Document



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

CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): August 7, 2019
http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=13046379&doc=30
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:
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))

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 August 7, 2019, AMAG Pharmaceuticals, Inc. (“AMAG”) issued a press release regarding its operating results for the three and six months ended June 30, 2019 and its intention to hold a conference call to discuss AMAG’s second 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: August 7, 2019




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Exhibit
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FOR IMMEDIATE RELEASE

AMAG PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2019 FINANCIAL RESULTS
AND PROVIDES CORPORATE UPDATE
Promoted products achieved sequential and year-over-year revenue and market share growth
2019 financial guidance lowered: exiting Makena intramuscular market and removing milestone revenue
Vyleesi on-track for national launch in September
Conference call scheduled for 8:00 a.m. ET today

WALTHAM, MA (August 7, 2019) AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited consolidated financial results for the second quarter ended June 30, 2019 and provided a business update.

“We are pleased to report both year-over-year and sequential revenue and market share growth in the quarter for each of our key commercial products - Makena subcutaneous (SC) auto-injector, Feraheme and Intrarosa. This strong, consistent execution by our commercial team positions us well for next month's launch of Vyleesi, our fourth commercial product,” said William Heiden, AMAG’s president and chief executive officer. “Despite the strong commercial success of our promoted products, we have lowered our 2019 financial guidance to reflect the impact of Makena intramuscular (IM) supply issues and our changed expectations of milestone payments due to us from a development partner related to ciraparantag.”
KEY UPDATES
Makena supply: due to sustained supply disruptions, resulting in loss of market share, and increased generic competition, the company made the decision to exit the IM market and, through mutual agreement, has terminated the arrangement with Prasco, LLC, its authorized generic partner.
Makena PROLONG study: in a recent meeting with the U.S. Food and Drug Administration (FDA) regarding PROLONG, the Agency informed the company that it plans to hold an Advisory Committee meeting. This meeting is expected to occur in the fourth quarter of 2019 to facilitate transparent discussions of the PROLONG trial and allow FDA to obtain the necessary input from Advisory Committee members and important stakeholders to inform regulatory decision-making for Makena. In addition to presentations by the company and the FDA, clinical experts, medical society representatives and patients will have the opportunity to provide their perspectives on the clinical importance and medical need for Makena.
Quarterly growth across all promoted products: strong revenue and market share performance in the second quarter
Makena® (hydroxyprogesterone caproate (HPC) injection) SC auto-injector achieved 63% market share of all FDA-approved HPC prescription volume in the quarter.
Feraheme® (ferumoxytol injection) achieved record market share of 17.2% in the quarter.
Intrarosa® (prasterone) exited the quarter at a TRx share of 4.8%, the highest share achievement since launch.
VyleesiTM (bremelanotide injection) on track for national launch in September: June 21 approval generated coverage from more than 300 news outlets across the country, which has helped drive early awareness of Vyleesi alongside the initial marketing campaign.
Development pipeline is progressing: the company expects to initiate a phase 3a study of ciraparantag in the fourth quarter of 2019. AMAG-423 Phase 2b/3a study continues to open new sites and enroll patients.

1


($M)
Three Months Ended June 30,
 
2019

 
2018

 
% Change

Total product revenues, net
$78.0
 
$146.2
 
(47
)%
Makena subcutaneous auto-injector
41.0

 
13.5

 
204
 %
Makena intramuscular - branded and generic
(10.0
)
 
91.8

 
(111
)%
Feraheme
42.1

 
37.7

 
12
 %
Intrarosa
4.9

 
3.2

 
53
 %
Operating (loss) income
$(115.8)
 
$41.9
 
N/A

Non-GAAP adjusted EBITDA1
$(24.4)
 
$59.7
 
N/A


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

COMMERCIAL PRODUCTS AND DEVELOPMENT PROGRAM UPDATES
Makena
The Makena SC auto-injector was launched in March 2018 and has continued to grow and increase its market share every quarter since launch. Second quarter 2019 revenues increased to $41.0 million, or 8.5%, over the first quarter of 2019. Market share grew 9 percentage points to 63%, compared with 54% in the first quarter of 2019. With no intramuscular product shipped, the $10.0 million of negative revenue for the Makena IM product, for the three months ended June 30, 2019, was the result of changes in estimated Medicaid and commercial liability obligations from prior periods.

As previously disclosed, AMAG’s primary third-party manufacturer failed to timely deliver Makena IM drug product to AMAG, which led to supply disruptions and ultimately an out-of-stock situation. These supply issues hindered AMAG’s ability to provide Makena IM product, which caused Prasco to lose significant market share. Although AMAG received notice of approval from the FDA of an additional manufacturing site for the Makena IM product late in the second quarter, AMAG and Prasco concluded that it was no longer commercially viable to recapture sufficient market share following the out-of stock situation. As such, AMAG made the decision to exit the generic IM market and reached a mutual agreement with Prasco to terminate their distribution and supply agreement on August 6, 2019.

