Form 8-K AMAG PHARMACEUTICALS For: Nov 02

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November 2, 2017 7:04 AM EDT



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 2, 2017

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.  ☐

1


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, (the “Exchange Act”) 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, (the “Securities Act”) except as expressly set forth by specific reference in such filing.
 
On November 2, 2017, AMAG Pharmaceuticals, Inc. (“AMAG”) issued a press release entitled “AMAG Pharmaceuticals Announces Third Quarter 2017 Financial Results and Business Highlights” regarding its operating results for the quarter and nine months ended September 30, 2017 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:
 



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
General Counsel, Senior Vice President of Legal Affairs, and Quality and Secretary
 
 
 
Date: November 2, 2017


3



EXHIBIT INDEX

Exhibit
Number
Description
99.1
 
Press release entitled “AMAG Pharmaceuticals Announces Third Quarter 2017 Financial Results and Business Highlights” issued by AMAG Pharmaceuticals, Inc. on November 2, 2017.
99.2
 
Copy of AMAG Pharmaceuticals, Inc.’s presentation slides dated November 2, 2017.



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amaglogo.gif

FOR IMMEDIATE RELEASE

AMAG PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2017 FINANCIAL RESULTS
AND BUSINESS HIGHLIGHTS
Intrarosa® (prasterone) launch progressing well with nearly 2,000 prescribing physicians
in the first 100 days since launch
Conference call scheduled for 8:00 a.m. ET today

WALTHAM, MA (November 2, 2017) – AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited consolidated financial results for the quarter ended September 30, 2017 and updated its full year 2017 financial guidance.

Total GAAP revenue for the third quarter of 2017 increased to $153.7 million, 7% higher than the same period last year. The year-over-year increase was driven by sales growth across the product portfolio, including strong performance from Feraheme® (ferumoxytol), which grew 17%. While third quarter sales of Makena® (hydroxyprogesterone caproate) grew 5% versus the same quarter of last year, ex-factory sales were lower than anticipated due to slower-than-expected growth in underlying demand and a reduction in channel inventory. The company reported an operating loss of $249.7 million in the third quarter of 2017 due to a $319.2 million non-cash accounting charge related to the impairment of an intangible asset. This compares with operating income of $38.8 million in the same period last year. Non-GAAP adjusted EBITDA totaled $56.7 million in the third quarter of 2017, compared with $76.2 million in the third quarter of 2016.1 

“Third quarter sales of Makena grew slower than forecasted, and we have updated our full year expectations accordingly. Feraheme and CBR are both on a steady growth track, and we are confirming our previous full year expectations for these products," said William Heiden, AMAG’s president and chief executive officer. “Looking ahead, we are preparing for the potential February 2018 approval of our next generation Makena subcutaneous auto-injector and for the broader Feraheme label. We also continue to invest in the growth of our new products, and are pleased with early physician and patient response to Intrarosa and the trajectory of the launch. In addition, we are preparing to submit our NDA for bremelanotide early next year.”

Third Quarter 2017 and Recent Business Highlights:
•
Launched Intrarosa, the first and only FDA-approved locally administered non-estrogen2 product for the treatment of moderate to severe dyspareunia (pain during intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause:
–
Made significant formulary progress with commercial insurers and are on track to achieve 65% unrestricted coverage by year end;
–
Visited 19,000 healthcare providers at least once since launch;
–
Broadly distributed patient copay savings cards to OB/GYN offices (also available at www.intrarosa.com); and
–
More than 6,000 prescriptions written in the first 100 days;
•
AMAG's partner, Endoceutics, Inc., initiated a Phase 3 study to assess the effectiveness of Intrarosa for the treatment of hypoactive sexual desire disorder (HSDD) in post-menopausal women;

1 See summaries of GAAP to non-GAAP adjustments at the conclusion of this press release.
2 Intrarosa is converted by enzymes in the body into androgens and estrogens, though the mechanism of action is not fully established.


1

•
Received U.S. Food and Drug Administration (FDA) acceptance for review of the Feraheme submission to broaden the current label to include the treatment of all adults with iron deficiency anemia (IDA) with a PDUFA date of February 2, 2018;
•
Feraheme abstracts selected for:
–
November 3 podium presentation (Phase 3 hypophosphatemia data) at the 2017 American Society of Nephrology (ASN) Annual Meeting in New Orleans;
–
December 11 poster presentation (Phase 3 safety and efficacy data) at the 2017 American Society of Hematology (ASH ) Annual Meeting in Atlanta;
•
Grew Makena market share to 50%;
•
Reached 700,000 units stored at Cord Blood Registry;
•
Held a productive pre-New Drug Application (NDA) meeting with the FDA and expect to submit the NDA for bremelanotide in the first quarter of 2018;
•
Continued balance sheet optimization by reducing debt by approximately $45 million during the third quarter of 2017 and subsequent period; and
•
Ended the quarter with $394.1 million of cash and investments.

Intrarosa Launch Update
Since AMAG launched Intrarosa on July 24, the product has been prescribed by nearly 2,000 healthcare providers (HCPs), and the number of HCPs gaining clinical experience with Intrarosa is growing rapidly. During the third quarter, AMAG implemented a comprehensive copay savings program that helps ensure access to any commercially insured patient who receives an Intrarosa prescription. The program has been successful in driving rapid patient uptake regardless of formulary status. The near-term negative impact of the program on net revenue per prescription and total Intrarosa revenues (updated 2017 Intrarosa revenue guidance to between $1 million and $3 million) is anticipated to improve significantly as commercial formulary coverage continues to expand. AMAG's current efforts focus on expanding physician awareness and education of Intrarosa, and the company expects to initiate a broad digital and social media patient engagement program in early 2018. This program will help the many women suffering from dyspareunia who are currently untreated to understand the benefits of a non-estrogen therapy and the importance of talking to their physician about their symptoms and treatment options.

Makena Intramuscular (IM) Formulation Update
While third quarter sales of Makena increased 5% year-over-year, they were lower than second quarter 2017 sales. This sequential quarter decrease was the result of a reduction in inventory related to a late second quarter inventory build, as well as slower growth in underlying demand, due in part to the adverse impact of the hurricanes in Florida and Texas. The company anticipates sales of Makena in the fourth quarter of 2017 to be lower than previously expected due to the continued impact of the reduced number of patients initiating therapy in the third quarter. Based on third quarter results and fourth quarter expectations, the company has updated 2017 Makena revenue guidance to between $385 million and $395 million.

