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): November 1, 2018

http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=12523463&doc=33
AMAG PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of incorporation)
001-10865
 
04-2742593
(Commission File
Number)
 
(IRS Employer Identification
No.)
1100 Winter St.
 
 
Waltham, Massachusetts
 
02451
(Address of principal executive
offices)
 
(Zip Code)

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

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

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Item 2.02. Results of Operations and Financial Condition.
 
The following information and Exhibit 99.1 and Exhibit 99.2 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
 
On November 1, 2018, AMAG Pharmaceuticals, Inc. (“AMAG”) issued a press release entitled “AMAG Pharmaceuticals Announces Third Quarter 2018 Financial Results and Provides Corporate Update” regarding its operating results for the three and nine months ended September 30, 2018 and its intention to hold a conference call to discuss AMAG’s third quarter 2018 financial results, recent business highlights and 2018 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: November 1, 2018




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Exhibit
http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=12523463&doc=33
FOR IMMEDIATE RELEASE

AMAG PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2018 FINANCIAL RESULTS
AND PROVIDES CORPORATE UPDATE
Achieved strong third quarter financial performance and increased full year 2018 guidance
Acquired AMAG-423 for severe preeclampsia, reaffirming the company's focus on delivering
innovative therapies that address unmet medical needs
Conference call scheduled for 8:00 a.m. ET today

WALTHAM, MA (November 1, 2018) – AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited consolidated financial results for the third quarter and year-to-date periods ended September 30, 2018. 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 all periods presented. Total revenues from continuing operations in the third quarter of 2018 totaled $122.2 million, compared with $124.3 million in the same period last year. While sales of the Makena® (hydroxyprogesterone caproate injection) subcutaneous (SC) auto-injector showed strong growth in the third quarter, intramuscular (IM) injection product revenues were negatively impacted by supply constraints from a third-party supplier and by the first generic entrant in the third quarter of 2018. The lower sales of Makena in the quarter were substantially offset by a 42% increase in sales of Feraheme® (ferumoxytol injection), as well as continued growth in Intrarosa® (prasterone) revenues. The company reported an operating loss from continuing operations of $19.3 million in the third quarter of 2018, compared with an operating loss of $254.2 million in the third quarter of 2017, which included a $319.2 million non-cash accounting charge. Non-GAAP adjusted EBITDA totaled $30.0 million in the third quarter of 2018, compared with $45.1 million in the third quarter of 2017.1 

“We have executed well in 2018 and are pleased to report strong financial results for the third quarter. In addition, over the first nine months of 2018, we secured two FDA approvals, divested the CBR business and strengthened our balance sheet, acquired AMAG-423, an orphan drug for the potential treatment of severe preeclampsia, launched the Intrarosa direct-to-consumer campaign, and prepared for the upcoming FDA advisory committee meeting for VyleesiTM, the trade name for bremelanotide," said William Heiden, AMAG president and chief executive officer. "We continue to exceed our top- and bottom-line 2018 forecasts, allowing us to increase our financial guidance three times since the beginning of the year, representing an additional $70 million in revenue and $50 million of adjusted EBITDA since we initially published our guidance in January."

Third Quarter 2018 and Recent Business Highlights:
Achieved 42% growth in net Feraheme sales year over year
Continued strong conversion of Makena IM product to the SC auto-injector; approximately 57% of brand revenue was from SC auto-injector
Prasco, the company's authorized generic partner, successfully launched Makena single- and multi-dose IM formulations
Grew Intrarosa revenue by 52% over the second quarter of 2018
Increased Intrarosa weekly market share to 4.5%, with more than 146,000 total prescriptions written by more than 11,300 healthcare providers since the July 2017 launch
Continued scientific support for Intrarosa's differentiation with an oral presentation at the Annual Meeting of The North American Menopause Society (NAMS)

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

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Launched Intrarosa branded and unbranded direct-to-consumer campaigns
Emmy®-nominated actress Cheryl Hines and leading menopause expert, Marla Shapiro, MD, -- spokespersons for the unbranded direct-to-consumer campaign
Acquired AMAG-423, an orphan drug candidate for the treatment of severe preeclampsia (previously referred to as 'Velo Option')
Completed sale of CBR for $530 million in cash; paid off $475 million of high-yield debt, eliminating nearly $40 million in annual cash interest expense
Ended the third quarter with $427.5 million of cash and investments

Third Quarter Ended September 30, 2018 (unaudited)
Financial Results from Continuing Operations (GAAP Basis)
Total revenues from continuing operations for the third quarter of 2018 decreased 2% to $122.2 million, compared with $124.3 million in the third quarter of 2017. Net product sales of Makena decreased 18% to $80.2 million in the third quarter of 2018, compared with $97.6 million in the same period last year. This decrease was due to supply disruptions of the Makena branded IM products (branded single-dose vial is currently out of stock), as well as generic competition entering the market in July of 2018. Net product sales of Feraheme and MuGard® increased 41% to $37.1 million in the third quarter of 2018, compared with $26.3 million in the third quarter of 2017. This increase was driven by high physician adoption following the expansion of the Feraheme label in February 2018. Intrarosa, which was commercially launched in July 2017, contributed $4.9 million in net sales during the third quarter of 2018, compared with $0.4 million in the same period last year.

Costs and expenses from continuing operations, including cost of product sales, totaled $141.6 million in the third quarter of 2018, compared with $378.6 million for the same period in 2017. Included in third quarter of 2017 costs and expenses was a $319.2 million Makena IM-related non-cash impairment charge, as well as an expense reversal of $49.9 million in selling, general and administrative (SG&A) expenses, which was recorded to reduce the Makena contingent consideration liability. Excluding these accounting adjustments, total costs and expenses from continuing operations in the third quarter of 2017 totaled $109.3 million, compared with $141.6 million in the third quarter of 2018. The year-over-year increase was driven by higher Makena-related non-cash amortization expense and increased SG&A expenses related to the continued commercialization of the broad Feraheme label, Makena SC auto-injector and Intrarosa, partially offset by a decrease in research and development (R&D) costs. Acquired IPR&D expense in the third quarter of 2018 consisted of $12.5 million related to AMAG's acquisition of the global rights to develop and market digoxin immune fab (ovine) for the treatment of severe preeclampsia (AMAG-423).

