amag-20200731
0000792977false00007929772020-08-052020-08-05


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): July 31, 2020
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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 classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.01 per shareAMAGNASDAQ 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.  



Item 2.02. Results of Operations and Financial Condition.
 
The information in this Item 2.02, including Exhibits 99.1 and 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 it 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 6, 2020, AMAG Pharmaceuticals, Inc. (“AMAG” or the “Company”) issued a press release regarding its operating results for the three and six months ended June 30, 2020 and its intention to hold a conference call to discuss the Company’s second quarter 2020 financial results and outlook, and to give a business update. A copy of the Company’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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On August 6, 2020, the Company announced that Brian Piekos was appointed AMAG’s Executive Vice President and Chief Financial Officer, effective as of August 13, 2020. Mr. Piekos had been serving as the Company’s interim Chief Financial Officer since June 8, 2020.

Mr. Piekos, age 46, joined AMAG in 2015 and has held a number of senior management positions with the Company. In his role as Chief Financial Officer, he will act as the Company’s principal financial officer and principal accounting officer and oversee the accounting, corporate finance, and investor relations teams. He has more than 20 years of corporate finance experience including strategic planning, financial reporting and capital market activities. Prior to AMAG, he held positions of increasing responsibility at Cubist Pharmaceuticals. Mr. Piekos began his career in investment banking having served as Vice President at Leerink Partners and as an analyst at Needham & Company.

In connection with his promotion to Chief Financial Officer, Mr. Piekos’s salary will be increased to $400,000 and he will be eligible to earn an annual performance bonus of forty-five percent (45%) of his base salary per year upon the achievement of certain performance goals determined by the Company’s Board of Directors (the “Board”) or the Compensation Committee of the Board in consultation with Mr. Myers, the Company’s Chief Executive Officer. The increased salary and bonus compensation are contingent on Mr. Piekos entering into a new nondisclosure agreement with non-compete.

There are no arrangements or understandings between Mr. Piekos and any other persons pursuant to which Mr. Piekos was elected as the Company’s Chief Financial Officer. With respect to the disclosure required by Item 401(d) of Regulation S-K, there are no family relationships between Mr. Piekos and any director or executive officer of the Company. With respect to Item 404(a) of Regulation S-K, there are no relationships or related transactions between Mr. Piekos and the Company that would be required to be reported.

Item 9.01. Financial Statements and Exhibits.
 
(d) Exhibits.
 
Exhibit
Number
 Description
99.1 
99.2 
104
Cover Page lnteractive Data File (embedded within the Inline XBRL document).


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, Chief Business Officer & Corporate Secretary
Dates: August 6, 2020



3
Document

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FOR IMMEDIATE RELEASE

AMAG PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2020 FINANCIAL RESULTS
AND PROVIDES CORPORATE UPDATE
Financial guidance reissued to include EBITDA-positive projection for second-half 2020

Strategic shift and momentum build through recent business development activities

Brian Piekos promoted to Chief Financial Officer

Conference call scheduled for 8:00 a.m. ET today

WALTHAM, MA (August 6, 2020) - AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited consolidated financial results for the second quarter ended June 30, 2020. The company reported total revenues for the second quarter of 2020 of $52.8 million, including revenue of $29.6 million from Feraheme® (ferumoxytol injection) and revenue of $22.3 million from Makena® (hydroxyprogesterone caproate injection). The company also reported an operating loss of $7.0 million and an adjusted EBITDA loss of $1.7 million in the second quarter of 2020.1

"Amidst the unprecedented uncertainty that COVID-19 placed on the healthcare system and our economy, AMAG's marketed therapeutics performed well in the second quarter due in part to our teams' ability to adapt in a rapidly-changing environment," said Scott Myers, AMAG's Chief Executive Officer. "Over the past three months, we have advanced the company's strategic evolution by reaching important milestones that include a strategic, ex-US partnership with Norgine to further progress ciraparantag and strengthen our company's ability to invest in our pipeline. We have also streamlined expenses by completing the divestment of Intrarosa® and Vyleesi® and making changes to our portfolio designed to further focus on programs with the highest potential to deliver innovative treatments for patients and unlock shareholder value."

2020 FINANCIAL GUIDANCE
($M)2020 Financial Guidance2
Total revenue$225 - $255
Operating loss$(40) - $(15)
Non-GAAP Adjusted EBITDA3$(5) - $20

"Strong execution across our portfolio throughout the COVID-19 pandemic allows us to reissue financial guidance that reflects the relative stability of Makena over the quarter and the momentum that Feraheme began to build in June, which saw record highs in monthly share and ex-factory volume," said Brian Piekos, Chief Financial Officer. "The guidance we are sharing today is designed to prioritize investments that will drive long-term growth while also putting us on track to return to positive adjusted EBITDA."


