SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): January 7, 2019
AMAG PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation)
(IRS Employer Identification
1100 Winter St.
(Address of principal executive
(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. ☐
Item 2.02. Results of Operations and Financial Condition.
The following information and Exhibits 99.1 and 99.2 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), except as expressly set forth by specific reference in such filing. On January 7, 2019, AMAG Pharmaceuticals, Inc. (“the Company”) issued a press release providing a business update, including preliminary unaudited fourth quarter and annual 2018 financial results and financial guidance for 2019. A copy of the Company’s press release is furnished herewith as Exhibit 99.1.
Item 7.01. Regulation FD Disclosure.
The following information and Exhibit 99.2 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act, except as expressly set forth by specific reference in such filing. The Company will present further details on the matters noted above at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on January 9, 2019, which presentation will be accessible by a live audio webcast through the Company’s website at www.amagpharma.com on January 9, 2019 at 7:30 a.m. Pacific Time (10:30 a.m. Eastern Time). During the conference, the Company intends to conduct meetings with third parties in which a corporate slide presentation will be presented. A copy of the Company's slide presentation, which will be referenced during the conference, including the Company's webcast presentation, is furnished herewith as Exhibit 99.2.
Item 9.01. Financial Statements and Exhibits.
The Company hereby furnishes the following exhibits:
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.
/s/ Joseph D. Vittiglio
Joseph D. Vittiglio
Executive Vice President, General Counsel, Quality & Corporate Secretary
January 7, 2019
FOR IMMEDIATE RELEASE
AMAG Pharmaceuticals Announces Preliminary 2018 Financial Results
and Provides 2019 Financial Guidance
Achieves 2018 revenue of between $471 million and $476 million, including approximately 28% growth in Feraheme® (ferumoxytol injection) sales
Acquisition of two development-stage assets creates a strong and diversified portfolio,
leveraging therapeutic area expertise
WALTHAM, Mass., January 7, 2019 – AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced preliminary unaudited fourth quarter and full year 2018 financial results and provided 2019 financial guidance.
The company will provide a portfolio update at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 9, 2019 at 7:30 a.m. PT (10:30 a.m. ET). A live audio webcast of the presentation and following breakout session will be accessible through the Investors section of AMAG’s website at www.amagpharma.com.
"In 2018, we achieved several key milestones including receiving two approvals from the U.S. Food and Drug Administration (FDA), launching both the Makena subcutaneous auto-injector and Feraheme broad label, and receiving FDA acceptance of our new drug application
for VyleesiTM (bremelanotide). In addition, we bolstered our pipeline by adding two promising late-stage development assets, AMAG-423 and ciraparantag, targeting orphan patient populations,” said William Heiden, AMAG’s president and chief executive officer.
“As we enter 2019, AMAG is in a unique position with a number of growing commercial products that together generate significant cash flows, allowing us to invest in the development and launch of our new pharmaceutical products. We have built an innovative and diversified portfolio that I believe positions us well for long-term growth and will deliver significant shareholder value,” added Mr. Heiden.
Preliminary Fourth Quarter and Full Year 2018 Financial Results (unaudited)
Fourth Quarter 2018
AMAG expects total revenues from continuing operations for the fourth quarter of 2018 to be between $85 million and $90 million. This includes Makena® (hydroxyprogesterone caproate injection) net product sales of between $46 million and $48 million, Feraheme and MuGard® net product sales of between $34 million and $36 million, and Intrarosa net product sales of between $5 million and $6 million. The Makena subcutaneous auto-injector maintained market share in the fourth quarter, as compared to the third quarter, despite the entry of generic competition to the intramuscular product. In addition, Makena ex-factory sales were impacted by a reduction in channel inventory levels in the fourth quarter, as compared to third quarter, due to temporary supply constraints, which are now resolved. Fourth quarter Feraheme revenues grew approximately 34% over prior year, driven by continuing success of the product’s expanded label. Intrarosa revenues were driven by strong prescription volume and market share growth in the quarter.
