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): August 2, 2018

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AMAG PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)

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

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

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

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

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

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

Emerging growth company  ☐

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

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Item 2.02. Results of Operations and Financial Condition.
 
The following information and Exhibit 99.1 and Exhibit 99.2 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
 
On August 2, 2018, AMAG Pharmaceuticals, Inc. (“AMAG”) issued a press release entitled “AMAG Pharmaceuticals Announces Second Quarter 2018 Financial Results and Provides Corporate Update” regarding its operating results for the three and six months ended June 30, 2018 and its intention to hold a conference call to discuss AMAG’s financial and operating results and recent business highlights. 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
 



2




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: August 2, 2018




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Exhibit
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FOR IMMEDIATE RELEASE

AMAG PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2018 FINANCIAL RESULTS
AND PROVIDES CORPORATE UPDATE
 
Achieved 12% revenue growth and record quarterly sales
Raising full year revenue and adjusted EBITDA guidance for pharmaceutical products
Conference call scheduled for 8:00 a.m. ET today

WALTHAM, MA (August 2, 2018) – AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited consolidated financial results for the quarter ended June 30, 2018. The company announced the sale of Cord Blood Registry® (CBR®) in June 2018, which is currently expected to close in mid-August 2018. As a result of the pending sale, CBR is being classified as discontinued operations for accounting purposes and is presented separately on AMAG’s GAAP consolidated statements of operations and consolidated balance sheets for all periods presented. The company has revised its full year 2018 financial guidance to reflect continued strong performance of its pharmaceutical products and the impact of the pending sale of CBR.

Total GAAP revenue from continuing operations (excluding CBR) increased in the second quarter of 2018 to $146.3 million, 12% higher than the same period last year. The year-over-year increase was driven by increased sales of Feraheme® (ferumoxytol injection) and Makena® (hydroxyprogesterone caproate injection), as well as the commercial launch of Intrarosa® (prasterone) in the third quarter of 2017. The company reported operating income from continuing operations of $41.9 million in the second quarter of 2018, compared with operating income of $3.3 million in the same period last year. Non-GAAP adjusted EBITDA (excluding CBR) totaled $60.6 million in the second quarter of 2018, compared with $41.4 million in the second quarter of 2017.1 

“We have had an extraordinary first half of 2018, with the achievement of a number of important regulatory milestones and strong commercial success across the portfolio," said Bill Heiden, AMAG’s president and chief executive officer. "In the second quarter, our commercial teams generated record setting sales performance for each of our products and these strong results, combined with confidence in our prospects for the second half of 2018, allow us to again raise both annual revenue and adjusted EBITDA guidance for our pharmaceutical business. The divestiture of CBR is another important step in our plan to align the company’s balance sheet with our strategic growth plan, which focuses on the development and commercialization of innovative pharmaceuticals."

Second Quarter 2018 and Recent Business Highlights:
Achieved record quarterly sales
Makena revenues exceeded $105 million in the quarter, reaching an all-time high market share of 51%
Feraheme sales grew 37% over the prior year, generating revenues of $37.7 million in the quarter



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


1


Grew Intrarosa ex-factory shipments by 40% over the first quarter of 2018 and generated $3.2 million of net revenue in the second quarter of 2018, which continued to be impacted by high gross to net adjustments
Announced sale of CBR for $530 million in cash, the net proceeds of which the company expects to use to pay off $475 million of its high yield debt
Received FDA acceptance of the company's new drug application for bremelanotide, with a PDUFA date of March 23, 2019
Continued strong conversion of Makena intramuscular product to the subcutaneous (SC) auto-injector
Approximately 60% of new enrollments through the Makena Care Connection through the end of the second quarter were for the SC auto-injector
Authorized AMAG's partner, Prasco, to launch an authorized generic of the Makena single- and multi-dose intramuscular formulations
Increased Intrarosa market share to 3.8%, with approximately 93,000 total prescriptions written by more than 9,100 healthcare providers since the July 2017 launch
CMS clarified its position on reimbursement, which now allows for reimbursement coverage for Intrarosa; AMAG has initiated discussions with payers for Medicare Part D coverage
Began the first phase of the unbranded and branded Intrarosa digital consumer campaigns
Continued the launch of Feraheme with the broad iron deficiency anemia label, which is already capturing additional market share
Achieved market share of 16.3% for the second quarter of 2018, compared with 11.2% for the first quarter of 2018
Ended the quarter with more than $410 million2 of cash and investments, an increase of more than $40 million from the first quarter of 2018

Second Quarter Ended June 30, 2018 (unaudited)
Financial Results from Continuing Operations (GAAP Basis)
As a result of the pending sale of CBR, which is expected to close in mid-August, AMAG's CBR business has been excluded from its continuing operations for all periods presented and is shown separately as discontinued operations.

Total revenues from continuing operations for the second quarter of 2018 increased 12% to $146.3 million, compared with $130.4 million in the second quarter of 2017. Sales of Feraheme and MuGard® increased 37% to $37.8 million in the second quarter of 2018, compared with $27.7 million in the second quarter of 2017.

Net product sales of Makena increased 2% to $105.2 million in the second quarter of 2018, compared with $102.7 million in the same period last year. Intrarosa, which was commercially launched in July 2017, contributed $3.2 million in net sales during the second quarter of 2018.

