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): May 7, 2019
http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=12884650&doc=4
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.  ☐
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

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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 May 7, 2019, AMAG Pharmaceuticals, Inc. (“AMAG”) issued a press release regarding its operating results for the three months ended March 31, 2019 and its intention to hold a conference call to discuss AMAG’s first quarter 2019 financial results, recent business highlights and 2019 outlook. A copy of AMAG’s press release is furnished herewith as Exhibit 99.1 and a copy of the presentation slides to be used during the conference call is furnished herewith as Exhibit 99.2.

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



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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
AMAG PHARMACEUTICALS, INC.
 
By:
/s/ Joseph D. Vittiglio
 
 
Joseph D. Vittiglio
Executive Vice President, General Counsel, Quality & Corporate Secretary
 
 
 
Dates: May 7, 2019




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Exhibit
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FOR IMMEDIATE RELEASE

AMAG PHARMACEUTICALS ANNOUNCES FIRST QUARTER 2019 FINANCIAL RESULTS
AND PROVIDES CORPORATE UPDATE
Achieved record Feraheme revenue growth and more than 50% market share for Makena auto-injector
Completed integration of Perosphere Pharmaceuticals Inc. and progressed ciraparantag clinical program
Reaffirms 2019 financial guidance
Conference call scheduled for 8:00 a.m. ET today

WALTHAM, MA (May 7, 2019) – AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited consolidated financial results for the first quarter ended March 31, 2019 and provided a business update.

Total revenue for the first quarter of 2019 was $75.8 million, compared with $117.4 million in the same period last year. Makena® (hydroxyprogesterone caproate injection) revenues were $31.3 million in the first quarter, compared with $90.0 million in the same period last year. This decline was primarily due to the mid-2018 entry of generic competition to the Makena intramuscular (IM) product, as well as IM supply constraints in the quarter (described below). Feraheme® (ferumoxytol injection) first quarter 2019 revenues increased to a record $40.0 million, or 59%, over the same period last year. Intrarosa® (prasterone) realized significant growth in net price as well as volume growth in the first quarter of 2019, as compared to the prior year period.

The company reported an operating loss of $117.7 million in the first quarter of 2019, compared with an operating loss of $50.8 million in the first quarter of 2018. Included in the loss in the first quarter of 2019 was a $74.9 million accounting impact related to the acquisition of Perosphere Pharmaceuticals Inc., which closed in the quarter. Consistent with its strategic plan and 2019 financial guidance, the company reported negative adjusted EBITDA of $26.6 million in the first quarter of 2019, compared with positive adjusted EBITDA of $30.0 million in the first quarter of 2018.1 

“While total Makena revenues in the first quarter were adversely impacted by a number of non-recurring charges, we are encouraged by the strong underlying demand for the subcutaneous auto-injector, and the progress made to replace our previous primary supplier of Makena IM with new inventory from two suppliers this second quarter," said William Heiden, AMAG's president and chief executive officer. "We're also proud of our Feraheme team and the continued growth that product has realized. The significant cash flow from these products helps fund the development of our novel pipeline assets, which we believe are the future value drivers of the company."

"In the first quarter, our development pipeline continued to progress nicely. We are eagerly awaiting a decision on the upcoming PDUFA date for VyleesiTM (bremelanotide) and the mid-year initiation of the Phase 3a clinical studies for ciraparantag," continued Mr. Heiden. “We look forward to discussing more about AMAG’s future at our Analyst Day that will be held on May 22 in New York, which will include panels for AMAG-423, Vyleesi and ciraparantag of key opinion leaders who will provide their expert views on the opportunity for and value of these new product candidates.”



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

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First Quarter 2019 and Recent Business Highlights:
Promoted Tony Casciano to chief commercial officer; Mr. Casciano led the successful launches of the Makena SC auto-injector and the Feraheme broad label
Achieved 59% growth in Feraheme net sales year-over-year
Makena SC auto-injector achieved 40% volume growth and captured 54% market share of all FDA-approved hydroxyprogesterone caproate prescription volume over the fourth quarter of 2018
Improved first quarter 2019 Intrarosa gross-to-net price by more than 30% over the fourth quarter of 2018; successfully combined and cross trained the women's health and maternal health sales forces into one team of approximately 125 sales representatives
Acquired Perosphere Pharmaceuticals, including ciraparantag, a development-stage drug candidate to reverse the anticoagulant effects of novel oral anticoagulants (NOACs) and low molecular weight heparin (LMWH)
Completed the study and submitted ambulatory blood pressure data to the FDA and continued activities supporting the potential launch of Vyleesi (PDUFA date: June 23, 2019)
Data presentations:
New and encore data related to Vyleesi for the treatment of hypoactive sexual desire disorder (HSDD) at the International Society for the Study of Women’s Sexual Health (ISSWSH)/International Society for Sexual Medicine (ISSM) joint meeting
New data related to Vyleesi for the treatment of HSDD and Feraheme related to iron deficiency anemia (IDA) resulting from abnormal uterine bleeding at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting
Reaffirmed 2019 financial guidance