The company reported an operating loss from continuing operations in the third quarter of 2018 of $19.3 million, compared with an operating loss of $254.2 million for the same period last year. The company reported a net loss from continuing operations of $64.7 million, or $1.88 loss per basic and diluted share, for the third quarter of 2018, compared with a net loss of $155.7 million, or $4.41 loss per basic and diluted share, for the same period in 2017. The primary driver of the third quarter 2018 net loss from continuing operations was a $35.9 million loss on extinguishment of debt, including a $28.1 million prepayment premium, which was incurred during the third quarter of 2018 as a result of the early redemption of the 2023 Senior Notes.

Financial Results from Continuing Operations (Non-GAAP Basis)1  
Total costs and expenses from continuing operations on a non-GAAP basis totaled $92.2 million in the third quarter of 2018, compared with $79.2 million in the third quarter of 2017. This increase was primarily due to higher SG&A expenses related to investments to support the continued commercialization of the broad Feraheme label, Makena SC auto-injector and Intrarosa, partially offset by lower R&D costs.

Non-GAAP adjusted EBITDA from continuing operations for the third quarter of 2018 was $30.0 million, compared with $45.1 million in the third quarter of 2017.


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Net Income from Discontinued Operations
As a result of the sale of CBR on August 6, 2018, CBR has been classified as discontinued operations for accounting purposes. Net income from discontinued operations in the third quarter of 2018 was $95.5 million, of which $89.6 million was the gain on the sale of the CBR business, compared with $3.7 million of net income for the same period in 2017.

Balance Sheet Highlights
As of September 30, 2018, the company’s cash and investments totaled $427.5 million, short-term debt totaled $21.4 million, and long-term total debt (2022 convertible notes) totaled $320.0 million (principal amounts outstanding).

Nine Months Ended September 30, 2018 (unaudited)
Financial Results (GAAP Basis)
Total revenues for the nine months ended September 30, 2018 increased 5.0% to $385.9 million, compared with $367.2 million for the same period in 2017. This increase is related to $20.3 million of additional sales of Feraheme year over year, as well as the addition of Intrarosa to the portfolio, partially offset by lower sales of Makena.

Costs and expenses from continuing operations, including cost of product sales, totaled $414.1 million for the nine months ended September 30, 2018, compared with $658.4 million for the same period in 2017. Included in the nine-month 2017 costs and expenses was a $319.2 million Makena IM-related non-cash impairment charge. Excluding this charge, total costs and expenses for the nine month 2017 period were $339.1 million, compared with $414.1 million for the nine-month 2018 period. The year-over-year increase was driven by higher Makena-related non-cash amortization expense and increased SG&A expenses related to investments to support the continued commercialization of the Feraheme broad label, Makena SC auto-injector and Intrarosa, partially offset by a decrease in R&D costs. Acquired IPR&D expense in the nine months ended September 30, 2018 consisted of $12.5 million related to AMAG's acquisition of the global rights to develop and market AMAG-423 and a $20 million milestone payment paid to Palatin upon FDA acceptance of the Vylessi new drug application. Acquired IPR&D expense in the nine months ended September 30, 2017 consisted of a $60 million upfront payment to Palatin for Vyleesi and an accounting charge of $5.8 million related to the transaction with Endoceutics to in-license Intrarosa.

The company reported an operating loss from continuing operations in the nine months ended September 30, 2018 of $28.2 million, compared with an operating loss of $291.1 million for the same period last year. The company reported a net loss from continuing operations of $148.6 million, or $4.33 loss per basic and diluted share, for the nine months ended 2018, compared with a net loss of $205.9 million, or $5.89 loss per basic and diluted share, for the same period in 2017. The primary driver of the third quarter 2018 net loss from continuing operations was a $35.9 million loss on extinguishment of debt, which included a $28.1 million prepayment premium that was incurred during the nine months ended September 30, 2018 as a result of the early redemption of the 2023 Senior Notes.

Financial Results (Non-GAAP Basis)1 
Non-GAAP adjusted EBITDA from continuing operations for the nine months ended September 30, 2018 was $119.3 million, compared with $135.5 million for the same period in 2017.

Net Income from Discontinued Operations
As a result of the sale, CBR is being classified as discontinued operations for accounting purposes. Net income from discontinued operations was $105.1 million for the nine months ended September 30, 2018, of which $89.6 million was the gain on the sale of the CBR business, as compared to $3.2 million in the same period in 2017.

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"I am pleased with the strong performance across the Company since the beginning of the year. Our execution has allowed us to achieve and/or exceed many of our goals and we are, therefore, once again increasing our financial guidance for 2018,” said Ted Myles, AMAG's chief financial officer. "We are excited about the tremendous potential of our new products and we plan to continue to invest in Intrarosa, while also making new investments in preparation for the launch of Vyleesi and the accelerated development of AMAG-423. With approximately $430 million in cash, we are well positioned to make these strategic investments, as well as to consider additional opportunities for product licensing and/or acquisition opportunities, so that we can deliver innovative products to patients with unmet medical needs and create additional value for shareholders."

