Document

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 7, 2019

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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 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:

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))

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.  ☐



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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, 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, except as expressly set forth by specific reference in such filing.
 
On February 7, 2019, AMAG Pharmaceuticals, Inc. (the “Company”) issued a press release regarding its operating results for the quarter and year ended December 31, 2018 and its intention to hold a conference call to discuss the Company’s financial results and provide a business update, including an update on recent corporate developments. A copy of the Company’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 2.05 Costs Associated with Exit or Disposal Activities.
 
On February 7, 2019, the Company announced that it was combining its women's and maternal health sales forces into one integrated sales team. This combined sales force will promote both Intrarosa and Makena and will provide healthcare professionals with one commercial point of contact as well as maximize efficiency and effectiveness for the promotion of the Company's commercial products. The Company will reduce its overall headcount by approximately 110 employees, approximately 100 of which were part of its field-based commercial organization with the remainder coming from its general and administrative functions. This workforce reduction is expected to be substantially completed in the first quarter of 2019.

As a result of these efforts, the Company expects to record restructuring charges and incur future cash expenditures totaling approximately $6.0 million in connection with the workforce reduction. 
 
The charges that the Company expects to incur in connection with the workforce reduction are estimates and subject to a number of assumptions, and actual results may differ materially. The Company may incur additional costs not currently contemplated due to events associated with or resulting from the workforce reduction.
Forward-Looking Statements
 
This report contains forward-looking information about the Company within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein or therein which do not describe historical facts, including, among others, expectations for the Company’s restructuring initiative, including the expected charges, the timing for incurring such charges and the timing for completing the workforce reductions 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 the Company’s restructuring initiative will not have the anticipated benefits, the actual charges that the Company incurs in connection with the workforce reduction may differ from those estimated as of the date of this report, the Company may incur additional costs not currently contemplated due to events associated with or resulting from the workforce reduction, the Company’s business may be disrupted as a result of the restructuring initiative, which could cause management distraction, the possibility that the workforce reduction will lead to additional and unexpected turnover, challenges with commercialization efforts of the Company’s portfolio of products and product candidates and supporting the Company’s business with the combined and streamlined sales force, as well as those risks identified in the Company’s filings with U.S. Securities and Exchange Commission (the “Commission”), including its Annual Report on Form 10-K for the year ended December 31, 2017, its Quarterly Reports on Form 10-Q for the quarters ended June 30, 2018 and September 30, 2018, its Current Reports and subsequent filings with the Commission, which are available at the Commission’s website at www.sec.gov. Any such risks and uncertainties could materially and adversely affect the Company’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on the Company’s stock price. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company 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.


2


Item 9.01. Financial Statements and Exhibits.
 
(d) Exhibits.
 
AMAG hereby furnishes the following exhibits:
 
Exhibit
Number
 
Description
99.1
 
99.2
 



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
Executive Vice President, General Counsel, Quality & Corporate Secretary

 
 
 
Date: February 7, 2019



4
Exhibit
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FOR IMMEDIATE RELEASE

AMAG Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Company Update
Reaffirms 2019 Financial Guidance and Announces Consolidation of
Women’s Health and Maternal Health Sales Forces
Conference Call Scheduled for 8:00 a.m. ET Today

WALTHAM, Mass., (February 7, 2019) - AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited consolidated financial results for the fourth quarter and full year ended December 31, 2018, which were in-line with previously announced preliminary results.

Total revenues from continuing operations for the full year of 2018 totaled $474.0 million, including record annual revenue of $135.0 million from Feraheme® (ferumoxytol injection), annual revenue of $322.3 million from Makena® (hydroxyprogesterone caproate injection) and its authorized generic, and annual revenue of $16.2 million from Intrarosa (prasterone). The company reported an operating loss from continuing operations of $47.0 million and adjusted EBITDA of $120.8 million in 2018.1

“We achieved key regulatory milestones in 2018 with two U.S. Food and Drug Administration (FDA) approvals and the acceptance of a new drug application (NDA). During the second half of 2018, we broadened our product pipeline with the addition of two promising development-stage assets, both of which underscore our commitment to bring forth new drugs in areas of significant unmet patient need," said William Heiden, AMAG’s president and chief executive officer. "Looking to the year ahead, we are reaffirming our 2019 financial guidance, which includes nearly $400 million in top-line revenue, increased investments in clinical development, investments in support of our commercial product portfolio, and the impact of a recently completed consolidation of the company’s women’s health and maternal health sales forces."

2018 Highlights and Recent Events:
Received FDA approval and successfully launched Makena subcutaneous auto-injector
Received FDA approval and launched Feraheme's expanded label, achieving 27% growth in 2018
Established strong healthcare provider support for Intrarosa and initiated direct-to-consumer campaign
Received FDA acceptance of Vyleesi NDA with a June 23, 2019 PDUFA date
Acquired AMAG-423, a late-stage orphan drug candidate in development for the treatment of severe preeclampsia
Acquired Perosphere Pharmaceuticals Inc. (closed in January 2019), including ciraparantag, a development-stage drug candidate to reverse the anticoagulant effects of novel oral anticoagulants (NOACs) and low molecular weight heparin (LMWH)
Divested the Cord Blood Registry (CBR) business and paid off $475 million of senior notes, eliminating cash interest expense of approximately $40 million per year
Achieved top- and bottom-line financial guidance, which was raised three times during 2018
____________________________
1 See summaries of GAAP to non-GAAP adjustments at conclusion of this press release.





Fourth Quarter Financial Results Ended December 31, 2018)
Financial results for the fourth quarter ended December 31, 2018 were aligned with AMAG's preliminary results issued on January 7, 2019. Total revenues from continuing operations for the fourth quarter of 2018 were $88.1 million, compared with $128.5 million for the same period in 2017. In the fourth quarter of 2018, sales of Makena totaled $46.9 million, compared with $100.4 million in the same period last year; sales of Feraheme and MuGard increased 33% to $35.3 million, compared with $26.6 million in the same period last year; and sales of Intrarosa totaled $5.9 million, compared with $1.5 million in the same period last year.

Total costs and expenses from continuing operations, including cost of product sales, were $107.0 million in the fourth quarter of 2018, compared with $141.3 million in the same period in 2017. The company reported an operating loss from continuing operations in the fourth quarter of 2018 of $18.8 million, compared with an operating loss from continued operations of $12.7 million for the same period last year. Non-GAAP adjusted EBITDA in the fourth quarter of 2018 totaled $1.5 million, compared with $53.6 million for the same period last year.1 

Full Year Financial Results Ended December 31, 2018
Revenues from continuing operations in 2018 totaled $474.0 million, compared with $495.8 million in 2017.
The $21.8 million decrease was primarily due to i) a decrease in Makena intramuscular product sales, partially offset by the successful launch of the Makena subcutaneous auto-injector, ii) record sales of Feraheme following the approval of it expanded label in February 2018, and iii) an increase in net sales of Intrarosa, which was launched in July 2017.