First Quarter Ended March 31, 2019 (unaudited)
Total revenues for the first quarter of 2019 were $75.8 million, compared with $117.4 million in the first quarter of 2018. First quarter 2019 net product sales of Makena were $31.3 million, which were lower than the $90.0 million reported in the first quarter of 2018, primarily due to the mid-2018 entry of generic competition to the Makena IM product, as well as IM supply constraints. Makena revenues in the first quarter of 2019 were further impacted by a number of gross-to-net charges, including: (i) $3.5 million of failure-to-supply penalties related to a temporary authorized generic (AGx) IM out of stock situation that occurred during the first quarter, (ii) approximately $5.0 million of increased Medicaid rebates related to the IM supply constraints in the quarter and best price implications, and (iii) $6.0 million change in estimate for Medicaid liability for prior period sales of the Makena IM product. The company expects to resolve its Makena IM supply constraints in the second quarter of 2019 and, therefore, believes charges (i) and (ii) described above are non-recurring in nature. During the first quarter of 2019, the company did not record any branded Makena IM revenues, and revenues for the AGx were adversely impacted by IM supply constraints. Sales of the Makena SC auto-injector totaled $37.8 million in the first quarter of 2019, which is net of the $5.0 million additional Medicaid rebates referenced above. Sales of Feraheme and MuGard® increased 59% to $40.1 million in the first quarter of 2019, compared with $25.2 million in the first quarter of 2018. Intrarosa contributed $4.4 million in net sales during the first quarter of 2019, compared with $2.2 million in the same period last year.

Operating expenses, including cost of product sales, were aligned with expectations, totaling $193.5 million in the first quarter of 2019, compared with $168.2 million for the same period in 2018. This increase was primarily due to: (i) the $74.9 million acquired in-process research and development charge related to the acquisition of Perosphere, (ii) a one-time restructuring charge of $7.4 million related to combining the company's women's health and maternal health sales forces, and (iii) higher research and development costs of $7.3 million related to the company's ongoing clinical development programs. These increases in operating expenses were partially off-set by a $45.4 million reduction in cost of product sales, driven primarily by lower intangible amortization expense.


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The company reported an operating loss from continuing operations in the first quarter of 2019 of $117.7 million, compared with an operating loss of $50.8 million for the same period last year, largely due to the Perosphere acquisition described above. The company reported a net loss from continuing operations of $122.1 million, or $3.54 loss per basic and diluted share, for the first quarter of 2019, compared with a net loss from continuing operations of $58.1 million, or $1.70 loss per basic and diluted share, for the same period in 2018. The net loss reported during the first quarter on 2019 was favorably impacted by a reduction in interest expense incurred, as compared to the prior year period. This was the result of the company retiring $475 million in high-yield bonds in the third quarter of 2018.

Non-GAAP adjusted EBITDA from continuing operations for the first quarter of 2019 was ($26.6) million, compared with $30.0 million in the first quarter of 2018.

Balance Sheet Highlights
As of March 31, 2019, the company’s cash and investments totaled $266.5 million, and long-term total debt totaled $320.0 million (representing the principal amounts outstanding of the 2022 convertible notes). Cash used during the first quarter of 2019 included: (i) $70.8 million related to the acquisition of Perosphere Pharmaceuticals, (ii) $21.4 million for the repayment of the balance of the company's 2019 Convertible Note, and (iii) $13.7 million for the repurchase of approximately 1.1 million shares of common stock.

Reaffirming 2019 Financial Guidance2 
The company reaffirmed the following financial guidance for 2019.
($M)
 
2019 Financial Guidance
Total revenue
 
$365 - $415
Operating loss3
 
($206) - ($176)
Adjusted EBITDA
 
($65) - ($35)

2 See reconciliations of 2019 GAAP to non-GAAP financial guidance at conclusion of this press release.
3 As previously reported, the 2019 operating loss guidance range issued in January 2019 excluded the potential accounting impact for the acquisition of Perosphere, which had not closed at that time. The operating loss guidance range has now been adjusted to incorporate the $74.9 million accounting impact of the Perosphere acquisition, which was recorded in the first quarter of 2019.

"We're pleased with the market uptake of the Makena SC auto-injector, which captured more than 50 percent share of patients treated with FDA-approved hydroxyprogesterone caproate in the first quarter, underscoring continued strong physician demand of this differentiated product and the sustainability of the Makena franchise," said Ted Myles, AMAG’s chief financial officer. "With the expected return of Makena IM supply in the second quarter, continued strong underlying demand for the SC auto-injector, impressive performance from Feraheme, as well as encouraging leading indicators from our Intrarosa direct-to-consumer campaign, we are reiterating our full year guidance for 2019."

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 first quarter 2019 financial results, recent business highlights and 2019 outlook.