For the fourth quarter of 2018, AMAG expects an operating loss of between $17 million and $27 million. Adjusted EBITDA (earnings before interest, taxes, depreciation and amortization) for the fourth quarter of 2018 is expected to be within the company’s forecasted range of between a loss of $5 million and positive adjusted EBITDA of $5 million.
Full Year 2018
AMAG expects full year 2018 revenues and adjusted EBITDA to be within the company’s most recently issued financial guidance range. Total revenues from continuing operations are expected to be between $471 million and $476 million. This includes Makena net product sales of between $321 million and $323 million, Feraheme and MuGard net product sales of between $134 million and $136 million, and Intrarosa net product sales of between $15 million and $16 million. As a result of the sale of Cord Blood Registry® (CBR), which closed on August 6, 2018, CBR’s results have been excluded from the financial results.
For the full year of 2018, AMAG expects an operating loss of between $45 million and $55 million and adjusted EBITDA of between $115 million and $125 million.2
The company ended 2018 with approximately $394 million in cash and investments, $21.4 million of short-term debt and $320 million of 2022 convertible notes (principal amount outstanding).
The company expects to report final financial results for the fourth quarter and audited results for the full year of 2018 in February.
The company has a number of goals and key milestones upcoming in 2019:
Expand use of Makena subcutaneous auto-injector
Continue successful Intrarosa direct-to-consumer campaign
Submit Vyleesi frequent-dosing study results prior to updated PDUFA date of June 23, 2019; prepare for 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 in/out-licensing opportunities
Meet/exceed financial guidance
The company is providing the following financial guidance for 2019:
$ in millions
2019 Financial Guidance
$365 - $415
($131) - ($101)
($65) - ($35)
"During 2018, we increased our financial guidance three times and today announced that we achieved our financial objectives for the full year of 2018,” said Ted Myles, AMAG's chief financial officer. “We also completed the transformation of our balance sheet, and with nearly $400 million of cash on hand and approximately $20 million in near-term debt, we are well positioned to advance our portfolio of novel products.”
“2019 will be a year of investment and we are in the fortunate position that our cash flow generating products and our balance sheet can support the development of our future products; each of which has significant revenue and growth prospects because they provide innovative therapeutic solutions to patients with unmet medical needs,” added Mr. Myles.
A live audio webcast of the company’s presentation and the following breakout session, along with the accompanying slide presentation at the 37th Annual J.P. Morgan Healthcare Conference, will be accessible through the Investors section of the company’s website at www.amagpharma.com on January 9, 2019 at 7:30 a.m. PT (10:30 a.m. ET). Following the conference, the webcast will be archived on the company’s website until February 9, 2019.
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.
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.
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.
Digoxin Immune Fab is marketed by another company for the FDA-approved treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose.
AMAG expects to acquire the global rights to Ciraparantag in connection with its pending acquisition of Perosphere Pharmaceuticals Inc., pursuant to an Agreement and Plan of Merger dated December 12, 2018. The acquisition is expected to close in the first quarter of 2019, subject to a number of customary closing conditions.
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 when ciraparantag binds to NOACs such as Xarelto®(rivaroxaban), Eliquis®(apixaban) and Savaysa®(edoxaban), as well as to Lovenox® (enoxaparin sodium injection), a low molecular weight heparin, it reestablishes the body’s ability to form clots.
Upon the close of the transaction, AMAG will 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 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.
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 preliminary fourth quarter and full year financial results, including revenues, operating loss and adjusted EBITDA; AMAG’s belief that temporary supply constraints of the Makena auto-injector are now resolved; expectations that AMAG’s full year 2018 revenues and adjusted EBITDA will be within its most recently issued financial guidance range; beliefs about AMAG’s pipeline, including the impact of the additions of AMAG-423 and ciraparantag; beliefs that AMAG’s cash flows allow it to invest in the development of its new products and expectations for its diversified portfolio, including its innovative nature and that it positions AMAG well for long-term growth and will deliver significant shareholder value; plans to report final, audited 2018 financial results in February 2019; AMAG’s 2019 goals and expectations; 2019 financial guidance, including total revenue, operating loss and adjusted EBITDA; beliefs that AMAG’s balance sheet and that its transformation has positioned it well to advance its portfolio of novel products; and AMAG’s expectations that 2019 will be a year of investment and that its cash flow generating products can support the development of its future products, and that each of these products has significant revenue and growth prospects 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 possibility that the closing conditions to the Perosphere transaction will not be met and that the parties will be unable to consummate the proposed transaction; 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 (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, 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. 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.