Costs and expenses from continuing operations, including cost of product sales, totaled $104.4 million in the second quarter of 2018, compared with $127.1 million for the same period in 2017. Included in selling, general and administrative (SG&A) expenses was an expense reversal of $49.8 million, which was recorded to remove the Makena contingent consideration liability because the company no longer believes that it is probable that the sales milestone will be achieved. Excluding this accounting adjustment, total costs and expenses from continuing operations increased by $27.1 million to $154.2 million. Cost of product sales increased by $44.7 million, of which $36.4 million was an increase in amortization expense primarily related to the Makena intramuscular intangible asset. Research and development costs decreased by $18.6 million during the period. Acquired IPR&D expense in 2017 consisted of $5.8 million in connection with consideration paid under the company's agreement with Endoceutics for the rights to Intrarosa.


2 Includes $60 million of cash and investments held in a CBR account, which is currently recorded as an asset held for sale. These cash and investments will be returned to AMAG upon closing of the transaction.
 


2



Operating income from continuing operations in the second quarter of 2018 was $41.9 million, compared with of $3.3 million for the same period last year. The company reported a net loss from continuing operations of $25.8 million, or $0.75 loss per basic and diluted share, for the second quarter of 2018, compared with a net loss of $14.3 million, or $0.41 loss per basic and diluted share, for the same period in 2017. The primary driver of the second quarter 2018 net loss from continuing operations was the $52 million expense incurred to increase the company's valuation allowance on its deferred tax assets.

Financial Results from Continuing Operations (Non-GAAP Basis)1  
Total costs and expenses from continuing operations on a non-GAAP basis totaled $85.7 million in the second quarter of 2018, compared with $89.0 million in the second quarter of 2017. This decrease was primarily due to lower research and development costs in 2018, partially offset by higher cost of product sales and higher SG&A expenses related to investments to support the launches of the broad Feraheme label, Makena SC auto-injector and Intrarosa.

Non-GAAP adjusted EBITDA (excluding CBR) for the second quarter of 2018 was $60.6 million, compared with $41.4 million in the second quarter of 2017.

Net Income from Discontinued Operations
As a result of the pending sale, CBR is being classified as discontinued operations for accounting purposes. Net income from discontinued operations in the second quarter of 2018 was $5.7 million compared with $0.2 million for the same period in 2017.
 
Balance Sheet Highlights
As of June 30, 2018, the company’s cash and investments totaled $410 million2 and total debt (principal amount outstanding) was $816.4 million.

"Continued execution across the business gives us confidence to increase our financial guidance for 2018," said Ted Myles, AMAG's chief financial officer. "The sale of CBR will allow us to eliminate the senior notes from our capital structure and strengthen our balance sheet as we continue to generate adjusted EBITDA. Our long-term strategy focuses on continuing to grow and further diversify our pharmaceutical portfolio. Our liquidity profile gives us considerable flexibility to invest in and grow our current products and to pursue new business development opportunities.”

2018 Financial Guidance Adjusted for CBR Divestiture and Revised Upward for Pharmaceutical Products3 
($M)
 
Previous Guidance4
Remove CBR
Expected Results
(mid-Aug - Dec)
5
Adjusted Guidance
Guidance Increase
(pharmaceutical products)
Updated 2018 Guidance
Total revenue
 
$540 - $580
$45
$495 - $535
$30
$525 - $565
GAAP Operating loss
 
($128) - ($108)
$8
($136) - ($116)
$77
($59) - ($39)
Non-GAAP adjusted EBITDA
 
$120 - $140
$17
$103 - $123
$22
$125 - $145

3 See reconciliations of 2018 GAAP to non-GAAP financial guidance at conclusion of this press release.
4 Financial guidance issued on May 2, 2018.
5 Assumes sale of CBR closes in mid-August of 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 second quarter 2018 financial results, recent business highlights and 2018 outlook.

Dial-in Number
U.S./Canada dial-in number: (877) 412-6083

3


International dial-in number: (702) 495-1202
Conference ID: 2757556

Replay dial-in number: (855) 859-2056
Replay International dial-in number: (404) 537-3406
Conference ID: 2757556

A telephone replay will be available from approximately 11:00 a.m. ET on August 2, 2018 through midnight on August 9, 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 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. We do this by leveraging our development and commercial expertise to invest in and grow our pharmaceutical products across a range of therapeutic areas, including women’s health. In addition, we seek to collaborate on and acquire promising therapies at various stages of development, and advance them through the clinical and regulatory process to deliver new treatment options to patients. 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.


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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.

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. 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

5


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 Bremelanotide
Bremelanotide, an investigational product, 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 bremelanotide 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, bremelanotide 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 bremelanotide.

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.

Bremelanotide has no known alcohol interactions.

Forward-Looking Statements
This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, AMAG’s anticipated timing for the closing of the CBR sale; beliefs that the divestiture of CBR is an important step in aligning AMAG’s balance sheet with its strategic growth plan; expectations that AMAG will use the transaction proceeds to pay off its high-yield debt; beliefs about AMAG’s accomplishments and second quarter financial results; expectations regarding AMAG's full year performance and updated financial guidance, including revenues, operating loss, and non-GAAP adjusted EBITDA; beliefs about market share for AMAG’s products; expectations for insurance coverage for Intrarosa; AMAG’s beliefs that it is well positioned to achieve its 2018 goals, including the updated 2018 guidance; and plans to continue to invest in 2018 to grow and further diversify its pharmaceutical portfolio and pursue new business development opportunities 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 the pending CBR sale will not close on the anticipated timeline, or at all, or that AMAG will not realize the expected benefits of, or face challenges to its business with, the CBR sale, once consummated, and the risk that generic sales of Makena will have a greater impact on AMAG’s revenues and supply chain than anticipated, 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.