Dial-in Number
U.S./Canada dial-in number: (877) 412-6083
International dial-in number: (702) 495-1202
Conference ID: 6850648

Replay dial-in number: (855) 859-2056
Replay International dial-in number: (404) 537-3406
Conference ID: 6850648


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A telephone replay will be available from approximately 11:00 a.m. ET on May 7, 2019 through midnight on May 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 costs and expenses and 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 after the unaudited condensed consolidated financial statements.

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.


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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.

A multicenter, randomized, double-blind, vehicle (placebo)-controlled clinical trial (the Meis trial), which served as the basis for the FDA’s approval of Makena, demonstrated a statistically significant and clinically relevant reduction in the rate of preterm birth at 37 weeks in the Makena arm (36.3%) compared to the placebo arm (54.9 %). 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

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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.


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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 (LMWH) 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, beliefs about the underlying demand for the subcutaneous auto-injector, the status of the Makena IM supply outage, the Company’s progress to replace its previous primary Makena IM supplier and expectations that the Makena supply outage will be remediated in the second quarter; beliefs about novel pipeline assets being the future value drivers of the company; expectations as to the timing of FDA approval for Vyleesi; expectations as to the timing of the Phase 3a clinical studies for ciraparantag; AMAG’s accomplishments and first quarter financial results, including the market share captured by AMAG’s products and such products’ performance; beliefs about physician support of the SC auto-injector and sustainability of the Makena franchise; expectations regarding Feraheme’s future performance; beliefs about the Intrarosa direct-to-consumer campaign; plans to continue to invest in AMAG’s products and product candidates; and expectations regarding AMAG's financial guidance, including revenues, operating loss, and non-GAAP adjusted EBITDA 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, the risk that sales of branded and generic formulations of Makena will continue to be negatively impacted by the supply disruption and recent and future generic entries in the market, including if the supply disruption is not remediated on the expected timeline, or at all; the risk that the FDA will not approve new suppliers for the Makena IM product in a timely manner, or at all, and, even if approved, the risk that any such newly approved supplier will encounter similar supply disruptions or that

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AMAG will otherwise be unable to meet demand for its products; the risk that the Makena brand will incur reputational harm as result of the supply outage or recently disclosed study results, which could harm AMAG’s ability to retain or regain market share and could further negatively impact sales; as well as 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, 2018 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 "A" logo, and "Feraheme® are registered trademarks 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 referenced in this report are the property of their respective owners


– Tables Follow –


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AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(Unaudited, amounts in thousands, except for per share data)
 
Three Months Ended March 31,
 
2019
 
2018
Revenues:
 
 
 
Makena
$
31,257

 
$
89,983

Feraheme/MuGard
40,058

 
25,200

Intrarosa
4,414

 
2,165

Other revenues
75

 
39

Total revenues
75,804

 
117,387

Operating costs and expenses:
 
 
 
Cost of product sales
18,477

 
63,912

Research and development expenses
18,066

 
10,809

Acquired in-process research and development
74,856

 
20,000

Selling, general and administrative expenses
74,682

 
73,431

Restructuring expenses
7,420

 

Total costs and expenses
193,501

 
168,152

Operating loss
(117,697
)
 
(50,765
)
 
 
 
 
Other income (expense):
 
 
 
Interest expense
(6,450
)
 
(15,977
)
Interest and dividend income
1,586

 
643

Other income
340

 

Total other expense, net
(4,524
)
 
(15,334
)
Loss from continuing operations before income taxes
(122,221
)
 
(66,099
)
Income tax benefit
(137
)
 
(8,000
)
Net loss from continuing operations
$
(122,084
)
 
$
(58,099
)
 
 
 
 
Discontinued Operations:
 
 
 
Income from discontinued operations
$

 
$
5,878

Income tax expense

 
2,021

Net income from discontinued operations
$

 
$
3,857

 
 
 
 
Net loss
$
(122,084
)
 
$
(54,242
)
 
 
 
 
Basic and diluted net income (loss) per share:
 

 
 

Loss from continuing operations
$
(3.54
)
 
$
(1.70
)
Income from discontinued operations

 
0.11

Basic and diluted net loss per share
$
(3.54
)
 
$
(1.59
)
 
 
 
 
Weighted average shares outstanding used to compute net income (loss) per share (basic and diluted)
34,469

 
34,162


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AMAG Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(Unaudited, amounts in thousands)
 
March 31, 2019
 
December 31, 2018
ASSETS
    
 
    
Current assets:
 

 
 

Cash and cash equivalents
$
137,917

 
$
253,256

Marketable securities
128,593

 
140,915

Accounts receivable, net
83,334

 
75,347

Inventories
29,664

 
26,691

Prepaid and other current assets
40,567

 
18,961

Note receivable

 
10,000

Total current assets
420,075

 
525,170

Property and equipment, net
8,995

 
7,521

Goodwill
422,513

 
422,513

Intangible assets, net
213,090

 
217,033

Operating lease right-of-use asset
7,024

 

Deferred tax assets
630

 
1,260

Restricted cash
495

 
495

Other long-term assets
29

 
1,467

Total assets
$
1,072,851

 
$
1,175,459

LIABILITIES AND STOCKHOLDERS’ EQUITY
 

 
 

