2017 Growth Drivers  Differentiate CBR’s offerings ‒ Highlight cord tissue storage offering ‒ Enhance product offerings  Build value proposition on storing newborn stem cells  Increase engagement with the HCP community 2016 Accomplishments  Increased 4Q revenue to $29.1M (non-GAAP)2  Grew revenue per consumer 8.5% year-over-year  Increased stored units by ~40k  Began implementation of enhanced messaging to better target millennial families

10 $23.2 $26.3 4Q-2015 4Q-2016 Feraheme: Differentiated Product, Expect Future Growth $88.5 $97.1 2015 2016 Fourth Quarter Revenue1 ($M) Full Year Revenue1 ($M) 2017 Growth Drivers  Continued growth in key segments  Optimize net revenue per gram  Prepare for expanded label to include IDA patients with all causes ‒ Would double addressable market, if approved  Pull through recent GPO access wins 2016 Accomplishments  Achieved $97M in revenues1  6% growth in grams over 2015  Expanded presence in integrated delivery networks and group purchasing organizations  Completed enrollment in head-to-head trial for broader indication, accelerating sNDA filing by 6 months to mid-2017 +13% +10% H E M A T O L O G Y / O N C O L O G Y : F E R A H E M E 1 Represents revenues from Feraheme only. Excludes revenues from MuGard as reported on financial statements.

GAAP Total Revenue and Operating Income 11 $108.7 $151.6 +39% 1 Collaboration revenue related to the termination of AMAG’s ex-US ferumoxytol marketing partnership agreement. 3-months ended December 31 ($M) $22.7 $14.6 12-months ended December 31 ($M) 4Q-2015 4Q-2016 $418.3 $532.1 $111.2 $78.9 2015 2016 +27% Makena CBRFeraheme/MuGard Collaboration revenue1 Operating Income

GAAP Financial Summary For the 3- and 12- Months Ended December 31 ($M, except per share data) Total revenues Costs and expenses Operating income Interest expense and other Net income (loss) before taxes Income tax expense (benefit) Net income (loss) Net income (loss) per basic share Net income (loss) per diluted share Weighted average basic shares Weighted average diluted shares2 1 Calculation requires the adjustment of interest expense to account for treatment of convertible debt. 2 See slide 32 for share reconciliation. 4Q-2016 4Q-2015 $151.6 $108.7 137.0 86.0 $14.6 $22.7 ($17.3) ($17.9) ($2.7) $4.8 $7.8 ($2.4) ($10.6) $7.2 ($0.31) $0.21 ($0.31) $0.20 34.3 34.7 34.3 42.8 2016 2015 $532.1 $418.3 453.2 307.1 $78.9 $111.2 ($69.8) ($71.4) $9.0 $39.8 11.5 7.0 ($2.5) $32.8 ($0.07) $1.04 ($0.07) $0.93 34.3 31.5 34.3 35.3 1 12

Non-GAAP Total Revenue and Adjusted EBITDA 13 $120.6 $153.0 +27% 3-months ended December 31 ($M) $61.3 $77.4 12-months ended December 31 ($M) 4Q-2015 4Q-2016 $397.4 $549.1 $213.4 $265.7 2015 2016 +38% Makena CBRFeraheme/MuGard Collaboration revenue4 Adjusted EBITDA 1 Represents CBR revenues from August 17, 2015 to December 31, 2015. CBR was acquired by AMAG on August 17, 2015. 2 Non-GAAP CBR revenue includes purchase accounting adjustments related to CBR deferred revenue of $11.8M and $19.1M for the fourth quarter and full year of 2015, respectively. 3 Non-GAAP CBR revenue includes purchase accounting adjustments related to CBR deferred revenue of $1.4M and $17M for the fourth quarter and full year of 2016, respectively. 4 Collaboration revenue related to the termination of AMAG’s ex-US ferumoxytol marketing partnership agreement. 33 1,22

Strong Cash Flow Generation 14 ($M) 12/31/16 12/31/15 Cash, cash equivalents and investments $5791 $466 Principal debt outstanding Convertible senior notes (2.5%) $200 $200 Term loan facility (4.75%) 328 346 2023 senior notes (7.875%) 500 500 Total debt outstanding $1,028 $1,046 ($M) 12/31/16 12/31/15 Net debt $454 $580 Net leverage ratio2 1.7x 2.7x Total leverage ratio2 3.9x 4.9x Added $113M of cash to Balance Sheet, net of $100M milestone payment, $20M stock repurchases and $17.5M debt payments 1 Amount represents 12/31/16 balance. On February 2, 2017, the company made a $60M payment to Palatin Technologies in connection with the closing of its licensing transaction. 2 Leverage ratios based on LTM adjusted EBITDA for each period.

