Document
false0000792977 0000792977 2019-11-01 2019-11-01



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K

CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): November 1, 2019
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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 Street,
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:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each class
 
Trading Symbol(s)
 
Name of each exchange on which registered
Common Stock, par value $0.01 per share
 
AMAG
 
NASDAQ Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company  
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  


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Item 2.02. Results of Operations and Financial Condition.
 
The following information and Exhibit 99.1 and Exhibit 99.2 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
 
On November 1, 2019, AMAG Pharmaceuticals, Inc. (“AMAG”) issued a press release regarding its operating results for the three and nine months ended September 30, 2019 and its intention to hold a conference call to discuss AMAG’s third quarter 2019 financial results, recent business highlights and 2019 outlook. A copy of AMAG’s press release is furnished herewith as Exhibit 99.1 and a copy of the presentation slides to be used during the conference call is furnished herewith as Exhibit 99.2.

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



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: November 1, 2019




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Exhibit
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FOR IMMEDIATE RELEASE

AMAG PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2019 FINANCIAL RESULTS
AND PROVIDES CORPORATE UPDATE
Commercial products achieve strong revenue and market share performance
VyleesiTM (bremelanotide injection) launched nationally in September
Committed to work with the FDA to keep Makena available for at-risk pregnant women
Conference call scheduled for 8:00 a.m. ET today

WALTHAM, MA (November 1, 2019) AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited consolidated financial results for the third quarter ended September 30, 2019 and provided a business update.

“We’re pleased with the strong performance of Feraheme which posted a record quarter of more than $44 million in revenue, and the Makena subcutaneous auto-injector which held market share and generated revenue of more than $41 million despite continued generic competition. As we look toward the remainder of 2019 and beyond, AMAG continues to focus on strong commercial execution and progressing our new drug candidates through clinical development, and we remain on track for adjusted EBITDA neutrality in 2020,” said William Heiden, AMAG president and chief executive officer. “While we are disappointed with the mixed vote of the U.S. Food and Drug Administration's (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC), we are committed to working with the FDA on a path forward that could allow at-risk pregnant women to continue to have access to Makena."

KEY UPDATES
Vyleesi launched nationally in September
Through four weeks post launch, more than 3,000 Vyleesi prescriptions have been written across more than 1,300 prescribing healthcare providers.
Continued strong revenue and market share performance across promoted products
Makena® (hydroxyprogesterone caproate injection) subcutaneous (SC) auto-injector maintained 63% market share of all FDA-approved hydroxyprogesterone caproate prescription volume in the quarter.
Feraheme® (ferumoxytol injection) grew market share to 17.5% in the third quarter.
Intrarosa® (prasterone) average market share of total prescriptions grew to 4.8%.




1


($M)
Three Months Ended September 30,
 
2019
 
2018
 
% Change
Total product revenues, net
$84.1
 
$122.2
 
(31
)%
Feraheme
44.2

 
37.0

 
20
 %
Makena subcutaneous auto-injector
41.3

 
39.2

 
5
 %
Makena intramuscular - branded and generic
(7.0
)
 
41.0

 
N/A

Intrarosa
5.6

 
4.9

 
14
 %
Other

 
0.1

 
-

Operating loss
$(18.0)
 
$(19.3)
 
N/A

Non-GAAP adjusted EBITDA1
$(8.2)
 
$30.0
 
N/A

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

MAKENA FDA ADVISORY COMMITTEE UPDATE
On October 29, 2019, the FDA held an advisory committee meeting to better understand and interpret the PROLONG (Progestin's Role in Optimizing Neonatal Gestation) confirmatory trial for Makena. While the committee discussed multiple questions, on the key question, seven committee members voted to leave the product on the market under accelerated approval and require a new confirmatory trial and nine advisory committee members voted to recommend that the FDA pursue withdrawal of approval for Makena. The approval of Makena was based on the Meis trial, conducted by the National Institute of Child Health and Human Development and the Maternal-Fetal Medicine Units Network and published in the New England Journal of Medicine in 2003. The PROLONG trial was conducted post approval under the FDA's Subpart H accelerated approval process.

Makena’s active ingredient, 17α hydroxyprogesterone caproate (often referred to as 17P), is the only FDA-approved treatment for pregnant women who have had a prior spontaneous preterm birth (which is a substantial risk factor for recurrent preterm birth). 17P has been recognized as the standard of care and used for more than a decade by healthcare providers to treat patients with a history of spontaneous preterm birth, which represents approximately 130,000 births a year in the U.S. The American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal-Fetal Medicine (SMFM) recently (October 25, 2019) reiterated their continued support of the use of Makena for at-risk pregnant women.

The withdrawal of all FDA-approved formulations of hydroxyprogesterone caproate would take away an important, and safe, treatment option for high-risk pregnant women. AMAG firmly believes in the safety and efficacy of Makena and remains committed to working collaboratively with the FDA on a path forward to ensure eligible pregnant women continue to have access to 17P, the only FDA-approved therapy for this orphan condition.

VYLEESI LAUNCH UPDATE
AMAG launched Vyleesi nationally in September with its established women’s health sales force of approximately 125 sales representatives who also support Makena and Intrarosa. In the four weeks since the national launch, more than 1,300 healthcare providers have prescribed Vyleesi, which has resulted in more than 3,000 prescriptions received by our specialty pharmacy partners to date.