Current liabilities:
 

 
 

Accounts payable
$
21,535

 
$
14,487

Accrued expenses
155,687

 
129,537

Current portion of convertible notes, net

 
21,276

Current portion of operating lease liability
3,529

 

Current portion of deferred revenue
2,112

 

Current portion of acquisition-related contingent consideration
118

 
144

Total current liabilities
182,981

 
165,444

Long-term liabilities:
 

 
 

Convertible notes, net
265,576

 
261,933

Long-term operating lease liability
4,328

 

Long-term deferred revenue
4,288

 

Long-term acquisition-related contingent consideration
218

 
215

Other long-term liabilities
741

 
1,212

Total liabilities
458,132

 
428,804

Commitments and contingencies
 

 
 

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; 33,746,828 and 34,606,760 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively
337

 
346

Additional paid-in capital
1,282,284

 
1,292,736

Accumulated other comprehensive loss
(3,376
)
 
(3,985
)
Accumulated deficit
(664,526
)
 
(542,442
)
Total stockholders’ equity
614,719

 
746,655

Total liabilities and stockholders’ equity
$
1,072,851

 
$
1,175,459


10


AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited, amounts in thousands)
 
Three Months Ended March 31,
 
2019
 
2018
Cash flows from operating activities:
 
 
 
Net loss
$
(122,084
)
 
$
(54,242
)
Adjustments to reconcile net loss to net cash provided by operating activities:
 
 
 
Depreciation and amortization
4,375

 
59,485

Provision for bad debt expense
(16
)
 
463

Amortization of premium/discount on purchased securities
(27
)
 
67

Non-cash equity-based compensation expense 
4,873

 
5,533

Amortization of debt discount and debt issuance costs
3,783

 
3,880

Change in fair value of contingent consideration
(6
)
 
626

Deferred income taxes
458

 
(6,643
)
Changes in operating assets and liabilities:
 
 
 

Accounts receivable, net
(7,971
)
 
3,093

Inventories
(2,973
)
 
3,534

Prepaid and other current assets
(21,606
)
 
(3,720
)
Accounts payable and accrued expenses
33,087

 
30,374

Deferred revenues
6,400

 
3,027

Other assets and liabilities
1,799

 
215

Net cash (used in) provided by operating activities
(99,908
)
 
45,692

Cash flows from investing activities:
 

 
 

Proceeds from sales or maturities of marketable securities
27,945

 
18,225

Purchase of marketable securities
(14,815
)
 
(21,102
)
Settlement of note receivable
10,000

 

Capital expenditures
(1,794
)
 
(923
)
Net cash provided by (used in) investing activities
21,336

 
(3,800
)
Cash flows from financing activities:
 

 
 

Payments to settle convertible notes
(21,417
)
 

Payments of contingent consideration
(17
)
 
(44
)
Payments for repurchases of common stock
(13,730
)
 

Proceeds from the exercise of common stock options
33

 
123

Payments of employee tax withholding related to equity-based compensation
(1,636
)
 
(2,348
)
Net cash used in financing activities
(36,767
)
 
(2,269
)
Net (decrease) increase in cash, cash equivalents, and restricted cash
(115,339
)
 
39,623

Cash, cash equivalents, and restricted cash at beginning of the period
253,751

 
192,770

Cash, cash equivalents, and restricted cash at end of the period
$
138,412

 
$
232,393

Supplemental data for cash flow information:
 
 
 
Cash paid for taxes
$
78

 
$
136

Cash paid for interest
$
267

 
$
18,971


11


AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended March 31, 2019
(Unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Acquired IPR&D
 
Restructuring
 
Operating Income / Adjusted EBITDA
GAAP
$
75,804

 
$
18,477

 
$
18,066

 
$
74,682

 
$
74,856

 
$
7,420

 
$
(117,697
)
Depreciation and intangible asset amortization

 
(3,943
)
 
(8
)
 
(424
)
 

 

 
 
Stock-based compensation

 
(202
)
 
(680
)
 
(3,325
)
 

 

 
 
Acquisition-related costs

 

 

 
(270
)
 

 

 
 
Restructuring

 

 

 

 

 
(7,420
)
 
 
Acquired IPR&D

 

 

 

 
(74,856
)
 
 
 
 
Non-GAAP Adjusted
$
75,804

 
$
14,332

 
$
17,378

 
$
70,663

 
$

 
$

 
$
(26,569
)





AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended March 31, 2018
(Unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Acquired IPR&D
 
Operating Income / Adjusted EBITDA
GAAP
$
117,387

 
$
63,912

 
$
10,809

 
$
73,431

 
$
20,000

 
$
(50,765
)
Depreciation and intangible asset amortization

 
(52,364
)
 

 
(759
)
 

 
 
Non-cash inventory step-up adjustments

 
(2,223
)
 

 

 

 
 
Stock-based compensation

 
(200
)
 
(720
)
 
(3,870
)
 

 
 
Adjustments to contingent consideration

 

 