Reconciliation of GAAP to Non-GAAP Preliminary Financial Results
(unaudited, amounts in millions)
GAAP operating loss
($27) – ($17)
($55) – ($45)
Depreciation and intangible asset amortization
Non-cash inventory step-up adjustments
Adjustments to contingent consideration
($5) - $5
$115 - $125
AMAG Pharmaceuticals, Inc.
Reconciliation of 2019 Financial Guidance of Non-GAAP Adjusted EBITDA
(unaudited, amounts in millions)
GAAP operating loss
($131) – ($101)
Depreciation and intangible asset amortization
Non-cash inventory step-up adjustments to contingent consideration
Non-GAAP adjusted EBITDA
($65) – ($35)
AMAG Pharmaceuticals JP Morgan 37th Healthcare Conference January 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 timeline for AMAG’s products and product candidates and expectations for AMAG’s product portfolio; AMAG’s belief that temporary supply constraints of the Makena auto-injector are now resolved; 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 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; beliefs about 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 AMAG-423 and the expected market opportunity; AMAG’s beliefs regarding the target product profile for AMAG-423, including the presumed mechanism of action, indication, and safety profile; AMAG’s beliefs regarding the clinical efficacy, safety data and population market of ciraparantag; 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; the expected timing for the closing of the Perosphere transaction; beliefs about annual peak revenue opportunities for Intrarosa, Vyleesi, AMAG-423 and ciraparantag; and AMAG’s 2019 goals and 2018 financial guidance, including forecasted GAAP revenue, GAAP 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 possibility that the closing conditions to the Perosphere transaction will not be met and that the parties will be unable to consummate the proposed transaction; 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 AMAG’s beliefs about annual peak sales for 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, 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
AMAG's Growing Innovative Pipeline Approved/ PHASE 1 PHASE 2 PHASE 3 Regulatory Review Marketed Ciraparantag1 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 HSDD Indication 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 (orphan drug designation) * HSDD: Hypoactive Sexual Desire Disorder 1 Merger transaction with Perosphere Pharmaceuticals Inc. expected to close in Q1-2019. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 3
AMAG's 2018 Accomplishments Option 4 Gained FDA approval and launched Makena subcutaneous auto-injector Gained FDA approval and launched Feraheme’s expanded label Established strong HCP support for Intrarosa and initiated DTC campaign Submitted new drug application (NDA) to FDA for Vyleesi Acquired orphan drug candidate (AMAG-423) for severe preeclampsia Signed merger agreement with Perosphere Pharmaceuticals (ciraparantag) Divested Cord Blood Registry business Paid off $475M of Senior Notes (eliminated ~$40M/year interest expense) Achieved financial guidance that was raised three times during 2018 © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 4
2018 Results Are Preliminary and Unaudited Achieved 2018 Financial Objectives ($M) 2018 Issued Guidance1 Preliminary Results January May August November 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 EBITDA2 $55 - $85 $75 - $95 $95 - $115 $115 - $125 $115 - $125 • 2018 record annual revenue of $134M - $136M • 2018 annual revenue of $15M - $16M • ~28% growth over 2017 • Strong Rx growth Relative to initial guidance provided at • 2018 annual revenue of $321M - $323M JPMorgan 20181 despite generic entry and supply challenges • Revenue exceeded by $64M • Adjusted EBITDA exceeded by $50M 1 Excludes Cord Blood Registry for each period. 2 See slide 31 for a reconciliation of GAAP to non-GAAP financials. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 5