Accordingly, the company recorded a $77.4 million non-cash charge to fully write-off the intangible asset associated with the IM form of Makena and an inventory write-down of $4.8 million. In addition, the company revised its full-year 2019 financial guidance.

Vyleesi
As previously reported, on June 21, 2019 the FDA approved Vyleesi, a melanocortin receptor agonist, to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The Vyleesi autoinjector is the first treatment for this patient population that can be self-administered as needed in anticipation of sexual activity. HSDD is characterized by low sexual desire that causes distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. AMAG is committed to working with payers and healthcare professionals to help ensure that women with HSDD have access to Vyleesi, as well as minimizing the cost burden to patients through a comprehensive copay assistance program. AMAG plans to launch Vyleesi nationally in September with approximately 125 sales representatives on the company's women's and maternal health salesforce who will be calling on an estimated 15,000 healthcare professionals.


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Ciraparantag
Ciraparantag, which has been granted fast track designation by the FDA, is in development as a single-dose, ready-to-use solution for use in patients treated with novel oral anticoagulants (NOACs) or low molecular weight heparin (LMWH) when reversal of the anticoagulant effect is needed for emergency surgery or serious uncontrolled bleeding. AMAG and Perosphere Technologies (an independent company) recently met with the FDA and Perosphere Technologies is preparing to submit an investigational device exemption (IDE) to enable the use of the automated coagulometer in a Phase 3a clinical study, which AMAG expects to begin in the fourth quarter of 2019. Separately, AMAG was recently informed by a development partner for ciraparantag of its intention to terminate the existing collaboration agreement. Although AMAG does not believe that this partner has grounds for termination, it has removed expected milestone payments from its 2019 financial guidance.

UPDATED 2019 FINANCIAL GUIDANCE
“Although our commercial teams delivered strong results for our promoted products, we are lowering our 2019 financial guidance because we exited the Makena IM market and revised our expectation of ciraparantag development milestone revenue. The changes to our 2019 guidance do not alter our previously-stated preliminary view that we will achieve neutral adjusted EBITDA in 2020,” said Ted Myles, AMAG’s chief financial officer. “With strong cash flows from our commercial products and our flexible cost structure, we believe we are well positioned to bring innovative therapies to patients in need and to build a new chapter of durable growth for shareholders. Our updated guidance and our preliminary view of an adjusted EBITDA-neutral 2020 reflects continued strong commercial performance from Makena SC auto-injector, Feraheme and Intrarosa, and includes a fully-funded launch of Vyleesi and our clinical development plans for AMAG-423 and ciraparantag."

2019 Financial Guidance
 
 
 
 
($M)
 
Updated
 
Previous
Total revenue
 
$325 - $355
 
$365 - $415
Operating loss
 
($286) - ($276)
 
($206) - ($176)
Adjusted EBITDA2
 
($85) - ($75)
 
($65) - ($35)

2 See reconciliations of 2019 GAAP to non-GAAP financial guidance at conclusion of this press release.

SECOND QUARTER ENDED JUNE 30
Revenue
Growth of the company’s key marketed products continued in the second quarter, with strong revenue and market share performance.
Makena SC auto-injector revenue grew to $41.0 million, compared with $13.5 million in the same period last year (launched March 2018).
The company did not ship any Makena IM product during the quarter, therefore the full impact of the $10.0 million change in estimated Medicaid and commercial rebate liabilities from prior period sales appears as negative revenue during the quarter.
Feraheme revenue increased to $42.1 million, an increase of 12% over the same period last year. Feraheme’s average quarterly market share increased to 17.2%, compared with 16.3% in the same period last year and 16.1% in the first quarter of 2019.
Intrarosa revenue totaled $4.9 million, compared with $3.2 million in the same period last year. TRx share increased to 4.5%, compared with 3.2% in the same period last year and 3.9% in the first quarter of 2019.