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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. MuGard® is a registered trademark of Abeona Therapeutics, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Cord Blood Registry® and CBR® are registered trademarks of Cbr Systems, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc.

Additional information regarding the sources of data presented in this release can be found in the presentation slides that accompany today’s conference call and webcast.




– 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 June 30,
 
Six Months Ended June 30,
 
2018
 
2017
 
2018
 
2017
Revenues:
 
 
 
 
 
 
 
Makena
$
105,172

 
$
102,681

 
$
195,156

 
$
189,136

Feraheme/MuGard
37,806

 
27,661

 
63,005

 
53,723

Intrarosa
3,241

 

 
5,406

 

Other revenues
35

 
29

 
75

 
53

Total revenues
146,254

 
130,371

 
263,642

 
242,912

Operating costs and expenses:
 
 
 
 
 
 
 
Cost of product sales
76,776

 
32,101

 
140,688

 
59,675

Research and development expenses
11,693

 
30,258

 
22,502

 
46,747

Acquired in-process research and development

 
5,845

 
20,000

 
65,845

Selling, general and administrative expenses
15,898

 
58,900

 
89,329

 
107,523

Total costs and expenses
104,367

 
127,104

 
272,519

 
279,790

Operating income (loss)
41,887

 
3,267

 
(8,877
)
 
(36,878
)
 
 
 
 
 
 
 
 
Other (expense) income:
 
 
 
 
 
 
 
Interest expense
(16,056
)
 
(17,256
)
 
(32,034
)
 
(35,556
)
Loss on debt extinguishment

 
(9,516
)
 

 
(9,516
)
Interest and dividend income
952

 
663

 
1,595

 
1,695

Other expense
(44
)
 
(69
)
 
(44
)
 
(43
)
Total other expense, net
(15,148
)
 
(26,178
)
 
(30,483
)
 
(43,420
)
Income (loss) from continuing operations before income taxes
26,739

 
(22,911
)
 
(39,360
)
 
(80,298
)
Income tax expense (benefit)
52,556

 
(8,659
)
 
44,556

 
(30,120
)
Net loss from continuing operations
$
(25,817
)
 
$
(14,252
)
 
$
(83,916
)
 
$
(50,178
)
 
 
 
 
 
 
 
 
Discontinued Operations:
 
 
 
 
 
 
 
Income from discontinued operations
7,158

 
373

 
13,036

 
494

Income tax expense
1,422

 
187

 
3,444

 
942

Net income (loss) from discontinued operations
5,736

 
186

 
9,592

 
(448
)
 
 
 
 
 
 
 
 
Net loss
$
(20,081
)
 
$
(14,066
)
 
$
(74,324
)
 
$
(50,626
)
 
 
 
 
 
 
 
 
Basic and diluted net (loss) income per share:
 

 
 

 
 

 
 

Loss from continuing operations
$
(0.75
)
 
$
(0.41
)
 
$
(2.45
)
 
$
(1.44
)
Income (loss) from discontinued operations
$
0.17

 
$
0.01

 
$
0.28

 
$
(0.01
)
Basic and diluted net loss per share:
$
(0.58
)
 
$
(0.40
)
 
$
(2.17
)
 
$
(1.45
)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weighted average shares outstanding used to compute net loss per share (basic and diluted)
34,358

 
35,145

 
34,261

 
34,764


8


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

 
 

Cash and cash equivalents
$
212,499

 
$
162,855

Marketable securities
138,672

 
136,593

Accounts receivable, net
103,353

 
91,460

Inventories
30,674

 
34,443

Prepaid and other current assets
12,465

 
11,009

Assets held for sale
77,161

 
45,508

Total current assets
574,824

 
481,868

Property and equipment, net
7,340

 
7,904

Goodwill
422,513

 
422,513

Intangible assets, net
261,692

 
375,479

Deferred tax assets
1,151

 
47,120

Restricted cash
495

 
495

Other long-term assets
103

 
266

Assets held for sale, net of current portion
559,300

 
564,711

Total assets
$
1,827,418

 
$
1,900,356

LIABILITIES AND STOCKHOLDERS’ EQUITY
 

 
 

Current liabilities:
 

 
 

Accounts payable
$
10,738

 
$
7,717

Accrued expenses
194,053

 
166,732

Current portion of convertible notes, net
20,727

 

Current portion of acquisition-related contingent consideration
210

 
49,399

Deferred revenues
182

 

Liabilities held for sale
52,962

 
53,870

Total current liabilities
278,872

 
277,718

Long-term liabilities:
 

 
 

Long-term debt, net
466,906

 
466,291

Convertible notes, net
254,902

 
268,392

Acquisition-related contingent consideration
631

 
686

Other long-term liabilities
918

 
1,204

Liabilities held for sale, net of current portion
98,285

 
95,821

Total liabilities
1,100,514

 
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; 34,390,068 and 34,083,112 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively
344

 
341

Additional paid-in capital
1,281,858

 
1,271,628

Accumulated other comprehensive loss
(4,295
)
 
(3,908
)
Accumulated deficit
(551,003
)
 
(477,817
)
Total stockholders’ equity
726,904

 
790,244

Total liabilities and stockholders’ equity
$
1,827,418

 
$
1,900,356


9


AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited, amounts in thousands)
 
