Document
false0000792977 0000792977 2020-01-06 2020-01-06



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): January 6, 2020
https://cdn.kscope.io/2ef2720a9b30824bd3f6bd40e7501e8a-amag_rgb.jpg
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 Street,
Waltham,
Massachusetts
 
02451
(Address of Principal Executive Offices)
 
(Zip Code)

(617) 498-3300
(Registrant’s telephone number, including area code)

(Former name or 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:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each class
 
Trading Symbol(s)
 
Name of each exchange on which registered
Common Stock, par value $0.01 per share
 
AMAG
 
NASDAQ Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company  
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

1



Item 2.02. Results of Operations and Financial Condition.
 
The information in this Item 2.02, including Exhibits 99.1 and 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 it 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 January 9, 2020, AMAG Pharmaceuticals, Inc. (“AMAG” or the “Company”) issued a press release providing a business update, including preliminary unaudited fourth quarter and annual 2019 financial results and financial guidance for 2020. A copy of the Company’s press release is furnished herewith as Exhibit 99.1. 

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On January 9, 2020, AMAG also announced that William Heiden plans to step down from his positions as AMAG’s President and Chief Executive Officer. AMAG’s Board of Directors (the “Board”) will be initiating a search for a successor, and it is expected that Mr. Heiden will remain in his roles until the earlier of such time as his successor is appointed and June 30, 2020 (the earlier of which, the “Separation Date”). The Company also announced that, effective immediately, Ted Myles, AMAG’s Chief Financial Officer, has been appointed to also serve as the Company’s Chief Operating Officer and Joseph Vittiglio, AMAG’s General Counsel, will also serve as the Company’s Chief Business Officer.

In connection with the transition described above, Mr. Heiden and the Company entered into a separation letter, dated January 7, 2020, pursuant to which Mr. Heiden will continue to serve as President and Chief Executive Officer, and as a member of the Board, until the Separation Date. Following the Separation Date, and subject to certain conditions, including the Company’s receipt of an effective release and waiver of claims from Mr. Heiden, Mr. Heiden will be entitled to 24 months of salary continuation, as well as accelerated vesting on all time-based stock options and other time-based equity awards to the extent such awards would have vested had he been employed for an additional 24 months following the Separation Date, in each case as provided in his employment agreement with the Company, dated February 7, 2014 and as amended on November 29, 2017 and January 1, 2018. Mr. Heiden will also be entitled to certain other benefits as provided in the separation letter, including a pro-rated bonus for the 2020 fiscal year (to be paid in 2021 based on actual performance at such time as 2020 bonuses are distributed to AMAG employees), the ability to exercise any outstanding stock options for a period of 180 days following the Separation Date, 12 months of COBRA coverage and reimbursed legal expenses in connection with the separation. Even if his actual last date of employment occurs prior to March 16, 2020, Mr. Heiden will be entitled to these benefits as though his Separation Date were March 16, 2020.

The foregoing description of the separation letter is not complete and is qualified in its entirety by reference to the letter, which is filed as Exhibit 10.1 to this Current Report on Form 8-K.

Biographical information for Mr. Myles and Mr. Vittiglio can be found beginning on page 30 of the Company’s definitive proxy statement filed with the U.S. Securities and Exchange Commission on September 20, 2019. AMAG has not determined any new or amended compensation arrangements with Mr. Myles or Mr. Vittiglio in connection with their new roles at this time. In the event any such arrangements are made or modified, AMAG will file an amendment to this report within four business days thereof.

Item 7.01. Regulation FD Disclosure. 

The information in this Item 7.01, including Exhibit 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing. The Company will present further details on the matters noted above at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on January 16, 2020, which presentation will be accessible by a live audio webcast through the Company’s website at www.amagpharma.com on January 16, 2020 at 9:30 a.m. Pacific Time (12:30 p.m. Eastern Time). During the conference, the Company intends to conduct meetings with third parties during which a corporate slide presentation will be presented. A copy of the Company’s slide presentation, which will be referenced during the conference, including the Company’s webcast presentation, is furnished herewith as Exhibit 99.2. 






2



Item 9.01. Financial Statement and Exhibits.

(d) Exhibits.





3



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
Chief Business Officer, General Counsel & Corporate Secretary
 
Dated:
January 9, 2020




4
Exhibit



January 7, 2020


Dear Bill:
This letter follows our recent discussions about your employment as president and chief executive officer of AMAG Pharmaceuticals, Inc. (together with its subsidiaries and affiliates, “AMAG” or the “Company”).
After discussions with your fellow directors, including the chairman of the Board, you and the rest of the Board have agreed that your employment with AMAG will end after an active transition period. For purposes of this letter, the time period between the date of this letter and the Termination Date (as defined below) will be the “Transition Period.” During the Transition Period, the Board will be conducting a search for your successor and you will continue in your role as a director and as the President and Chief Executive Officer of AMAG.
During the Transition Period you will continue to receive your current base salary, participate in AMAG’s benefit plans, and vest in all equity awards in accordance with the terms thereof (including that performance-based restricted stock unit award scheduled to vest on February 22, 2020 (the “2017 PSU Award”), which shall vest based on actual performance), and you will remain eligible to receive a bonus for the 2019 fiscal year (the “2019 Bonus”). Appendix A hereto lists your equity awards that are subject to further vesting.
It is currently anticipated that the last day of your employment and service on the Board will be the earlier of (x) June 30, 2020, and (y) the date your successor is appointed, provided either you or the Board may elect to end your employment and service on an earlier date. In any event, the last day of your employment shall be the “Termination Date” for purposes of this letter, and such termination shall be deemed a termination without Cause for purposes of your employment agreement with AMAG, dated February 7, 2014 and amended on November 29, 2017 and January 1, 2018 (the “Employment Agreement”).
Accordingly, you will be entitled to the earned but unpaid amounts set forth in Section 5(a) of your Employment Agreement and, assuming you satisfy the conditions in Section 5(b) of the Employment Agreement (the “Severance Conditions”), you will be entitled to (i) the severance pay and benefits set forth in such Section 5(b), (ii) if not previously paid, the 2019 Bonus you would have received had your employment not ended prior to the date on which bonuses for the 2019 fiscal year are paid to AMAG employees (to be paid to you on such date), (iii) a pro-rated bonus for the 2020 fiscal year (to be paid in 2021 at such time as 2020 bonuses are distributed to AMAG employees), based on the number of days you were employed during 2020, a target bonus of 85% of your current base salary, and AMAG’s performance versus goals in 2020, and (iv) provided you are eligible for and elect to continue receiving group health insurance pursuant to COBRA, 12 months of continued payments by the Company for the share of the premiums for such coverage that the Company currently pays on your behalf. Further, notwithstanding anything to the contrary in any of your award agreements, you shall be entitled to exercise your vested and outstanding stock options (including those in which you have vested pursuant to Section 5(b) of the Employment Agreement)