During the third quarter of 2017, AMAG updated its long-range revenue forecast to reflect new information received from a variety of sources related to potential generic competitors to the intramuscular formulation (IM) of Makena. Based on revised long-range projections, the company determined that the current fair market value of the Makena IM intangible asset was less than its net book value, and therefore recorded a non-cash impairment charge of $319.2 million. The company also determined that the current fair value of the Makena subcutaneous auto-injector (currently under review with the FDA) was greater than its carrying value and, therefore, was not impaired.

“We believe the long-term value of the Makena franchise resides in the next generation Makena subcutaneous auto-injector,” commented Mr. Heiden. “We continue to believe that generic entry to Makena IM will likely occur in the second half of 2018, and we are prepared to implement our generic strategy earlier if necessary.”


2

Third Quarter Ended September 30, 2017 (unaudited)
Financial Results (GAAP Basis)
Total revenues for the third quarter of 2017 increased 7% to $153.7 million, compared with $143.8 million in the third quarter of 2016. Net product sales of Makena increased 5% to $97.6 million in the third quarter of 2017, compared with $93.4 million in the same period last year. Sales of Feraheme and MuGard® increased 18% to $26.3 million in the third quarter of 2017, compared with $22.4 million in the third quarter of 2016. Service revenue from CBR increased 5% to $29.4 million in the third quarter of 2017, compared with $28.0 million in the same period last year.

Costs and expenses, including costs of product sales and services, totaled $403.5 million in the third quarter of 2017, compared with $105.0 million for the same period in 2016. This increase was primarily due to the $319.2 million Makena-related non-cash impairment charge, partially offset by an adjustment to contingent consideration of $49.9 million. Excluding these two accounting items, total costs and expenses increased to $134.2 million from $105.0 million in the prior year period. The increase is consistent with our previously stated plans to invest in the commercial launch of Intrarosa, including the company's newly hired women's health sales force and marketing programs to help drive awareness of Intrarosa. Research and development expenses decreased slightly versus the third quarter of last year. This decrease was primarily related to the completion of both the Feraheme study in support of the broader label and the Makena pharmacokinetic study for subcutaneous administration, partially offset by increased pre-NDA bremelanotide-related costs.

The impact of the non-cash impairment charge in the third quarter of 2017 contributed to an operating loss of $249.7 million in the third quarter of 2017, as compared to operating income of $38.8 million for the same period last year. The company reported a net loss of $152.1 million, or ($4.31) per basic and diluted share, for the third quarter of 2017, compared with net income of $16.2 million, or $0.47 per basic share and $0.43 per diluted share, for the same period in 2016.

Financial Results (Non-GAAP Basis)1  
Non-GAAP revenue totaled $155.1 million in the third quarter of 2017, up from $145.8 million in the third quarter of 2016.

Total costs and expenses on a non-GAAP basis totaled $98.4 million in the third quarter of 2017, compared with $69.6 million in the third quarter of 2016. This increase primarily related to investments the company has made to support the commercialization of Intrarosa.

Non-GAAP adjusted EBITDA for the third quarter of 2017 was $56.7 million, resulting in an adjusted EBITDA margin of 37%. This compares to non-GAAP adjusted EBITDA of $76.2 million in the third quarter of 2016. The decline in adjusted EBITDA for the third quarter of 2017 was in line with the company's expectations and previously stated plans to invest in the continued development and commercialization of its newer products to create long-term shareholder value.

Balance Sheet Highlights
As of September 30, 2017, the company’s cash and investments totaled $394.1 million and total debt (principal amount outstanding) was $841.4 million, net of approximately $20 million in repurchases of its convertible senior notes due in 2019. In addition, in October the company repurchased $25 million of the company's 7.875% senior notes due in 2023.

Updated 2017 Financial Guidance
"As part of our revised full year financial guidance, we expect to mitigate the impact of reduced revenue expectations on adjusted EBITDA through disciplined expense management," said Ted Myles, AMAG's chief financial officer. "The company's strong liquidity, which includes nearly $400 million of cash on hand, extended debt maturities and continued EBITDA generation, positions us well for future investment in our existing product base and additional business development to further expand our portfolio. 


3


 
 
2017 GAAP Guidance
 
2017 Non-GAAP Guidance3
$ in millions
 
Previous
Updated
 
Previous
Updated
Makena sales
 
$410 - $440
$385 - $395
 
$410 - $440
$385 - $395
Feraheme and MuGard sales
 
$100 - $110
No change
 
$100 - $110
No change
CBR service revenue
 
$110 - $120
No change
 
$115 - $1254
No change
Intrarosa sales
 
$5 - $15
$1 - $3
 
$5 - $15
$1 - $3
Total revenue
 
$625 - $685
$596 - $628
 
$630 - $690
$601 - $633
 
 
 
 
 
 
 
Net loss
 
($62) - ($31)
($235) - ($220)
 
N/A
N/A
Operating income (loss)
 
($23) - $27
($319) - ($299)
 
N/A
N/A
Adjusted EBITDA
 
N/A
N/A
 
$210 - $260
$210 - $230

3 See reconciliation of 2017 financial guidance at the conclusion of this press release.
4 Revenue includes purchase accounting adjustments related to CBR deferred revenue.

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 2017 financial results and recent business highlights.

Dial-in Number
U.S./Canada dial-in number: (877) 412-6083
International dial-in number: (702) 495-1202
Conference ID: 96691011

Replay dial-in number: (855) 859-2056
Replay International dial-in number: (404) 537-3406
Conference ID: 96691011

A telephone replay will be available from approximately 11:00 a.m. ET on November 2, 2017 through midnight on November 8, 2017.

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 revenue, non-GAAP costs and expenses, non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization), and non-GAAP adjusted EBITDA margin. These non-GAAP financial measures exclude certain amounts, revenue, 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.

4


About AMAG
AMAG is a biopharmaceutical company focused on developing and delivering important therapeutics, conducting clinical research in areas of unmet need and creating education and support programs for the patients and families we serve. Our currently marketed products support the health of patients in the areas of maternal and women's health, anemia management and cancer supportive care. Through CBR®, we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders, and have the potential to play a valuable role in the ongoing development of regenerative medicine. 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 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.

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,

5

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 of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.

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

About Feraheme® (ferumoxytol)
Feraheme received marketing approval from the FDA on June 30, 2009 for the treatment of IDA in adult CKD patients 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. Feraheme is contraindicated in patients with a known hypersensitivity to Feraheme or any of its components, or a history of allergic reaction to any intravenous iron product.