Six Months Ended June 30,
 
2018
 
2017
Cash flows from operating activities:
 
 
 
Net loss
(74,324
)
 
(50,626
)
Adjustments to reconcile net loss to net cash provided by operating activities:
 
 
 
Depreciation and amortization
126,183

 
59,563

Provision for bad debt expense
856

 
2,681

Amortization of premium/discount on purchased securities
93

 
168

Gain on disposal of fixed assets
(99
)
 

Non-cash equity-based compensation expense 
11,122

 
11,669

Non-cash IPR&D expense

 
945

Loss on debt extinguishment

 
9,516

Amortization of debt discount and debt issuance costs
7,851

 
6,679

Gains on marketable securities, net

 
(249
)
Change in fair value of contingent consideration
(49,184
)
 
2,786

Deferred income taxes
42,372

 
(29,677
)
Prepaid transaction costs
(3,865
)
 

Changes in operating assets and liabilities:
 
 
 

Accounts receivable, net
(11,265
)
 
233

Inventories
1,223

 
(1,145
)
Prepaid and other current assets
(756
)
 
(1,178
)
Accounts payable and accrued expenses
27,475

 
40,716

Deferred revenues
7,329

 
7,380

Other assets and liabilities
117

 
(1,029
)
Net cash provided by operating activities
85,128

 
58,432

Cash flows from investing activities:
 

 
 

Proceeds from sales or maturities of marketable securities
44,038

 
251,017

Purchase of marketable securities
(46,726
)
 
(85,249
)
Acquisition of Intrarosa intangible asset

 
(46,500
)
Capital expenditures
(1,553
)
 
(2,672
)
Net cash (used in) provided by investing activities
(4,241
)
 
116,596

Cash flows from financing activities:
 

 
 

Long-term debt principal payments

 
(328,125
)
Proceeds from 2022 Convertible Notes

 
320,000

Payment to repurchase 2019 Convertible Notes

 
(170,371
)
Proceeds to settle warrants

 
323

Payment of convertible debt issuance costs

 
(9,553
)
Payments of contingent consideration
(60
)
 
(119
)
Proceeds from the exercise of common stock options
1,473

 
1,130

Payments of employee tax withholding related to equity-based compensation
(2,362
)
 
(2,439
)
Net cash used in financing activities
(949
)
 
(189,154
)
Net increase (decrease) in cash, cash equivalents, and restricted cash
79,938

 
(14,126
)
Cash, cash equivalents, and restricted cash related to discontinued operations
(59,714
)
 
(62,622
)
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
212,994

 
200,150

Supplemental data for cash flow information:
 
 
 

10


Cash paid for taxes
$
4,181

 
$
3,191

Cash paid for interest
24,171

 
29,173

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
$

 
$
18,600


11


AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended June 30, 2018
(Unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Research & development
 
Acquired in-process research and development
 
Selling, general & administrative
 
Operating Income / Adjusted EBITDA
GAAP
$
146,254

 
$
76,776

 
$
11,693

 
$

 
$
15,898

 
$
41,887

Depreciation and intangible asset amortization

 
(61,423
)
 
(6
)
 

 
(668
)
 
 
Non-cash inventory step-up adjustments

 
(967
)
 

 

 

 
 
Stock-based compensation

 
(107
)
 
(608
)
 

 
(4,714
)
 
 
Adjustments to contingent consideration

 

 

 

 
49,810

 
 
Non-GAAP Adjusted
$
146,254

 
$
14,279

 
$
11,079

 
$

 
$
60,326

 
$
60,570






AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended June 30, 2017
(Unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Research & development
 
Acquired in-process research and development
 
Selling, general & administrative
 
Operating Income / Adjusted EBITDA
GAAP
$
130,371

 
$
32,101

 
$
30,258

 
$
5,845

 
$
58,900

 
$
3,267

Depreciation and intangible asset amortization

 
(25,042
)
 
(45
)
 

 
(220
)
 
 
Non-cash inventory step-up adjustments

 
(194
)
 

 

 

 
 
Stock-based compensation

 
(129
)
 
(1,095
)
 

 
(3,782
)
 
 
Adjustments to contingent consideration

 

 

 

 
(1,743
)
 
 
Acquired IPR&D

 

 

 
(5,845
)
 

 
 
Non-GAAP Adjusted
$
130,371

 
$
6,736

 
$
29,118

 
$

 
$
53,155

 
$
41,362




12


AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Six Months Ended June 30, 2018
(Unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Research & development
 
Acquired in-process research and development
 
Selling, general & administrative
 
Operating Income / Adjusted EBITDA
GAAP
$
263,642

 
$
140,688

 
$
22,502

 
$
20,000

 
$
89,329

 
$
(8,877
)
Depreciation and intangible asset amortization

 
(113,786
)
 
(6
)
 

 
(1,205
)
 
 
Non-cash inventory step-up adjustments

 
(3,191
)
 

 

 

 
 
Stock-based compensation

 
(307
)
 
(1,328
)
 

 
(9,180
)
 
 
Adjustments to contingent consideration

 

 

 
(20,000
)
 
49,184

 
 
Non-GAAP Adjusted
$
263,642

 
$
23,404

 
$
21,168

 
$

 
$
128,128

 
$
90,942





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

 
Revenue
 
Cost of product sales
 
Research & development
 
Acquired in-process research and development
 
Selling, general & administrative
 
Operating Income / Adjusted EBITDA
GAAP
$
242,912

 
$
59,675

 
$
46,747

 
$
65,845

 
$
107,523

 
$
(36,878
)
Depreciation and intangible asset amortization

 
(45,994
)
 