Updated 2018 Financial Guidance2 
The company updated its 2018 guidance to reflect business performance for the first nine months of 2018 and the outlook for the remainder of 2018. In addition, the guidance below reflects the sale of CBR, which closed on August 6, 2018.
($M)
 
Previous Guidance3
Updated 2018 Guidance3
Total revenue
 
$450 - $490
$470 - $490
GAAP Operating loss
 
($75) - ($55)
($72) - ($62)
Non-GAAP adjusted EBITDA
 
$95 - $115
$115 - $125

2 See reconciliations of 2018 GAAP to non-GAAP financial guidance at conclusion of this press release.
3 Previous and updated financial guidance reflects pro forma 2018 financial guidance from continuing operations (excludes CBR for the full year 2018).

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 third quarter 2018 financial results, recent business highlights and 2018 outlook.

Dial-in Number
U.S./Canada dial-in number: (877) 412-6083
International dial-in number: (702) 495-1202
Conference ID: 1963718

Replay dial-in number: (855) 859-2056
Replay International dial-in number: (404) 537-3406
Conference ID: 1963718

A telephone replay will be available from approximately 11:00 a.m. ET on November 1, 2018 through midnight on November 8, 2018. 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

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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.

About Intrarosa® (prasterone)
Intrarosa is a steroid 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. Intrarosa is administered locally in the vagina, and is converted by enzymes in the body into androgens and estrogens. The mechanism of action is not fully established. In clinical studies, Intrarosa demonstrated efficacy through improvement in percentage of superficial cells and parabasal cells, pH and pain with intercourse.

Intrarosa is contraindicated in women with undiagnosed abnormal genital bleeding.

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 four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥2 percent was vaginal discharge. In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥2 percent were vaginal discharge and abnormal pap smear. There were 11 cases of abnormal pap smears.

Please see full Prescribing Information available at www.intrarosa.com.

About Makena® (hydroxyprogesterone caproate injection)
Makena is a progestin indicated to reduce the risk of preterm birth in women pregnant with a single baby who have a history of singleton spontaneous preterm birth.
    
The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

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

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


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

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

About Feraheme® (ferumoxytol injection)
Feraheme received marketing approval from the FDA on June 30, 2009 for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) and was commercially launched by AMAG in the U.S. shortly thereafter. In February 2018, we received FDA approval to expand the Feraheme label to treat 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. Ferumoxytol is protected in the U.S. by seven issued patents covering the composition and dosage form of the product. Six of the issued patents are listed in the FDA’s Orange Book, the last of which expires in June 2023.

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. 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.

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

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

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

Women in the trials had the option, after completion of the trial, to continue in an 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.

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

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Vyleesi has no known alcohol interactions.

About AMAG-423 (digoxin immune Fab)
AMAG-423 is a polyclonal antibody in development for the treatment of severe preeclampsia in pregnant women. 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). Digoxin Immune Fab is thought to bind to these factors, causing a decrease in available serum EDLFs and inhibition of their activity. The DEEP trial, a smaller, prior 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.

Digoxin Immune Fab is marketed by another company for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose.

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 AMAG’s accomplishments and third quarter financial results; excitement about the tremendous potential of AMAG’s new products; plans to continue to invest in AMAG’s products and product candidates; beliefs that AMAG is well-positioned to make strategic investments; plans to accelerate the development of AMAG-423; plans to consider additional opportunities for product licensing and/or acquisition opportunities and create additional value for shareholders; and expectations regarding AMAG's full year performance and updated 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 Makena will continue to be negatively impacted by the supply disruption and recent and future generic entries in the market; the risk that we may be unable to gain approval of our product candidates, including Vyleesi and AMAG-423 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 our development efforts will be higher than anticipated, or that we have over-estimated the market and potential revenues for our products and product candidates, if approved, , 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, 2017 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 –


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AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(Unaudited, amounts in thousands, except for per share data)
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
2018
 
2017
 
2018
 
2017
Revenues:
 
 
 
 
 
 
 
Makena
$
80,221

 
$
97,635

 
$
275,377

 
$
286,771

Feraheme/MuGard
37,092

 
26,336

 
100,098

 
80,059

Intrarosa
4,925

 
360

 
10,331

 
360

Other revenues

 

 
75

 
53

Total revenues
122,238

 
124,331

 
385,881

 
367,243

Operating costs and expenses:
 
 
 
 
 
 
 
Cost of product sales
46,489

 
31,085

 
187,176

 
90,761

Research and development expenses
10,133

 
16,274

 
32,635

 
63,021

Acquired in-process research and development
12,500

 

 
32,500

 
65,845

Selling, general and administrative expenses
72,451

 
11,962

 
161,780

 
119,482

Impairment charges of intangible assets

 
319,246

 

 
319,246

Total costs and expenses
141,573

 
378,567

 
414,091

 
658,355

Operating loss
(19,335
)
 
(254,236
)
 
(28,210
)
 
(291,112
)
 
 
 
 
 
 
 
 
Other (expense) income:
 
 
 
 
 
 
 
Interest expense
(13,366
)
 
(16,847
)
 
(45,400
)
 
(52,403
)
Loss on debt extinguishment
(35,922
)
 
(314
)
 
(35,922
)
 
(9,830
)
Interest and dividend income
1,612

 
487

 
3,207

 
2,181

Other expense
(19
)
 

 
(63
)
 
(43
)
Total other expense, net
(47,695
)
 
(16,674
)
 
(78,178
)
 
(60,095
)
Loss from continuing operations before income taxes
(67,030
)
 
(270,910
)
 
(106,388
)
 
(351,207
)
Income tax (benefit) expense
(2,352
)
 
(115,197
)
 
42,204

 
(145,317
)
Net loss from continuing operations
$
(64,678
)
 
$
(155,713
)
 
$
(148,592
)
 
$
(205,890
)
 
 
 
 
 
 
 
 
Discontinued Operations:
 
 
 
 
 
 
 