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

About Cord Blood Registry® (CBR)
CBR is the world’s largest private newborn stem cell company. Founded in 1992, CBR is entrusted by parents with storing approximately 700,000 umbilical cord blood and cord tissue units. CBR is dedicated to advancing the clinical application of newborn stem cells by partnering with reputable research institutions on FDA-regulated clinical trials for conditions that have no cure today. For more information, visit www.cordblood.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

6

contained herein which do not describe historical facts, including, among others, the anticipated timing to submit the bremelanotide NDA in the first quarter of 2018; beliefs that the negative impact on net Intrarosa revenue per prescription will improve significantly as commercial formulary coverage expands; AMAG’s plans to initiate a broad digital and social media engagement program in early 2018 and the expected benefits of the program on untreated women suffering from dyspareunia; expectations that Makena revenues in the fourth quarter of 2017 will be lower than previously expected; AMAG’s 2017 updated financial guidance, including GAAP and non-GAAP revenues, GAAP operating income, non-GAAP adjusted EBITDA and GAAP and non-GAAP net income; AMAG’s belief that much of the impact of the reduction in expected 2017 revenues will be mitigated through expense management; beliefs that a generic competitor of the Makena IM product will enter the market in the second half of 2018; beliefs that disciplined expense management, strong liquidity profile and continued EBITDA generation positions AMAG well for future investment in its’ portfolio; expected 2017 third quarter financial results, including revenues and year end cash, cash equivalents and investments balances and total debt; and beliefs that newborn stem cells have the potential to play a valuable role in the development of regenerative medicine 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, 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, 2016 and subsequent filings with the SEC. 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. MuGard® is a registered trademark of Abeona Therapeutics, Inc. Makena® is a registered trademark of AMAG Pharmaceuticals IP, Ltd. Cord Blood Registry® and CBR® are registered trademarks of Cbr Systems, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc.




– Tables Follow –

7

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,
 
2017
 
2016
 
2017
 
2016
Revenues:
 
 
 
 
 
 
 
Makena
$
97,635

 
$
93,387

 
$
286,771

 
$
236,824

Feraheme/MuGard
26,336

 
22,390

 
80,059

 
71,500

Cord Blood Registry
29,410

 
27,965

 
84,365

 
71,863

Intrarosa
360

 
—

 
360

 
—

License fee, collaboration and other revenues
—

 
40

 
53

 
313

Total revenues
153,741

 
143,782

 
451,608

 
380,500

Operating costs and expenses:
 
 
 
 
 
 
 
Cost of product sales
31,085

 
25,706

 
90,761

 
65,942

Cost of services
5,559

 
4,984

 
16,130

 
15,705

Research and development expenses
16,274

 
17,116

 
63,021

 
45,579

Acquired in-process research and development
—

 
—

 
65,845

 
—

Selling, general and administrative expenses
31,307

 
57,216

 
182,719

 
172,314

Impairment charges of intangible assets
319,246

 
—

 
319,246

 
15,963

Restructuring expenses
—

 
—

 
—

 
712

Total costs and expenses
403,471

 
105,022

 
737,722

 
316,215

Operating (loss) income
(249,730
)
 
38,760

 
(286,114
)
 
64,285

 
 
 
 
 
 
 
 
Other (expense) income:
 
 
 
 
 
 
 
Interest expense
(16,847
)
 
(18,309
)
 
(52,403
)
 
(55,002
)
Loss on debt extinguishment
(314
)
 
—

 
(9,830
)
 
—

Interest and dividend income
487

 
838

 
2,181

 
2,319

Other (expense) income
—

 
(24
)
 
(43
)
 
197

Total other (expense) income
(16,674
)
 
(17,495
)
 
(60,095
)
 
(52,486
)
(Loss) income before income taxes
(266,404
)
 
21,265

 
(346,209
)
 
11,799

Income tax (benefit) expense
(114,343
)
 
5,069

 
(143,521
)
 
3,725

Net (loss) income
$
(152,061
)
 
$
16,196

 
$
(202,688
)
 
$
8,074

 
 
 
 
 
 
 
 
Net (loss) income per share
 
 
 
 
 
 
 
Basic
$
(4.31
)
 
$
0.47

 
$
(5.80
)
 
$
0.23

Diluted
$
(4.31
)
 
$
0.43

 
$
(5.80
)
 
$
0.23

 
 
 
 
 
 
 
 
Weighted average shares outstanding used to compute net loss per share:
 
 
 
 
 
 
 
Basic
35,311

 
34,171

 
34,948

 
34,377

Diluted
35,311

 
42,111

 
34,948

 
34,764


8

AMAG Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(Unaudited, amounts in thousands)
 
September 30, 2017
 
December 31, 2016
ASSETS
    
 
    
Current assets:
 

 
 

Cash and cash equivalents
$
257,914

 
$
274,305

Investments
136,186

 
304,781

Accounts receivable, net
97,762

 
92,375

Inventories
36,543

 
37,258

Prepaid and other current assets
11,430

 
9,839

Total current assets
539,835

 
718,558

Property, plant and equipment, net
24,833

 
24,460

Goodwill
639,484

 
639,484

Intangible assets, net
769,160

 
1,092,178

Restricted cash
2,653

 
2,593

Other long-term assets
801

 
1,153

Total assets
$
1,976,766

 
$
2,478,426

LIABILITIES AND STOCKHOLDERS’ EQUITY
 

 
 

Current liabilities:
 

 
 

Accounts payable
$
8,511

 
$
3,684

Accrued expenses
190,457

 
156,008

Current portion of long-term debt
—

 
21,166

Current portion of acquisition-related contingent consideration
99,106

 
97,068

Deferred revenues
41,623

 
34,951

Total current liabilities
339,697

 
312,877

Long-term liabilities:
 

 
 

Long-term debt, net
490,518

 
785,992

Convertible notes, net
264,899

 
179,363

Acquisition-related contingent consideration
1,582

 
50,927

Deferred tax liabilities
55,800

 
197,066

Deferred revenues
22,312

 
14,850

Other long-term liabilities
1,651

 
2,962

Total liabilities
1,176,459

 
1,544,037

Total stockholders’ equity
800,307

 
934,389

Total liabilities and stockholders’ equity
$
1,976,766

 
$
2,478,426


9

AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited, amounts in thousands)
 
Nine Months Ended September 30,
 
2017
 
2016
Cash flows from operating activities:
 
 
 
Net (loss) income
$
(202,688
)
 
$
8,074

Adjustments to reconcile net loss to net cash provided by operating activities:
 
 
 