Total costs and expenses from continuing operations, including cost of product sales, totaled $521.0 million in 2018, compared with $799.6 million in 2017. Included in the 2017 cost and expenses was a $319.2 million Makena intramuscular-related non-cash impairment charge. Excluding this charge, total costs and expenses increased by $40.6 million in 2018, compared to 2017. The year-over-year increase was due to i) higher cost of product sales, driven primarily by increased non-cash intangible asset amortization expenses of $28.0 million and higher royalty obligations related to the Makena subcutaneous auto-injector and Intrarosa products, and ii) planned increases in selling, general and administrative expenses, which primarily consisted of commercialization costs related to Intrarosa, the Makena subcutaneous auto-injector, and the Feraheme broad label. These increases were partially offset by lower research and development costs in 2018, compared to 2017, and a $33.3 million decrease in acquired in-process research and development expense.

The company reported an operating loss from continuing operations in 2018 of $47.0 million, compared with an operating loss of $303.8 million in 2017. The company reported a net loss from continuing operations of $169.3 million, or ($4.92) per basic and diluted share in 2018, compared with a net loss of $205.2 million, or ($5.88) per basic and diluted share in 2017.

2018 non-GAAP adjusted EBITDA of $120.8 million was in the middle of the most recently increased guidance range.1 

Net Income from Discontinued Operations
As a result of the sale of CBR in August 2018, CBR is classified as discontinued operations for accounting purposes. Net income from discontinued operations was $103.6 million in 2018, of which $87.1 million represents the gain on the sale of the CBR business, as compared to $5.9 million in the same period in 2017.

Balance Sheet Highlights
The company ended 2018 with $394.2 million in cash and investments, $21.4 million of short-term convertible notes, which will be paid off on February 15, 2019, and $320.0 million principal balance of outstanding on its 2022 convertible notes.






2019 Financial Guidance2 
The company reaffirms the following financial guidance for 2019.
($M)
2019 Financial Guidance
Total revenue
$365 - $415
Operating loss
($131) - ($101)
Adjusted EBITDA
($65) - ($35)
2 See reconciliation of 2019 GAAP to non-GAAP financial guidance at conclusion of this press release.

The Company’s 2019 financial guidance reflects the impact of a recent combination of the company’s women’s health and maternal health sales forces into one integrated sales team, which will promote both Intrarosa and Makena and now comprises approximately 125 sales representatives. Of the 110 displaced employees, approximately 100 were part of the field-based sales and commercial organization with the remainder coming from general and administrative functions. The company expects to record a one-time restructuring charge of approximately $6 million in the first quarter of 2019. The company’s financial guidance also encompasses a modest expansion of its hematology/oncology sales force to support the continued growth of Feraheme, continued investment in the development of its growing pipeline of clinical programs, and investments to support the anticipated launch of Vyleesi in the second half of 2019.

"Today we are reaffirming the financial guidance that we published in January. This financial guidance contemplated the addition of ciraparantag to the portfolio, the consolidation of our women’s health and maternal health sales forces and other measures that we have taken to increase efficiency,” said Ted Myles, AMAG’s chief financial officer. “We have a strong balance sheet, and with Feraheme and the Makena subcutaneous auto-injector expected to generate significant cash flow, we are well positioned to self-fund investments in the Intrarosa direct-to-consumer campaign, launch activities for Vyleesi, and the phase 2b/3a clinical programs for AMAG 423 and ciraparantag. This broad and diversified portfolio, combined with our financial flexibility and discipline, provides a unique platform to deliver innovative therapies to patients in need and to generate significant shareholder value.”

The company has a number of goals and key milestones in 2019:
Build on the success of the Makena SC auto-injector’s 46% fourth quarter 2018 market share (of FDA-approved hydroxyprogesterone caproate products)
Drive Feraheme market growth and market share growth to treat more patients suffering from iron deficiency anemia
Continue successful Intrarosa direct-to-consumer campaign; expanding treatment to more of the 18 million untreated women
Submit results to the FDA from the ambulatory blood pressure study assessing short-term daily use of Vyleesi prior to the June 23, 2019 PDUFA date; prepare for commercial launch in 2H-2019
Target full enrollment in AMAG-423 severe preeclampsia Phase 2b/3a clinical study by year end
Initiate ciraparantag anticoagulant reversal agent Phase 3a clinical studies
Pursue business development opportunities
Meet/exceed financial guidance

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 2018 financial results and recent developments.

Dial-in Number
U.S./Canada Dial-in Number: (877) 412-6083
International Dial-in Number: (702) 495-1202
Conference ID: 9185366





Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 9185366

A telephone replay will be available from approximately 11:00 a.m. ET on February 7, 2019 through midnight on February 14, 2019.

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 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 our 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.

APPROVED PRODUCTS
About Feraheme® (ferumoxytol injection)
Feraheme received marketing approval from the U.S. Food and Drug Administration (FDA) in June 2009 for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). In February 2018, the FDA approved the supplemental New Drug Application (NDA) to expand the label beyond the CKD indication to include all eligible adult IDA patients who have intolerance to oral iron or have had unsatisfactory response to oral iron in addition to patients who have CKD.

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated. Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products.

Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components, or a history of allergic reaction to any intravenous iron product. Feraheme may cause clinically significant hypotension. Excessive therapy with parenteral iron can lead to excess storage of iron and possible hemosiderosis. Administration of Feraheme may transiently affect the diagnostic ability of magnetic resonance imaging. The most common adverse reactions (≥ 2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.





Feraheme is protected in the U.S. by seven issued patents covering the composition and dosage form of the product, the last of which expires in June 2023. Certain of these patents are the subject of a settlement agreement with Sandoz Inc.

For additional product information, including full prescribing information and the Boxed Warning, please visit www.feraheme.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. Makena was approved by the FDA in February 2011 and was granted orphan drug exclusivity through February 3, 2018. In February of 2018, AMAG introduced the prefilled Makena auto-injector containing a short, thin, non-visible needle for subcutaneous use, offering patients and providers a new administration option.

Makena has certain limitations 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.
    
In a multicenter, randomized, double-blind, vehicle (placebo)-controlled clinical trial, Makena showed an 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.

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 (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 effect reported with the Makena auto-injector use (and higher than with the Makena intramuscular injection) was injection site pain.

AMAG developed the Makena auto-injector with its device partner Antares Pharma, Inc., which holds issued patents on the auto-injector device and drug-device combination, the last of which expires in 2034. AMAG also holds a U.S. patent directed to subcutaneous administration and dosing of the Makena auto-injector product, which expires in 2036.

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

About Intrarosa® (prasterone) vaginal inserts
Intrarosa is the only vaginal non-estrogen treatment indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Intrarosa contains prasterone, a synthetic form of dehydroepiandrosterone (DHEA), which is an inactive endogenous sex steroid. Prasterone is




converted by enzymes in the body into androgens and estrogens. Intrarosa’s mechanism of action is not fully established.

In clinical studies, Intrarosa demonstrated efficacy by reducing pain during intercourse (dyspareunia), as well as improvement in the percentage of superficial cells and parabasal cells, and vaginal pH. Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. Intrarosa has not been studied in women with a history of breast cancer.