The company is working with payers and healthcare professionals to help ensure that women with hypoactive sexual desire disorder (HSDD) have access to Vyleesi. To help women access treatment, AMAG offers a copay assistance program so that eligible patients can obtain their first four-pack of Vyleesi auto-injectors at no cost. Under the current copay program, women who choose to refill their prescriptions can receive a four-pack of Vyleesi for no more than $99.

CIRAPARANTAG UPDATE
The company is planning to conduct a clinical study in healthy volunteers to confirm the lowest effective dose of ciraparantag after reaching peak steady state blood concentrations of certain novel oral anticoagulant (NOAC)

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drugs. This proposed study will utilize an automated coagulometer developed by Perosphere Technologies, an independent company, to measure whole blood clotting time. The coagulometer requires FDA clearance for use in clinical studies through an investigational device exemption (IDE), which Perosphere Technologies will submit once the healthy subject study design is finalized. Over the past several months, Perosphere Technologies has completed additional analytic studies and AMAG continues to work with the FDA on the design of the next clinical study. Following the completion of this study (estimated second half 2020), the company plans to schedule an End of Phase 2 meeting with the FDA to discuss the design of the Phase 3 program evaluating the safety and efficacy of ciraparantag in the target patient population.

2019 FINANCIAL GUIDANCE UPDATE
“We’re tightening our guidance range for the full year of 2019. On a revenue basis, we are lowering the mid-point from $340 million to $325 million; however, we are lowering our expected adjusted EBITDA loss from a mid-point of $80 million to $70 million by continuing to carefully manage expenses and aggressively reprioritizing our spend to optimize the value in our portfolio," said Ted Myles, AMAG’s chief financial officer. "This is evident in our adjusted EBITDA loss trend, which was approximately $50 million in the first half of 2019 and we expect to be less than $20 million in the second half of 2019.”
Mr. Myles continued, “We firmly believe in Makena and are committed to working with the FDA. While these conversations continue, we recognize that the advisory committee vote heightens uncertainty around the durability of Makena revenue. We are prepared for a variety of potential scenarios and continue to look for ways to optimize the value of our portfolio to maximize shareholder value. As we gain more clarity on the path forward with the FDA regarding Makena, we’ll be in a better position to provide formal revenue and earnings guidance for 2020.”   
2019 Financial Guidance
 
 
 
 
($M)
 
Updated
 
Previous
Total revenue
 
$320 - $330
 
$325 - $355
Operating loss
 
($278) - ($268)
 
($286) - ($276)
Adjusted EBITDA2
 
($75) - ($65)
 
($85) - ($75)
2 See reconciliations of 2019 GAAP to non-GAAP financial guidance at conclusion of this press release.

THIRD QUARTER ENDED SEPTEMBER 30
Revenue
The company’s commercial organization drove strong market share and revenue performance across all key marketed products.
Makena SC auto-injector revenue totaled $41.3 million, compared with $39.2 million in the same period last year, which is in-line with the company's quarterly expectation for this product.
The company did not ship any Makena IM product during the third quarter of 2019, therefore the full impact of the change in estimated commercial rebate liabilities from prior period sales appears as negative revenue during the quarter.
Feraheme achieved record quarterly revenue of $44.2 million, an increase of 20% over the same period last year. Feraheme’s average quarterly market share increased to 17.5%, compared with 15.7% in the third quarter last year, and 17.2% in the second quarter of 2019.
Intrarosa revenue in the third quarter of 2019 totaled $5.6 million, compared with $4.9 million in the same period last year. The average quarterly share of total prescriptions grew to 4.8%, compared with 3.8% in the third quarter last year, and 4.3% in the second quarter of 2019.


3


($M)
Three Months Ended September 30,
 
2019
2018
Total product revenues, net
$84.1
$122.2
Feraheme
44.2

37.0

Makena subcutaneous auto-injector
41.3

39.2

Makena intramuscular - branded and generic
(7.0
)
41.0

Intrarosa
5.6

4.9

Other

0.1


Operating Expenses
Cost of products sales (CoPS) in the third quarter of 2019 decreased by $25.4 million, driven by a $26.7 million decrease in amortization expense associated with the Makena IM intangible asset. Non-amortization CoPS as a percent of net revenue increased due to a lower net price for Makena and a shift to products with higher CoPS and royalty burdens.
Research and development (R&D) expenses totaled $15.3 million, compared with $10.1 million in the third quarter of last year. This increase included additional clinical site initiations in Europe for the AMAG-423 development program.
In the third quarter of 2018, the company recorded $12.5 million of acquired in-process R&D (IPR&D) expense in connection with the acquisition of AMAG-423, with no comparable expense in the third quarter of 2019.
Selling, general and administrative (SG&A) expenses totaled $65.7 million in the third quarter of 2019, compared with $72.5 million in the third quarter of 2018. This decrease was primarily related to combining the company's maternal health and women's health sales forces in February 2019, partially offset by increased investment in the launch of Vyleesi.

($M)
Three Months Ended September 30,
 
2019
2018
Amortization of intangible assets
$4.2
$30.9
Direct cost of product sales
16.9

15.6

Total cost of product sales
21.1

46.5

Research and development expenses
15.3

10.1

Acquired in-process research and development

12.5

Selling, general and administrative expenses
65.7

72.5

Total costs and expenses
$102.1
$141.6

Balance Sheet
As of September 30, 2019, the company’s cash and investments totaled $191.5 million.
Long-term debt totaled $320.0 million (representing the principal amounts outstanding of the 2022 convertible notes).