Strong Financial Profile, Management Team & Corporate Infrastructure Market Access, Analytics, and Other Commercial Functions Continuing to Expand AMAG’s Product Portfolio 15 Future Product Digital Consumer Marketing Expertise, Public Relations and Medical Affairs Women’s Health (Including Maternal Health) Hematology / Oncology, Nephrology & Hospital RekyndaTM IntrarosaTM Makena® Leveraging expertise and acquiring innovative products/companies that provide long-term, durable growth potential and revenue streams

IntrarosaTM (prasterone) A first-of-its-kind, non-estrogen women’s health therapy

Exclusive U.S. License for Intrarosa  Will address a significant unmet need for post-menopausal women  Strong safety and efficacy profile  Large near-term commercial opportunity ‒ FDA approved in November 2016 ‒ 3 Orange Book listed patents out to 2031  Leverages AMAG’s current commercial platform in women’s health  Capital efficient transaction structure  Another key step forward in AMAG’s portfolio expansion strategy W O M E N ’ S H E A L T H : I N T R A R O S A 17

Intrarosa: Potential to Address Significant Unmet Need 18  Approximately 32M post-menopausal women in the U.S. suffer from symptoms of vulvar and vaginal atrophy (VVA)1 - 44% to 78% of women with VVA report symptoms of moderate-to-severe dyspareunia1,2 - Growing population of post-menopausal women in the U.S.  VVA is undertreated - ~10% are treated with prescription therapy - ~60% do not receive any treatment at all - Remainder using OTC products1  80% decline in use of estrogen therapy by post-menopausal women - Landmark Women’s Health Initiative (WHI)3 led to warnings of increased risks of certain types of cancers, cardio vascular disease and probable dementia associated with exogenous estrogen therapy  Safety concerns of systemic estrogen exposure are barriers to initiation and persistency with Rx treatment of VVA symptoms1  As a local, non-estrogen therapy, Intrarosa is not subject to a boxed warning or labeling restrictions associated with estrogen-containing therapies 1 Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive Health 2014:8 23–30. 2 F. Palma et al: Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study. 3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3607288/ W O M E N ’ S H E A L T H : I N T R A R O S A

Overview: Vulvovaginal Atrophy (VVA)1 19 3 2 W O M E N ’ S H E A L T H : I N T R A R O S A  Intrarosa is indicated for moderate-to-severe dyspareunia (pain during intercourse), a symptom of VVA, due to menopause  Post-menopausal VVA: - Common and underreported condition associated with decreased sex steroid levels - Results in tissue changes that decrease lubrication and erode superficial lining of the vagina - Symptoms include dyspareunia, dryness, irritation, itching, soreness - Most common in post-menopausal women – prevalence is ~50% of post-menopausal women - Current treatments include OTC lubricants, prescription oral and vaginal creams, inserts and a ring 1 Mayo Clin Proc v. 85(1); 2010 Jan PMC2800285 2 Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive Health 2014:8 23–30 3 The North American Menopause Society. Menopause. 2007;14:357-69

Non-Estrogen- Based  Intrarosa contains prasterone (DHEA), a precursor of hormones that is converted locally inside the vaginal cells into androgens and estrogens  Does not carry the boxed warning that is currently required in the labels of all estrogen-containing vaginal therapies ‒ Class labeling warns of the increased risks associated with exogenous estrogen therapy, as described from the results of the Women’s Health Initiative1, that has caused fear and apprehension among patients Clinical Efficacy  In two 12-week placebo-controlled efficacy trials, women taking Intrarosa experienced a significant reduction in moderate-to-severe dyspareunia, significant improvements in the percentage of vaginal superficial cells and parabasal cells (deeper layer), as well as vaginal pH (all primary endpoints were statistically significant) Safety  Favorable safety profile  52 week long-term safety study (n=422) in post-menopausal women showed no evidence of endometrial hyperplasia  Vaginal discharge and atypical pap smears were reported as a treatment-emergent adverse reaction in ≥ 2% of Intrarosa women  Contraindicated in women with undiagnosed abnormal uterine bleeding; precaution for use in women with current or past breast cancer 1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3607288/ Intrarosa: Strong Efficacy and Safety Profile W O M E N ’ S H E A L T H : I N T R A R O S A 20