for a period of 180 days following the later of (x) your Termination Date, and (y) the Early Termination Date (as defined below); provided, however, that in no event may any stock option award be exercised beyond the original maximum term of such award.
If the Board elects to end your employment such that the Termination Date is prior to March 16, 2020 (the “Early Termination Date”), and provided you satisfy each of the Severance Conditions, in addition to the foregoing amounts and benefits, the Company will (a) pay to you a lump sum payment equal to the base salary you would have received between your Termination Date and the Early Termination Date had you remained employed by the Company through the Early Termination Date, and (b) deem you to have vested in (and accelerate the vesting of) all equity awards that would have vested between your Termination Date and the Early Termination Date had you remained employed by the Company through the Early Termination Date (including, if then unvested, the 2017 PSU Award, which shall vest based on actual performance). In addition, in such event the Early Termination Date shall, for purposes of Section 5(b) of the Employment Agreement, be the date of termination of your employment for purposes of calculating the 24 months of vesting of all time-based stock options and other time-based equity awards you hold.
This letter shall serve as written notice under Section 4(d) of the Employment Agreement, and no further notice under such section shall be required. The Company agrees to reimburse you up to $15,000 in legal fees in connection with the matters addressed in this letter, including, for the avoidance of doubt, the negotiation of this letter agreement.
The Board sincerely thanks you for your contributions over the years and looks forward to a collaborative and productive transition period, followed by an amicable departure.

Very truly yours,
/s/ James Sulat
 
 
 
James Sulat
 
 
 
 
 
 
 
 
 
 
Accepted and acknowledged,
 
 
 
 
 
 
 
/s/ William K. Heiden
 
 
 
William K. Heiden












Appendix A
 
Grant Date
Type
Exercise Price
Original Grant
 
2/25/2019
Option
$15.51
70,000
 
3/2/2018
Option
$21.00
100,000
 
2/23/2017
Option
$23.75
65,000
 
3/1/2016
Option
$25.18
85,000
 
* Options vest over 4 years; 25% upon the 1st anniversary of the date of grant and quarterly thereafter. Option awards are subject to vest for 24 months following the date of termination for a termination without Cause, accelerated upon the release becoming non-revocable.
 
 
RSUs
 
 
 
 
Grant Date
Type
 
Original Grant
 
2/25/2019
RSU
 
31,000
 
3/2/2018
RSU
 
45,500
 
2/23/2017
RSU
 
30,000
 
* RSUs vest over 3 years, in three equal annual installments following the grant date. RSU awards are subject to vest for 24 months following the date of termination for a termination without Cause, accelerated upon the release becoming non-revocable.
 
 
PSUs
 
 
 
 
Grant Date
Type
 
Original Grant
 
2/23/2017
PSU
 
55,000
 
* PSUs vest as of the day immediately prior to the 3rd anniversary of the Grant Date. The amount above reflects the target award, although the award may be earned between 50-150%, depending upon the Company’s TSR relative to its peer group (and subject to a minimum performance threshold, below which no portion of the award would be earned). PSU awards are not subject to further vesting following the date of termination for a termination without Cause and therefore the PSU awards granted in 2018 and 2019 have been excluded from this schedule as such awards will not be subject to any vesting.
 


Exhibit


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FOR IMMEDIATE RELEASE

AMAG Pharmaceuticals Announces Leadership Transition, Results of Strategic Review
to Unlock Shareholder Value and Financial Update
Initiating CEO transition plan
Divesting Intrarosa® and Vyleesi®
2020 financial guidance reflects reduction in annual operating expenses of more than
$100M and a return to positive adjusted EBITDA

WALTHAM, Mass., January 9, 2020 – AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced the initiation of a leadership transition, the decision to divest Intrarosa and Vyleesi and financial updates.

Leadership Transition & Business Updates
AMAG announced that William Heiden plans to step down as AMAG’s President and Chief Executive Officer, and that the Company’s Board of Directors will immediately initiate a search for his successor, which it expects to complete by mid-2020. Mr. Heiden will remain in his role as President and CEO until a successor is appointed.

AMAG also recently completed a robust review of its product portfolio and strategy and engaged Goldman Sachs and Co., LLC as its financial advisor to assist in the review. The guiding principles for this strategic review included driving near- and long-term profitability and enhancing shareholder value. As a result of this review, AMAG will divest Intrarosa® (prasterone) and Vyleesi® (bremelanotide). The Company has received preliminary expressions of interest to acquire/sub-license the rights to these products. AMAG’s 2020 financial guidance indicates a return to positive adjusted EBITDA, reflecting the continued growth of Feraheme® (ferumoxytol injection) and a significant reduction in operating expenses, primarily associated with the divestiture of Intrarosa and Vyleesi. The 2020 revenue guidance reflects a range of potential revenue scenarios for Makena® (hydroxyprogesterone caproate injection) given the uncertainty caused by the FDA Advisory Committee meeting and soft fourth quarter results.

“The strategic decisions announced today will allow AMAG to leverage its commercial strengths and proven development and regulatory capabilities while focusing on core value drivers: developing ciraparantag and AMAG-423; driving the continued growth of Feraheme, which funds our two pipeline assets; and continuing our work to retain patient access to Makena,” said Mr. Heiden. “It has been an honor and a privilege to lead the team at AMAG. We've achieved numerous successes and overcome many challenges. As we implement the strategic shift announced today, my fellow directors and I believe that this is the right time for the board to identify a new CEO for the next leg of AMAG’s journey.”