In clinical studies, vaginal discharge and abnormal Pap smears were the most common adverse reactions (≥ 2%). Intrarosa is contraindicated in women with undiagnosed abnormal genital bleeding.

Intrarosa is protected by a number of U.S. patents and applications that are owned by Endoceutics, Inc. One issued patent includes drug product claims with a term that expires in 2031. Two additional issued patents include method of use claims and pharmaceutical dosage form claims with terms that expire in 2028.

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

PRODUCTS IN DEVELOPMENT
About VyleesiTM (bremelanotide)
Vyleesi, an investigational product candidate, is being developed for the treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women. Vyleesi is designed to be used in anticipation of a sexual encounter, and is thought to possess a novel mechanism of action that impacts the excitatory neural pathways in the brain to restore sexual desire.

Vyleesi has been studied in more than 30 clinical trials with over 2,500 women. AMAG’s NDA to the FDA was supported by clinical data from two large double-blind placebo-controlled Phase 3 studies in which Vyleesi met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire as measured by validated patient-reported outcomes. Women in the trials had the option, after completion of the trial, to continue in an 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 received Vyleesi.

The most common adverse events were nausea, flushing, injection site reactions and headache. The majority of events were reported to be transient and mild-to-moderate in intensity. Vyleesi has no known alcohol interactions.

Vyleesi is protected by a number of U.S. and foreign patents and applications that are owned by Palatin Technologies, Inc. Certain of the patents include claims directed to the Vyleesi drug composition and methods of use thereof with terms expiring in 2020, and other patents include claims directed to methods of treating female sexual dysfunction by subcutaneous administration of compositions that include Vyleesi with terms expiring in 2033.

About AMAG-423 (Digoxin Immune Fab (ovine))
AMAG-423 is a polyclonal antibody in development for the treatment of severe preeclampsia in pregnant women and has been granted both orphan drug and fast-track review designations by the FDA. There are currently no FDA-approved treatment options for severe preeclampsia, a leading cause of maternal and neonatal mortality.

Elevated levels of endogenous digitalis-like factors (EDLFs) have been found in the placental and maternal circulation of the majority of patients with preeclampsia, and the degree of elevation has been correlated with severity of changes in creatinine clearance (a measure of kidney function). AMAG-423 is thought to bind to EDLFs, causing a decrease in EDLF activity and thereby increasing their elimination.





The Digibind Efficacy Evaluation in Preeclampsia (DEEP) trial, a placebo-controlled Phase 2 proof-of-concept study in 51 pregnant women with severe preeclampsia, was suggestive of clinical benefit in both mothers and their babies. In the DEEP Trial, the most frequent adverse events were nausea, vomiting, gastroenteritis and hypotension.

AMAG is currently conducting a Phase 2b/3a clinical study, which is expected to enroll approximately 200 antepartum women with severe preeclampsia between 23 and 32 weeks gestation in a multi-center, randomized, double-blind, placebo-controlled, parallel-group study.

AMAG-423 is protected in the U.S. by four patents covering methods of using AMAG-423 to treat women exhibiting symptoms of preeclampsia or eclampsia, each of which expires in November 2022. AMAG-423 has been granted orphan drug designation by the FDA and, if approved, would expect to receive seven years of marketing exclusivity.

Another company is currently marketing Digoxin Immune Fab (ovine), an FDA-approved treatment for patients with life-threatening or potentially life-threatening digoxin toxicity or overdose, which is being sold in a different dosage than our currently expected dosage of AMAG-423.

About Ciraparantag
Ciraparantag is being investigated for patients treated with novel oral anticoagulants (NOACs) or low molecular weight heparin when reversal of the anticoagulant effect of these products is needed for emergency surgery, urgent procedures or due to life-threatening or uncontrolled bleeding. It is believed that ciraparantag exerts its effects by binding to and blocking the effects of NOACs such as Xarelto® (rivaroxaban), Eliquis® (apixaban) and Savaysa® (edoxaban), as well as to the LMWH Lovenox® (enoxaparin sodium injection), which in turn reestablishes normal clot formation.

AMAG plans to work with the FDA to confirm the design of the Phase 3 program, which is expected to include Phase 3 trials in healthy volunteers followed by a Phase 3b/4 trial in patients.

Ciraparantag has been well tolerated in clinical trials. To date, the most common adverse events related to ciraparantag have been mild transient sensations of coolness, warmth or tingling, skin flushing, and alterations in taste.

Ciraparantag has been granted Fast Track review designation by the FDA and has patent protection through 2034.

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 expected 2018 fourth quarter and full year financial results; beliefs about the Company’s development-stage assets; 2019 financial guidance, including total revenue, operating loss and adjusted EBITDA; the expected impact of the consolidation of the Company’s sales forces; the magnitude of restructuring charges we expect to incur and the expected timing of those charges; expectations as to increased efficiency in light of recent initiatives; expectations to expand the Company’s hematology/oncology sales force and intended investments in its development of its growing pipeline of clinical programs and in the anticipated launch of Vyleesi; beliefs about the strength of AMAG’s balance sheet and the ability of Feraheme and the Makena subcutaneous auto-injector to generate significant cash flow; AMAG’s belief that it is well positioned to self-fund investments in its products and product candidates and that it is in a unique position to deliver innovative therapies and generate significant shareholder value; and AMAG’s 2019 goals and key milestones, including expectations as to timing, 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 Company’s restructuring initiative will not have the anticipated benefits, the actual charges that the Company incurs in connection with the workforce reduction may differ from those estimated as of the date of this report, the Company may incur additional costs not currently contemplated due to events associated with or resulting from the workforce reduction, the Company’s business may be disrupted as a result of the cost savings initiative, which could cause management distraction, the possibility that the workforce reduction will lead to additional and unexpected turnover, challenges with commercialization efforts of the Company’s portfolio of products and product candidates and supporting the Company’s business with the combined and streamlined sales force, the risk that sales of Makena will continue to be negatively impacted by the supply disruption and recent and future generic entries in the market; the risk that AMAG may be unable to gain approval of its product candidates, including Vyleesi, AMAG-423 and ciraparantag, on a timely basis, or at all; the potential for such approvals, if obtained, to include unanticipated restrictions or warnings and the risk that the costs and time investments for AMAGs development efforts will be higher than anticipated, or that AMAG has over-estimated the market and potential revenues for its products and product candidates, if approved, including Intrarosa, Vyleesi, AMAG-423 and ciraparantag, 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, 2017, its Quarterly Reports on Form 10-Q for the quarters ending June 30, 2018 and September 30, 2018 and subsequent filings with the SEC, including Current Reports on Form 8-K and its upcoming Annual Report on Form 10-K for the year ended December 31, 2018, 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 forwardlooking statements.

AMAG Pharmaceuticals® and Feraheme® are registered trademark of AMAG Pharmaceuticals, Inc. VyleesiTM is a trademark of AMAG Pharmaceuticals, Inc. MuGard® is a registered trademark of Abeona Therapeutics, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc. Other trademarks referred in this report are the property of their respective owners.