Affected, but not yet seeking treatment Utilizing OTC treatments Previous estrogen therapy users Intrarosa: Sizable Untapped Market for Treating Dyspareunia 21 Currently on Rx estrogen therapy Safety concerns about estrogen- containing treatment options Efficacy and/or safety concerns about estrogen-containing treatment options Efficacy and/or not treating underlying pathology of VVA Unaware of condition/ treatment options and/or safety concerns Local (intra-vaginal) estrogen therapies = sales of >$1B per year1 1 Based on IMS SMART Tool NSP and NPA data. 2 IMS Health Plan Claims (April 2008-11). 3 AMAG estimate based on a) Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive Health 2014:8 23–30 and b) F. Palma et al: Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study. 4 Trinity Partners, Quantitative Market Assessment, December 2016 (n=100 PCPs, 100 OBGYNS). 5 Based on multiple publications based on patient surveys. 1.7M women2 ~6M women3,4 ~12M women5 W O M E N ’ S H E A L T H : I N T R A R O S A

Intrarosa Serves Significant Unmet Medical Need 22 1.7 M on estrogen therapy2 Local (intra-vaginal) estrogen therapies = sales of >$1B per year1 Brand(s) Current Intra-vaginal Therapies Intrarosa Administration Vaginal insert or cream by applicator Vaginal insert by applicator Indication Approved for various symptoms of VVA, including dyspareunia, atrophic vaginitis, dryness, itching and burning1 Approved for moderate-to- severe dyspareunia, a common symptom of VVA Boxed Warning Boxed warnings regarding increased risk of certain types of cancers, such as endometrial cancer, CVD and probable dementia No boxed warning Dosing Most require an initial induction phase of daily dosing with varying frequency thereafter Warnings: use lowest effective dose and shortest duration of treatment consistent with treatment goals Daily 1 Based on IMS SMART Tool NSP and NPA data. 2 IMS Health Plan Claims (April 2008-11). Safety concerns about estrogen- containing treatment options W O M E N ’ S H E A L T H : I N T R A R O S A

Leverages AMAG’s Current Commercial Platform  Leverage existing AMAG commercial and medical affairs teams - Deep relationships and experience with the OB/GYN community and women’s health KOLs - Successful patient access and commercial analytics platform - Strong record of consistent growth (40% in 2016) across current product portfolio - Significant experience building market awareness for new therapeutics and patient support programs  Expand current women’s health sales force - Targeting ~25,000 OB/GYNs across the country - Dedicated new ~150-person team focused on the launch of Intrarosa - Maintain current 100-person team’s focus on Makena/CBR promotion and preparations for subcutaneous auto-injector launch1 - Future sales force flexibility as portfolio evolves (e.g., launch of Rekynda)  Opportunities for label expansion and lifecycle management - Female Sexual Dysfunction  Deploy digital engagement platform - Consumer education/content about novel treatment alternative to estrogen-containing therapy Preparing for mid-2017 launch of recently approved first-of-its-kind therapy W O M E N ’ S H E A L T H : I N T R A R O S A 231 If regulatory approved is received.