Income from discontinued operations
5,838

 
4,506

 
18,873

 
4,998

Gain on sale of CBR business
89,581

 

 
89,581

 

Income tax (benefit) expense
(98
)
 
854

 
3,346

 
1,796

Net income from discontinued operations
95,517

 
3,652

 
105,108

 
3,202

 
 
 
 
 
 
 
 
Net income (loss)
$
30,839

 
$
(152,061
)
 
$
(43,484
)
 
$
(202,688
)
 
 
 
 
 
 
 
 
Basic and diluted net income (loss) per share:
 

 
 

 
 

 
 

Loss from continuing operations
$
(1.88
)
 
$
(4.41
)
 
$
(4.33
)
 
$
(5.89
)
Income from discontinued operations
2.77

 
0.10

 
3.06

 
0.09

Basic and diluted net income (loss) per share:
$
0.89

 
$
(4.31
)
 
$
(1.27
)
 
$
(5.80
)
 
 
 
 
 
 
 
 
Weighted average shares outstanding used to compute net income (loss) per share (basic and diluted)
34,492

 
35,311

 
34,339

 
34,948


8


AMAG Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(Unaudited, amounts in thousands)
 
September 30, 2018
 
December 31, 2017
ASSETS
    
 
    
Current assets:
 

 
 

Cash and cash equivalents
$
287,166

 
$
162,855

Marketable securities
140,368

 
136,593

Accounts receivable, net
85,091

 
91,460

Inventories
27,953

 
34,443

Prepaid and other current assets
13,182

 
11,009

Assets held for sale

 
45,508

Total current assets
553,760

 
481,868

Property and equipment, net
7,047

 
7,904

Goodwill
422,513

 
422,513

Intangible assets, net
230,747

 
375,479

Deferred tax assets
1,185

 
47,120

Restricted cash
495

 
495

Other long-term assets
69

 
266

Assets held for sale, net of current portion

 
564,711

Total assets
$
1,215,816

 
$
1,900,356

LIABILITIES AND STOCKHOLDERS’ EQUITY
 

 
 

Current liabilities:
 

 
 

Accounts payable
$
30,331

 
$
7,717

Accrued expenses
141,753

 
166,732

Current portion of convertible notes, net
20,999

 

Current portion of acquisition-related contingent consideration
208

 
49,399

Liabilities held for sale

 
53,870

Total current liabilities
193,291

 
277,718

Long-term liabilities:
 

 
 

Long-term debt, net

 
466,291

Convertible notes, net
258,376

 
268,392

Acquisition-related contingent consideration
615

 
686

Other long-term liabilities
1,288

 
1,204

Liabilities held for sale, net of current portion

 
95,821

Total liabilities
453,570

 
1,110,112

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; 34,522,957 and 34,083,112 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively
345

 
341

Additional paid-in capital
1,286,227

 
1,271,628

Accumulated other comprehensive loss
(4,161
)
 
(3,908
)
Accumulated deficit
(520,165
)
 
(477,817
)
Total stockholders’ equity
762,246

 
790,244

Total liabilities and stockholders’ equity
$
1,215,816

 
$
1,900,356


9


AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited, amounts in thousands)
 
Nine Months Ended September 30,
 
2018
 
2017
Cash flows from operating activities:
 
 
 
Net loss
(43,484
)
 
(202,688
)
Adjustments to reconcile net loss to net cash provided by operating activities:
 
 
 
Depreciation and amortization
158,002

 
88,941

Impairment of intangible assets

 
319,246

Provision for bad debt expense
754

 
3,503

Amortization of premium/discount on purchased securities
96

 
218

Gain on disposal of fixed assets
(99
)
 

Non-cash equity-based compensation expense 
14,599

 
18,058

Non-cash IPR&D expense

 
945

Loss on debt extinguishment
35,922

 
9,830

Amortization of debt discount and debt issuance costs
11,824

 
10,600

Gains on marketable securities, net
(1
)
 
(255
)
Change in fair value of contingent consideration
(49,175
)
 
(47,142
)
Deferred income taxes
43,747

 
(146,682
)
Gain on sale of the CBR business
(89,581
)
 

Transaction costs
(14,111
)
 

Changes in operating assets and liabilities:
 
 
 

Accounts receivable, net
7,175

 
(8,889
)
Inventories
3,587

 
(600
)
Prepaid and other current assets
1,101

 
(1,409
)
Accounts payable and accrued expenses
(4,280
)
 
29,977

Deferred revenues
8,658

 
14,134

Other assets and liabilities
159

 
(1,139
)
Net cash provided by operating activities
84,893

 
86,648

Cash flows from investing activities:
 

 
 

Proceeds from sales or maturities of marketable securities
60,146

 
279,526

Purchase of marketable securities
(64,400
)
 
(110,894
)
Acquisition of Intrarosa intangible asset

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

 

Capital expenditures
(1,913
)
 
(6,573
)
Net cash provided by investing activities
513,136

 
106,259

Cash flows from financing activities:
 

 
 

Long-term debt principal payments
(475,000
)
 
(328,125
)
Proceeds from 2022 Convertible Notes

 
320,000

Payment to repurchase 2019 Convertible Notes

 
(191,480
)
Payment of premium on debt extinguishment
(28,054
)
 

Proceeds to settle warrants

 
323

Payment of convertible debt issuance costs

 
(9,553
)
Payments of contingent consideration
(87
)
 
(165
)
Proceeds from the exercise of common stock options
2,635

 
2,350

Payments of employee tax withholding related to equity-based compensation
(2,632
)
 
(2,588
)
Net cash used in financing activities
(503,138
)
 
(209,238
)
Net increase (decrease) in cash, cash equivalents, and restricted cash
94,891

 
(16,331
)

10


Cash, cash equivalents, and restricted cash related to discontinued operations

 
(50,017
)
Cash, cash equivalents, and restricted cash at beginning of the period
192,770