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($M)
Three Months Ended June 30,
 
2019

2018

Total product revenues, net
$78.0
$146.2
Makena subcutaneous auto-injector
41.0

13.5

Makena intramuscular - branded and generic
(10.0
)
91.8

Feraheme
42.1

37.7

Intrarosa
4.9

3.2


Operating Expenses
Cost of products sales (CoPS) in the second quarter of 2019 included a $4.8 million write-down of Makena IM inventory; CoPS in the second quarter of 2018 included $61.4 million in amortization expense primarily related to the Makena IM intangible asset.
Selling, general and administrative (SG&A) expenses in the second quarter of 2018 included an expense reversal of $49.8 million related to the Makena contingent consideration liability because the company no longer believed that it was probable that a sales milestone would be achieved. Excluding this expense reversal, SG&A expenses increased by $11.6 million, or 18%, in the second quarter of 2019, compared with the same period last year, primarily due to increased marketing expenses related to the upcoming launch of Vyleesi.
The intangible asset impairment charge relates to the full impairment of the Makena IM intangible asset (described above).

($M)
Three Months Ended June 30,
 
2019

2018

Amortization of intangible assets
$3.9
$61.4
Direct cost of product sales
20.4

15.4

Total cost of product sales
24.3

76.8

Total Research and development expenses
15.0

11.7

Fair value of contingent consideration liability

(49.8
)
Other selling, general and administrative expenses
77.3

65.7

Total selling, general and administrative expenses
77.3

15.9

Impairment of intangible assets
$77.4
$0.0
Total costs and expenses
$194.0
$104.4

Balance Sheet
As of June 30, 2019, the company’s cash and investments totaled $261.0 million.
The FDA approval of Vyleesi triggered a $60.0 million payment obligation to Palatin Technologies, which was paid in July 2019.
Long-term debt totaled $320.0 million (representing the principal amounts outstanding of the 2022 convertible notes).

Operating Loss and Adjusted EBITDA
The impact of the $77.4 million non-cash impairment charge and the related $4.8 million inventory write-down in the second quarter of 2019 contributed to an operating loss of $115.8 million. The company reported negative adjusted EBITDA of $24.4 million in the second quarter of 2019.


4


($M)
Three Months Ended June 30,
 
2019
2018
Operating (loss) income
$(115.8)
$41.9
Non-GAAP adjusted EBITDA1
$(24.4)
$59.7

1 See summaries 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 second 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: 8573359

Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 8573359

A telephone replay will be available from approximately 11:00 a.m. ET on August 7, 2019 through midnight on August 14, 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 and non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization). These non-GAAP financial measures exclude certain amounts, expenses or income, from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP). Management believes this non-GAAP information is useful for investors, taken in conjunction with AMAG’s GAAP financial statements, because it provides greater transparency regarding AMAG’s operating performance. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of AMAG’s operating results as reported under GAAP, not as a substitute for GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

ABOUT AMAG
AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. 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; AMAG’s belief that strong commercial performance will position it well for the launch of Vyleesi; expectations for ciraparantag and AMAG-423 studies, including development timelines; expectations and plans for the FDA Advisory Committee meeting, including the purpose and timing thereof; plans to ensure that women with HSDD have access to Vyleesi, including at a reasonable cost; plans for the launch of Vyleesi, including launch timing and sales force efforts and the effect of AMAG’s direct-to-patient campaign for Vyleesi; updated 2019 guidance and expectations that AMAG will be adjusted EBITDA neutral by 2020; expectations related to development milestone payments from a development partner in light of such partners notice of intent to terminate the related agreement; characterizations that its strong cash flows and flexible cost structure will position AMAG well to build a new chapter of durable growth for shareholders 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 Makena franchise is currently solely dependent on sales from the Makena auto-injector in light of the company’s exit from the Makena IM market, and the Makena auto-injector may not be successful, including if (i) AMAG is unsuccessful in convincing patients to use or healthcare providers to prescribe the Makena auto-injector product and (ii) the FDA takes adverse action related to Makena in response to the results of the PROLONG study and the FDA’s ongoing review, including following the Advisory Committee meeting tentatively scheduled for the fourth quarter of 2019.  The PROLONG trial was conducted as part of an approval commitment under the FDA’s “Subpart H” accelerated approval process to confirm the efficacy of the Meis trial. The PROLONG trial results did not demonstrate a statistically significant difference between the treatment and placebo arms for the co-primary endpoints. Since the results of the PROLONG study were negative, the FDA could withdraw the approval of Makena, require us to generate or conduct additional clinical trials or update the approved labeling to include information on the PROLONG study, including the possibility of restrictions to the current indication or the insertion of new warnings or precautions. Although the usual regulatory process for a Subpart H approved product with a failed confirmatory trial is for the FDA to issue a Notice of Opportunity for Hearing to initiate the process to withdraw accelerated approval, the FDA indicated that it believed that an Advisory Committee is the preferred next step to inform regulatory decision-making for Makena. In addition, certain medical professional organizations and other societies could change their guidelines to physicians. The FDA has noted that it considered post-hoc subset analysis informative for hypothesis generation only and did not consider it adequate to support efficacy for any subgroup. The FDA further noted that it will not opine on the safety of Makena while the FDA review is ongoing. Any of these outcomes could negatively impact or prevent our ability to commercialize Makena, and could materially and adversely impact our stock price and results of operations. Risks and uncertainties that could cause actual results to differ materially from those discussed in AMAG’s forward-looking statements also include 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 quarter ended March 31, 2019, and subsequent filings with the SEC (including its upcoming Quarterly Report on Form 10-Q for the quarter ended June 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 August 7, 2019 for risks attendant to AMAG’s long-term outlook, including that it will be adjusted EBITDA neutral by 2020. 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.