Feraheme: Proven Ability to Grow Volume and Take Share – 34% growth over Q4-2017 to preliminary Q4-2018 revenues of between $34M - $36M • Q4-2018 avg. market share: 16.7%, 5 ppt. increase over Q4-20171 • Hematology/oncology segment market share >30%1 • Strong customer contract performance lowered net price per gram – ~8% IV iron market growth in 2018 over 20171 • Launched OB/GYN IV iron pilot program utilizing Maternal Health sales team • Expanded sales force to cover additional sites of care - e.g. gastroenterologists 1 AMAG estimates market share using IQVIA data and internal analytics. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 6
Strong Makena Subcutaneous Auto-injector Demand • Preliminary Q4-2018 revenues of $46M - $48M • Subcutaneous auto-injector (SC AI) success stabilizes the franchise into the future – Ex-factory revenues impacted by reduction in channel inventory due to temporary supply constraints, which are now resolved • Makena Care Connection® (MCC) critical for patient access to therapy; in Q4-20181: – >70% of branded Makena went through MCC – 59% of scripts submitted through MCC stated “Dispense as written” • Authorized generic allows for participation in the generic market 1 Makena Care Connection enrollment data. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 7
Significant Shareholder Value at AMAG Historical Value Drivers Fund Future Value Drivers ciraparantag AMAG-423 Fundingfunding HISTORICAL Value of AMAG FUTURE (≥2020) Value of AMAG © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 8
Feraheme® Makena® Intrarosa® VyleesiTM AMAG-423 Ciraparantag 9
Significant Unmet Medical Need in Large Underserved Market Intrarosa: First-in-class therapy to treat moderate to severe dyspareunia due to menopause • Dyspareunia – Common symptom of VVA (vulvar vaginal atrophy) in post-menopausal women • Only FDA approved locally administered Annual U.S. incidence of dyspareunia, a symptom of VVA non-estrogen therapy1 20 million women2 • Differentiated mechanism of action1 – Intrarosa converts locally into active androgens and U.S. women with dyspareunia not on Rx therapy estrogens to help restore vaginal tissue 18 million women (90%)2 • Unique safety profile – No boxed warning and no limitation on duration of use #1 reason affected patients not on Rx therapy: – Estrogen therapies contain a boxed warning about: Don’t want estrogen3 • Increased risk of cancer • Increased risk of cardiovascular disease • Probable dementia Annual U.S. peak revenue opportunity • Launched July 2017 >$500M4 1 Intrarosa is converted by enzymes in the body into androgens and estrogens, though the mechanism of action is not fully established. 2 AMAG estimate based on Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive Health 2014:8 23–30; Kingsberg et al. Vulvar and Vaginal Atrophy in Postmenopausal Women: Findings from the REVIVE Survey. J Sex Med 2013;101790-1799; and F. Palma et al: Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study; Intrarosa is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. 3 Market research sponsored by AMAG and conducted by Hall and Partners. June 2018. 4 Annual U.S. peak revenue opportunity is not guidance, but instead represents what the company believes to be AMAG's peak revenue opportunity based on internal estimates, including early market research conducted for each product. WOMEN’S HEALTH: INTRAROSA © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 10