 
276,898

Cash, cash equivalents, and restricted cash at end of the period
287,661

 
210,550

Supplemental data for cash flow information:
 
 
 
Cash paid for taxes
$
5,041

 
$
3,565

Cash paid for interest
43,546

 
50,892

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

 
$
12,555

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

 
$
9,300


11


AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended September 30, 2018
(Unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Acquired IPR&D
 
Operating Loss / Adjusted EBITDA
GAAP
$
122,238

 
$
46,489

 
$
10,133

 
$
72,451

 
$
12,500

 
$
(19,335
)
Depreciation and intangible asset amortization

 
(30,945
)
 
(6
)
 
(456
)
 

 
 
Non-cash inventory step-up adjustments

 
(412
)
 

 

 

 
 
Stock-based compensation

 
(281
)
 
(568
)
 
(4,202
)
 

 
 
Adjustments to contingent consideration

 

 

 
(9
)
 

 
 
Acquired IPR&D

 





 
(12,500
)
 
 
Non-GAAP Adjusted
$
122,238

 
$
14,851

 
$
9,559

 
$
67,784

 
$

 
$
30,044






AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended September 30, 2017
(Unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Intangible asset impairment charges
 
Operating Loss / Adjusted EBITDA
GAAP
$
124,331

 
$
31,085

 
$
16,274

 
$
11,962

 
$
319,246

 
$
(254,236
)
Depreciation and intangible asset amortization

 
(23,706
)
 
(29
)
 
(261
)
 

 
 
Non-cash inventory step-up adjustments

 
(300
)
 
(103
)
 

 

 
 
Stock-based compensation

 
(432
)
 
(799
)
 
(4,410
)
 

 
 
Adjustments to contingent consideration

 

 

 
49,929

 

 
 
Impairment charges of intangible assets

 

 

 

 
(319,246
)
 
 
Non-GAAP Adjusted
$
124,331

 
$
6,647

 
$
15,343

 
$
57,220

 
$

 
$
45,121




12


AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Nine Months Ended September 30, 2018
(Unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Acquired IPR&D
 
Operating Loss / Adjusted EBITDA
GAAP
$
385,881

 
$
187,176

 
$
32,635

 
$
161,780

 
$
32,500

 
$
(28,210
)
Depreciation and intangible asset amortization

 
(144,732
)
 
(12
)
 
(1,220
)
 

 
 
Non-cash inventory step-up adjustments

 
(3,602
)
 

 

 

 
 
Stock-based compensation

 
(588
)
 
(1,896
)
 
(12,149
)
 

 
 
Adjustments to contingent consideration

 

 

 
49,175

 

 
 
Acquired IPR&D

 





 
(32,500
)
 
 
Non-GAAP Adjusted
$
385,881

 
$
38,254

 
$
30,727

 
$
197,586

 
$

 
$
119,314





AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Nine Months Ended September 30, 2017
(Unaudited, amounts in thousands)

 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Acquired IPR&D
 
Intangible asset impairment charges
 
Operating Loss / Adjusted EBITDA
GAAP
$
367,243

 
$
90,761

 
$
63,021

 
$
119,482

 
$
65,845

 
$
319,246

 
$
(291,112
)
Depreciation and intangible asset amortization

 
(69,700
)
 
(118
)
 
(694
)
 

 

 
 
Non-cash inventory step-up adjustments

 
(1,228
)
 
(103
)
 

 

 

 
 
Stock-based compensation

 
(690
)
 
(2,651
)
 
(12,037
)
 

 

 
 
Adjustments to contingent consideration

 

 

 
47,143

 

 

 
 
Transaction/Acquisition-related costs

 

 

 
(1,462
)
 

 

 
 
Impairment charges of intangible assets

 

 

 

 

 
(319,246
)
 
 
Acquired IPR&D

 





 
(65,845
)
 

 
 
Non-GAAP Adjusted
$
367,243

 
$
19,143

 
$
60,149

 
$
152,432

 
$

 
$

 
$
135,519





13


AMAG Pharmaceuticals, Inc.
Reconciliation of GAAP to Non-GAAP 2018 Financial Guidance
(Unaudited, amounts in millions)

 
Previous Guidance4
Updated 2018 Guidance4
GAAP operating loss
($75) - ($55)
($72) - ($62)
Depreciation & intangible asset amortization
174
177
Stock-based compensation
21
22
Non-cash inventory step up and adjustments to contingent consideration
(45)
(45)
Acquired IPR&D
20
33
Non-GAAP adjusted EBITDA
$95 - $115
$115 - $125

4 Previous (August 2018) and updated financial guidance reflects 2018 financial guidance from continuing operations (excludes CBR for the full year 2018).




AMAG Pharmaceuticals, Inc.
Share Count Reconciliation
(Unaudited, amounts in millions)
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
 
 
2018
 
2017
 
2018
 
2017
 
Weighted average basic shares outstanding
 
34.5

 
35.3

 
34.3

 
34.9

 
Employee equity incentive awards
 

5 

5 

5 

5 
GAAP diluted shares outstanding
 
34.5

 
35.3

 
34.3

 
34.9

 
Employee equity incentive awards
 
0.5

6 
0.2

6 
0.3

6 
0.3

6 
Non-GAAP diluted shares outstanding
 
35.0

 
35.5

 
34.6

 
35.2

 

5 Employee equity incentive awards would be anti-dilutive in this period.
6 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