Operating Loss and Adjusted EBITDA
The company reported an operating loss of $18.0 million in the third quarter of 2019, compared with an operating loss of $19.3 million in the same period last year.
The company reported an adjusted EBITDA loss of $8.2 million in the third quarter of 2019, compared with adjusted EBITDA of $30.0 million in the third quarter of last year.
On a sequential basis, the adjusted EBITDA loss improved from $24.4 million in the second quarter of 2019 to $8.2 million, due to revenue growth across the commercial portfolio and lower SG&A expenses in the third quarter.


4


($M)
Three Months Ended September 30,
 
2019
2018
Operating loss
$(18.0)
$(19.3)
Non-GAAP adjusted EBITDA1
$(8.2)
$30.0

3 See reconciliations of GAAP to non-GAAP adjustments at the conclusion of this press release.

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 2019 financial results, recent business highlights and 2019 outlook.

DIAL-IN NUMBER
U.S./Canada Dial-in Number: (877) 412-6083
International Dial-in Number: (702) 495-1202
Conference ID: 6261528

Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 6261528

A telephone replay will be available from approximately 11:00 a.m. ET on November 1, 2019 through midnight on November 8, 2019.

The webcast with slides will be accessible through the Investors section of the company’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, non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization) and non-GAAP diluted shares outstanding. These non-GAAP financial measures exclude certain amounts, expenses or income, from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP). Management believes this non-GAAP information is useful for investors, taken in conjunction with AMAG’s GAAP financial statements, because it provides greater transparency regarding AMAG’s operating performance. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of AMAG’s operating results as reported under GAAP, not as a substitute for GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

ABOUT AMAG
AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas, including women’s health. For additional company information, please visit www.amagpharma.com.

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

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contained herein which do not describe historical facts, including, among others, beliefs about the performance of AMAG’s commercially available products; expectations regarding the effect of realignment of AMAG’s marketing spend in women’s health; expectations for ciraparantag and AMAG-423 studies, including development timelines; plans to work collaboratively with the FDA and expectations that there may be a path forward to ensure eligible patients continue to have access to 17P; plans to ensure that women with HSDD have access to Vyleesi, including at a reasonable cost; updated 2019 guidance, including expectations as to adjusted EBITDA loss for 2019; expectations that AMAG remains on track for adjusted EBITDA neutrality in 2020; and beliefs regarding AMAG's ability to optimize the value of its portfolio to maximize shareholder value 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 FDA will withdraw approval of Makena in line with the recommendation of BRUDAC that approval of 17P be withdrawn; the risk that the FDA could take other adverse action related to Makena given the findings and recommendation of BRUDAC; the risk that AMAG may not be able to generate additional efficacy data that will be satisfactory to the FDA (if the FDA permits AMAG to submit additional data to support or as a condition to the continued commercialization of Makena); the risk that healthcare providers may be reluctant to continue to prescribe the Makena auto-injector or the FDA may require that the Makena label include information on the PROLONG study, restrictions to the current indication or the insertion of new warnings or precautions, as well as those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2018, its Quarterly Report on Form 10-Q for the quarters ended March 31, 2019 and June 30, 2019, and subsequent filings with the SEC (including its upcoming Quarterly Report on Form 10-Q for the quarter ended September 30, 2019), which are available at the SEC’s website at www.sec.gov. Further, investors are encouraged to read those risks identified on slide 3 of AMAG’s presentation attached as Exhibit 99.2 to AMAG’s Current Report on Form 8-K furnished with the SEC on or about the date hereof for risks attendant to AMAG’s long-term outlook, including that it will be adjusted EBITDA neutral in 2020, which assumes that AMAG will be able to continue to commercialize Makena and that approval of the product will not be withdrawn by the FDA, which withdrawal was recommended by BRUDAC at their advisory committee meeting held on October 29, 2019. 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.




- Tables Follow -



6


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,
 
2019
 
2018
 
2019
 
2018
Revenues:
 
 
 
 
 
 
 
Feraheme
$
44,205

 
$
36,963

 
$
126,294

 
$
99,796

Makena
34,272

 
80,221

 
96,464

 
275,377

Intrarosa
5,607

 
4,925

 
14,898

 
10,331

Other product sales
23

 
129

 
156

 
302

Other revenues
24

 

 
231

 
75

Total revenues
84,131

 
122,238

 
238,043

 
385,881

Operating costs and expenses:
 
 
 
 
 
 
 
Cost of product sales
21,105

 
46,489

 
63,871

 
187,176

Research and development expenses
15,330

 
10,133

 
48,377

 
32,635

Acquired in-process research and development

 
12,500

 
74,856

 
32,500

Selling, general and administrative expenses
65,720

 
72,451

 
217,727

 
161,780

Impairment of intangible assets

 

 
77,358

 

Restructuring expenses

 

 
7,420

 

Total costs and expenses
102,155

 
141,573

 
489,609

 
414,091

Operating loss
(18,024
)
 
(19,335
)
 
(251,566
)
 
(28,210
)
 
 
 
 
 
 
 
 
Other income (expense):
 
 
 
 
 
 
 
Interest expense
(6,419
)
 
(13,366
)
 
(19,199
)
 
(45,400
)
Loss on debt extinguishment

 
(35,922
)
 

 
(35,922
)
Interest and dividend income
840

 
1,612

 
3,650

 
3,207

Gains on marketable securities, net
263

 

 
263

 

Other income
(45
)
 
(19
)
 
298

 
(63
)
Total other expense, net
(5,361
)
 
(47,695
)
 
(14,988
)
 
(78,178
)
Loss from continuing operations before income taxes
(23,385
)
 