Strategic Emphasis on Intrarosa Direct-to-Consumer: Impact is Emerging • Preliminary Q4-2018 revenue of $5M-$6M • 1 1 300% Strong prescription trends continue Weekly NRx Share INCREASE in avg. – Market grew 8.2% in 2018, largely driven by Intrarosa NRx share growth – Intrarosa TRxs totaled more than 176,000 in 2018 4.9% – Commercially insured Intrarosa market share tripled in Launch of DTC campaign 2018 to 6.7% 4.7% • Transitioning to new copay program design 4.5% +0.9 pts – Anticipate gross-to-net improvements 4.3% • Strong and growing physician support1 – Growing new prescribers 2,200+ every quarter in 2018 4.1% • > 13,000 physicians have prescribed Intrarosa +0.3 pts – Intrarosa Q4 prescriber TRx share: 23.6% of commercially 3.9% insured patients • Direct-to-consumer (DTC) campaign launched in September 3.7% 2018 demonstrating strong patient engagement – 3.5% 6/8/18 6/15/18 6/22/18 6/29/18 7/6/18 7/13/18 7/20/18 7/27/18 8/3/18 8/10/18 8/17/18 8/24/18 8/31/18 9/7/18 9/14/18 9/21/18 9/28/18 10/5/18 10/12/18 10/19/18 10/26/18 11/2/18 11/9/18 11/16/18 11/23/18 11/30/18 12/7/18 12/14/18 12/21/18 20M women reached 6/1/18 – 1M+ visitors to unbranded website – 700K visitors to intrarosa.com – Traffic to telemedicine sites growing 1 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 11
Feraheme® Makena® Intrarosa® VyleesiTM AMAG-423 Ciraparantag 12
Significant Unmet Medical Need for Millions of Women Vyleesi: investigational product for of low sexual desire/libido associated with distress • Novel product candidate – On demand use in anticipation of sexual activity – Self-administered subcutaneous auto-injector pen – Novel mechanism of action: melanocortin receptor agonist (MCR4) – No known alcohol interaction Affects 12 million U.S. women1 • Two large Phase 3 studies – Met co-primary, pre-specified endpoints Affects 5.8 million U.S. premenopausal women2 • Improvement in desire (1 in 10 premenopausal women)3,4 • Reduction in distress – Favorable safety profile 98% (5.7M) of affected premenopausal women not on therapy2 • Regulatory/launch timeline – Frequent-dosing study initiated Annual U.S. peak – June 23, 2019: NEW PDUFA date revenue opportunity – 2H-2019 anticipated commercial launch >$700M5 1 Shifren et al, Sexual Problems and Distress in United States Women; Obstetrics & Gynecology, Vol. 112, No. 5, November 2008; 2014 U.S. Census data. 2 Patient & Economic Flow Study sponsored by Palatin Technologies, Inc. and conducted by Burke Inc., April 2016. 3 Shifren JL, Monz BU, Russo PA, Segreti A, Johannes CB. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol. 2008;112(5):970–978. 4 Goldstein I, Kim NN, Clayton AH, et al. Hypoactive sexual desire disorder: International Society for the Study of Women’s Sexual Health (ISSWSH) expert consensus panel review. Mayo Clin Proc. 2017;92(1):114‐128. 5 Annual U.S. peak revenue opportunity is not guidance, but instead represents what the company believes to be AMAG's peak revenue opportunity based on internal estimates, including early market research conducted for each product. WOMEN’S HEALTH: VYLEESI © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 13
Met Co-primary Endpoints: Improvement in Desire and Reduction in Distress Change in FSFI-D (Desire) Score Change in FSDS-DAO (Distress) Score from Baseline to End of Core (Double-Blind) Study Phase1 from Baseline to End of Core (Double-Blind) Study Phase1 Placebo Vyleesi 1.75 mg Placebo Vyleesi 1.75 mg 0.00 n=314 n=313 n=285 n=282 p=0.0002 p<0.0001 -0.25 DAO DAO Item 13 - -0.36 -0.50 -0.42 -0.75 -0.73 -0.71 MeanChange FSDS in p<0.0001 p=0.0053 n=315 n=313 n=288 n=282 -1.00 Study 301 Study 302 • Compared with placebo, women taking Vyleesi had SIGNIFICANTLY INCREASED • Compared with placebo, women using Vyleesi had a SIGNIFICANT REDUCTION in SCORES on FSFI-D indicating an increase in desire DISTRESS as measured by FSDS-DAO Item 13 score at 6 months • Range of FSFI-D Score: 1.2 - 6.0 • Range of FSDS-DAO Item 13 Score: 0 - 4 P values determined by unadjusted Wilcoxon rank-sum test. Error bars are standard error of the mean. FSFI-D: Female Sexual Function Index - Desire Domain. FSDS-DAO: Female Sexual Distress Scale – Desire Arousal Orgasm. 1 Data on file from pivotal Phase 3 study. WOMEN’S HEALTH: VYLEESI © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 14