Depreciation and amortization
88,941

 
68,960

Impairment of intangible assets
319,246

 
15,963

Provision for bad debt expense
3,503

 
2,209

Amortization of premium/discount on purchased securities
218

 
518

Non-cash equity-based compensation expense 
18,058

 
16,809

Non-cash IPR&D expense
945

 
—

Loss on debt extinguishment
9,830

 
—

Amortization of debt discount and debt issuance costs
10,600

 
9,015

(Loss) gains on investments, net
(255
)
 
24

Change in fair value of contingent consideration
(47,142
)
 
5,106

Deferred income taxes
(146,682
)
 
2,573

Changes in operating assets and liabilities:


 


Accounts receivable, net
(8,889
)
 
13,390

Inventories
(600
)
 
(1,369
)
Receivable from collaboration
—

 
428

Prepaid and other current assets
(1,409
)
 
(1,293
)
Accounts payable and accrued expenses
29,977

 
19,940

Deferred revenues
14,134

 
21,888

Other assets and liabilities
(1,139
)
 
1,467

Net cash provided by operating activities
86,648

 
183,702

Cash flows from investing activities:
 
 
 
Proceeds from sales or maturities of investments
279,526

 
71,733

Purchase of investments
(110,894
)
 
(142,175
)
Intrarosa developed technology
(55,800
)
 
—

Change in restricted cash
(60
)
 
—

Capital expenditures
(6,573
)
 
(3,360
)
Net cash provided by (used in) investing activities
106,199

 
(73,802
)
Cash flows from financing activities:
 
 
 
Long-term debt principal payments
(328,125
)
 
(13,127
)
Proceeds from 2022 Convertible Notes
320,000

 
—

Payment to repurchase 2019 Convertible Notes
(191,480
)
 
—

Proceeds to settle warrants
323

 
—

Payment of convertible debt issuance costs
(9,553
)
 
—

Payments of contingent consideration
(165
)
 
(212
)
Payments for repurchases of common stock
—

 
(20,000
)
Proceeds from the issuance and exercise of common stock options
2,350

 
2,184

Payments of employee tax withholding related to equity-based compensation
(2,588
)
 
(2,171
)
Net cash used in financing activities
(209,238
)
 
(33,326
)
Net (decrease) increase in cash and cash equivalents
(16,391
)
 
76,574

Cash and cash equivalents at beginning of the period
274,305

 
228,705

Cash and cash equivalents at end of the period
$
257,914

 
$
305,279

Supplemental data for cash flow information:
 
 
 
Cash paid for taxes
$
3,565

 
$
4,611

Cash paid for interest
$
50,892

 
$
58,319

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

 
$
—



10

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
 
Cost of services
 
Research & development
 
Selling, general & administrative
 
Intangible asset impairment charges
 
Operating Income / Adjusted EBITDA
GAAP
$
153,741

 
$
31,085

 
$
5,559

 
$
16,274

 
$
31,307

 
$
319,246

 
$
(249,730
)
Purchase accounting adjustments related to CBR deferred revenue
1,376

 
—

 
—

 
—

 
—

 
—

 
 
Depreciation and intangible asset amortization
—

 
(23,706
)
 
(395
)
 
(29
)
 
(4,845
)
 
—

 
 
Non-cash inventory step-up adjustments
—

 
(300
)
 
—

 
(103
)
 
—

 
—

 
 
Stock-based compensation
—

 
(430
)
 
(135
)
 
(799
)
 
(5,024
)
 
—

 
 
Adjustments to contingent consideration
—

 
—

 
—

 
—

 
49,929

 
—

 
 
Impairment charges of intangible assets
—

 
—

 
—

 
—

 
—

 
(319,246
)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Non-GAAP Adjusted
$
155,117

 
$
6,649

 
$
5,029

 
$
15,343

 
$
71,367

 
$
—

 
$
56,729



AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended September 30, 2016
(Unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Cost of services
 
Research & development
 
Selling, general & administrative
 
Intangible asset impairment charges
 
Operating Income / Adjusted EBITDA
GAAP
$
143,782

 
$
25,706

 
$
4,984

 
$
17,116

 
$
57,216

 
$
—

 
$
38,760

Purchase accounting adjustments related to CBR deferred revenue
1,985

 
—

 
—

 
—

 
—

 
—

 
 
Depreciation and intangible asset amortization
—

 
(19,223
)
 
(359
)
 
(43
)
 
(5,047
)
 
—

 
 
Non-cash inventory step-up adjustments
—

 
(1,573
)
 
—

 
—

 
—

 
—

 
 
Stock-based compensation
—

 
(118
)
 
—

 
(858
)
 
(4,492
)
 
—

 
 
Adjustments to contingent consideration
—

 
—

 
—

 
—

 
(3,708
)
 
—

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Non-GAAP Adjusted
$
145,767

 
$
4,792

 
$
4,625

 
$
16,215

 
$
43,969

 
$
—

 
$
76,166



11

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
 
Cost of services
 
Research & development
 
Acquired in-process research and development
 
Selling, general & administrative
 
Intangible asset impairment charges
 
Operating Income / Adjusted EBITDA
GAAP
$
451,608

 
$
90,761

 
$
16,130

 
$
63,021

 
$
65,845

 
$
182,719

 
$
319,246

 
$
(286,114
)
Purchase accounting adjustments related to CBR deferred revenue
4,106

 
—

 
—

 
—

 
—

 
—

 
—

 
 
Depreciation and intangible asset amortization
—

 
(69,700
)
 
(1,178
)
 
(118
)
 
—

 
(16,613
)
 
—

 
 
Non-cash inventory step-up adjustments
—

 
(1,228
)
 
—

 
(103
)
 
—

 
—

 
—

 
 
Stock-based compensation
—

 
(689
)
 
(202
)
 
(2,651
)
 
—

 
(14,517
)
 
—

 
 
Adjustments to contingent consideration
—

 
—

 
—

 
—

 
—

 
47,142

 
—

 
 
Impairment charges of intangible assets
—

 
—

 
—

 
—

 
—

 
—

 
(319,246
)
 
 
Transaction/Acquisition-related costs
—

 
—

 
—

 
—

 
—

 
(1,462
)
 
—

 
 
Acquired IPR&D
—

 
—

 
—

 
—

 
(65,845
)
 
—

 
—

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Non-GAAP Adjusted
$
455,714

 
$
19,144

 
$
14,750

 
$
60,149

 
$
—

 
$
197,269

 
$
—

 
$
164,402



AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Nine Months Ended September 30, 2016
(Unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Cost of services
 