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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.



- Tables Follow -



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AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(Unaudited, amounts in thousands, except for per share data)
 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
2019
 
2018
 
2019
 
2018
Revenues:
 
 
 
 
 
 
 
Makena
$
30,935

 
$
105,172

 
$
62,192

 
$
195,156

Feraheme/MuGard
42,164

 
37,806

 
82,222

 
63,005

Intrarosa
4,877

 
3,241

 
9,291

 
5,406

Other revenues
133

 
35

 
208

 
75

Total revenues
78,109

 
146,254

 
153,913

 
263,642

Operating costs and expenses:
 
 
 
 
 
 
 
Cost of product sales
24,290

 
76,776

 
42,767

 
140,688

Research and development expenses
14,980

 
11,693

 
33,046

 
22,502

Acquired in-process research and development

 

 
74,856

 
20,000

Selling, general and administrative expenses
77,324

 
15,898

 
152,006

 
89,329

Impairment of intangible assets
77,358

 

 
77,358

 

Restructuring expenses

 

 
7,420

 

Total costs and expenses
193,952

 
104,367

 
387,453

 
272,519

Operating (loss) income
(115,843
)
 
41,887

 
(233,540
)
 
(8,877
)
 
 
 
 
 
 
 
 
Other income (expense):
 
 
 
 
 
 
 
Interest expense
(6,330
)
 
(16,056
)
 
(12,780
)
 
(32,034
)
Interest and dividend income
1,224

 
952

 
2,810

 
1,595

Other income
2

 
(44
)
 
342

 
(44
)
Total other expense, net
(5,104
)
 
(15,148
)
 
(9,628
)
 
(30,483
)
(Loss) income from continuing operations before income taxes
(120,947
)
 
26,739

 
(243,168
)
 
(39,360
)
Income tax (benefit) expense
(120
)
 
52,556

 
(257
)
 
44,556

Net loss from continuing operations
$
(120,827
)
 
$
(25,817
)
 
$
(242,911
)
 
$
(83,916
)
 
 
 
 
 
 
 
 
Discontinued Operations:
 
 
 
 
 
 
 
Income from discontinued operations
$

 
$
7,158

 
$

 
$
13,036

Income tax expense

 
1,422

 

 
3,444

Net income from discontinued operations
$

 
$
5,736

 
$

 
$
9,592

 
 
 
 
 
 
 
 
Net loss
$
(120,827
)
 
$
(20,081
)
 
$
(242,911
)
 
$
(74,324
)
 
 
 
 
 
 
 
 
Basic and diluted net (loss) income per share:
 

 
 

 
 

 
 

Loss from continuing operations
$
(3.57
)
 
$
(0.75
)
 
$
(7.12
)
 
$
(2.45
)
Income from discontinued operations

 
0.17

 

 
0.28

Basic and diluted net loss per share
$
(3.57
)
 
$
(0.58
)
 
$
(7.12
)
 
$
(2.17
)
 
 
 
 
 
 
 
 
Weighted average shares outstanding used to compute net (loss) income per share (basic and diluted)
33,807

 
34,358

 
34,136

 
34,261


8


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

 
 

Cash and cash equivalents
$
150,461

 
$
253,256

Marketable securities
110,583

 
140,915

Accounts receivable, net
83,183

 
75,347

Inventories
25,179

 
26,691

Prepaid and other current assets
24,549

 
18,961

Note receivable

 
10,000

Total current assets
393,955

 
525,170

Property and equipment, net
8,224

 
7,521

Goodwill
422,513

 
422,513

Intangible assets, net
191,789

 
217,033

Operating lease right-of-use asset
6,582

 

Deferred tax assets
630

 
1,260

Restricted cash
495

 
495

Other long-term assets
12

 
1,467

Total assets
$
1,024,200

 
$
1,175,459

LIABILITIES AND STOCKHOLDERS’ EQUITY
 

 
 

Current liabilities:
 

 
 

Accounts payable
$
26,946

 
$
14,487

Accrued expenses
214,211

 
129,537

Current portion of convertible notes, net

 
21,276

Current portion of operating lease liability
3,889

 