 
(626
)
 

 
 
Acquired IPR&D

 

 

 

 
(20,000
)
 
 
Non-GAAP Adjusted
$
117,387

 
$
9,125

 
$
10,089

 
$
68,176

 
$

 
$
29,997









12


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

 
2019 Financial Guidance
Operating loss3
($206) - ($176)
Depreciation & intangible asset amortization
36
Stock-based compensation
22
Non-cash inventory step up and adjustments to contingent consideration
1
Acquired IPR&D
75
Restructuring
7
Non-GAAP adjusted EBITDA
($65) - ($35)





AMAG Pharmaceuticals, Inc.
Share Count Reconciliation
(Unaudited, amounts in millions)
 
 
Three Months Ended March 31,
 
 
 
2019
 
2018
 
Weighted average basic shares outstanding
 
34.5

 
34.2

 
Employee equity incentive awards
 

4 

4 
GAAP diluted shares outstanding
 
34.5

 
34.2

 
Employee equity incentive awards
 
0.2

5 
0.2

5 
Non-GAAP diluted shares outstanding
 
34.7

 
34.4

 

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


CONTACT:
AMAG Pharmaceuticals, Inc.
Linda Lennox
Vice President, Investor Relations
O: 617-498-2846
M: 908-627-3424


13
q12019ex992
AMAG Pharmaceuticals First Quarter 2019 Financial Results May 7, 2019 © 2019 AMAG Pharmaceuticals, Inc. All© rights 2019 reservedAMAG 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, AMAG’s expectations for its product and product candidate portfolio, including the anticipated regulatory and clinical trial timelines for AMAG’s product candidates, including ciraparantag, AMAG-423 and Vyleesi; beliefs about novel pipeline assets being the future value drivers of the company; AMAG’s beliefs regarding Feraheme’s market share and further commercial opportunity; expectations related to the impact of changes to AMAG’s copay program on Intrarosa’s gross to net revenues; beliefs about Intrarosa’s market share and commercial opportunity; expectations regarding the impact of strong salesforce promotion and direct to consumer campaign on Intrarosa growth; AMAG’s beliefs regarding the market share and commercial opportunity for the Makena products; beliefs about the underlying demand for the subcutaneous auto-injector, the status of the Makena IM supply outage and that the temporary supply constraints for the intramuscular Makena product will be resolved in the second quarter of 2019; AMAG’s beliefs regarding payer and physician support of the Makena auto-injector; AMAG’s beliefs regarding the results of the Makena PROLONG trial, expectations for timing of the Company’s meeting with the FDA and for publication of a peer-reviewed article; AMAG’s beliefs regarding the impact of its direct-to-consumer disease state awareness campaign related to bremelantotide; characterizations of and beliefs about study and market data for the Company’s products and product candidates; AMAG’s expectations regarding the anticipated PDUFA date for Vyleesi; AMAG’s expectations regarding the efficacy of its direct-to-consumer campaign for Vyleesi; AMAG’s beliefs regarding the clinical development timeline for ciraparantag, including the timing, design, scope and objectives of planned Phase 3/4 programs and the potential receipt of milestone payments; AMAG’s expectations that it will use a coagulometer as part of its Phase 3b/4 clinical trial for ciraparantag; beliefs about the revenues driven by the continued growth of Feraheme, the Makena auto-injector, and Intrarosa; AMAG’s expectations regarding future research and development expenses and expansion of its hematology and oncology sales force; AMAG’s accomplishments and first quarter financial results, including the market share captured by AMAG’s products and such products’ performance; AMAG’s 2019 goals, 2019 financial guidance, including forecasted 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, challenges with commercialization efforts of AMAG’s portfolio of products and product candidates, including any impact from its recent restructuring initiative; the risk that sales of branded and generic formulations of Makena will continue to be negatively impacted by the supply disruption and recent and future generic entries in the market, including if the supply disruption is not remediated on the expected timeline, or at all; the risk that the FDA will not approve new suppliers for the Makena IM product in a timely manner, or at all, and, even if approved, the risk that any such newly approved supplier will encounter similar supply disruptions or that AMAG will otherwise be unable to meet demand for its products; the risk that the Makena brand will incur reputational harm as result of the supply outage or recently disclosed study results, which could harm AMAG’s ability to retain or regain market share and could further negatively impact sales; 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, 2018 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 "A" logo, and "Feraheme® are registered trademarks 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 referenced in this report are the property of their respective owners. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 2


 
Agenda 1 Q1-2019 Highlights and Recent Developments 2 Update on Commercial Products 3 Update on Development Pipeline Assets 4 Q1-2019 Financial Overview 5 Closing Remarks / Q&A © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 3