- Tables Follow -





AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(unaudited, amounts in thousands, except for per share data)
 
 
Three Months Ended December 31,
 
Year Ended December 31,
 
 
2018
 
2017
 
2018
 
2017
Revenues:
 
 
 
 
 
 
 
 
Makena
 
$
46,888

 
$
100,388

 
$
322,265

 
$
387,158

Feraheme/MuGard
 
35,271

 
26,612

 
135,369

 
106,671

Intrarosa
 
5,888

 
1,455

 
16,218

 
1,816

Other revenues
 
75

 
70

 
150

 
124

Total revenues
 
88,122

 
128,525

 
474,002

 
495,769

Costs and expenses:
 
 
 
 
 
 
 
 
Cost of product sales
 
28,716

 
70,587

 
215,892

 
161,349

Research and development expenses
 
12,211

 
11,996

 
44,846

 
75,017

Acquired in-process research and development
 

 

 
32,500

 
65,845

Selling, general and administrative expenses
 
66,030

 
58,667

 
227,810

 
178,151

Impairment of intangible assets
 

 

 

 
319,246

Restructuring expenses
 

 

 

 

Total costs and expenses
 
106,957

 
141,250

 
521,048

 
799,608

Operating (loss) income
 
(18,835
)
 
(12,725
)
 
(47,046
)
 
(303,839
)
Other income (expense):
 

 

 
 
 
 
Interest expense
 
(6,571
)
 
(15,978
)
 
(51,971
)
 
(68,382
)
Loss on debt extinguishment
 

 
(1,096
)
 
(35,922
)
 
(10,926
)
Interest and dividend income
 
2,120

 
628

 
5,328

 
2,810

Other (expense) income
 
(10
)
 
(27
)
 
(74
)
 
(70
)
Total other expense, net
 
(4,461
)
 
(16,473
)
 
(82,639
)
 
(76,568
)
(Loss) income from continuing operations before income taxes
 
(23,296
)
 
(29,198
)
 
(129,685
)
 
(380,407
)
Income tax expense (benefit)
 
(2,550
)
 
(29,936
)
 
39,654

 
(175,254
)
Net (loss) income from continuing operations
 
(20,746
)
 
738

 
(169,339
)
 
(205,153
)
 
 
 
 
 
 
 
 
 
Discontinued operations:
 

 

 

 

Income (loss) from discontinued operations
 

 
5,314

 
18,873

 
10,313

Gain on sale of CBR business
 
(2,506
)
 

 
87,076

 

Income tax expense (benefit)
 
(975
)
 
2,592

 
2,371

 
4,388

Net income (loss) from discontinued operations
 
(1,531
)
 
2,722

 
103,578

 
5,925

 
 
 
 
 
 
 
 
 
Net loss
 
$
(22,277
)
 
$
3,460

 
$
(65,761
)
 
$
(199,228
)
 
 
 
 
 
 
 
 
 
Basic net (loss) income per share:
 

 

 

 

(Loss) income from continuing operations
 
$
(0.60
)
 
$
0.02

 
$
(4.92
)
 
$
(5.88
)
Income (loss) from discontinued operations
 
(0.04
)
 
0.08

 
3.01

 
0.17

Total
 
$
(0.64
)
 
$
0.10

 
$
(1.91
)
 
$
(5.71
)
 
 
 
 
 
 
 
 
 
Diluted net (loss) income per share:
 
 
 
 
 
 
 
 
(Loss) income from continuing operations
 
$
(0.60
)
 
$
0.02

 
$
(4.92
)
 
$
(5.88
)
Income (loss) from discontinued operations
 
(0.04
)
 
0.08

 
3.01

 
0.17

Total
 
$
(0.64
)
 
$
0.10

 
$
(1.91
)
 
$
(5.71
)
 
 
 
 
 
 
 
 
 
Weighted average shares outstanding used to compute net income (loss) per share:
 
 
 
 
 
 
 
 
Basic
 
34,560

 
34,783

 
34,394

 
34,907

Diluted
 
34,560

 
34,879

 
34,394

 
34,907






AMAG Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(unaudited, amounts in thousands)

 
December 31, 2018
 
December 31, 2017
ASSETS
    
 
    
Current assets:
 

 
 

Cash and cash equivalents
$
253,256

 
$
162,855

Marketable securities
140,915

 
136,593

Accounts receivable, net
75,347

 
91,460

Inventories
26,691

 
34,443

Prepaid and other current assets
18,961

 
11,009

Note receivable
10,000

 

Assets held for sale

 
45,508

Total current assets
525,170

 
481,868

Property and equipment, net
7,521

 
7,904

Goodwill
422,513

 
422,513

Intangible assets, net
217,033

 
375,479

Deferred tax assets
1,260

 
47,120

Restricted cash
495

 
495

Other long-term assets
1,467

 
266

Assets held for sale, net of current portion

 
564,711

Total assets
$
1,175,459

 
$
1,900,356

LIABILITIES AND STOCKHOLDERS’ EQUITY
 

 
 

Current liabilities:
 

 
 

Accounts payable
$
14,487

 
$
7,717

Accrued expenses
129,537

 
166,732

Current portion of convertible notes, net
21,276

 

Current portion of acquisition-related contingent consideration
144

 
49,399

Liabilities held for sale

 
53,870

Total current liabilities
165,444

 
277,718

Long-term liabilities:
 

 
 

Long-term debt, net

 
466,291

Convertible notes, net
261,933

 
268,392

Acquisition-related contingent consideration
215

 
686

Other long-term liabilities
1,212

 
1,204

Liabilities held for sale, net of current portion

 
95,821

Total liabilities
428,804

 
1,110,112

 
 
 
 
Commitments and Contingencies (Note P)
 
 
 
Stockholders’ equity:
 

 
 

Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued

 

Common stock, par value $0.01 per share, 117,500,000 shares authorized; 34,606,760 and 34,083,112 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively
346

 
341

Additional paid-in capital
1,292,736

 
1,271,628

Accumulated other comprehensive loss
(3,985
)
 
(3,908
)
Accumulated deficit
(542,442
)
 
(477,817
)
Total stockholders’ equity
746,655

 
790,244

Total liabilities and stockholders’ equity
$
1,175,459

 
$
1,900,356







AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited, amounts in thousands, except for per share data)

 
Years Ended December 31,
 
2018
 
2017
Cash flows from operating activities:
 
 
 
Net loss
$
(65,761
)
 
$
(199,228
)
Adjustments to reconcile net loss to net cash provided by operating activities:
 
 
 
Depreciation and amortization
172,223

 
155,538

Impairment of intangible assets

 
319,246

Provision for bad debt expense
678

 
3,852

Amortization of premium/discount on purchased securities
87

 
302

(Gain) loss on disposal of fixed assets
(99
)
 
265

Non-cash equity-based compensation expense 
19,916

 
23,664

Non-cash IPR&D expense

 
945

Loss on debt extinguishment
35,922

 
10,301

Amortization of debt discount and debt issuance costs
15,658

 
14,395

(Gain) loss on sale of investments, net
(1
)
 
70

Change in fair value of contingent consideration
(49,607
)
 