Current portion of deferred revenue
1,128

 

Current portion of acquisition-related contingent consideration
128

 
144

Total current liabilities
246,302

 
165,444

Long-term liabilities:
 

 
 

Convertible notes, net
269,305

 
261,933

Long-term operating lease liability
3,504

 

Long-term deferred revenue
5,171

 

Long-term acquisition-related contingent consideration
183

 
215

Other long-term liabilities
228

 
1,212

Total liabilities
524,693

 
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; 33,899,954 and 34,606,760 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively
339

 
346

Additional paid-in capital
1,287,553

 
1,292,736

Accumulated other comprehensive loss
(3,032
)
 
(3,985
)
Accumulated deficit
(785,353
)
 
(542,442
)
Total stockholders’ equity
499,507

 
746,655

Total liabilities and stockholders’ equity
$
1,024,200

 
$
1,175,459


9


AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited, amounts in thousands)
 
Six Months Ended June 30,
 
2019
 
2018
Cash flows from operating activities:
 
 
 
Net loss
$
(242,911
)
 
$
(74,324
)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
 
 
 
Depreciation and amortization
9,089

 
126,183

Impairment of intangible assets
77,358

 

Provision for bad debt expense
(12
)
 
856

Amortization of premium/discount on purchased securities
(51
)
 
93

Write-down of inventory
4,836

 

Gain on disposal of fixed assets

 
(99
)
Non-cash equity-based compensation expense 
9,407

 
11,122

Non-cash IPR&D expense
18,029

 

Amortization of debt discount and debt issuance costs
7,513

 
7,851

Gains on marketable securities, net
(270
)
 

Change in fair value of contingent consideration
(21
)
 
(49,184
)
Deferred income taxes
630

 
42,372

Prepaid transaction costs

 
(3,865
)
Changes in operating assets and liabilities:
 
 
 

Accounts receivable, net
(7,825
)
 
(11,265
)
Inventories
(3,323
)
 
1,223

Prepaid and other current assets
(5,562
)
 
(756
)
Accounts payable and accrued expenses
35,479

 
27,475

Deferred revenues
(101
)
 
7,329

Other assets and liabilities
1,283

 
117

Net cash (used in) provided by operating activities
(96,452
)
 
85,128

Cash flows from investing activities:
 

 
 

Proceeds from sales or maturities of marketable securities
46,420

 
44,038

Purchase of marketable securities
(14,815
)
 
(46,726
)
Capital expenditures
(1,907
)
 
(1,553
)
Net cash provided by (used in) investing activities
29,698

 
(4,241
)
Cash flows from financing activities:
 

 
 

Payments to settle convertible notes
(21,417
)
 

Payments of contingent consideration
(27
)
 
(60
)
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

 
1,473

Payments of employee tax withholding related to equity-based compensation
(1,748
)
 
(2,362
)
Net cash used in financing activities
(36,041
)
 
(949
)
Net (decrease) increase in cash, cash equivalents, and restricted cash
(102,795
)
 
79,938

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

 
(59,714
)
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
$
150,956

 
$
212,994

Supplemental data for cash flow information:
 
 
 
Cash paid for taxes
$
433

 
$
4,181

Cash paid for interest
$
5,467

 
$
24,171


10


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

 
$

Milestone payment accrued for FDA approval of Vyleesi
$
60,000

 
$


11


AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended June 30, 2019
(Unaudited, amounts in thousands)
 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Intangible asset impairment charge
 
Operating Loss / Adjusted EBITDA
GAAP
$
78,109

 
$
24,290

 
$
14,980

 
$
77,324

 
$
77,358

 
$
(115,843
)
Depreciation and intangible asset amortization

 
(3,943
)
 
(336
)
 
(434
)
 

 
 
Stock-based compensation

 
(199
)
 
(680
)
 
(3,656
)
 

 
 
Asset impairment charges

 
(4,836
)
 

 

 
(77,358
)
 
 
Non-GAAP Adjusted
$
78,109

 
$
15,312

 
$
13,964

 
$
73,234

 
$

 
$
(24,401
)





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

 
$
76,776

 
$
11,693

 
$
15,898

 
$
41,887

Depreciation and intangible asset amortization

 
(61,423
)
 
(6
)
 
(449
)
 
 
Non-cash inventory step-up adjustments

 
(967
)
 

 

 
 
Stock-based compensation

 
(107
)
 
(608
)
 
(4,077
)
 
 
Adjustments to contingent consideration

 

 

 
49,810

 
 
Non-GAAP Adjusted
$
146,254

 
$
14,279

 
$
11,079

 
$
61,182

 
$
59,714






12


AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Six Months Ended June 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
$
153,913