(67,030
)
 
(266,554
)
 
(106,388
)
Income tax expense (benefit)
232

 
(2,352
)
 
(26
)
 
42,204

Net loss from continuing operations
$
(23,617
)
 
$
(64,678
)
 
$
(266,528
)
 
$
(148,592
)
 
 
 
 
 
 
 
 
Discontinued Operations:
 
 
 
 
 
 
 
Income from discontinued operations
$

 
$
5,838

 
$

 
$
18,873

Gain on sale of CBR business

 
89,581

 

 
89,581

Income tax (benefit) expense

 
(98
)
 

 
3,346

Net income from discontinued operations
$

 
$
95,517

 
$

 
$
105,108

 
 
 
 
 
 
 
 
Net (loss) income
$
(23,617
)
 
$
30,839

 
$
(266,528
)
 
$
(43,484
)
 
 
 
 
 
 
 
 
Basic and diluted net (loss) income per share:
 

 
 

 
 

 
 

Loss from continuing operations
$
(0.70
)
 
$
(1.88
)
 
$
(7.83
)
 
$
(4.33
)
Income from discontinued operations

 
2.77

 

 
3.06

Basic and diluted net (loss) income per share
$
(0.70
)
 
$
0.89

 
$
(7.83
)
 
$
(1.27
)
 
 
 
 
 
 
 
 
Weighted average shares outstanding used to compute net (loss) income per share (basic and diluted)
33,906

 
34,492

 
34,058

 
34,339


7


AMAG Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(Unaudited, amounts in thousands)
 
September 30, 2019
 
December 31, 2018
ASSETS
    
 
    
Current assets:
 

 
 

Cash and cash equivalents
$
119,800

 
$
253,256

Marketable securities
71,744

 
140,915

Accounts receivable, net
77,588

 
75,347

Inventories
28,644

 
26,691

Prepaid and other current assets
43,063

 
18,961

Note receivable

 
10,000

Total current assets
340,839

 
525,170

Property and equipment, net
7,912

 
7,521

Goodwill
422,513

 
422,513

Intangible assets, net
187,577

 
217,033

Operating lease right-of-use asset
6,642

 

Deferred tax assets
630

 
1,260

Restricted cash
495

 
495

Other long-term assets

 
1,467

Total assets
$
966,608

 
$
1,175,459

LIABILITIES AND STOCKHOLDERS’ EQUITY
 

 
 

Current liabilities:
 

 
 

Accounts payable
$
26,554

 
$
14,487

Accrued expenses
172,285

 
129,537

Current portion of convertible notes, net

 
21,276

Current portion of operating lease liability
3,994

 

Current portion of deferred revenue
1,128

 

Current portion of acquisition-related contingent consideration
113

 
144

Total current liabilities
204,074

 
165,444

Long-term liabilities:
 

 
 

Convertible notes, net
273,124

 
261,933

Long-term operating lease liability
3,344

 

Long-term deferred revenue
5,171

 

Long-term acquisition-related contingent consideration
180

 
215

Other long-term liabilities
87

 
1,212

Total liabilities
485,980

 
428,804

Commitments and contingencies
 

 
 

Stockholders’ equity:
 

 
 

Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued

 

Common stock, par value $0.01 per share, 117,500,000 shares authorized; 33,915,509 and 34,606,760 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively
339

 
346

Additional paid-in capital
1,292,458

 
1,292,736

Accumulated other comprehensive loss
(3,199
)
 
(3,985
)
Accumulated deficit
(808,970
)
 
(542,442
)
Total stockholders’ equity
480,628

 
746,655

Total liabilities and stockholders’ equity
$
966,608

 
$
1,175,459


8


AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited, amounts in thousands)
 
Nine Months Ended September 30,
 
2019
 
2018
Cash flows from operating activities:
 
 
 
Net loss
$
(266,528
)
 
$
(43,484
)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
 
 
 
Depreciation and amortization
13,871

 
158,002

Impairment of intangible assets
77,358

 

Provision for bad debt expense
(12
)
 
754

Amortization of premium/discount on purchased securities
(64
)
 
96

Write-down of inventory
4,872

 

Gain on disposal of fixed assets

 
(99
)
Non-cash equity-based compensation expense 
14,381

 
14,599

Non-cash IPR&D expense
18,029

 

Loss on debt extinguishment

 
35,922

Amortization of debt discount and debt issuance costs
11,332

 
11,824

Gains on marketable securities, net
(263
)
 
(1
)
Change in fair value of contingent consideration
(16
)
 
(49,175
)
Deferred income taxes
408

 
43,747

Gain on sale of the CBR business

 
(89,581
)
Transaction costs

 
(14,111
)
Changes in operating assets and liabilities:
 
 
 

Accounts receivable, net
(2,229
)
 
7,175

Inventories
(6,824
)
 
3,587

Prepaid and other current assets
(24,075
)
 
1,101

Accounts payable and accrued expenses
53,092

 
(4,280
)
Deferred revenues
(101
)
 
8,658

Other assets and liabilities
1,038

 
159

Net cash (used in) provided by operating activities
(105,731
)
 
84,893

Cash flows from investing activities:
 

 
 

Proceeds from sales or maturities of marketable securities
85,321

 
60,146

Purchase of marketable securities
(14,815
)
 
(64,400
)
Milestone payment for Vyleesi developed technology
(60,000
)
 

Proceeds from the sale of the CBR business

 
519,303

Capital expenditures
(2,098
)
 
(1,913
)
Net cash provided by investing activities
8,408

 
513,136

Cash flows from financing activities:
 