(47,686
)
Deferred income taxes
41,166

 
(178,421
)
Gain on sale of the CBR business
(87,076
)
 

Transaction costs
(14,111
)
 

Changes in operating assets and liabilities:
 
 
 
Accounts receivable, net
16,995

 
(14,978
)
Inventories
4,722

 
(2,331
)
Receivable from collaboration

 

Prepaid and other current assets
(16,097
)
 
(2,222
)
Accounts payable and accrued expenses
(32,568
)
 
16,834

Deferred revenues
8,658

 
17,080

Payment of contingent consideration in excess of acquisition date fair value

 
(10,432
)
Other assets and liabilities
95

 
(1,223
)
Net cash provided by operating activities
50,800

 
105,971

Cash flows from investing activities:
 
 
 
Proceeds from sales or maturities of marketable securities
85,342

 
294,957

Purchase of marketable securities
(89,956
)
 
(127,249
)
Acquisition of Intrarosa intangible asset

 
(55,800
)
Proceeds from the sale of the CBR business
519,303

 

Capital expenditures
(2,534
)
 
(8,988
)
Net cash provided by (used in) investing activities
512,155

 
102,920

Cash flows from financing activities:
 
 
 
Long-term debt principal payments
(475,000
)
 
(353,125
)
Proceeds from 2022 Convertible Notes

 
320,000

Payments to repurchase 2019 Convertible Notes

 
(191,730
)
Payment of premium on debt extinguishment
(28,054
)
 

Proceeds to settle warrants

 
323

Payment of convertible debt issuance costs

 
(9,553
)
Payment of contingent consideration
(119
)
 
(39,793
)
Payments for repurchases of common stock

 
(19,466
)
Proceeds from the exercise of common stock options
3,881

 
3,021

Payments of employee tax withholding related to equity-based compensation
(2,682
)
 
(2,696
)
Net cash used in financing activities
(501,974
)
 
(293,019
)
Net increase (decrease) in cash, cash equivalents and restricted cash
60,981

 
(84,128
)
Cash, cash equivalents and restricted cash at beginning of the year
192,770

 
276,898

Cash, cash equivalents and restricted cash at end of the year
$
253,751

 
$
192,770





 
 
 
 
Supplemental data of cash flow information:
 
 
 
Cash paid for taxes
$
5,345

 
$
5,296

Cash paid for interest
$
48,757

 
$
56,959

Non-cash investing and financing activities:
 
 
 
Fair value of common stock issued in connection with the acquisition of the Intrarosa intangible asset
$

 
$
12,555

Contingent consideration accrued for the acquisition of the Intrarosa intangible asset
$

 
$
9,300









AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended December 31, 2018
(unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Operating Loss / Adjusted EBITDA
GAAP
$
88,122

 
$
28,716

 
$
12,211

 
$
66,030

 
$
(18,835
)
Depreciation and intangible asset amortization

 
(13,714
)
 
(9
)
 
(372
)
 
 
Non-cash inventory step-up adjustments

 
(126
)
 

 

 
 
Stock-based compensation

 
(215
)
 
(637
)
 
(4,465
)
 
 
Adjustments to contingent consideration

 

 

 
432

 
 
Acquisition related costs

 

 

 
(1,257
)
 
 
Non-GAAP Adjusted
$
88,122

 
$
14,661

 
$
11,565

 
$
60,368

 
$
1,528






AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended December 31, 2017
(unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Operating Loss / Adjusted EBITDA
GAAP
$
128,525

 
$
70,587

 
$
11,996

 
$
58,667

 
$
(12,725
)
Depreciation and intangible asset amortization

 
(60,818
)
 
(63
)
 
(181
)
 

Non-cash inventory step-up adjustments

 
(919
)
 

 

 

Stock-based compensation

 
(194
)
 
(575
)
 
(4,150
)
 

Adjustments to contingent consideration

 

 

 
543

 

Non-GAAP Adjusted
$
128,525

 
$
8,656

 
$
11,358

 
$
54,879

 
$
53,632






AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Twelve Months Ended December 31, 2018
(unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Acquired IPR&D
 
Operating Loss / Adjusted EBITDA
GAAP
$
474,002

 
$
215,892

 
$
44,846

 
$
227,810

 
$
32,500

 
$
(47,046
)
Depreciation and intangible asset amortization

 
(158,446
)
 
(21
)
 
(1,592
)
 

 
 
Non-cash inventory step-up adjustments

 
(3,728
)
 

 

 

 
 
Stock-based compensation

 
(802
)
 
(2,533
)
 
(16,614
)
 

 
 
Adjustments to contingent consideration

 

 

 
49,607

 

 
 
Acquired IPR&D

 

 

 

 
(32,500
)
 
 
Acquisition related costs

 

 

 
(1,257
)
 

 
 
Non-GAAP Adjusted
$
474,002

 
$
52,916

 
$
42,292

 
$
257,954

 
$

 
$
120,840





AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Twelve Months Ended December 31, 2017
(unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Intangible asset impairment charges
 
Acquired IPR&D
 
Operating Loss / Adjusted EBITDA
GAAP
$
495,769


$
161,349

 
$
75,017

 
$
178,151

 
$
319,246

 
$
65,845

 
$
(303,839
)
Depreciation and intangible asset amortization

 
(130,518
)
 
(180
)
 
(876
)
 

 

 

Non-cash inventory step-up adjustments

 
(2,146
)
 
(103
)
 

 

 

 

Stock-based compensation

 
(882
)
 
(3,225
)
 
(16,187
)
 

 

 

Adjustments to contingent consideration

 

 

 
47,686

 

 

 

Acquired IPR&D

 

 

 

 

 
(65,845
)
 

Impairment charges of intangible assets

 

 

 

 
(319,246
)
 

 

Acquisition related costs

 

 

 
(1,462
)
 

 

 

Non-GAAP Adjusted
$
495,769

 
$
27,803

 
$
71,509

 
$
207,312

 
$

 
$

 
$
189,145







AMAG Pharmaceuticals, Inc.
Reconciliation of 2019 Financial Guidance of Non-GAAP Adjusted EBITDA
(Unaudited, amounts in millions)

Operating loss
($131) - ($101)
Depreciation and intangible asset amortization
43
Stock-based compensation
22
Non-cash inventory step up and adjustments to contingent consideration
1
Adjusted EBITDA
($65) - ($35)




AMAG Pharmaceuticals, Inc.
Share Count Reconciliation
(unaudited, amounts in millions)

 
Three Months Ended December 31,
 
Twelve Months Ended December 31,
 
 
2018
 
2017
 
2018
 
2017
 
Weighted average basic shares outstanding
34.6

 
34.8

 
34.4

 
34.9

 
Employee equity incentive awards

3 
0.1

3 

3 

3 
GAAP diluted shares outstanding
34.6

 
34.9

 
34.4

 
34.9

 
Employee equity incentive awards
0.3

4 

4 
0.3

4 
0.3

4 
Non-GAAP diluted shares outstanding
34.9

 
34.9

 
34.7

 
35.2

 

3 Employee equity incentive awards would be anti-dilutive in this period.
4 Reflects the non-GAAP dilutive impact of employee equity incentive awards.