 
Q1-2019 Highlights and Recent Developments • Promoted Tony Casciano to Chief Commercial Officer – Led the successful launches of the Makena subcutaneous (SC) auto-injector and the Feraheme broad label • Feraheme – Achieved 59% growth in Feraheme quarterly net sales year-over-year • Makena – SC auto-injector captured 54% volume market share of all FDA-approved hydroxyprogesterone caproate (HPC) products – Intramuscular (IM) supply constraints impacted overall Makena revenues in Q1-2019 • Intrarosa – Revised copay savings program improved net price, however impacted TRx volume in the quarter • Completed integration of Perosphere Pharmaceuticals and progressed ciraparantag clinical program • Reaffirming 2019 financial guidance © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 4


 
AMAG: Leveraging Two Strong Commercial Platforms Hematology and Women’s/Maternal Health Future ciraparantag AMAG-423 Commercial Hematology Women’s Health Maternal Health 48 sales representatives => Heme clinics & hospitals 124 sales representatives => OB/GYNS Strong Commercial Platform © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 5


 
Feraheme® Intrarosa® Makena® VyleesiTM Ciraparantag 6


 
Feraheme Continues to Grow with Expanded Label Record First Quarter 2019 Revenue Feraheme Growth ($M) • Strong execution with expanded IDA label $40.0 – Performance-based contracting drove volume, with stable price 59% • Q1-2019 average market share was 16.1%, compared 1 $25.1 with 11.2% in Q1-2018 – Greater than 30% share in hematology/oncology segment • Strong IV iron market growth of more than 9% year over year1 – Opportunity for further growth with educational initiatives with gastroenterologists and OB/GYNs Q1-2018 Q1-2019 1 AMAG estimates market share and market growth using IQVIA data and internal analytics. In January 2019, IQVIA began using a new reporting methodology to reflect more accurate data. Overall Rx numbers are 15%-20% lower than previously reported using the new IQVIA methodology. IV IRON DEFICIENCY ANEMIA: FERAHEME © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 7


 
Feraheme® Intrarosa® Makena® VyleesiTM Ciraparantag 8


 
Intrarosa Revenue and Market Share Trending Upward Quarterly Revenue Intrarosa Overall Market Share1 Q1-2019 $8.0 ($M) • Rx market volume impacted by $7.0 deductible resets with start of new year $5.9 4.4% $6.0 TRx NRx 4.2% • Modified patient copay savings $5.0 program $4.4 4.0% $4.0 3.8% • Combination of women’s health 3.6% and maternal health sales forces in $3.0 February 2019 $2.2 3.4% $2.0 3.2% • Strong salesforce promotion and DTC campaign expected to drive $1.0 3.0% growth in 2019 2/1/19 2/8/19 3/1/19 3/8/19 4/5/19 $0.0 1/4/19 1/11/19 1/18/19 1/25/19 2/15/19 2/22/19 3/15/19 3/22/19 3/29/19 4/12/19 4/19/19 Q1-2018 Q4-2018 Q1-2019 1 Intrarosa market share data based on IQVIA Xponent Plantrak data. WOMEN’S HEALTH: INTRAROSA © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 9


 
Feraheme® Intrarosa® Makena® VyleesiTM Ciraparantag 10


 
Makena Revenue Q1-2019 Strong SC auto-Injector volume growth overshadowed by gross-to-net charges Q1-2019 $46.9 • Makena SC auto-injector $45.8 ($3.5) ($5.0) – Recorded revenue of $37.8M $42.8 ($6.0) • Makena IM $35.1 $31.3 – Recorded $3.0M of profit share through AGx sales (limited supply) • Makena IM Supply Update – Expect resolution in Q2-2019 and AGx partner to be fully resupplied Q4-2018 Q1-2019 Failure-to-supply Higher gov't Change in Q1-2019 Pro-forma1 penalty rebates Medicaid estimates for prior period reserves Makena SC Makena IM AGx IM Total Makena 1 Q1-2019 pro-forma Makena SC auto-injector of $42.8M includes recorded revenue of $37.8M plus $5.0M related to the company’s estimate of higher government rebates related to the IM supply constraints. MATERNAL HEALTH: MAKENA © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 11


 
Continued Strong Physician Support of the SC Auto-injector All FDA-approved hydroxyprogesterone caproate (HPC) TRxs1 Q4-2018 Q1-2019 SC Auto-injector Q1-2019 vs. Q4-2018 1% • Grew market share by 7 percentage points 9% 11% • Achieved 40% volume growth over Q4-2018 22% • Continued favorable payer and prescriber support 47% 54% 34% – Broad payer coverage 22% • 66% of prescriptions state ‘dispense as written’2 • Value of Makena Care Connection® SC AI Branded IM AGx IM Other IM Generics 1 Specialty Pharmacy Demand Data; Valuecentric 867 Data; IQVIA SMART US Edition Integrated View – NSP. 2 Makena Care Connection enrollment data. MATERNAL HEALTH: MAKENA © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 12


 
PROLONG Study – WSJ Article “Medical Groups Say It’s Too Early To Make A Call” March 18, 2019 “The American College of • PROLONG did not confirm the original efficacy results of the Obstetricians and Gynecologists, the Meis trial, but did confirm favorable safety profile Society for Maternal-Fetal Medicine • Very different patient populations studied in PROLONG & Meis and March of Dimes said they stand • Prior clinical trials have demonstrated efficacy by their current recommendations of • Timeline: synthetic hormone injections and will – Q3-2019: Meeting with FDA evaluate information as it comes to . No immediate action anticipated light.” – Timing for publication of peer-reviewed article to be determined MATERNAL HEALTH: MAKENA © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 13