Significant* Improvements Across Multiple Secondary Endpoints Mean Change in FSFI + Scores from Baseline to End of Core Phase1 FSFI Total Score FSFI Satisfaction Domain Study 301 FSFI Orgasm Domain Vyleesi 1.75 mg Study 301 Placebo FSFI Lubrication Domain Study 302 Vyleesi 1.75 mg Study 302 FSFI Arousal Domain Placebo 0.00 0.75 1.50 2.25 3.00 Vyleesi was associated with SIGNIFICANT IMPROVEMENTS in FSFI total score, and satisfaction, orgasm, lubrication, and arousal domain scores compared with placebo * All Vyleesi scores p≤0.01. Greater changes mean improvement. + FSFI: Female Sexual Function Index. 1 Data on file from pivotal Phase 3 study. WOMEN’S HEALTH: VYLEESI © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 15
Feraheme® Makena® Intrarosa® VyleesiTM AMAG-423 Ciraparantag 16
Significant Unmet Medical Need with Global Commercial Opportunity AMAG-423 (Digoxin Immune Fab: DIF) in development for the treatment of severe preeclampsia • Preeclampsia is the leading cause of: – Maternal morbidity and mortality – Adverse neonatal outcomes • No effective treatments for preeclampsia Annual U.S. incidence of preeclampsia: – Only “treatment” is delivery of the baby, often times very preterm ~140,000 pregnant women3 • FDA granted AMAG-423 orphan status (7-years exclusivity expected at approval) and fast track review Annual U.S. incidence of severe preeclampsia: • Significant $2.2 billion annual burden to U.S. healthcare ~50,000 pregnant women3,4 system1 • Ex-U.S. estimated incidence of severe preeclampsia: ~1.6M 2 pregnant women Annual U.S. peak • Topline data expected 1H-2020; FDA approval and revenue opportunity commercial launch anticipated 1H-2021 >$1B5 + 1 Stevens W et al, Short-term costs of preeclampsia to the U.S. health care system. American Journal of Obstetrics & Gynecology. September 2017, Volume 217, Issue 3, pp237- 248.e16 . 2 Society for Maternal Fetal Medicine Clinical Opinion: Evaluation and management of severe preeclampsia before 34 weeks' gestation. SMFM Publications Committee, with the assistance of Baha M. Sibai. AJOG 2011; AMAG internal analytics. 3 Ananth, C. V., Keyes, K. M., & Wapner, R. J. (2013). Pre-eclampsia rates in the United States, 1980-2010: age-period-cohort analysis. The BMJ, 347, f6564. http://doi.org/10.1136/bmj.f6564. 4 AMAG Phase 2b/3a clinical trial population is a subset of the severe preeclampsia population. 5 Annual U.S. peak revenue opportunity is not guidance, but instead represents what the company believes to be AMAG's peak revenue opportunity based on internal estimates, including early market research conducted for each product. MATERNAL HEALTH: AMAG-423 © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 17
DEEP Trial: Improvements in Select Neonatal Outcome Measures 1 Primary composite endpoint in current Phase 2b/3a study Intraventricular Hemorrhage (IVH) Necrotizing Enterocolitis (NEC) Deaths Severe (grades 3 and 4) p=0.24 p=0.61 p=0.49 n=3 n=3 n=2 n=1 % of neonatal Deaths neonatal of % % of neonates with IVH with neonates of % % of neonates with NEC with neonates of % n=0 n=0 DIF n=24 Placebo n=27 DIF n=24 Placebo n=27 DIF n=24 Placebo n=27 1 Adair CD, Buckalew VM, Graves SW, et al. Digoxin immune fab treatment for severe preeclampsia. Am J Perinatal. 2010;27:655-62 MATERNAL HEALTH: AMAG-423 © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 18
AMAG-423: Phase 2b/3a Study Design • Study design: – Multi-center, randomized, double-blind, placebo-controlled, parallel group study with AMAG-423 – Dosing every 6 hours for 4 days • Study population: – 200 antepartum subjects with severe preeclampsia between 23 weeks/0 days and 31 weeks/6 days • Endpoints: – Primary outcome: composite endpoint comparing the incidence of babies who develop severe intraventricular hemorrhage, necrotizing enterocolitis or death – Secondary outcomes: change in baseline in serum creatinine, pulmonary edema, delivery latency, anti-hypertensive use, proportion of mothers with modified early obstetric warning score >=3 at 24 hours post final dose • Study update – AMAG has reinitiated existing study sites – Expansion of study sites to include regions outside of U.S. MATERNAL HEALTH: AMAG-423 © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 19