Mr. Heiden added, “We continue to believe in the significant long-term potential of Intrarosa and Vyleesi. However, the uncertainty around the long-term durability of Makena revenues makes it challenging to invest in both our promising pipeline and in the physician and consumer marketing required to support these two new products. Given the significant future commercial potential of ciraparantag and AMAG-423 to fulfill unmet medical needs of patients, AMAG made the difficult decision to divest Intrarosa and Vyleesi. The Company is seeking a transaction with a party that can make the investments necessary to maximize the value of these two important women’s healthcare products.”




In addition to the announced CEO transition, Chief Financial Officer Ted Myles will assume the additional role of Chief Operating Officer, effective immediately, expanding his responsibilities to include technical operations, global supply chain and quality. General Counsel Joseph Vittiglio will assume the additional role of Chief Business Officer, focusing on managing the divestiture of Intrarosa and Vyleesi and out-licensing opportunities in ex-U.S. territories, primarily for AMAG’s development-stage programs.

Gino Santini, Chairman of AMAG’s Board, said, “The Board is committed to pursuing strategies that will unlock value for AMAG shareholders and better leverage the Company’s strengths and proven capabilities. We are confident that taking the strategic actions announced today will position AMAG for future growth and enable the Company to better serve patients.”

Mr. Santini continued, “The Board would like to thank Bill for his visionary leadership, transforming AMAG from a single-product company to one with an in-house clinical development team that has gained three FDA product approvals in the last two years, and is progressing two late-stage development products through the regulatory process. For nearly eight years, Bill developed and executed on strategies to invest in products that have benefited hundreds of thousands of patients and which hold the potential of reaching many more in the future. The Board looks forward to working with Bill on a seamless transition, as well as continuing to work with AMAG’s outstanding executive leadership team to drive near- and long-term results.”

Preliminary 2019 Financial Results and 2020 Financial Guidance
AMAG announced preliminary unaudited fourth quarter and full year 2019 financial results and provided 2020 financial guidance, reflecting the Company’s focus on profitability in 2020. The Company expects to report final financial results for the fourth quarter and audited results for the full year of 2019 in early March.

Preliminary, Unaudited Fourth Quarter Financial Results

 
($M)
Three Months Ended December 31,
 
2019 Preliminary
 
 
2018 Actual

Total revenues, net
$86 - $91
 
 

$88.1

Feraheme
40 - 42
 
 
35.2

Makena
24 - 27
 
 
46.9

Intrarosa
6.5
 
 
5.9

Other product revenue
(0.50)
 
 
0.1

   Collaboration revenue
16
 
 
--

Operating loss
($22) - ($12)
 
 

($18.80
)
Non-GAAP adjusted EBITDA
($10) - $0
 
 

$1.5



__________________________
1 Includes the recognition of $16M of collaboration revenue due to the termination and settlement agreement entered into with Daiichi Sankyo, Inc. (DSI) in December 2019 related to a clinical trial collaboration agreement that AMAG acquired as part of the Perosphere acquisition. As part of the settlement, AMAG received $10M in cash from DSI in December 2019. 
2 Operating loss does not include the impact of material impairment charges or the associated acceleration of amortization, which are likely to be recognized in the 2019 audited financial statements.
3 See reconciliation of GAAP to non-GAAP preliminary financial results at the conclusion of this press release.




Preliminary, Unaudited Full Year Financial Results

 
($M)
Twelve Months Ended December 31, 2018
 
2019 Preliminary
 
 
2018 Actual

Total revenues, net
$324 - $329
 
 

$474.0

Feraheme
167 - 169
 
 
135.4

Makena
120 - 123
 
 
322.3

Intrarosa
21
 
 
16.2

Other product revenue
(1)
 
 
0.1

   Collaboration revenue1
16
 
 
--

Operating loss2
($274) - ($264)
 
 

($47.00
)
Non-GAAP adjusted EBITDA3
($70) - ($60)
 
 

$120.8


The Company ended 2019 with approximately $170 million in cash and investments and $320 million of 2022 convertible notes (principal amount outstanding).

Key priorities for 2020 include:
Complete successful CEO transition
Divest Intrarosa and Vyleesi to align with the new strategic direction
Drive continued Feraheme growth
Work with the FDA to maintain patient access to Makena
Advance ciraparantag and AMAG-423 development programs
Pursue ex-US portfolio partnering opportunities
Meet/exceed financial guidance
2020 Financial Guidance4
 
 
 
($M)
 
 
 
Total revenue
 
 
$230 - $280
Operating income
 
 
$2 - $32
Non-GAAP adjusted EBITDA
 
 
$20 - $50

Mr. Myles stated, “With the divestiture of Intrarosa and Vyleesi and the associated expense reductions, the AMAG of 2020 will be more streamlined and focused to drive Feraheme growth, support the development of our two pipeline assets and deliver positive adjusted EBITDA. While we remain committed to working with the FDA to maintain patient access to Makena, we will be managing Makena-related expenses so that the product is cash flow positive. Our financial guidance includes a reduction of operating expenses of more than $100 million in 2020 relative to 2019. We believe our 2020 plan, including the revised capital allocation strategy, maintains our strong commitment to patients and best positions AMAG to generate sustainable, long-term shareholder value.”

INFORMATION FOR LIVE AUDIO WEBCAST AT THE 38TH J.P. MORGAN HEALTHCARE CONFERENCE
The Company will provide a live update at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 16, 2020 at 9:30 a.m. PT (12:30 p.m. ET). A live audio webcast of the presentation and the

4 See reconciliations of 2020 GAAP to non-GAAP financial guidance at the conclusion of this press release. 2020 financial guidance reflects management’s current assumptions about the potential impact of multiple scenarios across our product portfolio, including (i) various potential regulatory outcomes related to Makena and (ii) that the divestitures of Intrarosa and Vyleesi will be reported in discontinued operations for accounting purposes in 2020. Therefore, 2020 financial guidance excludes revenue and expenses related to Intrarosa and Vyleesi.




following breakout session will be accessible in the Investors section of AMAG’s website at www.amagpharma.com. on January 16, 2020 at 9:30 a.m. PT (12:30 p.m. ET). Following the conference, the webcast will be archived on the Company’s website until February 17, 2020.