 
$
42,767

 
$
33,046

 
$
152,006

 
$
74,856

 
$
7,420

 
$
77,358

 
$
(233,540
)
Depreciation and intangible asset amortization

 
(7,886
)
 
(345
)
 
(858
)
 

 

 

 
 
Stock-based compensation

 
(401
)
 
(1,360
)
 
(6,981
)
 

 

 

 
 
Acquisition-related costs

 

 

 
(270
)
 

 

 

 
 
Acquired IPR&D

 

 

 

 
(74,856
)
 

 

 
 
Restructuring

 

 

 

 

 
(7,420
)
 

 
 
Asset impairment charges

 
(4,836
)


 

 

 

 
(77,358
)
 
 
Non-GAAP Adjusted
$
153,913

 
$
29,644

 
$
31,341

 
$
143,897

 
$

 
$

 
$

 
$
(50,969
)




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

 
Revenue
 
Cost of product sales
 
Research & development
 
Selling, general & administrative
 
Acquired IPR&D
 
Operating Loss / Adjusted EBITDA
GAAP
$
263,642

 
$
140,688

 
$
22,502

 
$
89,329

 
$
20,000

 
$
(8,877
)
Depreciation and intangible asset amortization

 
(113,786
)
 
(6
)
 
(764
)
 

 
 
Non-cash inventory step-up adjustments

 
(3,191
)
 

 

 

 
 
Stock-based compensation

 
(307
)
 
(1,328
)
 
(7,948
)
 

 
 
Adjustments to contingent consideration

 

 

 
49,184

 

 
 
Acquired IPR&D

 

 

 

 
(20,000
)
 
 
Non-GAAP Adjusted
$
263,642

 
$
23,404

 
$
21,168

 
$
129,801

 
$

 
$
89,269





13


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
($286) - ($276)
($206) - ($176)
Depreciation & intangible asset amortization
18
36
Stock-based compensation
19
22
Non-cash inventory step up and adjustments to contingent consideration
1
Acquired IPR&D
75
75
Restructuring
7
7
Asset impairment charges
82
Non-GAAP adjusted EBITDA
($85) - ($75)
($65) - ($35)





AMAG Pharmaceuticals, Inc.
Share Count Reconciliation
(Unaudited, amounts in millions)
 
 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
 
 
2019
 
2018
 
2019
 
2018
 
Weighted average basic shares outstanding
 
33.8

 
34.4

 
34.1

 
34.3

 
Employee equity incentive awards
 

3 

3 

3 

3 
GAAP diluted shares outstanding
 
33.8

 
34.4

 
34.1

 
34.3

 
Employee equity incentive awards
 


0.4

4 


0.3

4 
Non-GAAP diluted shares outstanding
 
33.8

 
34.8

 
34.1

 
34.6

 

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


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


14
a2q22019ex992
AMAG Pharmaceuticals Second Quarter 2019 Financial Results August 7, 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 regarding the impact of changes to AMAG’s copay program on Intrarosa’s gross to net revenues; beliefs about Intrarosa’s market share and commercial opportunity; AMAG’s beliefs regarding the market share and commercial opportunity for the Makena products; beliefs regarding the effect of AMAG’s withdrawal of the intramuscular Makena product from the market; AMAG’s beliefs regarding payer and physician support of the Makena auto-injector; AMAG’s beliefs regarding the results of the Makena PROLONG trial and expectations and plans for the Company’s meeting with the FDA’s Advisory Committee; characterizations of and beliefs about study and market data for the Company’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 planned 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 growth of Feraheme, the Makena auto-injector and Intrarosa; beliefs about the effect of the Vyleesi commercial launch on revenues; AMAG’s accomplishments and second 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; expectations related to development milestone payments from a development partner in light of such partners notice of intent to terminate the related agreement, and beliefs about the strength of AMAG’s balance sheet and expectations to transform the Company’s profile in 2019 (including the key goals in connection therewith) 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, challenges with commercialization efforts of AMAG’s portfolio of products and product candidates, including any impact from its recent restructuring initiative; the risk that the Makena brand will incur reputational harm as result of the recently disclosed study results, which could harm AMAG’s ability to retain or regain market share and could further negatively impact sales; the risk that the Makena franchise is currently dependent exclusively on sales from the Makena auto-injector product following AMAG’s withdrawal of the Makena IM product from the market; 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. 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; and (vi) external pricing / reimbursement. 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 Vyleesi, ciraparantag and AMAG-423 and potential future portfolio expansion. 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 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, (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 Q2-2019 Highlights and Recent Developments 2 Q2-2019 Financial Overview 3 Vyleesi Launch 4 Development Pipeline and Closing Remarks 5 Q&A © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 4