 
 

Long-term debt principal payments

 
(475,000
)
Payments to settle convertible notes
(21,417
)
 

Payment of premium on debt extinguishment

 
(28,054
)
Payments of contingent consideration
(50
)
 
(87
)
Payments for repurchases of common stock
(13,730
)
 

Proceeds from the issuance of common stock under the ESPP
851

 

Proceeds from the exercise of common stock options
30

 
2,635

Payments of employee tax withholding related to equity-based compensation
(1,817
)
 
(2,632
)
Net cash used in financing activities
(36,133
)
 
(503,138
)
Net (decrease) increase in cash, cash equivalents, and restricted cash
(133,456
)
 
94,891


9


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

 
192,770

Cash, cash equivalents, and restricted cash at end of the period
$
120,295

 
$
287,661

Supplemental data for cash flow information:
 
 
 
Cash paid for taxes
$
456

 
$
5,041

Cash paid for interest
$
5,467

 
$
43,546

Non-cash investing and financing activities:
 
 
 
Settlement of note receivable in connection with Perosphere acquisition
$
10,000

 
$


10


AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended September 30, 2019
(Unaudited, amounts in thousands)

 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Acquired IPR&D
 
Operating Loss / Adjusted EBITDA
GAAP
$
84,131

 
$
21,105

 
$
15,330

 
$
65,720

 
$

 
$
(18,024
)
Depreciation and intangible asset amortization

 
(4,212
)
 
(126
)
 
(445
)
 

 
 
Stock-based compensation

 
(225
)
 
(691
)
 
(4,058
)
 

 
 
Non-GAAP Adjusted
$
84,131

 
$
16,668

 
$
14,513

 
$
61,217

 
$

 
$
(8,267
)








AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended September 30, 2018
(Unaudited, amounts in thousands)

 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Acquired IPR&D
 
Operating Loss / Adjusted EBITDA
GAAP
$
122,238

 
$
46,489

 
$
10,133

 
$
72,451

 
$
12,500

 
$
(19,335
)
Depreciation and intangible asset amortization

 
(30,945
)
 
(6
)
 
(456
)
 

 
 
Non-cash inventory step-up adjustments

 
(412
)
 

 

 

 
 
Stock-based compensation

 
(281
)
 
(568
)
 
(4,202
)
 

 
 
Adjustments to contingent consideration

 

 

 
(9
)
 

 
 
Acquired IPR&D

 

 

 

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

 
$
14,851

 
$
9,559

 
$
67,784

 
$

 
$
30,044



11


AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Nine Months Ended September 30, 2019
(Unaudited, amounts in thousands)

 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Acquired IPR&D
 
Restructuring
 
Intangible asset impairment charge
 
Operating Loss / Adjusted EBITDA
GAAP
$
238,043

 
$
63,871

 
$
48,377

 
$
217,727

 
$
74,856

 
$
7,420

 
$
77,358

 
$
(251,566
)
Depreciation and intangible asset amortization

 
(12,097
)
 
(471
)
 
(1,304
)
 

 

 

 
 
Stock-based compensation

 
(626
)
 
(2,051
)
 
(11,039
)
 

 

 

 
 
Acquisition-related costs

 

 

 
(270
)
 

 

 

 
 
Acquired IPR&D

 

 

 

 
(74,856
)
 

 

 
 
Restructuring

 

 

 

 

 
(7,420
)
 

 
 
Asset impairment charges

 
(4,836
)


 

 

 

 
(77,358
)
 
 
Non-GAAP Adjusted
$
238,043

 
$
46,312

 
$
45,855

 
$
205,114

 
$

 
$

 
$

 
$
(59,238
)







AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Nine Months Ended September 30, 2018
(Unaudited, amounts in thousands)

 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Acquired IPR&D
 
Operating Loss / Adjusted EBITDA
GAAP
$
385,881

 
$
187,176

 
$
32,635

 
$
161,780

 
$
32,500

 
$
(28,210
)
Depreciation and intangible asset amortization

 
(144,732
)
 
(12
)
 
(1,220
)
 

 
 
Non-cash inventory step-up adjustments

 
(3,602
)
 

 

 

 
 
Stock-based compensation

 
(588
)
 
(1,896
)
 
(12,149
)
 

 
 
Adjustments to contingent consideration

 

 

 
49,175

 

 
 
Acquired IPR&D

 

 

 

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

 
$
38,254

 
$
30,727

 
$
197,586

 
$

 
$
119,314





12


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

 
Updated 2019 Financial Guidance
Previous 2019 Financial Guidance
Operating loss
($278) - ($268)
($286) - ($276)
Depreciation & intangible asset amortization
20
18
Stock-based compensation
19
19
Acquired IPR&D
75
75
Restructuring
7
7
Asset impairment charges
82
82
Non-GAAP adjusted EBITDA
($75) - ($65)
($85) - ($75)





AMAG Pharmaceuticals, Inc.
Share Count Reconciliation
(Unaudited, amounts in millions)

 
 
Three Months Ended September 30,
 
Nine Months Ended September 30,
 
 
 
2019
 
2018
 
2019
 
2018
 
Weighted avg. basic and diluted shares outstanding
 
33.9

 
34.5

 
34.1

 
34.3

 
Employee equity incentive awards
 

4 
0.5

5 

4 
0.3

5 
Non-GAAP diluted shares outstanding
 
33.9

 
35.0

 
34.1

 
34.6

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


CONTACT:
AMAG Pharmaceuticals
Linda Lennox
908-627-3424


13
q32019ex992
AMAG Pharmaceuticals Third Quarter 2019 Financial Results November 1, 2019 © 2019 AMAG Pharmaceuticals, Inc. All© rights 2019 reservedAMAG Pharmaceuticals, Inc. All rights reserved 1