Feraheme® Makena® Intrarosa® VyleesiTM AMAG-423 Ciraparantag 20
Anticoagulant Market Growing • Anticoagulants (often referred to as blood thinners) reduce the ability of the blood to form clots – Approved to prevent stroke and pulmonary emboli in patients with atrial fibrillation or a history of clots in the legs or lungs • Novel oral anticoagulants (NOACs) were introduced starting in 2010 – Xarelto® (rivaroxaban); Eliquis® (apixaban); Savaysa® (edoxaban); Pradaxa® (dibigatran) – Lack of reversal agents has been a barrier to broader use – Anticipate broader future use of NOACs • October 2018 approval of expanded label for Xarelto® (rivaroxaban) to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease • Use of NOACs and low molecular weight heparin (LMWH) increase risk of serious bleeding complications (1.5%-2% of patients per year)1 • Reversal agents approved by FDA: – Praxbind® for Pradaxa® (dabigatran) – initially approved October 2015; full approval April 2018 – AndexXa® for Xarelto® (rivaroxaban) and Eliquis® (apixaban) – approved May 2018 1 Tepper, Ping G et al. (2018 ) Real-world comparison of bleeding risks among non-valvular atrial fibrillation patients prescribed apixaban, dabigatran, or rivaroxaban” PLOS ONE 13(11): e0205989. https://doi.org/10.1371/journal.pone.0205989. HEMATOLOGY: Ciraparantag © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 21
Ciraparantag Addresses a Serious Unmet Medical Need 1 Significant global commercial potential Ciraparantag: The next-generation broad spectrum anticoagulant reversal agent Patients in U.S. Patients in EU5 and Japan Patients on NOAC/LMWH therapy Xarelto®, Eliquis®, Savaysa®, Pradaxa®, 2 2 Lovenox® ~6 million ~9 million Estimated NOAC/LMWH patients per 2 2 year requiring a reversal agent ~100,000 ~130,000 Target hospitals 3,000 Annual U.S. peak revenue opportunity >$500M3 1 If regulatory approval is received. Merger transaction with Perosphere Pharmaceuticals Inc. expected to close in Q1-2019. 2 Perosphere sponsored commercial assessment report conducted by a third party in May 2016. EU5 comprises France, Germany, Italy, Spain, and United Kingdom. 3 Annual U.S. peak revenue opportunity is not guidance, but instead represents what the company believes to be AMAG’s peak revenue opportunity based on internal estimates, including market research conducted. HEMATOLOGY: Ciraparantag © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 22
Phase 2 Data1 Demonstrated Safety and Efficacy, Supporting Phase 3 Development Ciraparantag demonstrated a statistically significant reduction (p<0.001) in WBCT* one hour after dosing for each NOAC and LMWH compared to placebo Eliquis® (apixaban ) - Placebo vs. 200mg Xarelto® (rivaroxaban) - Placebo vs. 200mg 40% 40% 35% 35% RivaroxabanPlacebo Placebo WBCT ApixabanPlacebo Placebo 30% WBCT 30% Rivaroxaban200mg ciraparantag 200mg PER977 25% Apixaban200mg 200mg ciraparantag PER977 25% 20% 20% baseline 15% baseline 15% 10% 10% 5% 5% 0% 0% Changefrom -5% Changefrom -5% -1 0 1 2 3 4 5 6 7 8 9 10 11 12 -1 0 1 2 3 4 5 6 7 8 9 10 11 12 Hours post ciraparantag Hours post ciraparantag Savaysa® (edoxaban) - Placebo vs. 100mg Lovenox® (enoxaparin) - Placebo vs. 200mg 40% 40% 35% 35% WBCT Ph2Placebo Edoxaban Placebo LMWHPlacebo Placebo 30% WBCT 30% Ph2100mg Edoxaban ciraparantag 100mg PER977 25% 25% LMWH200mg 200mg ciraparantag PER97 20% 20% baseline 15% baseline 15% 10% 10% 5% 5% 0% 0% Changefrom -5% Changefrom -5% -1 0 1 2 3 4 5 6 7 8 9 10 11 12 -1 0 1 2 3 4 5 6 7 8 9 10 11 12 Hours post ciraparantag Hours post ciraparantag * WBCT: Whole blood clotting time. 1 Data on file from ongoing Phase 2a study. HEMATOLOGY: Ciraparantag © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 23