AMAG: At the Nexis of Key Drivers in Women’s Health Science Patients Healthcare Providers W O M E N ’ S H E A L T H : I N T R A R O S A Awareness-building capabilities and novel product create transformational opportunity  New mechanism of action  New therapeutic class  Only non-estrogen therapy with no boxed warning  Proven experience  Expanded share of voice  Broad patient access  Congress engagement  Ease of application  Patient assistance and affordability programs  Digital awareness & engagement 24

• $50M upfront cash payment and 600K shares of AMAG stock • Up to $10M on delivery of commercial supply for launch • $10M on the first anniversary of the effective date of the agreement • Sales milestones • $15M payment when net sales exceed $150M annually • $30M payment when net sales exceed $300M annually • $850M of payments triggered at various net sales levels exceeding $500M annually • Tiered royalties as a percent of net sales starting at mid-teens Intrarosa: Designed to Build Long-Term Shareholder Value 25 Transaction • Licensed U.S. rights from Endoceutics, a private pharmaceutical company based in Quebec City, Canada • Founded by Fernand Labrie, MD, PhD, a world-renowned endocrinologist • Endoceutics research/development focused in the field of women’s health • Endoceutics will supply product to AMAG Licensor • Hart-Scott-Rodino (HSR) review • Expect to close transaction in first half of 2017Timing • Will co-fund Phase 3 program of Intrarosa for the treatment of female sexual dysfunctionDevelopment

Upcoming Value Drivers and Potential Product Launches Frank Thomas President and Chief Operating Officer

AMAG Portfolio: Multiple Value Drivers 27 Milestone 2017 2018 MAKENA AUTO-INJECTOR PROGRAM Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Topline PK data sNDA submission Expected FDA action and commercial launch FERAHEME IDA LABEL EXPANSION Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Enrollment completed Topline data sNDA submission Expected FDA action and commercial launch INTRAROSA Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Commercial launch in dyspareunia Initiate Phase 3 female sexual dysfunction study REKYNDA Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 NDA submission Expected FDA action and commercial launch VELO – SEVERE PREECLAMPSIA Initiate Phase 2b/3a study  

Key Product Launch Milestones 28 Makena subcutaneous auto-injector Velo (severe preeclampsia) IDA (non-CKD) R ev e nu e Today 2017 2018 2019 2020 5 Potential Product Launches over Next 4 Years

AMAG Pharmaceuticals Q&A February 14, 2017

Appendix

Reconciliation of GAAP to Non-GAAP 2016 Results 31 ($M) GAAP operating income Purchase accounting adjustments related to CBR deferred revenue Non-cash collaboration revenue Depreciation & intangible asset amortization Inventory reserve Non-cash inventory step-up adjustments Stock-based compensation Adjustments to contingent consideration Option rights to license orphan drug Impairment charges of intangible assets Transaction-related costs Restructuring costs Non-GAAP adjusted EBITDA 4Q-2016 4Q-2015 $14.6 22.7 1.4 11.8 -- -- 29.1 16.9 -- 1.0 1.0 0.9 5.7 5.7 20.6 (0.3) -- -- 3.7 -- 1.3 0.2 0.0 2.4 $77.4 $61.3 2016 2015 $78.9 $111.2 17.0 19.1 -- (40.0) 94.2 57.5 -- 1.0 5.7 12.8 22.5 17.2 25.7 4.3 -- 10.0 19.7 -- 1.3 13.8 0.7 6.5 $265.7 $213.4

Share Count Reconciliation 32 (M) Weighted average basic shares outstanding Employee equity incentive awards Convertible notes Warrants GAAP diluted shares outstanding Employee equity incentive awards Convertible notes Effect of bond hedge and warrants Non-GAAP diluted shares outstanding 4Q-2016 4Q-2015 34.3 34.7 --1 0.7 --1 7.4 --1 --1 34.3 42.8 0.8 -- -- -- -- (1.2) 35.1 41.6 2016 2015 34.3 31.5 --1 1.4 --1 --1 --1 2.4 34.3 35.3 0.5 -- -- 7.4 -- (3.5) 34.8 39.2 1 Employee equity incentive awards, convertible notes and warrants would be anti-dilutive in this period utilizing the “if-converted” method, which adjusts net income for the after-tax interest expense applicable to the convertible notes. 2 Reflects the Non-GAAP dilutive impact of employee equity incentive awards and convertible notes. 3 Reflects the impact of the non-GAAP benefit of the bond hedge and warrants. 2 2 2 33

AMAG Pharmaceuticals 2016 Financial Results and Intrarosa License Agreement February 14, 2017