Research & development
 
Selling, general & administrative
 
Intangible asset impairment charges
 
Restructuring
 
Operating Income / Adjusted EBITDA
GAAP
$
380,500

 
$
65,942

 
$
15,705

 
$
45,579

 
$
172,314

 
$
15,963

 
$
712

 
$
64,285

Purchase accounting adjustments related to CBR deferred revenue
15,600

 
—

 
—

 
—

 
—

 
—

 
—

 
 
Depreciation and intangible asset amortization
—

 
(48,909
)
 
(1,063
)
 
(98
)
 
(15,034
)
 
—

 
—

 
 
Non-cash inventory step-up adjustments
—

 
(3,856
)
 
—

 
(861
)
 
—

 
—

 
—

 
 
Stock-based compensation
—

 
(386
)
 
(9
)
 
(2,582
)
 
(13,831
)
 
—

 
—

 
 
Adjustments to contingent consideration
—

 
—

 
—

 
—

 
(5,106
)
 
—

 
—

 
 
Impairment charges of intangible assets
—

 
—

 
—

 
—

 
—

 
(15,963
)
 
—

 
 
Restructuring costs
—

 
—

 
—

 
—

 
—

 
—

 
(712
)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Non-GAAP Adjusted
$
396,100

 
$
12,791

 
$
14,633

 
$
42,038

 
$
138,343

 
$
—

 
$
—

 
$
188,295



12

AMAG Pharmaceuticals, Inc.
Reconciliation of 2017 Financial Guidance of Non-GAAP Adjusted EBITDA
(Unaudited, amounts in millions)

 
2017
 
Previous
 
Updated
 
Financial Guidance
 
Financial Guidance
GAAP Net Loss
($62) - ($31)

 
($235) - ($220)

Adjustments:
 
 
 
Interest expense, net
66

 
68

Loss on debt extinguishment
10

 
10

Provision for income tax benefit
(37) - (18)

 
(162) - (157)

Operating income (loss)
($23) - $27

 
($319) - ($299)

Purchase accounting adjustments related to CBR deferred revenue
6

 
6

Depreciation and intangible asset amortization
127

 
155

Non-cash inventory step-up adjustments
2

 
2

Stock-based compensation
27

 
27

Adjustments to contingent consideration
5

 
(46
)
Impairment of intangible assets
—

 
319

Acquired IPR&D5
66

 
66

Non-GAAP adjusted EBITDA
$210 - $260

 
$210 - $230


5 Reflects accounting charges associated with one-time upfront payments to Palatin and Endoceutics as required under the terms of the licensing agreements.



13

AMAG Pharmaceuticals, Inc.
Share Count Reconciliation
(Unaudited, amounts in millions)
 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
 
 
2017
 
2016
 
2017
 
2016
 
Weighted average basic shares outstanding
 
35.3

 
34.2

 
34.9

 
34.4

 
Employee equity incentive awards
 
—

6 
0.5


—

6 
0.4


Convertible notes
 
—

6 
7.4


—

6 
—

6 
GAAP diluted shares outstanding
 
35.3

 
42.1

 
34.9

 
34.8

 
Employee equity incentive awards
 
0.2

7 
—


0.3

7 
—

 
Effect of bond hedge and warrants
 
—

 
(7.4
)
8 
—

 
—

 
Non-GAAP diluted shares outstanding
 
35.5

 
34.7

 
35.2

 
34.8

 

6 Employee equity incentive awards and convertible notes would be anti-dilutive in this period.
7 Reflects the non-GAAP dilutive impact of employee equity incentive awards.
8 Reflects the impact of the non-GAAP benefit of the bond hedge and warrants.


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


14
AMAG Pharmaceuticals Q3-2017 Financial Results & Corporate Update November 2, 2017 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, beliefs regarding the Makena market opportunity and Makena’s position in the market; future growth drivers for Makena, including its ability to continue to gain share from compounders, grow the Makena @Home administration, expand use in the late preterm birth segment, prepare to launch the Makena subcutaneous auto-injector and prepare for potential competitive threat; growth drivers for Cord Blood Registry (CBR), including plans to differentiate CBR’s offerings, build value proposition on storing newborn stem cells and leverage advancements in stem cell research; growth drivers for Feraheme, including continued growth in key segments, completion of recent group purchasing organization (GPO) sales, optimizing net revenue per gram, and expectations that the size of the addressable market, if the broader indication is approved, would double and would require minimal sales force expansion; expectations regarding the commercial opportunity and revenue potential of Intrarosa, including the number of women who suffer from dyspareunia in the U.S.; Intrarosa launch priorities, including affordable access for patients and increased market awareness and physician prescribing; AMAG’s unrestricted commercial coverage goal of 65% by year end; beliefs that Intrarosa prescriptions will increase as healthcare professionals gain clinical experience; AMAG’s 2017 updated financial guidance, including forecasted GAAP and non-GAAP revenues, GAAP net income and operating income, and non-GAAP adjusted EBITDA; beliefs that AMAG’s strong cash and investments balance and positive EBITDA generation support investments in its’ portfolio development; expectations regarding regulatory timelines for Intrarosa, authorized generic readiness for the Makena intramuscular formulation, the Makena subcutaneous auto-injector, the Feraheme broader label, bremelanotide and Velo, including anticipated FDA actions and commercial launches for each product, as applicable; and AMAG’s key priorities related to its products and product candidates, portfolio expansion and financial goals; 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, those risks identified in AMAG’s Securities and Exchange Commission (“SEC”) filings, including its Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent filings with the SEC. 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 Pharmaceuticals IP, Ltd. Cord Blood Registry® and CBR® are registered trademarks of Cbr Systems, Inc. Intrarosa® is a trademark of Endoceutics, Inc. 2

 
Q3-2017 Earnings Call Agenda Q3-2017 Highlights and Recent Events 1 5 Q&A 2 Product Portfolio Commercial Overview 4 Key Priorities and Closing Remarks 3 Financial Results and Guidance Update 3

 
Bill Heiden President & CEO Q3-2017 Highlights and Recent Events 4

 
AMAG’s Expanding Portfolio of Products Feraheme  Treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD)  The only FDA-approved therapy to reduce recurrent preterm birth in certain at-risk women  World’s largest umbilical cord stem cell collection and storage company  Candidate for the treatment of severe preeclampsia  An investigational product for the on- demand treatment of hypoactive sexual desire disorder (HSDD) MuGard  Management of oral mucositis, a common side effect of radiation or chemotherapy Maternal and Women’s Health Hematology / Oncology Pregnancy & Birth Wellness Post-Menopausal Health Makena Velo Option Cord Blood Registry Bremelanotide Intrarosa  FDA-approved locally administered non- estrogen1 product to treat moderate to severe dyspareunia (pain during sex), a symptom of VVA, due to menopause, which does not carry a boxed warning in its label 5 1 Intrarosa is converted by enzymes in the body into androgens and estrogens, though the mechanism of action is not fully established.