CONTACTS:
Investors:
Linda Lennox
908-627-3424

Media:
Sarah Connors
781-296-0722 





ex992fy18
AMAG Pharmaceuticals 2018 Financial Results & Company Update February 7, 2019 © 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, the anticipated regulatory and clinical trial timeline for AMAG’s product candidates, including ciraparantag, AMAG- 423 and Vyleesi; AMAG’s expectations for its product and product candidate portfolio; AMAG’s beliefs regarding Feraheme’s market share and commercial opportunity; AMAG’s beliefs regarding the Makena auto-injector’s market share and commercial opportunity; AMAG’s belief that its historical value drivers will fund future value drivers; beliefs about Intrarosa’s market share and commercial opportunity; characterizations of and beliefs about study and market data; AMAG’s beliefs regarding the impact of its direct-to-consumer campaign for Intrarosa, including trends in prescriptions and patient engagement; expectations related to the impact of changes to AMAG’s copay program on Intrarosa’s gross to net revenues; AMAG’s expectations for its product development milestone calendar; AMAG’s expectations for the Vyleesi Phase 3 studies, including favorable safety profile; beliefs about the market for, and the anticipated timeline for launch of, Vyleesi (if approved); beliefs about preeclampsia, including the potential benefits of and market opportunity for AMAG-423 (if approved); AMAG’s beliefs about the use and benefits of novel oral anticoagulants; AMAG’s beliefs regarding the clinical efficacy, safety data, differentiation, commercial opportunity and population market of ciraparantag; ciraparantag’s anticipated path to approval (if approved); expectations regarding the U.S. and world-wide market size for AMAG’s products and product candidates; beliefs about the global and domestic market opportunities for AMAG’s products and product candidates; beliefs about annual peak revenue opportunities for Intrarosa, Vyleesi, AMAG-423 and ciraparantag; AMAG’s 2019 goals, 2019 financial guidance, including forecasted GAAP revenue, GAAP operating loss, and non-GAAP adjusted EBITDA, and key inputs and drivers thereof; and beliefs about the strength of AMAG’s balance sheet and expectations to transform the Company’s profile in 2019 (including the key goals in connection therewith) are based on management’s current expectations and beliefs and 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, AMAG’s restructuring initiative will not have the anticipated benefits, the actual charges that AMAG incurs in connection with the workforce reduction may differ from those estimated as of the date of this report, AMAG may incur additional costs not currently contemplated due to events associated with or resulting from the workforce reduction, AMAG’s business may be disrupted as a result of the cost savings initiative, which could cause management distraction, the possibility that the workforce reduction will lead to additional and unexpected turnover, challenges with commercialization efforts of AMAG’s portfolio of products and product candidates and supporting AMAG’s business with the combined and streamlined sales force, the risk that sales of Makena will continue to be negatively impacted by the supply disruption and recent and future generic entries in the market; the risk that AMAG may be unable to gain approval of its product candidates, including Vyleesi, AMAG-423 and ciraparantag, on a timely basis, or at all; the potential for such approvals, if obtained, to include unanticipated restrictions or warnings and the risk that the costs and time investments for AMAG’s development efforts will be higher than anticipated, or that AMAG has over-estimated the market and potential revenues for its products and product candidates, if approved, including Intrarosa, Vyleesi, AMAG-423 and ciraparantag, and those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10‐K for the year ended December 31, 2017, its Quarterly Reports on Form 10-Q for the quarters ending June 30, 2018 and September 30, 2018 and subsequent filings with the SEC, including Current Reports on Form 8-K and its upcoming Annual Report on Form 10-K for the year ended December 31, 2018, 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® and Feraheme® are registered trademark of AMAG Pharmaceuticals, Inc. VyleesiTM is a trademark of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc. Other trademarks referred in this report are the property of their respective owners. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 2


 
Agenda 1 2018 Accomplishments 2 Commercial Product Portfolio Update 3 Development Product Portfolio Update – Focus on Ciraparantag 4 Financial Overview 5 Q&A © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 3


 
2018 Accomplishments Intrarosa® (prasterone) .  Established strong healthcare provider support . Initiated direct-to-consumer campaign VyleesiTM (bremelanotide) . FDA acceptance of new drug application (NDA)  . Initiated frequent dosing study in healthy volunteers Makena® (hydroxyprogesterone caproate) .  Received FDA approval for subcutaneous (SC) auto-injector . Stabilized franchise through successful launch of SC auto-injector Feraheme® (ferumoxytol injection) .  Received FDA approval and launched expanded label . Achieved record annual sales of $135 million Business Development .  Acquired orphan drug candidate (AMAG-423) for the treatment of severe preeclampsia . Acquired Perosphere Pharmaceuticals, including ciraparantag, an anticoagulant reversal agent Financial .  Achieved financial guidance that was raised three times during 2018 . Divested the Cord Blood Registry business; paid off $475M of senior notes (eliminated ~$40M per year of interest expense) © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 4


 
Achieved 2018 Financial Objectives Increased financial guidance three times throughout 2018 Preliminary Results ($M) 2018 Issued Guidance1,3 Issued in January 2019 January 2018 May 2018 August 2018 November 2018 FY 2018 Total revenue $380 - $440 $420 - $460 $450 - $490 $470 - $490 $471 - $476 Operating loss ($169) - ($139) ($149) - ($129) ($75) - ($55) ($72) - ($62) ($55) – ($45) Adjusted EBITDA $55 - $85 $75 - $95 $95 - $115 $115 - $125 $115 - $1252 ($M) Actual 2018 Financial Results Total revenue $474 Relative to guidance provided in January 2018 • Revenue exceeded by $64M Operating loss ($47) • Adjusted EBITDA exceeded by $51M Adjusted EBITDA2 $121 1 Excludes Cord Blood Registry’s financial results for each period presented. 2 See slide 27 for a reconciliation of GAAP to non-GAAP financial results. 3 See slide 28 for a reconciliation of GAAP to non-GAAP financial guidance. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 5


 
Historical Value Drivers HISTORICAL Value of AMAG © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 6


 
Feraheme Continues to Grow with Expanded Label Annual Feraheme Revenue ($M) Feraheme Growth • Strong execution with expanded lDA label drove 27% significant volume increases in 2018 – Performance-based contracting drove volume, with stable annual price • Q4-2018 average market share rose to 16.6%, compared with 11.6% in Q4-20171 – Greater than 30% share from hematology/oncology clinics • Strong 8% IV iron market growth; opportunity for further growth with educational initiatives with gastroenterologists and OB/GYNs1 1 AMAG estimates market share using IQVIA data and internal analytics. IV IRON DEFICIENCY ANEMIA: FERAHEME © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 7