 
TM Feraheme® Intrarosa® Makena® VyleesiTM Ciraparantag 14


 
AMAG Data Presentations at ACOG Annual Meeting May 3-6  Nashville, TN Vyleesi (bremelanotide)1 Feraheme (ferumoxytol) Research Podium Session Research Poster Session “Bremelanotide for HSDD: Contraceptive Subgroups “Sustained Improvements in Anemia and Fatigue of AUB Efficacy Analysis” after a Single Course of Ferumoxytol: 6-month Follow-up” Conclusion: Independent of the type of contraceptive Conclusion: Study found that for the majority of patients, used, bremelanotide demonstrated significant improvements in fatigue and improvements in sexual desire and related quality of life domains were achieved and distress in premenopausal women with HSDD sustained for 6 months following a single treatment of ferumoxytol Research Poster Session “Efficacy of Bremelanotide Across HSDD Duration Subgroups” Conclusion: Bremelanotide demonstrated efficacy in premenopausal women regardless of HSDD duration Bremelanotide significantly restored sexual desire across HSDD duration quartiles and showed improvements in decreasing distress 1 Safety and efficacy of bremelanotide have not been established by the FDA. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 15


 
Unbranded Disease State Awareness Campaigns Launched Bremelanotide PDUFA date: June 23, 2019 Healthcare Provider (HCP) Direct-to-Consumer (DTC) Disease State Awareness Disease State Awareness Campaign Launch, March 2019 Campaign Launch, April 2019 — — • It’s Not About Sex campaign unblush campaign launched on debuted at ISSWSH on March 7 April 30 includes: and was also presented at • Website: unblush.com ACOG in early May • Video • Social media content • The digital campaign, which launched on March 25, has • Media/journalists event hosted generated benchmark- by Conde Nast in New York City exceeding metrics, including 570k impressions and over 3k visits to HerHSDD.com in the first week alone • First campaign email to HCPs saw a 46% open rate WOMEN’S HEALTH: VYLEESI © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 16


 
Feraheme® Intrarosa® Makena® VyleesiTM Ciraparantag 17


 
Ciraparantag Clinical Development Program Progressing Planning for End of Phase 2 meeting with FDA 2H-2019 prior to initiating Phase 3b/4 clinical trial • Whole blood clotting time (WBCT) is currently a manual Automated coagulometer measures WBCT in ~2 minutes measure of the time it takes for blood to clot – clinically relevant physiologic outcome • WBCT (manual) was the clinical endpoint measured in the Phase 2b clinical trials • Perosphere Technologies has developed an automated coagulometer to measure WBCT1 – Investigative Device Exemption (IDE) for coagulometer will be submitted to FDA prior to initiating Phase 3a trial – Pre submission meeting with FDA scheduled – IDE submission expected mid year • Preparing applications for breakthrough and orphan designations 1 AMAG has entered into an agreement with Perosphere Technologies for rights to a automated coagulometer, which could be utilized in the Phase 3 clinical program. HEMATOLOGY: CIRAPARANTAG © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 18


 
Financial Overview 19


 
First Quarter Financial Results $M Q1-2019 Q1-20181 Makena $31.3 $90.0 Feraheme/MuGard 40.1 25.2 Intrarosa 4.4 2.2 • Operating expense summary Total revenues $75.8 $117.4 – Increases driven by: . Acquired IPR&D of ~$75M related to acquisition of Cost of product sales 18.5 63.9 Perosphere . Research and development expenses 18.0 10.9 One-time restructuring charge of $7.4M related to combining the Women’s and Maternal Health sales forces Acquired in-process research and development 74.9 20.0 . R&D higher related to ongoing clinical development Selling, general and administrative expenses 74.7 73.4 programs, including AMAG-423 and ciraparantag Restructuring expenses 7.4 -- – Partially offset by lower cost of product sales of $45.5M due to Total costs and expenses 193.5 168.2 decrease in amortization of Makena intangible asset Operating loss ($117.7) ($50.8) • Adjusted EBITDA loss aligned with company’s plan and strategic evolution Non-GAAP adjusted EBITDA2 ($26.6) $30.0 1 Excludes Cord Blood Registry’s financial results. 2 See slide 28 for a reconciliation of GAAP to non-GAAP financial results. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 20


 
Strong Balance Sheet ($M) 3/31/19 12/31/18 Cash, cash equivalents and investments $267 $394 Short-term debt: Convertible senior notes (2.5%) due Feb. 2019 $0 $21 Long-term debt: Convertible senior notes (3.25%) due 2022 $320 $320 FINANCIAL OVERVIEW © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 21