 
Q3 Highlights and Recent Events Intrarosa  Launched the first and only FDA- approved locally administered non- estrogen product for dyspareunia on July 24  Phase 3 study initiated to assess the effectiveness of Intrarosa for HSDD (hypoactive sexual desire disorder) in post-menopausal women Bremelanotide  Held productive pre-NDA meeting with FDA  Expect to submit NDA for bremelanotide in Q1-2018 for HSDD for pre-menopausal women 6 Women’s Health Maternal Health Makena  Achieved Makena market share of greater than 50% CBR  Reached 700,000 cord blood and cord tissue units stored  CBR held its first ever Facebook live event generating >200,000 views

 
Q3 Highlights and Recent Events Cont. Feraheme  Received FDA acceptance for review of Feraheme submission to broaden the current label to include the treatment of all adults with IDA with February 2, 2018 PDUFA date  Feraheme abstracts selected for: – Nov. 3 podium presentation at ASN (Phase 3 hypophosphatemia data) – Dec. 11 poster presentation at ASH (Phase 3 safety and efficacy data) 7 Hematology Financial  Grew GAAP revenue – 19% increase YTD-2017 compared with YTD-2016 – 7% increase in Q3-2017 compared with Q3-2016  Further delevered by ~$45M – $20M of convertible senior notes due in 2019 repurchased in Sept. 2017 – $25M of 7.785% Senior Notes due in 2023 repurchased in Oct. 2017  Ended Q3-2017 with ~$394M of cash and investments

 
Product Portfolio Commercial Overview Nik Grund Chief Commercial Officer 8

 
Makena: Continued Growth $93.4 $97.6 Q3-2016 Q3-2017 Makena Revenue ($M) M A T E R N A L H E A L T H : M A K E N A +5% 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 Based on 140,000 patients, >16 injections/patient and net revenue of ~$425-$450/injection. 3 Off guidance represents patients treated outside guidance of Society for Maternal Fetal Medicine, including patients treated with unapproved therapies and untreated patients. Off Guidance3 30% September 30, 2017 Makena 50% Compounded Hydroxyprogesterone Caproate 20% $1B Market Opportunity2 Estimated Makena Market Share up 3 percentage points over Q2-20171 9

 
Inventory Weeks on Hand 2.6 2.9 2.4 est. 2.6 Makena: Increasing Underlying Demand1 M A T E R N A L H E A L T H : M A K E N A Makena Ex-factory Doses Makena Demand Doses 0 50 100 150 200 250 Q1-2017 Q2-2017 Q3-2017 Q4-2017 guidance (thousands) 1 Based on actual dispensing (shipments to physician/hospital/patients) data (doses) from the company’s distributor network. Q3 Revenue Impacts  Storm impact depressing dose per patient and slowing new enrollments  Timing of July 4th holiday drove up end of Q2 inventory  No increase in dose per patient and lower than expected share gains 10

 
M A T E R N A L H E A L T H : M A K E N A Makena Growth Drivers 1 If regulatory approval is received. Continue share gains from compounders and grow Makena @Home administration 2 Expand use in late preterm birth segment 3 Prepare for potential competitive threat in 2018 4 Prepare for Q1-2018 launch of sub-q auto- injector1 1 11

 
CBR: Attractive Recurring Revenue Stream 12 Differentiate CBR’s offerings – Grew first time enrollments, the most profitable segment – Held first ever CBR Facebook live event 1 Build value proposition on storing newborn stem cells – Harmonizing annual storage price – Stabilized new enrollment pricing 2 Leverage advancements in stem cell research with OB/GYN’s and pregnant families 3 CBR 2017 Growth Drivers $28.0 $29.4 Q3-2016 Q3-2017 GAAP CBR Revenue ($M) $30.0 $30.8 Q3-2016 Q3-2017 Non-GAAP CBR Revenue1 ($M) 1 Non-GAAP CBR revenue includes purchase accounting adjustments related to CBR deferred revenue of $2.0M and $1.4M for Q3-2016 and Q3-2017, respectively.

 
Solid Financial Performance; Expected Future Growth $22.3 $26.1 Q3-2016 Q3-2017 Feraheme Revenue1 ($M) 17% H E M A T O L O G Y / O N C O L O G Y : F E R A H E M E 2017 Growth Drivers  Continued growth in key segments  Pull through recent GPO access wins  Optimize net revenue per gram  Prepare for expanded label to include all IDA patients2 – PDUFA date: February 2, 2018 – Would double addressable market, if approved3 – Minimal expansion required from current commercial footprint 1 Represents Feraheme revenues only. Excludes MuGard revenues as reported on financial statements. 2 If regulatory approval is received for expansion of the label to include all IDA patients who have an intolerance or unsatisfactory response to oral iron. 3 AMAG estimates market opportunity using ~$600/gram and 1.3M grams (Q2-2017 IMS data annualized). 13

 
4.5M Total U.S. Patients Diagnosed with Iron Deficiency Anemia4 Diagnosed IDA Patients  Under the care of other physician specialists, including 1.5M in women’s health H E M A T O L O G Y / O N C O L O G Y : F E R A H E M E 14 1 If regulatory approval is received for broader IDA indication. 2 AMAG estimates market opportunity using ~$600/gram and 1.3M grams (Q3-2017 IMS data annualized). 3 AMAG estimates current market using IMS data and internal analytics. 4 Global Intravenous (I.V.) Iron Drugs Market Report: 2015 Edition. Feraheme 25%3 Other IV irons 75%3 Label expansion doubles addressable IV iron market1 Large IV Iron Market of $780M1,2 Current Addressable IV Iron Market: $390M3 Additional Addressable Estimated IV Iron Market: $390M ‒ Iron deficiency anemia caused by other diseases – Iron deficiency anemia caused by CKD

 
Intrarosa Update 15

 
16 Intrarosa: Two Key Differentiators W O M E N ’ S H E A L T H : I N T R A R O S A Non-Estrogen1 with No Boxed Warning Differentiated Mechanism of Action 1 Intrarosa is converted by enzymes in the body into androgens and estrogens, though the mechanism of action is not fully established. ® DHEA levels decrease with age