 
Continued Strong Conversion from Makena IM to SC Auto-injector Annual Makena Revenue ($M) Makena Stability • Q4-2018 SC auto-injector – Achieved $35M revenue • Ex-factory sales impacted by a reduction in channel inventory levels at year end due to temporary supply constraints, which are now resolved – Achieved favorable payer and prescriber support: • Broad payer coverage • Makena Care Connection® – ~60% of prescriptions state ‘dispense as written’1 Makena SC Makena IM AGx IM 1 Makena Care Connection enrollment data. 2 Specialty Pharmacy Demand Data; Valuecentric 867 Data; IQVIA SMART US Edition Integrated View – NSP. MATERNAL HEALTH: MAKENA © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 8


 
Significant Shareholder Value at AMAG Historical Value Drivers Fund Future Value Drivers ciraparantag AMAG-423 Fundingfunding HISTORICAL Value of AMAG FUTURE Value of AMAG Historical Value Drivers Fund Future Value Drivers © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 9


 
Intrarosa HCP Prescribing and Market Share Continue to Increase Direct-to-Consumer (DTC) campaign demonstrating strong patient engagement Annual Intrarosa Revenue ($M) Intrarosa Growth • Strong prescription trends continue2 – 13.6% overall TRx market growth in 2018 – 159,000 TRxs in 2018 – 13,000+ physicians have prescribed Intrarosa • 2,200+ new prescribers every quarter in 2018 – 6.4% Q4 market share of commercially insured patients; tripled in 2018 • Transitioned to new copay program in January 2019 – Anticipate gross-to-net improvements • DTC campaign demonstrating strong patient engagement – Traffic to telemedicine sites growing – 20M+ women reached – 1M+ visitors to unbranded website – 700,000+ visitors to Intrarosa.com 1 1 Intrarosa was commercially launched in July 2017. 2 Intrarosa TRx’s, market share data and number of HCP prescribers are based on IQVIA Xponent Plantrak data. WOMEN’S HEALTH: INTRAROSA © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 10


 
Accessing the 90% of Women Who are Not Being Treated with Rx 2019 Branded consumer campaign resulting 5 in patients asking for Intrarosa Increase HCP prescribing and make 4 Intrarosa the 1st choice treatment 2018 3 Educate with unbranded condition awareness campaign Create affordable access 2 for all patients 2017 Intrarosa Increase market awareness GROWTH STRATEGY 1 LAUNCH PRIORITIES WOMEN’S HEALTH: INTRAROSA © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 11


 
AMAG's Growing Innovative Pipeline Approved/ Phase 1 Phase 2 Phase 3 Regulatory Review Marketed Ciraparantag Anticoagulant reversal agent (potential for orphan drug designation) Treatment of iron deficiency anemia H E M A T O L O G Y AMAG-423 Treatment of severe preeclampsia Digoxin Immune (orphan drug designation) Fab (ovine) TM Treatment of low desire or libido with associated distress (HSDD*) in premenopausal women Treatment for moderate to severe dyspareunia (pain during sex) in postmenopausal women Treatment to reduce recurrent preterm birth in certain at-risk women W O M E N ’ S H E A L T H C A R E * HSDD: Hypoactive Sexual Desire Disorder © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 12


 
AMAG Product Development Milestone Calendar 1H-2019 2H-2019 1H-2020 2H-2020 1H-2021 2H-2021 June 23 Potential Vyleesi PDUFA date commercial launch 423 - Target complete enrollment in Phase 2b/3a trial Topline data NDA submission Potential FDA approval AMAG End of Phase 2 Complete Phase 1 Closed Perosphere NDA submission Potential FDA approval meeting with FDA; 3a trials; acquisition Initiate Phase 3a trials announce topline data Apply for orphan Initiate and breakthrough Phase 3b/4 trial designation Ciraparantag 1 Ciraparantag NDA submission expected to include only the first 50-100 patients in the Phase 3b clinical trial, based on precedent. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 13


 
Novel Oral Anticoagulant (NOAC) Use Growing • 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 and pulmonary embolism – Use of NOACs increases risk of serious bleeding complications (1.5%-2% of patients per year)1 • NOACs were introduced starting in 2010 – Xarelto® (rivaroxaban); Eliquis® (apixaban); Savaysa® (edoxaban); Pradaxa® (dabigatran) – Lack of reversal agents has been a barrier to broader use – Anticipate broader future use of NOACs • October 2018: Expanded label for Xarelto® use in patients with chronic coronary artery or peripheral artery disease • American Heart Association 2019 guidelines recommend use of NOACs over warfarin in majority of patients with atrial fibrillation2 • To manage bleeding, a reversal agent may be critical in cases such as: Emergency/urgent surgery Serious/life-threatening bleeding Major trauma Anticoagulant overdose or invasive procedures (e.g., GI, intra-abdominal, intracranial) 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. 2January 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. HEMATOLOGY: Ciraparantag © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 14


 
Ciraparantag: Differentiated Anticoagulation Reversal Therapy Well suited for use in emergency room setting Storage & Duration Prothrombotic Reversal Agent Dosing Preparation of Action Signal Praxbind® • Requires storage at • One treatment given as 2 • Sustained effect over • No prothrombotic o o o o Biologic that binds Pradaxa® 2 -8 C (36 -46 F) sequential IV doses 24 hours signal AndexXa® • Requires storage at • One treatment given as a 30 • Anticoagulation starts • Boxed warning related o o o o Biologic that binds Xarelto® and Eliquis® 2 -8 C (36 -46 F) minute bolus followed by infusion to return to normal to thromboembolic • Complex and lengthy over 2 hours immediately after risks, ischemic risks, preparation • Requires different doses based on cessation of dosing cardiac arrest, and timing of last NOAC dose sudden death Ciraparantag • Room temperature • Given as a single IV injection dose • Demonstrates a • No prothrombotic Small molecule in development to bind: storage • Potential for a fixed dose for all Xa sustained effect over signal to date • Xa inhibitors: Xarelto®, Eliquis®, Savaysa® • Ready-to-use inhibitors 24 hours • LMWH: Lovenox® HEMATOLOGY: Ciraparantag © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 15


 
Action of Anticoagulants and Ciraparantag in the Blood Clotting Cascade Whole Blood Clotting Time (WBCT) is the most clinically relevant measure in healthy volunteers F XII WBCT is currently a manual measure of the time it takes Clotting Cascade for blood to clot – clinically relevant physiologic outcome F XI Ciraparantag Normal WBCT BINDS to and Increases by ~30% ~8-10 minutes F IX INACTIVATES in patients taking NOACs F VII F VIII Ciraparantag Perosphere Technologies is developing an automated coagulometer to measure WBCT Factor Xa Inhibitors • Small, portable device (infrared light beam) that measures WBCT in ~2 Xarelto® (rivaroxaban) F X F Xa Eliquis® (apixaban) minutes Savaysa® (edoxaban) • GMP devices have been manufactured and are undergoing validation • Investigative Device Exemption (IDE) for coagulometer will be submitted for approval prior to initiating Phase 3a trial F V WBCT (manual) was the clinical endpoint measured in the Phase F II (prothrombin) F II a (prothrombin) 2b clinical trials • Healthy volunteers, placed on NOAC therapy (increase WBCT), then ciraparantag administered to ‘reverse’ or return WBCT to baseline Blood (pre-anticoagulation) levels F F I (fibrinogen) I a (fibrin) Clot HEMATOLOGY: Ciraparantag © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 16