 
Promoted Products Continue to Grow SC Auto-Injector Quarterly Market Share1 Record Revenues & Market Share2 Highest Market Share Since Launch3 5.0% Revenues % % 54 63 YoY: up 12% 4.5% TRx QoQ: grew more than 5% 4.0% NRx 3.5% Market share 3.0% Q1-2019 Q2-2019 17.2% 2Q-2019 avg. market share Jan Feb Mar Apr May Jun $41.0 $42.1 $37.8 $40.0 5.3% 8.5% Quarterly Net $4.4 $4.9 Revenues 11.4% Q1-2019 2Q-2019 Q1-2019 Q2-2019 Q1-2019 Q2-2019 1 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. 2 Feraheme market share based on IQVIA data and internal analytics. 3 Intrarosa market share based on IQVIA Xponent Plantrak data. © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 5


 
Makena Update Exiting AGx • Sustained IM supply disruption • Loss of IM market share IM market • Increased generic competition FDA scheduled AdCom meeting • FDA to hear from AMAG and experts to PROLONG interpret PROLONG data and inform regulatory decision-making • Tentatively scheduled for Q4-2019 © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 6


 
VyleesiTM (bremelanotide injection) Approved June 21st Significant Media Coverage Following Approval On Track for National Launch in September Sheryl Kingsberg, a clinical psychologist, said that "the impact of sexual dysfunction on a woman's self-esteem, on her body image, on her self- confidence and on her relationship is profound.” © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 7


 
Financial Overview


 
Second Quarter Financial Results Revenue summary ($M) Q2-2019 Q2-2018 • Makena SC auto-injector revenue continues to grow Makena subcutaneous (SC) $41.0 $13.5 – Increased to $41.0M, up 204% over Q2-2018 and 8.5% auto-injector over Q1-2019 Makena intramuscular (IM) – • Makena IM (10.0) 91.8 branded and generic – ($10.0)M related to changes in estimate to prior period reserves Feraheme 42.1 37.7 – Exited IM market in August 2019 • Feraheme growth driven by volume Intrarosa 4.9 3.2 • Intrarosa growth driven by volume and more favorable gross-to-net; revised copay program in 2019, on growth trajectory Total revenues $78.0 $146.2 FINANCIAL OVERVIEW © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 9


 
Second Quarter Financial Results Operating expense and income/loss summary Three Months Ended June 30, • Decline in CoPS related to decrease in Makena-related amortization, ($M) 2019 2018 partially offset by higher direct CoPS Amortization of intangible assets $3.9 $61.4 • R&D increase primarily related to trials for AMAG-423, ciraparantag Direct cost of product sales 20.4 15.4 and investment in development personnel Total cost of product sales $24.3 $76.8 • SG&A increase primarily due to $50M Makena contingent expense Total R&D expenses $15.0 $11.7 reversal in Q2-2018 and increase in Women’s Health marketing expense in Q2-2019 Fair value of contingent consideration liability — (49.8) • Recorded a one-time non-cash impairment charge of $77.4 million on Other SG&A expenses 77.3 65.7 Makena IM asset (full write off) Total SG&A expenses $77.3 $15.9 – Multiple factors led AMAG to reassess FV of Makena IM asset . IM supply issues and related loss of market share Impairment charges of Makena IM intangible assets 77.4 — . Expected termination of the Prasco agreement and decision to exit AGx Total costs and expenses $194.0 $104.4 IM market . Multiple generic competitors to the IM product – Operating loss of $115.8M includes $77.4M impairment charge and Operating (loss) income ($115.8) $41.9 related $4.8M inventory write-down Adjusted EBITDA ($24.4) $59.7 – Non-GAAP adjusted EBITDA totaled ($24.4)M 1 See slide 24 for a reconciliation of GAAP to non-GAAP financial results. FINANCIAL OVERVIEW © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 10


 
2019 Financial Guidance1 6-Mos. Original 2019 Guidance Updated August 2019 Guidance ($M) 2019 Actual2 Low Mid High Low Mid High Total revenue $154 $365 $390 $415 $325 $340 $355 GAAP operating loss ($234) ($206) ($191) ($176) ($286) ($281) ($276) Non-GAAP adjusted EBITDA ($51) ($65) ($50) ($35) ($85) ($80) ($75) Updated Guidance: • Stable Makena SC auto-injector revenue Key Assumptions • Continued growth for Feraheme and Intrarosa • Removal of milestone payments due from ciraparantag development partner • Continued investments in Vyleesi, AMAG-423 and ciraparantag 1 See slide 25 for a reconciliation of GAAP to non-GAAP financial guidance. 2 See slide 24 for a reconciliation of GAAP to non-GAAP financial results. FINANCIAL OVERVIEW © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 11