USE OF NON-GAAP FINANCIAL MEASURES 
AMAG has presented certain non-GAAP financial measures, including non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization). These non-GAAP financial measures exclude certain amounts, expenses or 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. 
 
ABOUT AMAG 
AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas, including women’s health. For additional company information, please visit www.amagpharma.com. 

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 that the leadership transition and divestiture of Intrarosa and Vyleesi will allow AMAG to leverage its commercial strengths and development and regulatory capabilities and position AMAG for future growth; expectations for the leadership transition, including the timing to complete the CEO search; plans to work with the FDA regarding patient access to Makena; beliefs related to the significant long-term potential of Intrarosa and Vyleesi and the significant future commercial potential of AMAG-423 and ciraparantag; expectations that AMAG will return to positive adjusted EBITDA and be able to unlock shareholder value; plans to reduce operating expenses; beliefs that Feraheme revenues will continue to grow; expectations that AMAG’s full year 2019 revenues and adjusted EBITDA will be within its most recently issued financial guidance range; 2019 preliminary fourth quarter and full year financial results, including revenues, operating loss and adjusted EBITDA; AMAG’s 2020 key priorities, including expectations and beliefs regarding (i) AMAG’s ability to successfully achieve benefits from its leadership transition plan, including managing the search for and transition to a new chief executive officer, (ii) AMAG’s ability to successfully divest Intrarosa and Vyleesi and the effect and amount of associated expense reductions, (iii) AMAG’s ability to drive continued Feraheme growth sufficient to support AMAG’s development programs, (iv) AMAG’s ability to ensure continued patient access to Makena and that Makena is cash flow positive in 2020, (v) AMAG’s pipeline, including AMAG-423 and ciraparantag, (vi) AMAG’s ability to successfully out-license its products or product candidates in ex-U.S. territories and (vii) AMAG’s ability to meet or exceed its 2020 financial guidance; 2020 financial guidance, including total revenue, operating income and positive adjusted EBITDA, and the related assumptions used to determine the guidance ranges, including various potential regulatory outcomes for Makena and the treatment of Vyleesi and Intrarosa as discontinued operations; and plans to report final, audited 2019 financial results in late February or early March 2020; 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, the risk that AMAG will be unable to successfully divest Intrarosa and Vyleesi or that the effect and amount of expense reductions associated with the planned divestments will be less than anticipated, or that cash expenditures will be greater than anticipated; the risk that the FDA will recommend that Makena be removed from the market, particularly in light of the recommendation of the Advisory Committee of the FDA; the risk that, even if the FDA does not recommend that Makena be removed from the market, sales of Makena will continue to be negatively impacted, including as a result of the recommendation of the Advisory Committee; the risk that AMAG will be unable to successfully achieve the anticipated benefits from its leadership transition plan; the possibility that AMAG will encounter challenges retaining or attracting talent; the risk that AMAG may be unable to gain approval of its product candidates, including AMAG-423 and ciraparantag, on a timely basis, or at all; the potential for such approvals, if obtained, to include unanticipated restrictions or warnings; the risk that the costs and time investments for AMAG’s development efforts will be higher than anticipated; the possibility that AMAG has over-estimated the market and potential revenues for its products and product candidates, if approved, including AMAG-423 and ciraparantag; the risk that Feraheme and Makena will not achieve the level of revenues needed to support AMAG’s development efforts, including because (i) such efforts require greater costs than anticipated, (ii) because approval of any such products is withdrawn, (iii) the FDA takes other adverse action with respect to any such products or (iv) Sandoz Inc. launches a generic version of Feraheme in accordance with the 2018 settlement agreement we entered into with Sandoz; the risk that AMAG will be unable to successfully identify and enter into partnerships with out-licensees for its product candidates in ex-U.S. territories, which could delay the commercialization of those product candidates in certain geographies; the risk that AMAG will not be able to continue to execute on its business plan; the speculative nature of AMAG’s estimates as to market share for its products and potential market share for its product candidates and the risk that such estimates are inaccurate; and those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10‐K for the year ended December 31, 2018, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2019, June 30, 2019 and September 30, 2019 and subsequent filings with the SEC, which are available at the SEC’s website at www.sec.gov. Any such risks and uncertainties could materially and adversely affect AMAG’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG’s stock price. 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®, Feraheme® and Vyleesi® are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc.
 

-Tables Follow-





Reconciliation of GAAP to Non-GAAP Preliminary Financial Results
 
 
($M)
Q4-2019
Preliminary
Q4-2018
Actual
FY 2019
Preliminary
FY 2018
Actual
GAAP operating loss
($22) - ($12)

($18.80
)
($274) - ($264)

($47.00
)
Depreciation and intangible asset amortization
7.0
14.0

21.0
160.0

Non-cash inventory step-up adjustments
--
0.1

--
3.7

Stock-based compensation
5.0
5.3

18.5
19.9

Adjustments to contingent consideration
--
(0.40)

--
(49.60)

Restructuring
--
--

7.4
--

Transaction/acquisition-related costs
--
1.3

0.3
1.3

Acquired IPR&D
--
--

74.9
32.5

Asset impairment charges
--
--

82.2
--

Non-GAAP adjusted EBITDA
($10) - $0

$1.5

($70) – ($60)
120.8




Reconciliation of GAAP to non-GAAP 2020 Financial Guidance ($M)
 
GAAP operating income
$2 - $32
Depreciation
2
Stock-based compensation
16
Non-GAAP adjusted EBITDA
$20 - $50


AMAG CONTACTS:
Investors:
Linda Lennox
908-627-3424

Media:
Rushmie Nofsinger
781-530-6838
###

ex2211920
AMAG Pharmaceuticals JP Morgan 38th Healthcare Conference January 2020 © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 1