1 See reconciliations of GAAP to non-GAAP adjustments at the conclusion of this press release
2 2020 Operating Loss financial guidance excludes the accounting impact of the following subsequent events announced in July: termination of the Vyleesi license agreement with Palatin and costs associated with discontinuing the AMAG-423 program.
3 See reconciliations of 2020 GAAP to non-GAAP financial guidance at the conclusion of this press release.
1


PORTFOLIO UPDATES
Ciraparantag (AMAG-977) – As previously announced, AMAG has completed an exclusive licensing agreement with Norgine, a leading European specialist pharmaceutical company, to develop and commercialize ciraparantag in Europe, Australia and New Zealand. Through this agreement, AMAG has received a total of $30 million in upfront consideration and could receive up to $260 million in future contingent development and commercial milestones4 together with escalating double-digit royalties. Additionally, Norgine has committed to contribute one-third of the costs of the Phase 3 clinical program, which would be conducted by AMAG to support regulatory approval of ciraparantag by the U.S. Food and Drug Administration, the European Medicines Agency, and the Medicines and Healthcare Products Regulatory Agency. AMAG will continue to oversee the Phase 3 clinical program, while working closely with Norgine to develop and execute a global development strategy. The company believes this partnership will unlock value in ciraparantag and further strengthen AMAG’s ability to continue investing in innovative therapies that address urgent unmet medical needs.

On July 12, AMAG presented a poster of data titled “Efficacy and Safety of Ciraparantag in Reversing Apixaban and Rivaroxaban in Healthy Adults” at the 2020 International Society on Thrombosis and Haemostatis (ISTH) virtual annual meeting. This presentation shared data from two Phase 2 randomized, placebo-controlled, dose ranging studies which showed safety and efficacy of ciraparantag reversing the effects of apixaban and rivaroxaban in healthy adults age 50-75 years. Results from both studies, which randomized a total of 113 subjects, showed that steady-state anticoagulation induced by apixaban or rivaroxaban was reversed by a single IV infusion of ciraparantag in a dose-related manner as assessed by whole blood clotting time (WBCT).

AMAG-423 – The AMAG-423 Phase 2b/3a study was designed to explore a potential treatment for severe preeclampsia, a serious medical condition that impacts about 50,000 women in the US each year. As previously disclosed, the small population of eligible patients made the study difficult to enroll. The COVID-19 pandemic has led to a global pause for various clinical research projects across therapeutic areas, including the AMAG-423 Phase 2b/3a study. In light of these extended and ongoing delays to study completion, AMAG decided to conduct an interim analysis with data from 55 subjects to validate original study assumptions that were based on the 51-subject proof-of-concept DEEP study completed in 2007. In order to continue keeping AMAG blinded to study treatment assignments, the independent Data and Safety Monitoring Board (DSMB) was tasked with conducting the interim analysis.

Following this interim analysis, the DSMB provided a unanimous recommendation to stop the study, based upon the low likelihood that future enrollment would demonstrate a benefit of AMAG-423 in women with severe preeclampsia. Importantly, there were no safety concerns raised during this study. AMAG has accepted the DSMB’s recommendation to stop the study and is currently focused on ensuring an appropriate closeout of the study in partnership with investigators and other relevant stakeholders.

Divestiture of Intrarosa® and Vyleesi® – As previously announced, AMAG has completed the divestment of Intrarosa® and Vyleesi® which reduces operating expenses and allows the company to focus on optimizing its marketed assets and developing its innovative pipeline.

CORPORATE UPDATES
Leadership Appointments - The company has appointed Brian Piekos as its Chief Financial Officer, effective as of August 13, 2020. Mr. Piekos has served as interim CFO since June 2020 after holding several senior management positions since joining AMAG in 2015.


SECOND QUARTER ENDED JUNE 30
Revenue
Second quarter revenue totaled $52.8 million, compared to $77.8 million for the same period in 2019. This decrease was due to the negative impact of COVID-19 and the October 2019 unfavorable FDA Advisory Committee recommendation on Makena.
4 40.0 million of such milestones would be paid to the former equity holders of Perosphere Pharmaceuticals Inc. pursuant to the Agreement and Plan of Merger with Perosphere.
2


Feraheme achieved second quarter revenue of $29.6 million, a decrease of 30 percent over the same period last year. Feraheme’s average quarterly market share was 17.3 percent in the second quarter of 2020, compared to 17.2 percent in the second quarter of 2019.
Makena second quarter revenue totaled $22.3 million, a decrease of 27 percent over the same period last year. Makena’s average quarterly market share was 66 percent in the second quarter of 2020, compared to 63 percent in the second quarter of 2019.