(89
)
 

 
(433
)
 
 
Non-cash inventory step-up adjustments

 
(928
)
 

 

 

 
 
Stock-based compensation

 
(258
)
 
(1,851
)
 

 
(7,626
)
 
 
Adjustments to contingent consideration

 

 

 

 
(2,786
)
 
 
Transaction/Acquisition-related costs

 

 

 

 
(1,472
)
 
 
Acquired IPR&D

 

 

 
(65,845
)
 

 
 
Non-GAAP Adjusted
$
242,912

 
$
12,495

 
$
44,807

 
$

 
$
95,206

 
$
90,404





13


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

2018 Financial Guidance Adjusted for CBR Divestiture and Revised Upward for Pharmaceutical Products
 
Previous Guidance6
Remove CBR Expected Results
(mid-Aug - Dec)
Adjusted Guidance
Updated 2018 Guidance
GAAP operating loss
($128) - ($108)
$8
($136) - ($116)
($59) - ($39)
Depreciation & intangible asset amortization
200
8
192
186
Stock-based compensation
24
1
23
23
Non-cash inventory step up and adjustments to contingent consideration
4
--
4
(45)
Acquired IPR&D
20
--
20
20
Non-GAAP adjusted EBITDA
$120 - $140
$17
$103 - $123
$125 - $145

6 Financial guidance issued on May 2, 2018.




AMAG Pharmaceuticals, Inc.
Share Count Reconciliation
(Unaudited, amounts in millions)
 
 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
 
 
2018
 
2017
 
2018
 
2017
 
Weighted average basic shares outstanding
 
34.4

 
35.1

 
34.3

 
34.8

 
Employee equity incentive awards
 

7 

7 

7 

7 
GAAP diluted shares outstanding
 
34.4

 
35.1

 
34.3

 
34.8

 
Employee equity incentive awards
 
0.4

8 
0.4

8 
0.3

8 
0.5

8 
Non-GAAP diluted shares outstanding
 
34.8

 
35.5

 
34.6

 
35.3

 

7 Employee equity incentive awards would be anti-dilutive in this period.
8 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
q22018ex992
Q2-2018 Financial Results August 2, 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, the expected regulatory time line for all product candidates; beliefs about the expected U.S. market opportunity for preeclampsia treatment; expectations for insurance coverage for Intrarosa; AMAG’s expected approach to optimizing the Makena franchise; beliefs that higher utilization, growing monthly number of accounts and early converted accounts are early indicators of Feraheme’s launch success; expectations regarding the Feraheme market strategy, including expansion to infusion and OB/GYN settings; beliefs about the market opportunity for Intrarosa, including expected prescriptions; the key growth drivers for Intrarosa; beliefs about the Intrarosa marketing campaign, including potential consumer reach; AMAG’s beliefs regarding the target product profile for bremelanotide, including the presumed mode of administration, indication, safety profile and presumed mechanism of action; the breadth and make up of the hypoactive sexual desire disorder market and the expected market potential opportunity for bremelanotide; expectations that the majority of cash proceeds from the expected CBR divestiture will be used to pay off AMAG’s bond debt; beliefs that the expected debt pay off will align AMAG’s balance sheet with its long‐term growth strategy; beliefs that AMAG will continue to expand through growth of its current portfolio and additional business development; AMAG’s 2018 financial guidance, including total revenue, operating loss and adjusted EBITDA; and AMAG’s 2018 key priorities 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 the pending CBR sale will not close on the anticipated timeline, or at all, or that AMAG will not realize the expected benefits of, or face challenges to its business with, the CBR sale, once consummated, and the risk that generic sales of Makena will have a greater impact on AMAG’s revenues and supply chain than anticipated, 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 trademarks of AMAG Pharmaceuticals, Inc. MuGard® is a registered trademark of Abeona Therapeutics, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Cord Blood Registry® and CBR® are registered trademarks of Cbr Systems, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc. © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 2


 
Agenda 1 Q2-2018 Highlights 2 Product Portfolio Update 3 Q2-2018 Financial Overview 4 Key Priorities and Closing Remarks 5 Q&A © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 3


 
Strong Execution Total Revenue ($M) Q2-2018 Highlights $176.3 Announced sale of CBR $158.4 CBR Underscores focus on Strengthens CBR development and balance $146.3 12% commercialization of sheet $130.4 pharmaceutical products FDA accepts NDA for bremelanotide with PDUFA date of 3/23/19 Strong Q2-2018 income generation; increased cash and investments by more than $40M to $410M1 Q2-2017 Q2-2018 Continuing Operations Discontinued Operations 1 Includes $60 million of cash and investments held in a CBR account, which is currently recorded as an asset held for sale. These cash and investments will be returned to AMAG upon closing of the transaction. © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 4


 
Growing Innovative Pipeline Approved/ PHASE 1 PHASE 2 PHASE 3 Regulatory Review Marketed Treatment of iron deficiency anemia Treatment to reduce recurrent preterm birth in certain at-risk women Treatment for moderate to severe dyspareunia (pain during sex) in postmenopausal women 1 Treatment of low desire or libido with HSDD study associated distress in postmenopausal women Treatment of low desire or libido with PDUFA Bremelanotide associated distress in premenopausal AdComm Q1-2019 03/23/19 women Severe preeclampsia Treatment of severe preeclampsia (Velo option) 1 HSDD: Hypoactive Sexual Desire Disorder © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 5