14
a3q2018ex992
Q3-2018 Financial Results November 1, 2018 © 2018 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, expectations for Feraheme pricing; beliefs about Feraheme’s resiliency to INFeD®; beliefs about the conversion from the Makena IM to SC auto-injector; plans to protect the Makena brand by continued conversion to the SC auto-injector and patient access; expectations about supply of Makena, including when additional supply will be available; beliefs about generic economics; beliefs about Intrarosa market share; beliefs about Intrarosa media coverage and marketing initiatives; expectations for 2018 financial guidance, including revenues, operating loss and adjusted EBITDA; expectations that the fourth quarter will be a period of continued investment to drive future value; AMAG’s key themes for 2019, including product revenue growth, a decline in Makena IM revenues, the planned launch of Vylessi (if approved), increased investments in AMAG-423, Vyleesi and Intrarosa and capital allocations from AMAG’s balance sheet to fuel its investments; beliefs that AMAG’s balance sheet is strengthening; beliefs about shareholder value and AMAG’s portfolio; beliefs about annual peak revenue opportunities for AMAG-423, Vyleesi and Intrarosa; beliefs about preeclampsia, the market for, and the anticipated timeline for the FDA’s Advisory Committee meeting, launch of, AMAG-423 (if approved); 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 the market for Intrarosa; beliefs that the AMAG portfolio is innovative and plans to deliver multiple value drivers; the anticipated regulatory timeline for AMAG’s products and product candidates; and plans to undertake additional licensing and acquisition transactions and the expected areas of such expansion 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 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 and AMAG-423, 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 AMAG-423, Vyleesi and Intrarosa, as well as 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 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. Further, the endnotes included at the end of this presentation include information that is critical to an investor’s understanding of the materials presented and we strongly encourage investors to read such information carefully and in its entirety. © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 2


 
Agenda 1 Q3-2018 Highlights 2 Commercial Product Portfolio Update 3 Q3-2018 Financial Overview 4 Value Drivers 5 Q&A © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 3


 
Third Quarter 2018 Highlights and Recent Developments 42% Feraheme revenue growth year over year Completed the sale of CBR • Underscores focus on development and commercialization of pharmaceutical products Makena brand revenue from subcutaneous (SC) $475M high yield notes paid-off 57% auto-injector • Eliminated ~$40M/year cash interest expense • Significant de-levering event ~$430M cash and $21M short-term debt Exceeded campaign benchmark metrics with condition awareness campaign featuring actress Cheryl Hines and branded Intrarosa campaign AMAG-423 © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 4


 
Feraheme Makena Intrarosa 5


 
Feraheme Continues to Grow with Expanded Label Feraheme Revenue1 ($M) Feraheme Growth $37.0 • Q3-2018 vs. Q3-2017 – Volume increased by 31% – Market share rose from 12.3% to 15.8%2 42% $26.1 – Performance based contracting supports increased net price by 11% • Launched OB/GYN IV iron pilot program utilizing Maternal Health sales team • Continued account conversion demonstrates resiliency to INFeD® resupply (especially in hem/onc segment) Q3-2017 Q3-2018 IV IRON DEFICIENCY ANEMIA: FERAHEME © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 6


 
Feraheme Continues to Grow with Expanded Label Feraheme volume demand grew versus Q2-2018, despite INFeD return IV Iron Deficiency Anemia (IDA) Quarterly Market Share by Product3 Q3 INFeD Return to Market Impact4 Ferrlecit / Q3-2018 Q3 vs. Q2 INFeD Feraheme Injectafer Venofer Total Nulecit 5.9% Market Share Change +5 pp 0 pp -1 pp -3 pp -1 pp -- All 10.7% Channels +10,860 Volume Change +18,129 +318 -823 -4,686 -2,078 +3.3% 34.2% 15.8% Market Share Change +5 pp 0 pp -4 pp -1 pp 0 pp -- Hem/Onc +1,432 Volume Change +4,658 +500 -3,123 -400 -203 33.4% +1.6% Feraheme Injectafer® Venofer® INFeD® Ferrlecit®/Nulecit IV IRON DEFICIENCY ANEMIA: FERAHEME © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 7


 
Feraheme Makena Intrarosa 8


 
Continued Strong Conversion from Makena IM to SC Auto-injector 57% of Q3-2018 Makena brand revenue from subcutaneous auto-injector Makena Revenue ($M) Q3-2018 Results $105.2 • Continued strong conversion from IM to SC auto-injector $97.6 – 57% of brand revenue from SC auto-injector $80.2 • First generic to Makena single-dose IM entered market in July 2018 • Authorized generic (AGx) partner (Prasco) launched immediately following availability of first generic – Launched single- and multi-dose IM – Immediately gained >75% of generic market share5 • Managing supply issues with branded IM products – AGx IM available – Branded single-dose IM vials currently out of stock Q3-2017 Q2-2018 Q3-2018 Makena SC Makena IM AGx IM MATERNAL HEALTH: MAKENA © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 9


 
Optimize Makena Franchise Performance & Sustainability Protect the Brand Participate in Generic Market • Continue to convert usage to Makena SC auto-injector • Partnered with Prasco, an experienced – Promote the benefits of the SC auto-injector authorized generic company – Brand loyalty: 56% of Q3 scripts through Makena Care • Captured significant majority of generic Connection® state “dispense as written” vs. 40% in Q2 market share in Q3 • Protect patient access to Makena SC auto-injector • Attractive economics to AMAG – Reinforce value of Makena Care Connection – Proactive, targeted payer strategy MATERNAL HEALTH: MAKENA © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 10