EX-99.3

FOR IMMEDIATE RELEASE

AMAG AND ENDOCEUTICS ENTER INTO AN EXCLUSIVE U.S. LICENSE AGREEMENT FOR INTRAROSA^TM (PRASTERONE)

Recently approved first-of-its-kind, non-estrogen prescription therapy for a common symptom of menopause

Conference call scheduled for 8 a.m. ET today

WALTHAM, Mass. and Quebec, Canada (February 14, 2017) - AMAG Pharmaceuticals, Inc. (Nasdaq: AMAG) and Endoceutics, Inc. today announced that they have entered into an exclusive license agreement that provides AMAG with U.S. commercial rights to Intrarosa^TM (prasterone). Intrarosa is the only FDA-approved, locally administered, daily, non-estrogen product for the treatment of moderate-to-severe dyspareunia (pain during intercourse), a common symptom of vulvar and vaginal atrophy (VVA), due to menopause. Unlike conventional pharmacological estrogen-containing medications, Intrarosa does not carry a boxed safety warning in its label.

“AMAG is pleased to add another product to its expanding women’s health portfolio and to work with Endoceutics founder Dr. Fernand Labrie, a world-renowned endocrinologist who led the development of this innovative treatment approach,” said William Heiden, chief executive officer of AMAG. “Intrarosa will address a compelling unmet medical need for post-menopausal women suffering today from moderate-to-severe dyspareunia who are interested in alternatives to their current treatment or most of whom choose to go untreated due to safety concerns about conventional synthetic estrogen-containing therapies. We look forward to introducing this new, differentiated therapy to women and their healthcare providers.”

The transaction represents a further expansion into women’s health and is an important step in continuing to execute AMAG’s growth strategy. Earlier this month, AMAG announced the closing of a license agreement with Palatin Technologies, Inc., for the exclusive North American rights to develop and commercialize Rekynda^TM (bremelanotide), a potential novel treatment for hypoactive sexual desire disorder, the most common form of female sexual dysfunction (FSD). The addition of these two products will allow AMAG to address key needs across the continuum

of women’s healthcare, with three potential new product launches over the next two years, starting with Intrarosa in 2017, followed by the Makena subcutaneous auto-injector and Rekynda, if approved.

Intrarosa enters an existing billion dollar-plus market for intravaginal prescription therapies that treat VVA symptoms. There are an estimated 64 million post-menopausal women in the U.S., and as many as 32 million women suffer from VVA symptoms.¹ Studies suggest that between 44 percent and 78 percent of women with VVA suffer from dyspareunia.^2,3 According to patient survey data, more than half of women who report symptoms of dyspareunia are not currently being treated with a prescription therapy or seeking treatment.⁴ 

Intrarosa contains prasterone, a precursor of hormones that is converted locally inside the vaginal cells into androgens and estrogens with no meaningful increases detected in the blood. Intrarosa does not carry the boxed warnings currently included in the labels of conventional estrogen-containing medications which highlight the increased risk of certain types of cancers, such as endometrial cancer, as well as cardiovascular disorders and probable dementia. While Intrarosa is currently approved for the treatment of moderate-to-severe dyspareunia, Endoceutics and AMAG have agreed to co-develop the product as a potential treatment for FSD in post-menopausal women.

“As a non-estrogen containing treatment, Intrarosa is a novel vaginal prescription therapy that provides an important alternative for patients with moderate-to-severe dyspareunia, a common symptom of post-menopausal VVA,” said Dr. Fernand Labrie, founder and chief executive officer of Endoceutics. “Intrarosa stimulates the body’s natural ability to produce hormones locally and thus significantly reduces pain during intercourse. Because Intrarosa does not contain estrogen, patients may feel more comfortable seeking treatment than with synthetic traditional estrogen-containing hormone therapies.”

“Endoceutics is committed to ensuring that Intrarosa becomes the standard of care for the treatment of VVA. In addition to AMAG’s investments in the success of Intrarosa, Endoceutics plans to put an additional $20 million toward supporting educational programs in 2017,” Dr. Labrie continued.

AMAG will be expanding its women’s health sales force beyond the ​current​ 100-person​ ​ Makena​- and CBR-focused team with approximately 150 additional sales representatives dedicated to the commercialization of Intrarosa. This expanded sales force will allow AMAG to call on a larger number of OB/GYNs, as well as provide AMAG with future sales force deployment flexibility in women’s health, such as the potential launch of Rekynda in early 2019. AMAG expects to launch Intrarosa in the U.S. in mid-2017.