 
Phase 2b Study: Reversal of Xarelto® Ongoing study in healthy subjects; high dose group demonstrates 100% response rate Ciraparantag or placebo dose 0.0% Baseline & Xarelto® dose WBCT reversed to within 10% n n n n 1 of baseline within 30 minutes Placebo Ciraparantag 60 mg Ciraparantag 120 mg Ciraparantag 180 mg 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. HEMATOLOGY: Ciraparantag © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 17


 
Favorable Safety Profile of Ciraparantag Ciraparantag was well tolerated in over 250 subjects dosed in Phase 1/2 clinical studies to date • Across Phase 1/2 clinical studies (5 completed studies, 2 ongoing studies) to date – Over 250 healthy adult subjects have received ciraparantag; doses ranged from 3 to 360 mg per IV administration – The most common adverse events related to ciraparantag were mild transient sensations of warmth, coolness, or tingling, skin flushing, and alterations in taste • No ciraparantag-related serious adverse events – No adverse impact on vital signs, safety laboratory testing or ECG parameters (including QTc analyses) – No procoagulant effect: no impact on WBCT when administered alone, and no significant difference between placebo and ciraparantag in hypercoagulability markers D-dimer or prothrombin fragments 1.2 (f1.2) * Healthy volunteers HEMATOLOGY: Ciraparantag © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 18


 
Ciraparantag Path to Approval 1H-2019 2H-2019 1H-2020 2H-2020 1H-2021 2H-2021 End of Phase 2 Complete Phase 1 Closed Perosphere NDA submission Potential FDA approval meeting with FDA; 3a trials; acquisition Initiate Phase 3a trials announce topline data Apply for orphan Initiate and breakthrough Phase 3b/4 trial designation 1 NDA submission expected to include only the first 50-100 patients in Phase 3b clinical trial, based on precedent. HEMATOLOGY: Ciraparantag © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 19


 
Financial Overview 20


 
2018 Financial Results within Guidance Range For 12-months ended December 311 $M 2018 2017 • Makena decline due to IM generic competition and supply Makena $322.3 $387.2 constraints; partially offset by success of auto-injector launch in Q2-2018 and AGx Feraheme/MuGard 135.4 106.7 Intrarosa 16.2 1.8 • Record Feraheme revenue driven by success with broad label Other .1 .1 • Intrarosa growth from volume; net price lower than expected Total revenues $474.0 $495.8 • Cost of product sales includes a $28M increase of intangible Cost of product sales 215.9 161.4 asset amortization expense in 2018 Research and development expenses 44.8 75.0 – Increase in non-amortization COGS as a percentage of revenue driven by product mix shift; royalties for Makena auto-injector and Acquired in-process research and development 32.5 65.8 Intrarosa Selling, general and administrative expenses 227.8 178.2 • R&D lower due to completion of auto-injector and Feraheme Impairment of intangible assets -- 319.2 broad label development in late 2017 Total costs and expenses 521.0 799.6 • Acquired IPR&D: Operating loss ($47.0) ($303.8) – 2018: $32.5M related to AMAG-423 and Vyleesi – 2017: $65.8M related to the Palatin and Endoceutics transactions Non-GAAP Adjusted EBITDA $120.8 $189.1 1 Excludes Cord Blood Registry’s financial results for each period presented. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 21


 
Reaffirming 2019 Financial Guidance Published on January 7, 2019 Key inputs and drivers of financial guidance • Spending includes increase in R&D – Completion of Phase 2 development of ciraparantag, initiation ($M) 2019 Financial Guidance1 of Phase 3a trial – Targeting full enrollment of AMAG-423 Phase 2b/3a trial Total revenue $365 - $415 • SG&A Operating loss ($131) - ($101)2 – Impact of consolidation of women’s health and maternal health sales forces Adjusted EBITDA ($65) - ($35) – Shift of spend to DTC to engage 18 million women with dyspareunia not on prescription therapy – Anticipated launch of Vyleesi – Modest expansion of hematology/oncology sales team • Revenues driven by continued growth of Feraheme, Makena SC auto-injector and Intrarosa 1 See slide 28 for a reconciliation of GAAP to non-GAAP financial guidance. 2 2019 financial guidance excludes potential accounting impact for the acquisition of Perosphere Pharmaceuticals Inc. © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 22


 
Strong Balance Sheet ($M) 12/31/18 12/31/17 Cash, cash equivalents and investments $3941 $329 Short-term debt: Convertible senior notes (2.5%) due Feb. 2019 $ 21 $ 21 Long-term debt: Convertible senior notes (3.25%) due 2022 $320 $320 Senior notes (7.875%) due 2023 $ 0 $475 1 $394M cash balance does not include approximately $58 million paid in January 2019 to acquire Perosphere Pharmaceuticals Inc. FINANCIAL OVERVIEW © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 23


 
Strong Execution Transforms Company Profile in 2019 2019 Goals  Expand use of Makena SC auto-injector  Drive Feraheme growth  Continue successful Intrarosa direct-to-consumer campaign  Submit Vyleesi frequent-dosing study data  Prepare for Vyleesi commercial launch in 2H-2019  Target full enrollment in AMAG-423 Phase 2b/3a study by year end  Initiate ciraparantag Phase 3a clinical study  Pursue business development opportunities  Meet/exceed financial guidance © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 24


 
AMAG Pharmaceuticals Q&A © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 25


 
Appendix 26


 
Reconciliation of GAAP to Non-GAAP Financial Results Preliminary Results Issued in January 2019 $M 2018 2017 2018 GAAP operating income (loss) ($47.0) ($303.8) ($55) - ($45) Depreciation and intangible asset amortization 160.0 131.6 161 Non-cash inventory step-up adjustments 3.7 2.2 4 Stock-based compensation 19.9 20.3 20 Adjustments to contingent consideration (49.6) (47.7) (49) Impairment charges of intangible assets -- 319.2 -- Acquired IPR&D 32.5 65.8 33 Transaction / acquisition related costs 1.3 1.5 1 Non-GAAP adjusted EBITDA $120.8 $189.1 $115 - $125 APPENDIX © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 27


 
Reconciliation of GAAP to Non-GAAP Financial Guidance Guidance Issued ($M) January 2018 May 2018 August 2018 November 2018 January 2019 GAAP operating loss ($169) – ($139) ($149) – ($129) ($75) - ($55) ($72) - ($62) ($131) – ($101) Depreciation & intangible asset amortization 179 179 174 177 43 Stock-based compensation 21 21 21 22 22 Non-cash inventory step up and adjustments 4 4 (45) (45) 1 to contingent consideration Acquired IPR&D 20 20 20 33 -- Non-GAAP adjusted EBITDA $55 - $85 $75 - $95 $95 - $115 $115 - $125 ($65) – ($35) APPENDIX © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 28


 
AMAG Pharmaceuticals 2018 Financial Results & Company Update February 7, 2019 © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 29