 
Affected, but not currently seeking treatment Utilizing OTC treatments Dyspareunia: Sizable Untapped Treatment Market Currently on Rx estrogen therapy Local (intra-vaginal) estrogen therapies = sales of >$1B per year2 1.7M women3 ~6M women3 ~12M women3 W O M E N ’ S H E A L T H : I N T R A R O S A ~20M women in U.S. suffer from dyspareunia, a symptom of VVA1 New potential patients represent a market opportunity of ~$14B/year4 17 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 Based on IMS SMART Tool NSP and NPA data for total VVA prescriptions. 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 Company estimated based on IMS SMART Tool NSP and NPA data. 2017 Focus

 
Intrarosa Early Launch Priorities 18 W O M E N ’ S H E A L T H : I N T R A R O S A 1. Create affordable access for patients  Increase in percent of covered lives 2. Increase market awareness  Number of first time prescribers 3. Increase HCP prescribing  Market share  Number of HCPs prescribing  NRx and TRx (growth) Focused on HCP experience and patient access to treatment

 
Intrarosa Launched July 24, 2017 19  Launched speakers program with >160 meetings scheduled in Q4-2017  Samples being distributed to HCP offices to facilitate new patient starts  Broad and affordable patient access from launch – 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) – Growing commercial insurance coverage W O M E N ’ S H E A L T H : I N T R A R O S A

 
62% 14% 24% 49% 23% 2% 26% Launch Priority 1: Tracking to 65% Year End Goal W O M E N ’ S H E A L T H : I N T R A R O S A 1 IMS FIA data, last 24 months, July 2017. 2 Market research sponsored by AMAG and conducted by Insight Strategy Advisors. 3 MMIT data as of 7/24/17, 9/30/17 and 10/31/17. 20 Commercial Lives Covered3 At Launch At September 30 Today  Approximately 2/3 of prescriptions for VVA are commercial pay1  Top 18 accounts represent >85% of covered lives2  Commercial copay savings card widely available Not covered Covered (unrestricted) Covered (PA/ST) Preferred 39% 38% 2% 21%

 
Ensuring Success: Increase Market Awareness 70% 18% 4% 4% 4% OB/GYN Nurse Practitioner Physicians Asst. Family and Internal Medicine Other 21 W O M E N ’ S H E A L T H : I N T R A R O S A 1,963 Total HCPs Have Prescribed Intrarosa to date1 88% of Prescribing HCPs are OB/GYNs and NPs  HCPs continue to be exposed to Intrarosa with sales force objective to drive expanded trial and clinical experience – 19,000 HCPs have been visited by an Intrarosa sales rep at least once 1 Based on IMS data.

 
• Attendance of ~700 (largest since conference began 20 years ago) • Maternal and women’s healthcare topics presented by nationally recognized speakers/experts Oct. 11-14, Seattle, WA NAMS 2017 Annual Meeting Planning Meeting October 6, 2017 Confidential - For Internal Use Only. Do Not Distribute. NAMS Annual Meeting Oct. 11-13, Philadelphia, PA • Intrarosa Booth ‒ High engagement during all exhibit sessions • Product Theater ‒ 250+ attendees • Intrarosa featured prominently in other independent podium sessions • Panay: Treating VVA/GSM with lubricants, moisturizers and vaginal DHEA • Pinkerton: NAMS 2017 position statement on hormone therapy. • WISDOM survey report Recent Intrarosa Events W O M E N ’ S H E A L T H : I N T R A R O S A 22

 
Ensuring Success: Increase HCP Prescribing W O M E N ’ S H E A L T H : I N T R A R O S A Vagifem/Yuva fem [VALUE] Estrace [VALUE] Premarin [VALUE] Estring [VALUE] Osphena [VALUE] Intrarosa [VALUE] Overall Market Share1 (Week ending 10/13/17) Product Market Share of Intrarosa Prescribers1 (Since 7/24/17) Intrarosa at overall 1% share, but amongst early adopters has achieved an 8% share [CATEG ORY NAME] [VALUE] Estrace, 32% Premari n, 20% [CATEG ORY NAME] [VALUE] [CATEG ORY NAME] [VALUE] [CATEG ORY NAME] [VALUE] 23 1 Based on IMS data.

 
Performance vs. Previous Osphena® Launch 24 W O M E N ’ S H E A L T H : I N T R A R O S A Aggregate TRx totals in first 13 weeks of launch – Intrarosa vs. Osphena1 TRx Intrarosa Osphena - 1,000 2,000 3,000 4,000 5,000 6,000 7,000 1 2 3 4 5 6 7 8 9 10 11 12 13 Week # 1 Based on IMS data for the first 13 weeks of the respective launches.

 
Affected, but not currently seeking treatment Utilizing OTC treatments Dyspareunia: Sizable Untapped Treatment Market Currently on Rx estrogen therapy Local (intra-vaginal) estrogen therapies = sales of >$1B per year2 1.7M women3 ~6M women3 ~12M women3 W O M E N ’ S H E A L T H : I N T R A R O S A ~20M women in U.S. suffer from dyspareunia, a symptom of VVA1 New potential patients represent a market opportunity of ~$14B/year4 25 2017 Focus 201 8 A d d itio n al E ff o rt s 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 Based on IMS SMART Tool NSP and NPA data for total VVA prescriptions. 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 Company estimated based on IMS SMART Tool NSP and NPA data.

 
 Only FDA-approved non-estrogen1 locally administered product for moderate to severe dyspareunia due to menopause – Only product without a boxed warning  Differentiated mechanism of action  Significant market opportunity with sizeable revenue potential  Only 13 weeks into launch, significant progress in: – Creating immediate patient access – Accelerating awareness – Initiating physician and patient experience Intrarosa: In Summary W O M E N ’ S H E A L T H : I N T R A R O S A 1 Intrarosa is converted by enzymes in the body into androgens and estrogens, though the mechanism of action is not fully established. 26

 
Financial Results and Guidance Update Ted Myles Chief Financial Officer 27

 
$143.71 $153.7 ($249.7) $38.8 $380.21 $451.61 $64.3 ($286.1) Q3-2016 Q3-2017 Makena revenue CBR revenue Feraheme/MuGard revenue GAAP Operating income (loss) 7% YTD-2016 YTD-2017 19% 3-months Ended September 30 9-months Ended September 30 1 Excludes $40,000 in Q3-2016, $313,000 YTD-2016 and $53,000 YTD-2017 of “License fee, collaboration and other revenues”. Continued Product Revenue Growth and Portfolio Investments 28 Intrarosa revenue GAAP Financials ($M)