 
Severe Preeclampsia Program1 Significant unmet medical need with large market opportunity • Leading cause of maternal morbidity and mortality and adverse neonatal outcomes – Condition characterized by hypertension and end organ damage in pregnant women – Preeclampsia affects 136,000 pregnant women in U.S. annually2,3 • Severe preeclampsia impact 37% of women with preeclampsia3 Estimated – No effective treatments, other than (premature) delivery of baby ~$1B U.S. market • Current interventions do not treat underlying pathophysiology opportunity4 • Mid/late-stage product development opportunity ‒ Digoxin Immune Fab (polyclonal antibody) ‒ Granted Fast Track and Orphan Drug designation ‒ Proof-of-principal clinical data – Currently enrolling patients in Phase 2b/3a study • Primary endpoint is composite endpoint of severe intraventricular hemorrhage, necrotizing enterocolitis or death of newborn by 36 weeks corrected gestational age • 24 patients enrolled to-date 1 In July 2015, AMAG entered into an option agreement with Velo Bio, LLC to acquire the rights to digoxin immune fab. 2 Task Force Report “Hypertension in Pregnancy,” issued by ACOG (November 2013). 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 estimate based on market research and internal analytics. © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 6


 
Makena® Feraheme® Intrarosa® Bremelanotide 7


 
Makena: Record Quarterly Revenue and Market Share Market Share1 Makena Revenue ($M) June 30, 2018 $105.2 $102.7 Off Guidance2 30% Makena 51% Compounded Hydroxy- progesterone Caproate 19% Q2-2017 Q2-2018 1 Company estimates Makena market share based on distributor dispensing data and all other market share based on physician market research data conducted by AMAG. 2 Off guidance represents patients treated outside guidance of Society for Maternal Fetal Medicine, including patients treated with unapproved therapies and untreated patients. MATERNAL HEALTH: MAKENA © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 8


 
Optimize Makena Franchise Performance & Sustainability Protect the Brand Share in Generic Market • Convert usage to Makena SC auto-injector • First generic ANDA approved in June for – ~60% Makena Care Connection (MCC) enrollments are for single-dose intramuscular Makena SC auto-injector hydroxyprogesterone caproate (HPC) ‒ Priced at 15% discount to Makena WAC • Protect patient access to Makena SC auto-injector – Reinforce value of MCC • Partnered with Prasco, an experienced • Logistics support authorized generic company • Reimbursement support – Prasco launched single- and multi-dose • Patient assistance programs intramuscular HPC immediately following July availability of first generic HPC – Targeted payer strategy – Physician support: ~40% of prescriptions through MCC are “DISPENSE AS WRITTEN” MATERNAL HEALTH: MAKENA © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 9


 
Positive Physician Feedback Regarding Makena Subcutaneous (SC) Auto-injector1 Perceptions of Makena SC Auto-injector Benefits of Makena SC Auto-injector Benefits Over Intramuscular (% Selecting) (% mentioned, unaided) 70% Ease of use / ease of administration 22% 1% (pre-loaded, single-dose) 34% Administration friendly (SC, accurate dosing, needle guard) 77% 31% Discreet Very beneficial Somewhat beneficial Not beneficial (administered in back of arm, thinner needle) 1 Auto-injector experience market research conducted by ThinkGen, May 2018. N=125, sample only includes HCPs who are aware of the auto-injector. MATERNAL HEALTH: MAKENA © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 10


 
Makena® Feraheme® Intrarosa® Bremelanotide 11


 
Record Quarterly Feraheme Revenue and Market Share Feraheme gained >5 market share points over Q1-2018 IV Iron Deficiency Anemia (IDA) Feraheme Revenue1 ($M) Quarterly Market Share by Product2 $37.7 Q2-2018 0.6% Feraheme $27.5 37% 11.7% Injectafer 36.6% Venofer 16.3% INFeD 34.8% Ferrlecit/Nulecit Q2-2017 Q2-2018 1 Represents Feraheme revenue only. Excludes MuGard revenue as reported on financial statements. 2 AMAG estimates average quarterly market share using IQVIA (formerly IMS) data and internal analytics. IV IRON DEFICIENCY ANEMIA: FERAHEME © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 12


 
Growing Share through Clinical Differentiation and New Broad Label Feraheme monthly market share1 SALINE SHORTAGE IMPACT 17.1% 16.2% 15.4% Indicators of Launch Success 12.3% 11.8% Early converted Higher utilization Growing monthly 10.7% accounts 10.2% of Feraheme in number of producing accounts ordering existing large incremental Feraheme accounts volume Dec-17 Jan-18 Feb-18 Mar-18 Apr-18 May-18 Jun-18 1 AMAG estimates market share using IQVIA (formerly IMS) data and internal analytics. IV IRON DEFICIENCY ANEMIA: FERAHEME © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 13


 
IV Iron Market Represents Small Subset of Patients Who Suffer from IDA 4.5M total U.S. patients diagnosed with iron deficiency anemia1 Diagnosed IDA Patients • Under the care of other physician specialists, including in women’s health, where AMAG has a strong commercial presence 700,000 IV iron patients2 Market Expansion Strategy • Increasing share in infusion setting • Increase anemia patient referrals from OB/GYNs ‒ Pilot with Maternal Health sales force in 2H-2018 ‒ Potential to expand initiative in 2019 1 Global Intravenous (I.V.) Iron Drugs Market Report: 2015 Edition. 2 AMAG estimates number of non-dialysis IV patients using 1.3M grams and an estimated average dose per course of therapy. IV IRON DEFICIENCY ANEMIA: FERAHEME © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 14