 
Forward-Looking Statements This presentation contains forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, AMAG’s expectations for its product and product candidate portfolio, including the anticipated regulatory and clinical trial timelines for AMAG’s product candidates, including ciraparantag and AMAG-423; beliefs about novel pipeline assets being the future value drivers of the company; AMAG’s beliefs regarding the market share and further commercial opportunity for Feraheme; beliefs about Intrarosa’s market share and commercial opportunity; AMAG’s beliefs regarding the continued viability of AMAG’s commercialized products, including the Makena SC auto-injector, and the continued viability of the Makena platform; beliefs that AMAG will be able to work collaboratively with the FDA and expectations that there may be a path forward for Makena; beliefs regarding the effect of AMAG’s withdrawal of the intramuscular Makena product from the market; beliefs regarding the effect of generic competitors to the intramuscular Makena product; beliefs regarding the effect of challenges with third-party manufacturers of the intramuscular Makena product; AMAG’s beliefs regarding physician support of the Makena auto-injector; characterizations of and beliefs about study and market data for AMAG’s products and product candidates; AMAG’s beliefs regarding the market share and commercial opportunity for Vyleesi; AMAG’s expectations regarding the efficacy of its direct-to-consumer campaign and Early Experience initiative for Vyleesi; AMAG’s expectations regarding the efficacy of its salesforce promotion for Vyleesi; AMAG’s beliefs regarding the clinical development timeline for ciraparantag, including the timing of AMAG’s planned Phase 3a clinical trial; beliefs about the revenues driven by the continued commercialization of Makena, Feraheme, Intrarosa and Vyleesi; beliefs about the effect of the Vyleesi commercial launch on revenues; AMAG’s accomplishments and third quarter financial results, including the market share captured by AMAG’s products and such products’ performance; AMAG’s 2019 goals, 2019 financial guidance, including forecasted GAAP operating loss and non-GAAP adjusted EBITDA, and key inputs and drivers thereof; beliefs about AMAG’s balance sheet 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 FDA will withdraw approval of Makena in line with the recommendation of BRUDAC that approval of 17P be withdrawn; the risk that the FDA could take other adverse action related to Makena given the findings and recommendation of BRUDAC; the risk that AMAG may not be able to generate additional efficacy data that will be satisfactory to the FDA (if the FDA permits AMAG to submit additional data to support or as a condition to the continued commercialization of Makena); the risk that healthcare providers may be reluctant to continue to prescribe the Makena auto-injector or the FDA may require that the Makena label include information on the PROLONG study, restrictions to the current indication or the insertion of new warnings or precautions; and those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10‐K for the year ended December 31, 2018 and subsequent filings with the SEC, which are available at the SEC’s website at www.sec.gov. Any such risks and uncertainties could materially and adversely affect AMAG’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG’s stock price. AMAG cautions you not to place undue reliance on any forward‐looking statements, which speak only as of the date they are made. AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward‐looking statements. AMAG Pharmaceuticals®, the logo and designs, and "Feraheme® are registered trademarks of AMAG Pharmaceuticals, Inc. VyleesiTM is a trademark of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc. Other trademarks referenced in this report are the property of their respective owners. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 2


 
Cautionary Disclosure Regarding AMAG’s Long-term Outlook AMAG has made forward looking estimates of its long-term outlook, including that it will be adjusted EBITDA neutral by 2020. AMAG’s growth trajectory and expectations for adjusted EBITDA on a multi-year timeframe are based on a strategy of maximizing commercial product opportunities to fund investments in new products, with various assumptions, including certain assumptions about the progression and approval of AMAG’s product candidates and the continued viability of AMAG’s commercialized products, including the Makena SC auto-injector. In addition to the risk factors and forward-looking statements disclosed above, these estimates involve risks and uncertainties related to: (i) the success of AMAG’s development pipeline; (ii) an increased focus on durable assets; (iii) ongoing efforts to leverage clinical development capabilities against later-stage, lower-risk development opportunities which are themselves subject to considerable risk; (iv) the cash-flows required to the fund AMAG’s evolving business model, including its development efforts; (v) the uncertain and highly speculative commercial potential of therapeutic areas of interest; (vi) external pricing / reimbursement and (vii) the continued viability of the Makena platform. The purpose of this adjusted EBITDA estimate is not to provide financial guidance or forecasts, but rather to illustrate AMAG’s current growth model based on current plans for the advancement of ciraparantag and AMAG-423 and potential future portfolio expansion and the continued commercialization of Makena, Feraheme, Intrarosa and Vyleesi. These estimates include assumptions based on current circumstances with respect to, among other things, (A) design, enrollment, timing and successful execution of clinical trials, (B) anticipated timetables for regulatory filings and related reviews and potential approvals of products, and approved indications, (C) cost and timing for development efforts and commercial launches, (D) forecasted volumes and pricing and (E) the continued approval and performance of AMAG’s commercialized products. Additional risk factors include, among others, (i) the risk that AMAG’s commercial products will not achieve the level of revenues needed to support AMAG’s research and development efforts, including because such efforts require greater costs than anticipated, or because such revenues fall short of expectations, including because approval of any such products is withdrawn or the FDA takes other adverse action with respect to any such products, (ii) the speculative nature of the addressable market for the indications being pursued for AMAG’s product candidates, (iii) the risk that the FDA will not approve AMAG’s product candidates for commercial use on the expected timeframe, for the anticipated indications, uses and label, or at all, and (iv) the risk that AMAG will not be able to continue to execute on its business plan. There can be no assurance that all or any of the assumptions and estimates built into our long-term models will prove correct, and we caution you not to place undue reliance on such statements and the overall progression of revenue or adjusted EBITDA for our products, as the timing of regulatory approvals, clinical study results, commercial launch, supply availability, competition, volume and pricing may turn out to be significantly different from our current estimates. You are strongly encouraged to read those risks and uncertainties identified above and in AMAG’s filings with the SEC. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 3