 
Feraheme Makena Intrarosa 11


 
Intrarosa HCP Prescribing and Market Share Continue to Increase 6 Intrarosa Rx Volume As of September 30, 2018 (data reported as of last week of each month) 5,000 • >146,000 TRx’s written since launch7 4,500 – Increase of 53,000 since June 30 4,000 • 11,300 HCP prescribers since launch7 3,500 – Increase of 2,200 prescribers since June 30 3,000 2,500 • 83% commercial lives covered8 2,000 7 Number Number of Scripts • Continued growth in market share 1,500 – 4.5% TRX weekly share (overall) 1,000 – 6.3% TRx weekly share (commercial only) 500 0 Jul-17 Jul-18 Jan-18 Jun-18 Oct-17 Apr-18 Sep-17 Feb-18 Sep-18 Dec-17 Aug-18 Aug-17 Nov-17 Mar-18 May-18 TRx NRx WOMEN’S HEALTH: INTRAROSA © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 12


 
September Campaigns Kick Started Integrated Direct-to-Consumer Program Condition Awareness Campaign Branded Campaign Patient Consults MD Cheryl Hines, Emmy®-nominated actress Office visit or on-line 360M+ impressions 650K unique visitors to site 10M+ women reached in Sept 40% ahead of benchmark 2x benchmark 30% ahead of benchmark Garnered coverage in top Robust digital campaign generating Learnings from condition awareness consumer media - The View, engagement significantly above campaign leveraged for strong start to People.com, Parade, US industry average branded campaign Weekly, Healthline and more 5x increase in non-paid site traffic 30% increase in Intrarosa site traffic © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 13


 
Financial Overview 14


 
Revenue, Operating Loss and Adjusted EBITDA ($M)* Q3-2017 Q3-2018 $124.3 $0.4 $122.2 $4.9 • Makena SC auto-injector revenue of $40M $97.6 $80.2 • Feraheme revenue growth of 42% $45.1 • Q3-2017 operating loss includes $319M 45.1 $30.0 impairment charge and $50M expense reversal 30 $26.3 $37.1 • Q3-2018 operating loss includes IPR&D of $12.5M for acquisition of AMAG-423 ($19.3) • $30M of adjusted EBITDA with ($254.2) significant investments in SG&A Feraheme/MuGard Revenue Makena Revenue Intrarosa Revenue GAAP Operating Loss Non-GAAP Adjusted EBITDA * See slide 26 for a reconciliation of GAAP to non-GAAP financial results. FINANCIAL OVERVIEW © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 15


 
2018 Financial Guidance* Strong execution throughout year resulted in three upward guidance moves in 2018 Pharma Revenue Guidance $70M; Adjusted EBITDA $50M from January 2018 Guidance ($M) January 2018 May 2018 August 2018 November 2018 Total revenue $380 - $440 $420 - $460 $450 - $490 $470 - $490 Operating loss ($169) - ($139) ($149) – ($129) ($75) – ($55) ($72) - ($62) Adjusted EBITDA $55 - $85 $75 - $95 $95 - $115 $115 -$125 * See slide 27 for a reconciliation of GAAP to non-GAAP 2018 financial guidance; all periods of financial guidance reflect 2018 financial guidance from continuing operations (excludes CBR for the full year 2018). FINANCIAL OVERVIEW © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 16


 
2018 Financial Results and Guidance Q4-2018 will be a period of continued investment to drive future value Updated November 2018 Guidance ($M) 9-Mos. 2018 Actual* Low Mid High Total revenue $385.9 $470 $480 $490 GAAP operating loss ($28.2) ($72) ($67) ($62) Non-GAAP Adjusted EBITDA $119.3 $115 $120 $125 Key Themes for 2019 • Growing: • Investing: – Revenues from Intrarosa, Feraheme and Makena SC auto-injector – Vyleesi launch • Launching: – Intrarosa direct-to-consumer campaign – Vyleesi (assuming FDA approval in Q1-2019) – Accelerated development of AMAG-423 • Expecting: • Allocating: – Makena IM revenues to decline vs. 2018 – Capital from balance sheet to fuel investments * See slide 26 for a reconciliation of GAAP to non-GAAP financial results. FINANCIAL OVERVIEW © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 17


 
Strengthening Balance Sheet ($M) 9/30/18 12/31/17 Cash, cash equivalents and investments $428 $3299 Short-term debt: Convertible senior notes (2.5%) due 2019 $ 21 $ 21 Long-term debt: Convertible senior notes (3.25%) due 2022 $320 $320 Senior notes (7.875%) due 2023 $ 0 $475 FINANCIAL OVERVIEW © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 18


 
Significant Shareholder Value at AMAG Historical Value Drivers Fund Future Value Drivers AMAG-423 AMAG-423 ™ Vyleesi™ Vyleesi HISTORICAL Value at AMAG FUTURE (≥2020) Value at AMAG © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 19


 
Significant Unmet Medical Need with Global Commercial Opportunity AMAG-423 in development for the treatment of severe preeclampsia • Preeclampsia is the leading cause of:10 – 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 ~140,000 pregnant women15 preterm11 • FDA granted AMAG-423 orphan status (7-years Annual U.S. incidence of severe preeclampsia: exclusivity expected at approval) and fast track review ~50,000 pregnant women15,16 • Significant $2.2 billion annual burden to U.S. healthcare system12 Annual U.S. peak • Ex-U.S. estimated incidence of severe preeclampsia: revenue opportunity ~1.6M pregnant women13 – Developing countries incidence of preeclampsia is 7x 17 higher than in developed countries14 >$1B + • 2021 commercial launch, if approved MATERNAL HEALTH: AMAG-423 © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 20


 
Significant Unmet Medical Need for Millions of Women Vyleesi: investigational product for premenopausal women with HSDD* • Medical condition of low sexual desire/libido associated with distress • Novel mechanism of action – Melanocortin receptor agonist (MCR4) 12 million U.S. women with HSDD18 • Used in anticipation of sexual activity – Self-administered auto-injector pen 5.8 million U.S. premenopausal women with HSDD19 • Two Large Phase 3 studies (1 in 10 premenopausal women)20,21 – Met co-primary, pre-specified endpoints • Improvement in desire 99% (5.7M) of premenopausal • Reduction in distress women not on therapy19 – Favorable safety profile • Regulatory/Launch timeline Annual U.S. peak revenue opportunity – January 2019 FDA Advisory Committee – March 23, 2019 PDUFA Action date 17 – Q2-2019 commercial launch, if approved >$700M * HSDD: Hypoactive Sexual Desire Disorder WOMEN’S HEALTH: VYLEESI © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 21