 
Makena® Feraheme® Intrarosa® Bremelanotide 15


 
Intrarosa is Differentiated from Estrogen Therapies Non-estrogen treatment1  Differentiated MOA1   Unique safety profile (no boxed warning) 1 Intrarosa is converted by enzymes in the body into androgens and estrogens, though the mechanism of action is not fully established. WOMEN’S HEALTH: INTRAROSA © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 16


 
Significant Momentum with HCPs Continues At 3/31/18 At 6/30/18 TRx’s written since launch1 ~50,000 ~93,000 HCP prescribers since launch1 ~6,600 ~9,100 Total week ending market share1 2.8% 3.8% Commercial lives covered (unrestricted)2 74% 75% CMS clarified that drugs for the treatment of Medicare Part D coverage moderate to severe dyspareunia due to menopause are not excluded from coverage 1 Based on IQVIA (formerly IMS) data. 2 MMIT data adjusted for non-reporters and MMIT timing delays. WOMEN’S HEALTH: INTRAROSA © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 17


 
Intrarosa HCP Prescribing and Market Share Continue to Increase Rx Volume1 • High level of sales force HCP engagement 4,500 – Averaged 2,000 weekly prescribers in Q2, a 41% increase 4,000 over Q1 3,500 – ~200 speaker programs held in Q2 3,000 • Intrarosa NRx market share continues to grow: 2,500 – 5.6% NRx share (commercial only), 3.8% overall 2,000 • Second half 2018 growth drivers 1,500 Number Number of Scripts – Publications on androgenic benefit 1,000 – Medicare Part D clarification 500 – Branded DTC launch 0 – Co-pay card removes cost barrier TRx NRx 1 Based weekly data as reported in the last week of each month from IQVIA (formerly IMS). WOMEN’S HEALTH: INTRAROSA © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 18


 
Commercial Copay Savings Program Removing cost as a barrier and driving persistency • Comprehensive commercial copay savings program – $0 copay first month on therapy (regardless of formulary access) – Refill copays are no greater than $25 (regardless of formulary access) • Copay card driving high gross to net (GTN), but impact declining every month as insurance pull through occurs – Copay card facilitating starts and persistency – Rapid growth nationally of high deductible plans impacting copay card programs (and GTN) – Evaluating modification to copay program based on maturity of launch • 40% of Intrarosa patients are still on therapy at six months – Copay card patients are significantly more persistent than non-copay card patients • More than twice as many patients getting to a second fill • Almost four times as many getting to a sixth fill WOMEN’S HEALTH: INTRAROSA © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 19


 
90% of Women with Dyspareunia Not on Prescription Therapy 20M women in U.S. suffer from dyspareunia, a symptom of VVA1 ~1.7M2 18M Currently on Rx U.S. women with dyspareunia not on prescription therapy2 estrogen therapy New potential patients represent a market opportunity of ~$14B/year4 #1 reason women don’t seek treatment: DON’T WANT ESTROGEN5 ~6M3 ~12M3 Utilizing OTC Affected, but not currently treatments seeking treatment 1 Intrarosa is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. 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. 3 AMAG estimates based on: a) Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive Health 2014:8 23–30; b) Kingsberg et al. Vulvar and Vaginal Atrophy in Postmenopausal Women: Findings from the REVIVE Survey. J Sex Med 2013;101790-1799; and c) F. Palma et al: Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study. 4 AMAG estimated based on IMS SMART Tool NSP and NPA data 5 Market research sponsored by AMAG and conducted by Hall and Partners. June 2018. WOMEN’S HEALTH: INTRAROSA © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 20


 
Key Intrarosa Growth Drivers Accessing the 90% of women who are not being treated with Rx Branded consumer campaign resulting 5 in patients asking for Intrarosa Increase HCP prescribing and make Intrarosa the 1st choice treatment 4 3 Educate with unbranded condition awareness campaign Create affordable access for all patients 2 Intrarosa 1 Increase market awareness GROWTH STRATEGY LAUNCH PRIORITIES WOMEN’S HEALTH: INTRAROSA © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 21


 
Coming Soon: Unbranded and Branded Consumer Campaigns PHASE 1: I N MARKET NOW PHASE 2: COMING SOON Copay Registration on Intrarosa.com Paid Search Campaign 1,400+ copay registrations Updated Intrarosa.com and media campaign 35,000+ visits to Intrarosa.com to date (730 redeemed) to date Robust media plan reaches 20M women 45-64 avg 30 times through year end April 2 April 19 August Apr May Jun Jul Aug Sep Oct 2019 May 2 June 2 August September Facebook page Condition Awareness Website Patient Support Program Condition Awareness PR Campaign 2.6M engagements to date PauseSexPain.com & Media Campaign Integrated email, direct • 316,000 visitors since June 6th mail, text program to • Media plan to reach 16M women drive INTRAROSA 45-64 avg 20 times through year end adherence WOMEN’S HEALTH: INTRAROSA © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 22