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 and • One treatment given as 2 • Sustained effect over • No prothrombotic Biologic that binds Pradaxa® (dabigatran) preparation sequential IV doses 24 hours signal • Needs to be stored at 2o-8o C (36o-46o F) AndexXa® • Requires storage and • One treatment given as a 30 • Anticoagulation starts • Prothrombotic signal Biologic that binds Xarelto® (rivaroxaban) lengthy preparation minute bolus followed by infusion to return to normal led to boxed warning and Eliquis® (apixaban) • Needs to be stored at over 2 hours immediately after 2o-8o C (36o-46o F) • Requires different doses based on cessation of dosing timing of last NOAC dose Ciraparantag • Room temperature • Given as a single IV injection dose • Sustained effect over • No prothrombotic Small molecule in development to bind: storage and ready-to- • Fixed dose for all Xa inhibitors 24 hours signal to date • Xa inhibitors: Xarelto® (rivaroxaban), use (no preparation) Eliquis® (apixaban), Savaysa® (edoxaban) • LMWH (Lovenox®) (enoxaparin) HEMATOLOGY: Ciraparantag © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 24
AMAG Milestones 1H-2019 2H-2019 1H-2020 2H-2020 1H-2021 2H-2021 June 23 Potential Vyleesi PDUFA date commercial launch 423 - Accelerate patient enrollment in Topline data NDA filing Potential FDA approval Phase 2b/3a trial AMAG End of Phase 2 Complete Phase NDA submission1 Potential FDA approval Perosphere meeting with FDA; 3a trials; Close transaction 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 be based on first 50-100 patients in Phase 3b clinical trial, based on precedent. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 25
The Year Ahead 2019 26
Strong Financial Profile Supports Company Transformation 2019 Financial Guidance Strengthening Balance Sheet ($M) 2019 Financial Guidance1,2 ($M) 12/31/18 12/31/17 Total revenue $365 - $415 Cash, cash equivalents and investments $394 $329 Operating loss ($131) - ($101) Short-term debt: Convertible senior notes Adjusted EBITDA ($65) - ($35) $ 21 $ 21 (2.5%) due 2019 Long-term debt: Convertible senior notes (3.25%) due 2022 $320 $320 Senior notes (7.875%) due 2023 $ 0 $475 1 See slide 32 for a reconciliation of GAAP to non-GAAP financial guidance. 2 2019 financial guidance excludes potential accounting impact for the acquisition of Perosphere Pharmaceuticals Inc. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 27
Key 2019 Corporate Goals Option 4 Expand use of Makena subcutaneous auto-injector Drive Feraheme growth Continue successful Intrarosa direct-to-consumer campaign Submit Vyleesi frequent-dosing study data Prepare for Vyleesi commercial launch in 2H-2019 Target full enrollment in AMAG-423 Phase 2b/3a study by year end Initiate ciraparantag Phase 3a clinical study Pursue in/out-licensing opportunities Meet/exceed financial guidance © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 28
Breakout Session: Yorkshire Room © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 29
Reconciliation of GAAP to Non-GAAP Preliminary Financial Results ($M) FY 2018 GAAP operating loss ($55) – ($45) Depreciation and intangible asset amortization 161 Non-cash inventory step-up adjustments 4 Stock-based compensation 20 Adjustments to contingent consideration (49) Transaction / acquisition related costs 1 Acquired IPR&D 33 Non-GAAP adjusted EBITDA $115 - $125 APPENDIX © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 31
Reconciliation of GAAP to Non-GAAP 2019 Financial Guidance ($M) 2019 Financial Guidance GAAP 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 Non-GAAP adjusted EBITDA ($65) – ($35) APPENDIX © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 32
AMAG Pharmaceuticals JP Morgan 37th Healthcare Conference January 2019 © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 33