 
Reaffirming 2019 Financial Guidance Key inputs and drivers of financial guidance • Revenues driven by – Continued growth of Feraheme, Makena SC auto-injector and Intrarosa ($M) 2019 Financial Guidance1 – Resolution of Makena IM supply issue – ~$20M in expected ciraparantag development milestone Total revenue $365 - $415 payments from a global pharma partner • Spending includes increase in R&D Operating loss2 ($206) - ($176) – Completion of Phase 2 development of ciraparantag, initiation of Phase 3a trial Adjusted EBITDA ($65) - ($35) – Continuing enrollment of AMAG-423 Phase 2b/3a trial • SG&A – Impact of consolidation of women’s health and maternal health sales forces – Anticipated launch of Vyleesi in Q3-2019 – Modest expansion of hematology/oncology sales team 1 See slide 29 for a reconciliation of GAAP to non-GAAP financial guidance. 2 As previously reported, the 2019 operating loss guidance range issued in January 2019 excluded the potential accounting impact for the acquisition of Perosphere, which had not closed at that time. The operating loss guidance range has now been adjusted to incorporate the $74.9 million accounting impact of the Perosphere acquisition, which was recorded in the first quarter of 2019. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 22


 
AMAG's Growing Innovative Pipeline Progress on 2019 goals Approved/ Phase 1 Phase 2 Phase 3 Regulatory Review Marketed Anticoagulant reversal agent Ciraparantag (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) 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 23


 
Significant Shareholder Value at AMAG Historical Value Drivers Fund Future Value Drivers ciraparantag AMAG-423 Fundingfunding HISTORICAL Value of AMAG FUTURE Value of AMAG © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 24


 
AMAG Analyst Day – May 22, 2019 FEATURED EXTERNAL SPEAKERS: AMAG-423 (in development for the treatment of severe preeclampsia) • John Barton, MD, OB/GYN, MFM specialist at Baptist Health, Lexington, KY • Baha Sibai, MD, Professor, Department of OB/GYN and Reproductive Sciences, UT Physicians Maternal-Fetal Medicine Center, Texas Medical Center • Q&A with panel VyleesiTM (in development for HSDD; PDUFA date: June 23rd) Please join senior executives and Key Opinion leaders • David Portman, MD, Founder, Director Emeritus, Principal Investigator, The Columbus to discuss AMAG’s product portfolio and development pipeline Center for Women’s Health • Sheryl Kingsberg, PhD, Chief, Division of Behavioral Medicine, University Hospitals Cleveland Medical Center, Cleveland, OH 7:30 a.m. - Breakfast and Registration • HSDD patient – fireside chat with patient and Dr. Kingsberg 8:30 a.m. - Presentations and Q&A • Q&A with panel 12:00 p.m. - Buffet Lunch with Management & KOLs Ciraparantag (in development as an anticoagulant reversal agent) • Jack Ansell, MD, former Chairman, Department of Medicine at Lenox Hill; Professor of Medicine at NYU School of Medicine • Joseph Bledsoe, MD, Dept. of Emergency Medicine, Intermountain Healthcare, Salt Lake City, UT; Stanford University medical faculty: Intermountain-Stanford collaborative • C. Michael Gibson, MD, Interventional cardiologist, cardiovascular researcher, Beth Israel Deaconess Medical Center, Boston, MA • Q&A with panel © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 25


 
AMAG Pharmaceuticals First Quarter 2019 Financial Results Q&A © 2019 AMAG Pharmaceuticals, Inc. All© rights 2019 reservedAMAG Pharmaceuticals, Inc. All rights reserved 26


 
Appendix 27


 
Reconciliation of GAAP to Non-GAAP Financial Results $M Q1-2019 Q1-2018 Operating loss ($117.7) ($50.8) Depreciation and intangible asset amortization 4.4 53.2 Non-cash inventory step-up adjustments -- 2.2 Stock-based compensation 4.2 4.8 Acquisition-related costs 0.2 -- Adjustments to contingent consideration -- 0.6 Acquired IPR&D 74.9 20.0 Restructuring 7.4 -- Adjusted EBITDA ($26.6) $30.0 APPENDIX © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 28


 
Reconciliation of GAAP to Non-GAAP 2019 Financial Guidance 2019 Financial Guidance ($M) Operating loss1 ($206) – ($176) Depreciation & intangible asset amortization 36 Stock-based compensation 22 Non-cash inventory step up and adjustments to contingent consideration 1 Acquired IPR&D 75 Restructuring 7 Adjusted EBITDA ($65) – ($35) 1 2019 operating loss guidance originally issued in January 2019 excluded the potential accounting impact for the acquisition of Perosphere Pharmaceuticals Inc., which closed later in January 2019. The $74.9 million accounting impact has been added to the 2019 operating loss guidance in the table above. APPENDIX © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 29


 
AMAG Pharmaceuticals First Quarter 2019 Financial Results May 7, 2019 © 2019 AMAG Pharmaceuticals, Inc. All© rights 2019 reservedAMAG Pharmaceuticals, Inc. All rights reserved 30