 
Forward-Looking Statements 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, 2019 preliminary fourth quarter and full year financial results, including revenues, operating loss and adjusted EBITDA; expectations related to the time to complete a CEO search and that Mr. Heiden will remain in his role until a successor is found; plans to divest Vyleesi and Intrarosa and beliefs about such products; plans to reduce operating expenses; beliefs that a streamlined portfolio and infrastructure will position AMAG for near- and long-term profitability; AMAG’s expectations that Feraheme will continue to grow and provide positive cash flow to fund its development programs; expectations that Makena will be cash flow positive in 2020; 2020 financial guidance, including forecasted GAAP operating income and positive adjusted EBITDA and the related assumptions used to determine the guidance ranges, including the various potential regulatory outcomes for Makena and the treatment of Vyleesi and Intrarosa as discontinued operations; AMAG’s expectations for its product and product candidate portfolio, including beliefs about the assumptions regarding market share and commercial potential of AMAG’s key commercial products and commercial potential of its key product candidates; plans to continue to invest in late-stage development programs and the results thereof; beliefs about the behaviors of patients and prescribers of 17P and the associated risks; beliefs about the NOAC market and that ciraparantag’s characteristics may make it the ideal reversal agent; beliefs regarding WBCT and plans for the automated coagulometer; expectations that there is a strong scientific rationale for AMAG-423; beliefs that AMAG will be able to work collaboratively with the FDA on a path forward that would allow for continued patient access to Makena; the anticipated regulatory and clinical trial timelines for ciraparantag; AMAG’s expectations regarding the potential for ex-U.S. out-licensing and partnership opportunities; and AMAG’s 2020 goals and key areas of focus, including expectations and beliefs regarding (i) AMAG’s ability to successfully achieve benefits from its leadership transition plan, including managing the search for and transition to a new chief executive officer, (ii) AMAG’s ability to successfully divest Intrarosa and Vyleesi and the effect and amount of associated expense reductions; (iii) AMAG’s ability to drive continued Feraheme growth sufficient to support AMAG’s development programs, (iv) AMAG’s ability to ensure continued patient access to Makena and that Makena is cash flow positive in 2020, (v) AMAG’s pipeline, including AMAG-423 and ciraparantag, (vi) AMAG’s ability to successfully out-license its products or product candidates in ex-U.S. territories and (vii) AMAG’s ability to meet or exceed its 2020 financial guidance 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: the risk that AMAG will be unable to successfully divest Intrarosa and Vyleesi or that the effect and amount of expense reductions associated with the planned divestments will be less than anticipated, or that cash expenditures will be greater than anticipated; the risk that the FDA will recommend that Makena be removed from the market, particularly in light of the recommendation of the Advisory Committee of the FDA; the risk that, even if the FDA does not recommend that Makena be removed from the market, sales of Makena will continue to be negatively impacted, including as a result of the recommendation of the Advisory Committee; the risk that AMAG will be unable to successfully achieve the anticipated benefits from its leadership transition plan; the possibility that AMAG will encounter challenges retaining or attracting talent; the risk that AMAG may be unable to gain approval of its product candidates, including AMAG-423 and ciraparantag, on a timely basis, or at all; the potential for such approvals, if obtained, to include unanticipated restrictions or warnings; the risk that the costs and time investments for AMAG’s development efforts will be higher than anticipated; the possibility that AMAG has over-estimated the market and potential revenues for its products and product candidates, if approved, including AMAG-423 and ciraparantag; the risk that Feraheme and Makena will not achieve the level of revenues needed to support AMAG’s development efforts, including because (i) such efforts require greater costs than anticipated, (ii) because approval of any such products is withdrawn, (iii) the FDA takes other adverse action with respect to any such products or (iv) Sandoz Inc. launches a generic version of Feraheme in accordance with the 2018 settlement agreement we entered into with Sandoz; the risk that AMAG will be unable to successfully identify and enter into partnerships with out-licensees for its product candidates in ex-U.S. territories, which could delay the commercialization of those product candidates in certain geographies; the risk that AMAG will not be able to continue to execute on its business plan; the speculative nature of AMAG’s estimates as to market share for its products and potential market share for its product candidates and the risk that such estimates are inaccurate and those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10‐K for the year ended December 31, 2018, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2019, June 30, 2019 and September 30, 2019, and subsequent filings with the SEC, which are available at the SEC’s website at www.sec.gov. Any such risks and uncertainties could materially and adversely affect AMAG’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG’s stock price. 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®, the logo and designs, Feraheme® and Vyleesi ® are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc. © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 2


 
2019 In Review 3


 
AMAG's 2019 Year In Review Option 4 Completed acquisition of Perosphere Pharmaceuticals and added ciraparantag to development portfolio Grew Feraheme to record revenue of $167M-$169M and achieved Q4 market share of 17.7%1 • IM supply disruptions resulted in removal of both brand and authorized generic Mixed year for Makena • Maintained strong Q4 market share of 63% for subcutaneous auto-injector, but experienced market contraction and price erosion post AdCom meeting 2019 • PROLONG study results and AdCom meeting challenges brand durability YEAR IN REVIEW Steadily grew Intrarosa revenue and market share Gained FDA approval of Vyleesi and commercially launched in September Advanced enrollment in Phase 2b/3a trial for orphan drug candidate AMAG-423 for severe preeclampsia 1) All data is preliminary and unaudited; Feraheme market share is based on IQVIA data and internal analytics. © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 4


 
2019 Financial Results Preliminary and unaudited ($M) Actual Preliminary Preliminary Guidance 9-months 2019 Q4-2019 FY 2019 FY 2019 Revenue Feraheme $126 $40 - $42 $167- 169 -- Makena 97 24 - 27 120 - 123 -- Intrarosa 15 6.5 21 -- Other product revenue -- (0.5) (1) -- Collaboration revenue1 -- 16 16 -- Total revenue $238 $86 - $91 $323 - $328 $320 - $330 Operating loss2 ($252) ($22) - ($12) ($274) - ($264) ($278) - ($268) Adjusted EBITDA3 ($59) ($10) - $0 ($70) - ($60) ($75) - ($65) 1) Includes the recognition of $16M of collaboration revenue due to the termination and settlement agreement entered into with Daiichi Sankyo, Inc. (DSI) in December 2019 related to a clinical trial collaboration agreement that AMAG acquired as part of the Perosphere acquisition. As part of the settlement, AMAG received $10M in cash from DSI in December 2019. 2) Operating loss does not include the impact of material impairment charges or the associated acceleration of amortization, which are likely to be recognized in the 2019 audited financial statements. 3) See slide 31 for a reconciliation of GAAP to non-GAAP financials. © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 5