 
Agenda 1 Q3-2019 Highlights 2 Makena FDA Advisory Committee Meeting Update 3 Vyleesi Launch Update 4 Q3 Financial Results and Guidance 5 Development Pipeline Update 6 Closing Remarks/Q&A © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 4


 
Strong Key Commercial Products’ Performance Subcutaneous Auto-injector Record Revenues & Market Share1 Quarterly Market Share2 TRx/NRx Average Market Share3 5.0% Revenues 4.5% % 63% 63% YoY: up nearly 20% 54 4.0% TRx QoQ: up more than 5% 3.5% 3.0% NRx Market share 2.5% 2.0% Q1-2019 Q2-2019 Q3-2019 17.5% 3Q-2019 avg. market share Q1'18 Q2'18 Q3'18 Q4'18 Q1'19 Q2'19 Q3'19 Feraheme Quarterly Net Revenues Makena Quarterly Net Revenues Intrarosa Quarterly Net Revenues $44.2 $42.1 $40.0 $41.0 $41.3 $37.8 $5.6 $4.4 $4.9 Q1-2019 Q2-2019 Q3-2019 Q1-2019 Q2-2019 Q3-2019 Q1-2019 Q2-2019 Q3-2019 1 Feraheme market share based on IQVIA data and internal analytics. 2 Makena SC auto-injector market share is based on all FDA-approved hydroxyprogesterone caproate TRxs. Data based on Specialty Pharmacy Demand Data; Valuecentric 867 Data; and IQVIA SMART US Edition Integrated View – NSP. 3 Intrarosa market share based on IQVIA Xponent Plantrak data. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 5


 
Makena FDA Advisory Committee Meeting Update 6


 
Makena PROLONG Update PROLONG Study Results Published (October 25) • The American Journal of Perinatology • Primary author Dr. Sean Blackwell puts results in perspective in discussion section Professional Societies Recently Updated Guidelines (October 25) • American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal-Fetal Medicine (SMFM) continue to support the use of Makena FDA Advisory Committee Meeting (October 29) • Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) ‒ 7 members voted to keep Makena on the market and generate more data through a new confirmatory trial ‒ 9 members voted to recommend that the FDA pursue withdrawal from the market ‒ BRUDAC’s recommendation not binding, but will be considered by FDA in making its decision ‒ AMAG is committed to working collaboratively with the FDA on the path forward that could allow at-risk pregnant women to continue to have access to Makena. WOMEN’S HEALTH: MAKENA © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 7


 
Vyleesi National Launch – September 2019 8


 
Vyleesi Launched Nationally September 2019 First FDA-approved as-needed treatment option for premenopausal women1 Early experience program built demand and enhanced market knowledge ahead of launch Accelerating Approximately 125 sales professionals Engagement now targeting 15,000 HCPs Social and digital reach is driving consumer awareness Enabling Copay program supporting patients Early Access while payer coverage builds 1Vyleesi is approved for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). WOMEN’S HEALTH: VYLEESI © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 9


 
Early Feedback I have had 4 different providers requesting me to come by and detail Vyleesi. Those requests came from no access offices. Vyleesi sales rep WOMEN’S HEALTH: VYLEESI © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 10


 
Encouraging Early Launch Metrics Early metrics through one month post launch 12.6M 120k+ 1,300+ 1 women 40.7M symptom prescribers have been impressions checkers 3,000+ reached completed prescriptions1 What you can expect post first full quarter when we report 4Q19 Early Digital & formulary Number of New patient Total Early repeat social media coverage prescribers starts prescriptions prescription campaign wins metrics 1 Number of prescribers and prescriptions from Vyleesi Specialty Pharmacy Status/Dispense data provided by ValueCentric. WOMEN’S HEALTH: VYLEESI © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 11


 
Financial Overview 12


 
Sequential Quarter Revenue Summary • Makena SC auto-injector: ($M) Q3-2019 Q2-2019 – Revenue stable at ~$40M per quarter and in-line with company expectations Makena subcutaneous (SC) $41.3 $41.0 auto-injector Makena intramuscular (IM) – (7.0) (10.0) branded and generic Total Makena $34.3 $31.0 Feraheme 44.2 42.1 • Makena IM:1 Intrarosa 5.6 4.9 – No shipments in Q3 and Q2, therefore full impact of changes in estimated Medicaid and commercial rebates TOTAL REVENUES $84.1 $78.0 from prior period sales appear as a negative • Feraheme achieved record revenue – Driven by volume 1 AMAG withdrew Makena IM from the market in Q2-2019 and does not expect any future revenue from Makena IM. FINANCIAL OVERVIEW © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 13