 
Strong Balance Sheet ($M) 6/30/19 12/31/18 Cash, cash equivalents and investments $2611 $394 Long-term debt: Convertible senior notes (3.25%) due 2022 $320 $320 1 $261M cash balance does not reflect July 2019 $60M milestone payment to Palatin. FINANCIAL OVERVIEW © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 12


 
Vyleesi Launch – September 2019 13


 
FDA Approved Vyleesi COMMERCIAL LAUNCH IN SEPTEMBER (not actual size) WOMEN’S HEALTH: VYLEESI © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 14


 
Early Excitement 1. AWARENESS 2. EVALUATION 3. CONSIDERATION www STAYING on SITE for 500K over 1 minute 80K visitors to + 51% vs. benchmark symptom checker unblush.com VIEWING at least completions 2 pages/session + 62% vs. benchmark WOMEN’S HEALTH: VYLEESI © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 15


 
On Track for National Launch in September EARLY EXPERIENCE program National LAUNCH ~125 sales representatives on women’s and maternal health salesforce Patients have the opportunity to be among the first to access Vyleesi Sales & marketing teams learn more about the market to refine plans ahead of national launch (not actual size) Call on ~15,000 healthcare professionals WOMEN’S HEALTH: VYLEESI © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 16


 
Ensuring Access to Vyleesi for Women with HSDD Market Access team focused on securing commercial coverage Launching with copay program: • $0 copay on first Rx • $99 max copay on subsequent refills *Administer subcutaneously as needed at least 45 minutes before anticipated sexual activity. The duration of its effect aft each does is unknown. Do not administer more than one dose within 24 hours or more than 8 doses per month. WOMEN’S HEALTH: VYLEESI © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 17


 
Ready to Launch Vyleesi in September Bring first FDA-approved as-needed treatment option to premenopausal women with HSDD Driving awareness of HSDD F O C U S O N Fostering conversations between patients and HCPs Differentiating Vyleesi in marketplace WOMEN’S HEALTH: VYLEESI © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 18


 
Development Pipeline Continues to Progress 19


 
Strong Progress on Strategic Evolution 2017-2022 Maximizing commercial product opportunities and building the portfolio Approved/ Phase 1 Phase 2 Phase 3 Regulatory Review Marketed Treatment of iron deficiency anemia CKD HEMATOLOGY Treatment to reduce recurrent preterm birth in certain at-risk women SC autoinjector sNDA W O M E N ’ S HEALTHCARE © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 20


 
Development Pipeline is Progressing Commercial products funding investments in development and launch of new products 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 21


 
AMAG Pharmaceuticals Second Quarter 2019 Financial Results Q&A © 2019 AMAG Pharmaceuticals, Inc. All© rights 2019 reservedAMAG Pharmaceuticals, Inc. All rights reserved 22


 
Appendix 23


 
Reconciliation of GAAP to Non-GAAP Financial Results ($M) YTD-2018 YTD-2019 Q2-2018 Q2-2019 GAAP operating income ($8.9) ($233.5) $41.9 ($115.8) Depreciation and intangible asset amortization 114.6 9.1 61.8 4.7 Non-cash inventory step-up adjustments 3.2 -- 1.0 -- Stock-based compensation 9.6 8.7 4.8 4.5 Adjustments to contingent consideration (49.2) -- (49.8) -- Restructuring -- 7.4 -- -- Transaction / acquisition-related costs -- 0.3 -- -- Acquired IPR&D 20.0 74.9 -- -- Asset impairment charges -- 82.2 -- 82.2 Non-GAAP adjusted EBITDA $89.3 ($50.9) $59.7 ($24.4) APPENDIX © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 24


 
Reconciliation of GAAP to Non-GAAP 2019 Financial Guidance 2019 Financial Guidance ($M) Previous Guidance Revised Guidance Operating loss1 ($206) – ($176) ($286) – ($276) Depreciation & intangible asset amortization 36 18 Stock-based compensation 22 19 Non-cash inventory step up and adjustments to contingent consideration 1 -- Acquired IPR&D 75 75 Restructuring 7 7 Asset impairment charges -- 82 Adjusted EBITDA ($65) – ($35) ($85) – ($75) APPENDIX © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 25


 
AMAG Pharmaceuticals Second Quarter 2019 Financial Results August 7, 2019 © 2019 AMAG Pharmaceuticals, Inc. All© rights 2019 reservedAMAG Pharmaceuticals, Inc. All rights reserved 26