 
Continued Product Revenue Growth and Portfolio Investments $395.81 $188.3 $455.71 $164.4 YTD 2016 YTD 2017 15% $145.71 $76.2 $155.1 $56.7 Q3-2016 Q3-2017 6% 1 See slide 37 for a reconciliation of GAAP to non-GAAP financial results. 2 Excludes license fee, collaboration and other revenues of $40,000 in Q3-2016, $313,000 YTD-2016 and $53,000 YTD-2017. 3 Includes purchase accounting adjustments related to CBR deferred revenue of $1.4M in Q3-2017, $2.0M in Q3-2016, $4.1M YTD-2017 and $15.6M YTD-2016. 29 3-months Ended September 30 9-months Ended September 30 Non-GAAP Financials1 ($M) Makena revenue CBR revenue3 Feraheme/MuGard revenue GAAP Operating income (loss) Intrarosa revenue

 
Updated 2017 Financial Guidance 30 ($M) 2017 GAAP Guidance 2017 Non-GAAP Guidance1 Previous Updated Previous Updated Makena sales $410 - $440 $385 - $395 $410 - $440 $385 - $395 Feraheme/MuGard sales $100 - $110 No change $100 - $110 No change CBR service revenue $110 - $120 No change $115 - $1252 No change Intrarosa sales $5 - $15 $1 - $3 $5 - $15 $1 - $3 Total revenue $625 - $685 $596 - $628 $630 - $690 $601 - $633 Net loss ($62) - ($31) ($235) – ($220) N/A N/A Operating income (loss) ($23) - $27 ($319) – ($299) N/A N/A Adjusted EBITDA N/A N/A $210 - $260 $210 - $230 1 See slide 38 for a reconciliation of 2017 financial guidance. 2 Revenue includes purchase accounting adjustments related to CBR deferred revenue.

 
 Longer term debt maturities that better align with business strategy  Strong cash and investments balance of $394M and positive EBITDA generation support investments in: – Next generation products in current portfolio – Advancement of new product portfolio (Intrarosa and bremelanotide) – Expansion of portfolio through business development Financial Results and Improved Balance Sheet Support Evolving Business Model 31

 
Key Priorities & Closing Remarks Bill Heiden President & CEO 32

 
AMAG Portfolio: Multiple Value Drivers Milestone 2017 2018 2019 INTRAROSA Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Commercial launch in dyspareunia Initiate Phase 3 HSDD study Initiate digital consumer campaign MAKENA INTRAMUSCULAR FORMULATION Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Authorized generic readiness MAKENA SUBCUTANEOUS AUTO-INJECTOR Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Topline PK data sNDA submission Expected FDA action and launch FERAHEME IDA LABEL EXPANSION Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Topline data Regulatory submission Expected FDA action and launch BREMELANOTIDE Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 NDA submission FDA advisory committee meeting Expected FDA action and launch VELO – SEVERE PREECLAMPSIA Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Initiate Phase 2b/3a study        33

 
Key Priorities Intrarosa  Drive successful launch ‒ Continue to increase the number of commercial covered lives ≥65% ‒ Expand number of prescribing physicians/nurses ‒ NRx and TRx (growth) Makena  Increase patient market share and adherence to therapy  Prepare for Q1-2018 launch of sub-q auto-injector1  Prepare for potential 2018 competitive threat CBR  Continue to grow new enrollments Feraheme  Hold/increase market share and grow market  Prepare for launch of broader IDA (all causes) label in 1H-20181 Bremelanotide  Conclude all work in preparation for Q1-2018 NDA filing Portfolio Expansion  Expand and diversify product portfolio with longer-lived, durable assets through licensing or acquisition transactions Financial  Continue to drive toward non-GAAP revenue of $617M (midpoint of guidance)  Grow adjusted EBITDA to $220M (midpoint of guidance) 1 If regulatory approval is received. 34

 
AMAG Pharmaceuticals Q&A 35

 
Appendix 36

 
Reconciliation of GAAP to Non-GAAP Financial Results ($M) GAAP operating income (loss) Purchase accounting adjustments related to CBR deferred revenue Depreciation and intangible asset amortization Non-cash inventory step-up adjustments Stock-based compensation Adjustments to contingent consideration Restructuring costs Transaction / acquisition related costs Acquired IPR&D Impairment charge of intangible assets Non-GAAP adjusted EBITDA Q3-2017 Q3-2016 YTD-2017 YTD-2016 ($249.7) $38.8 ($286.1) $64.3 1.4 2.0 4.1 15.6 28.9 24.6 87.6 65.1 0.4 1.6 1.3 4.7 6.4 5.5 18.1 16.8 (49.9) 3.7 (47.1) 5.1 -- -- -- 0.7 -- -- 1.5 -- -- -- 65.8 -- 319.2 -- 319.2 16.0 $56.7 $76.2 $164.4 $188.3 37

 
Reconciliation of GAAP to Non-GAAP 2017 Financial Guidance 2017 Financial Guidance ($M) GAAP net loss ($235) – ($220) Adjustments: Interest expense, net 68 Loss on debt extinguishment 10 Provision for income tax benefit (162) – (157) Operating income (loss) ($319) – ($299) Purchase accounting adjustments related to CBR deferred revenue 6 Depreciation & intangible asset amortization 155 Non-cash inventory step-up adjustments 2 Stock-based compensation 27 Adjustments to contingent consideration (46) Intangible asset impairment 319 Acquired IPR&D1 66 Non-GAAP adjusted EBITDA $210 - $230 1 Reflects final transaction accounting treatment for Endoceutics license transaction that closed April 3, 2017. 38

 
Share Count Reconciliation 1 Employee equity incentive awards and convertible notes would be anti-dilutive in this period. 2 Reflects the Non-GAAP dilutive impact of employee equity incentive awards. 3 Reflects the impact of the non-GAAP benefit of the bond hedge and warrants. (M) Q3-2017 Q3-2016 YTD 2017 YTD 2016 Weighted average basic shares outstanding 35.3 34.2 34.9 34.4 Employee equity incentive awards --1 0.5 --1 0.4 Convertible notes --1 7.4 --1 --1 GAAP diluted shares outstanding 35.3 42.1 34.9 34.8 Employee equity incentive awards 0.22 -- 0.32 -- Effect of bond hedge and warrant -- (7.4)3 -- -- Non-GAAP diluted shares outstanding 35.5 34.7 35.2 34.8 39

 
AMAG Pharmaceuticals Q3-2017 Financial Results & Corporate Update November 2, 2017 40

 

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