($M)Three Months Ended June 30,
20202019
Total revenues$52.8$77.8
Feraheme29.642.1
Makena22.330.6
Intrarosa1.24.9
Other(0.4)0.2


Operating Expenses
Total costs and expenses decreased by $134.2 million to $59.8 million in the second quarter of 2020, as compared to the second quarter of 2019.
Cost of products sales in the second quarter of 2020 decreased by $6.1 million, as compared with the second quarter of last year. Direct cost of product sales for the three months ended June 30, 2019 included a $4.8 million one-time inventory write-down related to the Makena IM product. Excluding this one-time inventory write-down, direct cost of product sales declined in the second quarter of 2020 due to reduced Feraheme and Makena sales and the divestment of Intrarosa.
Research and development (R&D) expenses totaled $8.3 million, compared to $15.0 million in the first quarter of last year. This decrease was primarily related to lower costs for Vyleesi following FDA approval in 2019 and COVID-19 related delays in clinical trials.
Selling, general and administrative (SG&A) expenses decreased by approximately $37.8 million, or 49 percent, in the second quarter of 2020, compared to the same period in 2019. This decrease was primarily due to decreases in marketing spend related to women’s health assets and reduced compensation-related costs as a result of the May 2020 restructuring.

($M)Three Months Ended June 30,
20202019
Amortization of intangible assets$9.0$3.9
Direct cost of product sales9.220.3
Total cost of product sales18.224.2
Research and development expenses8.315.0
Selling, general and administrative expenses39.677.3
Impairment of intangible assets77.4
Gain on sale of assets(14.4)
Restructuring expenses8.2
Total costs and expenses$59.8$194.0

Operating Loss and Adjusted EBITDA
The company reported an operating loss of $7.0 million in the second quarter of 2020, compared to an operating loss of $116.2 million in the same period last year.
The company reported a loss in adjusted EBITDA of $1.7 million in the second quarter of 2020, compared to a loss in adjusted EBITDA of $24.7 million in the same period last year.

3


($M)Three Months Ended June 30,
20202019
Operating loss$(7.0)$(116.2)
Non-GAAP adjusted EBITDA5$(1.7)$(24.7)

The financial figures and statements referenced herein have been adjusted to correct immaterial errors in Makena revenue in the historical periods 2016 through the first quarter of 2020; in aggregate, Makena revenue is reduced by $6.3 million over the four-year period. This error was identified by the company during the second quarter of 2020 and relates to the timely accrual of certain governmental rebates. The company and our independent auditors are still reviewing the prior period financial statements and the potential impact on our internal controls over financial reporting for the periods. Therefore, the financials set forth in this release are preliminary and may be updated in the company’s quarterly report on Form 10Q for the quarter ended June 30, 2020. As a result, investors are cautioned not to place undue reliance on these financial statements.

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 2020 financial results and recent business updates.

DIAL-IN NUMBERS
U.S./Canada Dial-in Number: (877) 412-6083
International Dial-in Number: (702) 495-1202
Conference ID: 4548238

Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 4548238

A telephone replay will be available from approximately 11:00 a.m. ET on August 6, 2020 through midnight on August 20, 2020

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.

5 See reconciliations of GAAP to non-GAAP adjustments at the conclusion of this press release.
4


ABOUT AMAG
AMAG is a commercial stage biopharmaceutical 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. 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 contained herein which do not describe historical facts, including, among others, statements regarding the performance of AMAG’s marketed therapeutics, including about the stability of Makena and the momentum of Feraheme through the COVID-19 pandemic; beliefs about the team’s adaptability, the benefits of and expectations for recent business milestones, AMAG’s current pipeline and AMAG’s ability to invest in such pipeline; plans to deliver innovative treatments and unlock shareholder value; beliefs regarding the impact, including on a go-forward basis, of the COVID-19 pandemic on AMAG’s revenues, results of operations and overall business and industry; expectations for the Norgine arrangement, including the ability to unlock value in ciraparantag and invest in innovative therapies; beliefs about AMAG-423; plans to use streamlined operations and to optimize its pipeline; statements regarding 2020 financial guidance, including the expectation of achieving EBITDA positive and the impact of recent events on such guidance, such as the termination of the Palatin license agreement and costs associated with discontinuing the AMAG-423 trial, and statements about AMAG’s ability to deliver long-term growth 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, risks and uncertainties related to the scale and scope of the COVID-19 pandemic and its impact on AMAG’s revenues and operations, including clinical trials, as well as COVID-19’s impact on AMAG’s business partners, healthcare providers, patients, employees and the health care industry and worldwide economies generally, risks related to AMAG’s ability to manage the recently streamlined business and achieve anticipated results in a timely manner or at all, including any unintended consequences from such efforts; the possibility that AMAG’s independent auditors will identify a material weakness as part of their review stemming from the immaterial accounting errors, or that they will identify other errors or corrections, including errors or corrections that could materially impact our financial statements and results provided in this press release; the accounting impact of AMAG’s recent business development activity could have an impact on 2020 guidance; revenue expectations and estimates may be inaccurate, including as a result of regulatory action with respect to Makena or due to COVID-19, AMAG may not successfully develop and obtain approval for ciraparantag or may face challenges in supporting its relationship with Norgine, 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, 2019, its Current Reports on Form 8-K, its Quarterly Reports on Form 10-Q, including for the quarter ended March 31, 2020, and in any subsequent filings with the SEC, including AMAG’s upcoming Form 10-Q for the quarter ended June 30, 2020 , 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. Makena® is a registered trademark of AMAG Pharma USA, Inc. Any other trademarks referred to in this report are the property of their respective owners.