 
Significant Unmet Medical Need in Large Underserved Market Intrarosa: First-in-class therapy to treat moderate to severe dyspareunia • Dyspareunia – Common symptom of VVA* in post- menopausal women • Only FDA approved locally administered non-estrogen therapy22 Annual U.S. incidence of dyspareunia, a symptom of VVA • Differentiated mechanism of action22 20 million women23 – Intrarosa converts locally into active androgens and estrogens to help restore U.S. women with dyspareunia not on Rx therapy vaginal tissue 18 million women (90%)23 • 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 Don’t want estrogen24 about: • Increased risk of cancer Annual U.S. peak • Increased risk of cardiovascular disease revenue opportunity • Probable dementia • Launched July 2017 >$500M 17 * VVA: vulvar vaginal atrophy WOMEN’S HEALTH: INTRAROSA © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 22


 
Innovative Pipeline Delivering Multiple Value Drivers Approved/ PHASE 1 PHASE 2 PHASE 3 Regulatory Review Marketed AMAG-423 Digoxin Immune Treatment of severe preeclampsia 2020 2021 Fab (ovine) Treatment of low desire or libido with PDUFA TM AdCom: January 2019 Vyleesi associated distress in premenopausal 03/23/19 women Treatment for moderate to severe dyspareunia (pain during sex) in postmenopausal women Data 2020 2021 HSDD* Indication 1H-2019 Treatment of iron deficiency anemia Treatment to reduce recurrent preterm birth in certain at-risk women Additional Women’s healthcare, hematology and licensing & adjacencies acquisitions * HSDD: Hypoactive Sexual Desire Disorder © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 23


 
Q&A © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 24


 
Appendix 25


 
Reconciliation of GAAP to Non-GAAP Financial Results ($M) Q3-2017 Q3-2018 YTD-2018 GAAP operating loss ($254.2) ($19.3) ($28.2) Depreciation and intangible asset amortization 24.0 31.4 146.0 Non-cash inventory step-up adjustments 0.4 0.4 3.6 Stock-based compensation 5.6 5.0 14.6 Adjustments to contingent consideration (49.9) -- (49.2) Impairment charges of intangible assets 319.2 -- -- Acquired IPR&D -- 12.5 32.5 Non-GAAP adjusted EBITDA $45.1 $30.0 $119.3 APPENDIX © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 26


 
Reconciliation of GAAP to Non-GAAP 2018 Financial Guidance Financial guidance issued throughout 201825 Updated ($M) January 2018 May 2018 August 2018 November 2018 GAAP operating loss ($169) – ($139) ($149) – ($129) ($75) - ($55) ($72) - ($62) Depreciation & intangible asset amortization 179 179 174 177 Stock-based compensation 21 21 21 22 Non-cash inventory step up and 4 4 (45) (45) adjustments to contingent consideration Acquired IPR&D 20 20 20 33 Non-GAAP adjusted EBITDA $55 - $85 $75 - $95 $95 - $115 $115 - $125 APPENDIX © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 27


 
Endnotes 1. Represents Feraheme revenue only. Excludes MuGard revenue as reported on financial statements. 2. Feraheme market share based on IQVIA data and internal analytics. 3. Average quarterly market share of IV iron products based on IQVIA data. 4. Market share and volume data of IV iron products based on IQVIA data. 5. Prasco market share based on Symphony data. 6. Intrarosa Rx volume based on weekly IQVIA data as reported in the last week of each month. 7. Intrarosa TRx’s, HCP prescribers and market share based on IQVIA data. 8. MMIT data for commercial lives, unrestricted and adjusted for non-disadvantaged plans under contract. 9. Includes cash of $29.3 million previously held in a CBR account, which was reported in ‘assets held for sale’ at December 31, 2017. These funds were returned to AMAG upon close of the transaction in August 2018. 10. Task Force Report “Hypertension in Pregnancy,” issued by ACOG (November 2013). 11. Agunanne E et al, Marinobufagenin Levels in Preeclamptic Patients: A Preliminary Report. American Journal of Perinatology/Volume 28, Number 7, 2011, p 509. 12. 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. 13. Society for Maternal Fetal Medicine Clinical Opinion: Evaluation and management of severe preeclampsia before 34 weeks’ gestation. SMFS Publications Committee, with the assistance of Baha M. Sibai. AJOG 2011; AMAG internal analytics. 14. Preeclampsia Foundation, “Preeclampsia and Maternal Mortality: a Global Burden,” www.preeclampsia.org, accessed 10/31/18. 15. 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. 16. AMAG Phase 2b/3a clinical trial population is a subset of the severe preeclampsia population. 17. 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. 18. Shifren et al, Sexual Problems and Distress in United States Women; Obstetrics & Gynecology, Vol. 112, No. 5, November 2008; 2014 U.S. Census data. 19. Patient & Economic Flow Study sponsored by Palatin Technologies, Inc. and conducted by Burke Inc., April 2016. 20. 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. 21. 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. 22. Intrarosa is converted by enzymes in the body into androgens and estrogens, though the mechanism of action is not fully established. 23. 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. 24. Market research sponsored by AMAG and conducted by Hall and Partners. June 2018. 25. All periods of financial guidance reflect 2018 financial guidance from continuing operations (excludes CBR for the full year 2018). © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 28


 
Q3-2018 Financial Results November 1, 2018 © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 29