 
Recently Announced News – January 9, 2020 6


 
Experienced Leadership Team Committed to Realize AMAG’s Potential Leadership Transition William Heiden will step down as • AMAG’s Board of Directors has initiated a search for his successor, which it expects to complete by mid-2020 President and Chief Executive Officer • Mr. Heiden will remain in his role until the appointment of his successor Ted Myles Julie Krop, MD Joseph Vittiglio Chief Financial Officer and General Counsel and Chief Medical Officer Chief Operating Officer Chief Business Officer • Nearly 20 years of executive leadership • More than 20 years experience in clinical • More than 25 years of experience at at several biopharma companies development and regulatory affairs with large law firm and as in-house counsel • Proven financial acumen; retired nearly history of multiple FDA approvals at several biopharma companies $1B in debt at AMAG • Experience across multiple therapeutic • Experience in complex biopharma • Deep operational and capital markets areas for both biologics and small licensing / collaborations and M&A expertise molecules • Deep legal, compliance and operational • Board certified internal medicine and expertise endocrinology and former Robert Wood Johnson Clinical Scholar Tony Casciano Kelly Schick Chief Commercial Officer Chief Human Resources Officer • 20 years experience in sales and marketing • More than 15 years of human resource across a range of therapeutic areas experience in pharmaceutical industry • Successful drug launches across multiple • Led large organization transformation and therapeutic areas change • Strategic planning and implementation • Expertise in talent management, building process of mature brands, line extensions strong corporate culture and driving and portfolio maximization in global organizational engagement organization © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 7


 
Current Portfolio Valuable but Requires Extensive Resources PHYSICIAN/CONSUMER(DTC) PHYSICIAN DRIVEN DRIVEN Hematology Maternal Health Women’s Health COMMERCIAL Divest PIPELINE Ciraparantag AMAG-423 Divest Vyleesi and Intrarosa Completed strategic review of product portfolio • Vyleesi launch is off to a strong start and strategy to unlock shareholder value and return to positive adjusted EBITDA in 2020 • Intrarosa continues to grow steadily • Received preliminary expressions of interest to acquire/sub-license the rights to these products © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 8


 
Streamlined Portfolio and Infrastructure Positions AMAG for Near- and Long-term Profitability PHYSICIAN DRIVEN PORTFOLIO Hematology Maternal Health SNAPSHOT 2020 COMMERCIAL PIPELINE Ciraparantag AMAG-423 Feraheme • Provides continued growth and positive cash flow ‒ Sufficient to fund pipeline assets Focus on • Exploring new opportunities for future growth Core Value Makena Drivers • Risk profile heightened with PROLONG study results and FDA AdCom meeting ‒ Soft Q4-2019 results inform view of 2020 ‒ Proactively managing product to be cash-flow positive Development Assets • Continue to invest in late-stage development programs with opportunities to address significant unmet medical needs ‒ Development assets provide opportunity for next chapter of long-term revenue growth © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 9


 
2020 Financial Guidance Reflects a Return to Positive Adjusted EBITDA 2020 FINANCIAL GUIDANCE1 ($M) Total revenue $230 - $280 Operating income2 $2 - $32 Adjusted EBITDA3 $20 - $50 Continued growth of Risk-adjusted topline view of Significant reduction in Feraheme to fund the Makena given the uncertainty operating expenses (>$100M) development of pipeline assets caused by: vs. 2019 • FDA Advisory Committee outcome • Driven by divestiture of Intrarosa • Soft Q4-2019 enrollments and and Vyleesi revenue 1) 2020 financial guidance reflects management’s current assumptions about the potential impact of multiple scenarios across our product portfolio, including (i) various potential regulatory outcomes related to Makena and (ii) that the divestitures of Intrarosa and Vyleesi will be reported in discontinued operations for accounting purposes in 2020. Therefore, 2020 financial guidance excludes revenue and expenses related to Intrarosa and Vyleesi. 2) Operating loss does not include the impact of material impairment charges or the associated acceleration of amortization, which are likely to be recognized in the 2019 audited financial statements. 3) See slide 32 for a reconciliation of GAAP to non-GAAP financial guidance. © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 10


 
Core Value Drivers: 2020 and Beyond 11


 
Feraheme® (ferumoxytol injection) 12


 
Continued Strong Feraheme Performance1 $200 Consistent Revenue Growth $100 Revenue ($M) $0 2017 2018 2019 • Build on strong performance of past years, including record annual 2019 revenues 300,000 − Performance-based contracting drives volume, Consistent with stable price Volume 200,000 Growth 100,000 • Strong IV iron market growth Ex-factory Grams 0 • 2017 2018 2019 Feraheme to fund development of pipeline assets • Exploring new opportunities for future growth Growing 20% Market 15% Share2 10% Avg. Market Share 5% 0% 2017 2018 2019 1) Data is preliminary. FERAHEME © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 13


 
Makena® (hydroxyprogesterone caproate injection) 14


 
Preterm Birth is a Significant Public Health Issue in the U.S. MEIS TRIAL PROLONG TRIAL Conducted in U.S. patient population Conducted primarily in non-U.S. which had a high rate of preterm birth patient population Demonstrated a Did not show a reduction in preterm birth rates 30% reduction Lower risk patient population with significantly in preterm birth rates lower preterm birth rates than Meis trial (in both the treatment and placebo arms) Confirmed strong safety profile of Makena ACOG and SMFM reiterated continued support (post-PROLONG) for the use of Makena in at-risk pregnant women Today, Makena (and generic 17P1) If Makena is no longer available, AMAG is committed to working is the only FDA-approved therapy those committed to the use of 17P collaboratively with the FDA on a to reduce the risk of preterm birth would likely seek compounded path forward that could allow at- drug, which could create a risk pregnant women to continue potential safety risk to have access to Makena 1) Hydroxyprogesterone caproate injection MAKENA © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 15