 
Makena® Feraheme® Intrarosa® Bremelanotide 23


 
Significant Market Opportunity in Area of High Unmet Need 1 Bremelanotide Overview Self-administered auto-injector PEN NOVEL mechanism of action: used in ANTICIPATION melanocortin receptor agonist (MCR4) of sexual activity TWO Phase 3 studies met co-primary, pre-specified endpoints on desire and distress Favorable SAFETY profile Investigational product for premenopausal WOMEN used to treat Large market OPPORTUNITY Low desire/libido with associated distress affects 1 in 10 premenopausal women2,3 (Hypoactive Sexual Desire Disorder or HSDD) 1 If regulatory approval is received. 2 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. [PubMed] 3 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. WOMEN’S HEALTH: BREMELANOTIDE © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 24


 
Financial Overview 25


 
Divestiture of Cord Blood Registry • $530M all-cash sale – Announced June 15, 2018; expected to close mid-August 2018 – Majority of net proceeds expected to be used to retire $475M Senior Notes • Debt repayment will align balance sheet with long-term growth strategy – Focus on investing and growing pharmaceutical product portfolio – Continue to expand through additional business development FINANCIAL OVERVIEW © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 26


 
Strong Financial Results While Investing in the Future GAAP product revenue and operating income from continuing operations ($M)1 $146.3 $3.2 $130.4 12% $37.8  $27.7 5% Intrarosa Revenue $102.7 $105.2 Feraheme/MuGard Revenue Makena Revenue $41.9 GAAP Operating Income $3.3 Q2-2017 Q2-2018 1 Excludes revenue and operating income from CBR. FINANCIAL OVERVIEW © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 27


 
Strong Financial Results While Investing in the Future Product revenue and non-GAAP adjusted EBITDA from continuing operations ($M)1 $146.3 $3.2 $130.4 12% $37.8 $27.7 Intrarosa Revenue $102.7 $105.2 Feraheme/MuGard Revenue $60.6 Makena Revenue $41.4 Adjusted EBITDA Q2-2017 Q2-2018 1 See slide 34 for a reconciliation of GAAP to non-GAAP financials. Excludes revenue and adjusted EBITDA from CBR. FINANCIAL OVERVIEW © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 28


 
2018 Financial Guidance: Adjusted for CBR Divestiture and Revised Upward to Reflect Strong Execution 1 Remove CBR Guidance Increase Previous Expected Results Adjusted (pharmaceutical Updated ($M) Guidance2 (mid-Aug - Dec)3 Guidance products) 2018 Guidance Total revenue $540 - $580 $45 $495 - $535 $30 $525 - $565 GAAP operating (loss) income ($128) - ($108) $8 ($136) - ($116) $77 ($59) - ($39) Non-GAAP adjusted EBITDA $120 - $140 $17 $103 - $123 $22 $125 - $145 1 See slide 35 for a reconciliation of 2018 financial guidance. 2 Financial guidance issued on May 2, 2018. 3 Assumes sale of CBR closes in mid-August 2018. FINANCIAL OVERVIEW © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 29


 
Strengthening Balance Sheet ($M) 3/31/18 6/30/18 Cash, cash equivalents and investments $371 $4101 Principal debt outstanding: Convertible senior notes (2.5%) due 2019 $ 21 $ 21 Convertible senior notes (3.25%) due 2022 320 320 Senior notes (7.875%) due 20232 475 475 Total debt outstanding (current) $816 $816 1 Includes $60 million of cash and investments held in a CBR account, which is currently recorded as an asset held for sale. These cash and investments will be returned to AMAG upon closing of the transaction. 2 Expected to be paid in full with proceeds from sale of CBR. FINANCIAL OVERVIEW © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 30


 
2018 Key Priorities Progress to-date Bremelanotide Submit NDA in Q1-2018 Continue to drive HCP prescribing and initiate Intrarosa consumer campaign Launch subcutaneous auto-injector and drive Makena conversion Feraheme Launch broad IDA label and grow market share Cord Blood Registry Complete divestiture and eliminate high yield bonds Business Development Build shareholder value through portfolio expansion Financial Meet or beat financial guidance © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 31


 
Q&A © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 32


 
Appendix 33


 
Reconciliation of GAAP to Non-GAAP Financial Results1 ($M) Q2-2017 Q2-2018 GAAP operating income $3.3 $41.9 Depreciation and intangible asset amortization 25.4 62.1 Non-cash inventory step-up adjustments 0.2 1.0 Stock-based compensation 5.0 5.4 Adjustments to contingent consideration 1.7 (49.8) Acquired IPR&D 5.8 ― Non-GAAP adjusted EBITDA $41.4 $60.6 1 Excludes financial results from CBR. APPENDIX © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 34


 
Reconciliation of GAAP to Non-GAAP 2018 Financial Guidance Adjusted for CBR divestiture and revised upward to reflect expected pharmaceutical products results in 2H-2018 Remove CBR Previous Expected Results Adjusted Updated ($M) Guidance1 (mid-Aug – Dec)2 Guidance 2018 Guidance GAAP operating (loss) income ($128) - ($108) $8 ($136) - ($116) ($59) - ($39) Depreciation & intangible asset amortization 200 8 192 186 Stock-based compensation 24 1 23 23 Non-cash inventory step up and adjustments 4 -- 4 (45) to contingent consideration Acquired IPR&D 20 -- 20 20 Non-GAAP adjusted EBITDA $120 - $140 $17 $103 - $123 $125 - $145 1 Financial guidance issued on May 2, 2018. 2 Assumes sale of CBR closes in mid-August. APPENDIX © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 35


 
Q2-2018 Financial Results August 2, 2018 © 2018 AMAG Pharmaceuticals, Inc. All rights reserved 36