 
Year-over-Year Quarterly Revenue Summary Third quarter 2019 financial results ($M) Q3-2019 Q3-2018 • Makena IM year-over-year decrease related to: Makena subcutaneous (SC) $41.3 $39.2 ▪ Generic entrants in July 2018 auto-injector ▪ Third-party manufacturing challenges Makena intramuscular (IM) – (7.0) 41.0 ▪ Withdrawal of the IM form from the market in Q2-2019 branded and generic – Feraheme grew 20%, achieving record revenue of Total Makena $34.3 $80.2 more than $44M Feraheme 44.2 37.0 – Vyleesi is included in “Other” ▪ $0 copay on first prescription Intrarosa 5.6 4.9 ▪ $99 maximum out-of-pocket for refills Other -- 0.1 TOTAL REVENUES $84.1 $122.2 FINANCIAL OVERVIEW © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 14


 
Operating Expense and Income/Loss Summary Third quarter 2019 financial results Three Months Ended September 30, • Decline in CoPS primarily related to: – ($M) 2019 2018 Decrease in amortization expense associated with Makena IM intangible asset Amortization of intangible assets $4.2 $30.9 – Direct CoPS increased due to a shift to products with higher CoPS and royalty burdens Direct cost of product sales 16.9 15.6 Total cost of product sales $21.1 $46.5 • R&D increase driven by AMAG-423 development program, including additional clinical site initiations in Europe Research and development $15.3 $10.1 Acquired in-process research and development -- $12.5 • Q3-2018: recorded $12.5 million of acquired IPR&D expense in connection with the acquisition of AMAG-423 Selling, general and administrative $65.7 $72.5 • SG&A decrease primarily due to combining the maternal TOTAL COSTS AND EXPENSES $102.1 $141.6 health and women’s health sales forces in February 2019 • Non-GAAP adjusted EBITDA: – Year-over-year increase in loss primarily related to lower revenues Operating loss ($18.0) ($19.3) from Makena IM Adjusted EBITDA1 ($8.2) $30.0 1 See slide 22 for a reconciliation of GAAP to non-GAAP financial results. FINANCIAL OVERVIEW © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 15


 
2019 Financial Guidance 1 Updated 2019 Guidance (November) Previous 2019 Guidance (August) ($M) Low Mid High Low Mid High Total revenue $320 $325 $330 $325 $340 $355 GAAP operating loss ($278) ($273) ($268) ($286) ($281) ($276) Non-GAAP adjusted EBITDA ($75) ($70) ($65) ($85) ($80) ($75) 1 See slide 23 for a reconciliation of GAAP to non-GAAP financial guidance. FINANCIAL OVERVIEW © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 16


 
Development Pipeline Update 17


 
Development Pipeline is Progressing Commercial products help fund development programs Regulatory Approved/ Phase 1 Phase 2 Phase 3 Review Marketed Treatment of iron deficiency anemia Anticoagulant reversal agent Ciraparantag (potential for orphan drug designation) HEMATOLOGY Treatment to reduce recurrent preterm birth in certain at-risk women Treatment for moderate to severe dyspareunia (pain during sex) in postmenopausal women TM Treatment of low desire or libido with associated distress (HSDD*) in premenopausal women AMAG-423 Treatment of severe preeclampsia WOMEN’S HEALTHCAREDigoxin Immune (orphan drug designation) Fab (ovine) * HSDD: Hypoactive Sexual Desire Disorder © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 18


 
Focus: Looking Ahead Makena Continue enrollment and additional SC Auto- Maintain strong market share AMAG-423 site initiations, including EU injector FDA AdComm follow up IDE submission (Perosphere Technologies) Vyleesi Continue to drive successful launch Ciraparantag Complete healthy volunteer study Continue to focus on maximizing Feraheme 2020 Continue growth shareholder value © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 19


 
AMAG Pharmaceuticals Third Quarter 2019 Financial Results Q&A © 2019 AMAG Pharmaceuticals, Inc. All© rights 2019 reservedAMAG Pharmaceuticals, Inc. All rights reserved 20


 
Appendix 21


 
Reconciliation of GAAP to Non-GAAP Financial Results ($M) Q3-2019 Q3-2018 9-Mos. 2019 9-Mos. 2018 GAAP operating income ($18.0) ($19.3) ($251.6) ($28.2) Depreciation and intangible asset amortization 4.8 31.4 13.9 146.0 Non-cash inventory step-up adjustments -- 0.4 -- 3.6 Stock-based compensation 5.0 5.0 13.7 14.6 Adjustments to contingent consideration -- -- -- (49.2) Restructuring -- -- 7.4 -- Transaction / acquisition-related costs -- -- 0.3 -- Acquired IPR&D -- 12.5 74.9 32.5 Asset impairment charges -- -- 82.2 -- Non-GAAP adjusted EBITDA ($8.2) $30.0 ($59.2) $119.3 APPENDIX © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 22


 
Reconciliation of GAAP to Non-GAAP 2019 Financial Guidance 2019 Financial Guidance ($M) Revised Guidance Previous Guidance Operating loss ($278) – ($268) ($286) – ($276) Depreciation & intangible asset amortization 20 18 Stock-based compensation 19 19 Acquired IPR&D 75 75 Restructuring 7 7 Asset impairment charges 82 82 Adjusted EBITDA ($75) – ($65) ($85) – ($75) APPENDIX © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 23


 
AMAG Pharmaceuticals Third Quarter 2019 Financial Results November 1, 2019 © 2019 AMAG Pharmaceuticals, Inc. All© rights 2019 reservedAMAG Pharmaceuticals, Inc. All rights reserved 24