 
Managing Makena to Remain Cash Flow Positive in 2020 Subcutaneous Auto-injector • Well established in the marketplace ‒ Entered 2020 with a strong market share for subcutaneous auto-injector of 63% • Uncertainty surrounding Makena’s future following AdCom meeting ‒ AdCom meeting outcome negatively impacted Makena Care Connection enrollments and prescriptions in Q4 ‒ Focused on working with FDA to maintain patient access • Proactively managing Makena to be cash flow positive in 2020 MAKENA © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 16


 
Development Pipeline Ciraparantag 17


 
Novel Oral Anticoagulant (NOAC) Use Growing Improved reversal agents could lead to even broader NOAC use Anticoagulants (often referred to as blood thinners) reduce the ability of the blood to form clots • Prevention of stroke in patients with nonvalvular atrial fibrillation • Prevention and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) 2010 Introduction of NOACs Xarelto® (rivaroxaban) | Eliquis® (apixaban) | Savaysa® (edoxaban) | Pradaxa® (dabigatran) • October 2018 approval of expanded label for Xarelto® to reduce the risk of major cardiovascular Anticipate broader events in patients with chronic coronary artery disease or peripheral artery disease future use of NOACs • American Heart Association 2019 guidelines recommend use of NOACs over warfarin in majority of patients with atrial fibrillation1 1) January CT, et al. 2019 Focused Update on Atrial Fibrillation. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. CIRAPARANTAG © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 18


 
Anticoagulants and Need for Reversal Agents Ciraparantag: in development as an anticoagulant reversal agent • Use of NOACs and LMWH increase risk of serious bleeding complications (1.5%-2% of patients per year)1 • To manage bleeding, a reversal agent may be critical in cases such as: Emergency/urgent surgery Serious/Life-threatening Major Anticoagulant or invasive procedures bleeding (e.g., GI, intra- trauma overdose abdominal, intracranial) • Reversal agents approved by FDA: – Praxbind® for reversal of Pradaxa® (dabigatran) – initially approved October 2015; full approval April 2018 – Andexxa® for reversal of Xarelto® and Eliquis® due to life-threatening or uncontrolled bleeding– approved May 2018 1) Tepper, Ping G et al. (2018 ) Real-world comparison of bleeding risks among non-valvular atrial fibrillation patients prescribed apixaban, dabigatran, or rivaroxaban” PLOS ONE 13(11): e0205989. https://doi.org/10.1371/journal.pone.0205989. CIRAPARANTAG © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 19


 
Large Unmet Medical Need with Significant Global Commercial Potential Large unmet medical need • Opportunity to provide an improved reversal agent to NOACs Numerous characteristics suggest U.S. market opportunity ciraparantag may offer a more optimal reversal agent 2 • Ready to use ~6 Million ~150,000 • Potential for a fixed dose for all Xa inhibitors Patients on NOAC / LMWH patients • Demonstrates sustained effect over 24 hours after NOAC / LMWH therapy1 per year requiring a one IV dose reversal agent ‒ Opportunity to include patients requiring emergent surgery • No prothrombotic signal to date Potential ex-U.S. partnership opportunities Every 1% of patients requiring reversal treatment = $36M3 / Year 1) Perosphere sponsored commercial assessment report conducted by a third party in May 2016. 2) AMAG estimate based on the following: (i) Zhu J., Alexander GC, et al. Pharmacotherapy 2018 September; 38(9): 907-920. (ii) Sindet-Pedersen C, et al. European Heart Journal - Cardiovascular Pharmacotherapy (2018) 4, 220–227. (iii) Garcia D, Alexander JH, et al. Blood 2014 124: 3692-3698. (iv) www.aha-org/statistics/fast-facts-us-hospitals. (v) Balakrishna, P, et al. Blood 2017 130:5585. (vi) www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.hem. 3 Illustrative of commercial opportunity for overall NOAC/LMWH market. Price reference: The currently approved reversal agent (coagulation factor Xa recombinant, inactivated-zhzo) price of ~$24,000. CIRAPARANTAG © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 20


 
Phase 2b Study of Ciraparantag: Reversal of Xarelto® Rapid and sustained reversal of NOACs in healthy volunteer study Mean Whole Blood Clotting Time (WBCT) by Timepoint Individual Responder Analysis (n=12 per dose) Ciraparantag or placebo dose 1 100.0% 40% Placebo 100% Baseline +3 days of Ciraparantag 60 mg dosing Ciraparantag 120 mg 80% 30% with Ciraparantag 180 mg 66.7% Xarelto® 58.3% 60% 20% 40% % of % Subjects of 10% 20% WBCT % of Normal BaselineWBCT % Normalof 0.0% 0% 0% Baseline Day 3 0.25 0.5 0.75 1 2 4 6 8 24 *WBCT reversed to within 10% of Hours Post Dose -10% baseline within 30 minutes and sustained for 24 hours 1) Doses previously presented as ciraparantag acetate doses: 300 mg acetate = 180 mg; 200 mg acetate = 120 mg; 100 mg acetate = 60 mg. CIRAPARANTAG © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 21


 
Whole Blood Clotting Time (WBCT) is a Good Measure of Anticoagulation • WBCT is a measure of the time it takes for blood to clot – clinically relevant physiologic outcome Perosphere Technologies’ broad spectrum 1 – WBCT is currently evaluated manually Point-of-Care coagulometer – Anticoagulant activity (and reversal) is best measured by WBCT – WBCT (manually measured) was the clinical endpoint measured in the Phase 2b clinical trials • Perosphere Technologies has developed an automated coagulometer to measure WBCT at the bedside, with results within minutes1 – Progressing through validation for submission of Investigative Device Exemption (IDE) for FDA approval – AMAG plans to utilize the automated coagulometer in its clinical development program – Once IDE is approved, plan to conduct small healthy volunteer study with automated coagulometer, then schedule end-of-Phase 2 meeting with FDA to review Phase 3 study design 1) AMAG entered into an agreement with Perosphere Technologies related to the development and clinical supply of the automated coagulometer, which the company plans to utilize in the Phase 3 clinical program. CIRAPARANTAG © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 22