“Three Orange Book-listed patents with terms out to 2031, a sizeable untapped market and overlap with our current physician call points make Intrarosa an excellent strategic opportunity for AMAG that will help drive growth and sustained shareholder value,” said Frank Thomas, president and chief operating officer of AMAG. “The additions of FDA-approved Intrarosa and recently licensed Rekynda will meaningfully add to our expanding women’s health portfolio.

AMAG’s strong cash position, combined with the cash-generating potential of our current businesses, puts us in an excellent position to continue to pursue additional acquisition and licensing opportunities.”

Transaction Details

Under the terms of the license agreement, AMAG will receive the right to commercialize and develop Intrarosa in the U.S. for the treatment of VVA and FSD. At closing, AMAG will pay Endoceutics $50 million of total upfront consideration and issue Endoceutics 600,000 unregistered shares of AMAG common stock. In addition, AMAG will pay Endoceutics up to $10 million upon delivery of adequate launch quantities of Intrarosa and $10 million upon the first anniversary of the effective date of the agreement. Endoceutics will be entitled to certain sales milestone payments, including a first sales milestone payment of $15 million, which would be triggered when Intrarosa annual net U.S. sales exceed $150 million, and a second milestone payment of $30 million, which would be triggered when annual net U.S. sales exceed $300 million. Should annual net U.S. sales exceed $500 million, there are additional sales milestone payments of up to $850 million, which would be triggered at various sales thresholds. AMAG will also pay Endoceutics tiered royalties as a percent of Intrarosa net sales ranging from the mid-teens (for calendar year net sales up to $150 million) to the mid-twenties (for any calendar year net sales that exceed $1 billion). At closing, AMAG and Endoceutics will also enter into a supply agreement, under which Endoceutics will supply Intrarosa to AMAG.

AMAG has also committed to co-fund a Phase 3 clinical program, which would be conducted by Endoceutics to support regulatory approval of Intrarosa for the treatment of certain types of FSD in post-menopausal women. The direct costs of the potential FSD label expansion study will be shared equally by the parties and capped at up to $20 million for AMAG. The transaction does not include the transfer of any Endoceutics employees or facilities.

The license transaction is expected to close in the first half of 2017 and is subject to customary closing conditions, including U.S. antitrust approval.

Advisors

EVOLUTION Life Science Partners LLC, a division of Gordian Investments, LLC acted as advisor to Endoceutics.Goodwin Procter LLP served as AMAG’s legal advisor on the transaction and Cooley LLP served as legal advisor to Endoceutics.

Conference Call and Webcast Access

AMAG Pharmaceuticals, Inc. will host a conference call and webcast today at 8:00 a.m. ET to discuss the Intrarosa license agreement, as well as the company's 2016 financial results announced today in a separate news release.

Dial-in Number

U.S./Canada Dial-in Number: (877) 412-6083

International Dial-in Number: (702) 495-1202

Conference ID: 65936323

Replay Dial-in Number: (855) 859-2056

Replay International Dial-in Number: (404) 537-3406

Conference ID: 65936323

A telephone replay will be available from approximately 11:00 a.m. ET on February 14, 2017 through midnight on February 21, 2017.

The webcast with slides will be accessible through the Investors section of AMAG’s website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.

About Intrarosa^TM (Prasterone)

Intrarosa is the only FDA-approved, locally administered, daily non-estrogen steroid for the treatment of moderate-to-severe dyspareunia (pain during intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa contains prasterone, also known as dehydroepiandrosterone (DHEA). Prasterone is an inactive endogenous steroid, which is converted locally into androgens and estrogens to help restore the vaginal tissue as indicated by improvements in the percentage of superficial cells, parabasal cells, and pH. The mechanism of action is not fully established.

In two primary 12-week placebo-controlled efficacy trials, women taking Intrarosa experienced a significant reduction in dyspareunia, as well as significant improvements in the percentage of vaginal superficial cells and parabasal cells, as well as vaginal pH. In clinical trials, the most common adverse reactions were vaginal discharge and abnormal pap smear. Intrarosa has not been studied in women with a history of breast cancer.