 
AMAG-423 23


 
Severe Preeclampsia: Significant Unmet Medical Need Globally AMAG-423 (Digoxin Immune Fab: DIF) in development for the treatment of severe preeclampsia Preeclampsia is the Maternal morbidity Adverse neonatal leading cause of: and mortality outcomes No effective treatments FDA granted AMAG-423 Significant $2.2 billion for preeclampsia orphan status annual burden to U.S. (7-years exclusivity 1 Only “treatment” is delivery of healthcare system the baby, often times very expected at approval) preterm and fast track review 1) Stevens W et al, Short-term costs of preeclampsia to the U.S. health care system. American Journal of Obstetrics & Gynecology. September 2017, Volume 217, Issue 3, pp237- 248.e16 . AMAG-423 © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 24


 
Large Unmet Medical Need with Significant Global Commercial Potential Annual U.S. incidence of Annual U.S. incidence of preeclampsia SEVERE preeclampsia Large unmet medical need ~140,000 ~50,000 pregnant women1 pregnant women2 Potential ex-U.S. opportunities Every 1% of patients with severe preeclampsia = $70M3 / Year 1) Ananth, C. V., Keyes, K. M., & Wapner, R. J. (2013). Pre-eclampsia rates in the United States, 1980-2010: age-period-cohort analysis. The BMJ, 347, f6564. http://doi.org/10.1136/bmj.f6564. 2) AMAG Phase 2b/3a clinical trial population is a subset of the severe preeclampsia population. 3) Illustrative of commercial opportunity for overall severe preeclampsia market. Price reference Price reference: $140,000/patient average annual cost for orphan drug, EvaluatePharma®, Orphan Drug Report 2017. AMAG-423 © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 25


 
Strong Scientific Rationale for AMAG-423 Reverses effect of EDLFs on sodium pump activity MECHANISM OF ACTION • Endogenous digitalis-like factors (EDLFs) are 30 DEEP Trial4: Sodium Pump Activity circulating inhibitors of the Na+ K+ ATPase pump 25 (Surrogate for EDLF Activity) (“sodium pump”) and when elevated can lead to vasoconstriction, elevated blood pressure, and 20 1 15 decreased blood flow n=19 n=15 10 n=21 n=22 • Elevations in EDLFs have been implicated in a 5 n=20 n=12 n=21 number of diseases including hypertension and 0 1 n=19 preeclampsia -5 % Change from baseline from Change % -10 p=0.05 p=0.10 p=0.07 • DIF binds to and reverses effects of EDLFs 0-12h 12-24h 24-48h restoring sodium pump activity and has the (LOCF)* potential to improve vascular blood flow2,3 ‒ DIF ‒ Placebo * Last observation carried forward 1) Lam GK et al. Digoxin antibody fragment, antigen binding (Fab), treatment of preeclampsia in women with EDLF: a secondary analysis of the DEEP Trial. American Journal of Obstetrics & Gynecology. August 2013, pp119.e1- 119.e6. 2) DigiFab® Prescribing Information, 12.1 Mechanism of Action. 3) Wang Y et al, Digoxin Immune Fab Protects Endothelial Cells from Ouabain-Induced barrier Injury. Am J Reprod Immunol. Author manuscript; available in PMC 2016 December 07. 4 Adair CD, Buckalew VM, Graves SW, et al. Digoxin immune fab treatment for severe preeclampsia. Am J Perinatol. 2010;27:655-62. AMAG-423 © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 26


 
DEEP Trial: Improvements in Select Neonatal Outcome Measures1 Primary composite endpoint in current Phase 2b/3a study of AMAG-423 Intraventricular Hemorrhage (IVH) Necrotizing Enterocolitis (NEC) Deaths Severe (grades 3 and 4) p=0.24 p=0.61 p=0.49 n=3 n=3 n=2 n=1 % of neonatal Deaths neonatal of % % of neonates with IVH with neonates of % % of neonates with NEC with neonates of % n=0 n=0 DIF n=24 Placebo n=27 DIF n=24 Placebo n=27 DIF n=24 Placebo n=27 1) Adair CD, Buckalew VM, Graves SW, et al. Digoxin immune fab treatment for severe preeclampsia. Am J Perinatal. 2010;27:655-62 AMAG-423 © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 27


 
2020: Goals and Key Areas of Focus for AMAG Divest Intrarosa and Work with the FDA Complete successful Drive continued Vyleesi to align with to maintain patient CEO transition Feraheme growth new strategic direction access to Makena Advance ciraparantag Pursue ex-U.S. Meet/exceed and AMAG-423 portfolio partnering financial guidance development programs opportunities © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 28


 
Breakout Session: Kent Room © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 29


 
Appendix 30


 
Reconciliation of GAAP to Non-GAAP Preliminary Financial Results ($M) 9-Mos 2019 Q4-2019 FY 2019 GAAP operating loss ($251.6) ($22) - ($12) ($274) - ($264) Depreciation and intangible asset amortization 13.9 7.0 21.0 Stock-based compensation 13.7 5.0 18.5 Restructuring 7.4 -- 7.4 Transaction/acquisition-related costs 0.3 -- 0.3 Acquired IPR&D 74.9 -- 74.9 Asset impairment charges 82.2 -- 82.2 Non-GAAP adjusted EBITDA ($59.2) ($10) - $0 ($70) - ($60) APPENDIX © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 31


 
Reconciliation of GAAP to Non-GAAP 2020 Financial Guidance ($M) 2020 Financial Guidance GAAP operating income $2 - $32 Depreciation 2 Stock-based compensation 16 Non-GAAP adjusted EBITDA $20 - $50 APPENDIX © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 32


 
AMAG Pharmaceuticals JP Morgan 38th Healthcare Conference January 2020 © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 33