About AMAG

AMAG is a biopharmaceutical company focused on developing and delivering important therapeutics, conducting clinical research in areas of unmet need and creating education and support programs for the patients and families we serve. Our currently marketed products support the health of patients in the areas of women’s health, anemia management and cancer supportive care. Through CBR®, we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders, and have the potential to play a valuable role in the ongoing development of regenerative medicine. For additional company information, please visit www.amagpharma.com. 

About Endoceutics

Endoceutics is a private pharmaceutical company operating in the field of women’s health and hormone-sensitive cancer prevention and treatment. Endoceutics research focuses on developing non estrogen-based therapies for vulvar and vaginal atrophy, sexual dysfunction and the other symptoms of menopause, including hot flashes, osteoporosis, muscle loss and type 2 diabetes. Hormonal therapies for breast, uterine and prostate cancer, male hypogonadism as well as endometriosis are also under development.

Endoceutics has five Phase 3 product candidates addressing large market opportunities and two Phase 1/2 product candidates. Endoceutics has exclusive worldwide rights to patents, patent applications, technology and know-how related to all its products.

Forward-Looking Statements

This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. 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, among others, statements regarding AMAG’s anticipated further expansion in and commitment to women’s health through the licensing transaction with Endoceutics, Inc., including beliefs that AMAG will serve key needs across the continuum of women’s healthcare; the ability of Intrarosa to treat moderate-to-severe dyspareunia; beliefs as to the timing of the commercial launch of Intrarosa, the Makena subcutaneous auto-injector and Rekynda; beliefs regarding Intrarosa’s potential benefits and market opportunity; whether patients may feel more comfortable seeking treatment with Intrarosa than with traditional estrogen-containing hormone therapies; AMAG’s commercialization launch strategy of Intrarosa, including its plans to invest significantly and expand its existing sales force; the ability of patents covering Intrarosa and AMAG’s current physician call points to make Intrarosa a growth opportunity that drives shareholder value; expected investments by Endoceutics in education programs in 2017; the ability to execute future acquisition and licensing opportunities; anticipated clinical development plans and costs for Intrarosa to support regulatory approval of FSD; expected timing for the closing of the transaction; the timing and amounts of future milestone payments; expected investment amounts by AMAG in the potential FSD label expansion and beliefs that newborn stem cells have the potential to play a valuable role in the development of regenerative medicine 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, among others, (1) the possibility that the closing conditions set forth in the License Agreement, including, those related to antitrust clearance, will not be met and that the parties will be unable to consummate the proposed transactions; (2) the possibility that AMAG will not realize the expected benefits of the transaction, including the anticipated market opportunity and the ability of its current or expanded sales force to successfully commercialize Intrarosa; (3) the possibility that significant safety or drug interaction problems could arise with respect to Intrarosa; (4) the ability of AMAG to drive awareness of dyspareunia and the potential benefits of Intrarosa; (5) uncertainties regarding the manufacture of Intrarosa; (6) uncertainties relating to patents and proprietary rights associated with Intrarosa in the United States; (7) that the cost of the transaction to AMAG will be more than planned and/or will not provide the intended positive financial results; (8) that AMAG or Endoceutics will fail to fully perform their respective obligations under the License Agreement or the Supply Agreement; (9) uncertainty regarding AMAG’s ability to compete in the dyspareunia market in the United States; and (10) other risks identified in AMAG’s Securities and Exchange Commission (“SEC”) filings, including its Annual Report on Form 10-K for the year ended December 31, 2015, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016, June 30, 2016 and September 30, 2016 and subsequent filings with the SEC, including

its Current Reports on Form 8-K filed with the SEC on January 9, 2017 and February 3, 2017, as well as in its upcoming Annual Report on Form 10-K for the year ended December 31, 2016. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.

CONTACT:

Investors:

Linda Lennox

Vice President, Investor Relations

908-627-3424

Media:

Katie Payne

Vice President, External Affairs

202-669-6786

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¹ Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive Health 2014:8 23-30.

² Ibid.

³ F. Palma et al: Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study.
⁴ Multiple publications based on patient surveys.