- Tables Follow -
5


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,
2020201920202019
Revenues:
Feraheme$29,635  $42,074  $74,068  $82,089  
Makena22,325  30,593  45,888  61,534  
Intrarosa1,216  4,877  4,385  9,291  
Other(447) 90  (1,199) 133  
Total product revenues52,729  77,634  123,142  153,047  
Other revenues26  133  58  208  
Total revenues52,755  77,767  123,200  153,255  
Operating costs and expenses:
Cost of product sales18,180  24,290  42,539  42,767  
Research and development expenses8,263  14,980  19,443  33,046  
Acquired in-process research and development—  —  —  74,856  
Selling, general and administrative expenses39,568  77,324  92,266  152,006  
Impairment of intangible assets—  77,358  —  77,358  
Gain on sale of assets(14,444) —  (14,444) —  
Restructuring expenses8,197  —  8,197  7,420  
Total costs and expenses59,764  193,952  148,001  387,453  
Operating loss (7,009) (116,185) (24,801) (234,198) 
Other income (expense):
Interest expense(6,700) (6,330) (13,303) (12,780) 
Interest and dividend income327  1,224  804  2,810  
Other (expense) income (22)  1,288  342  
Total other expense, net(6,395) (5,104) (11,211) (9,628) 
Loss before income taxes(13,404) (121,289) (36,012) (243,826) 
Income tax benefit(160) (120) (60) (257) 
Net loss$(13,244) $(121,169) $(35,952) $(243,569) 
Basic and diluted net loss per share$(0.39) $(3.58) $(1.05) $(7.14) 
Weighted average shares outstanding used to compute net loss per share (basic and diluted)34,353  33,807  34,228  34,136  

6


AMAG Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(Unaudited, amounts in thousands)
June 30, 2020December 31, 2019
ASSETS        
Current assets:  
Cash and cash equivalents$98,521  $113,009  
Marketable securities48,594  58,742  
Accounts receivable, net65,104  94,163  
Inventories30,388  31,553  
Prepaid and other current assets20,950  19,100  
Total current assets263,557  316,567  
Property and equipment, net3,031  4,116  
Goodwill422,513  422,513  
Intangible assets, net3,946  23,620  
Operating lease right-of-use asset22,007  23,286  
Deferred tax assets—  630  
Restricted cash495  495  
Total assets$715,549  $791,227  
LIABILITIES AND STOCKHOLDERS’ EQUITY  
Current liabilities:  
Accounts payable$12,944  $27,021  
Accrued expenses144,567  183,382  
Current portion of operating lease liability3,488  4,077  
Current portion of acquisition-related contingent consideration—  17  
Total current liabilities160,999  214,497  
Long-term liabilities:  
Convertible notes, net
285,137  277,034  
Long-term operating lease liability19,263  19,791  
Other long-term liabilities828  89  
Total liabilities466,227  511,411  
Commitments and contingencies  
Stockholders’ equity:  
Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued—  —  
Common stock, par value $0.01 per share, 117,500,000 shares authorized; 34,463,373 and 33,999,081 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively344  339  
Additional paid-in capital1,303,095  1,297,917  
Accumulated other comprehensive loss(2,964) (3,239) 
Accumulated deficit(1,051,153) (1,015,201) 
Total stockholders’ equity249,322  279,816  
Total liabilities and stockholders’ equity$715,549  $791,227  

7


AMAG Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited, amounts in thousands)
 Six Months Ended June 30,
 20202019
Cash flows from operating activities:  
Net loss$(35,952) $(243,569) 
Adjustments to reconcile net loss to net cash used in operating activities:  
Depreciation and amortization19,791  9,089  
Impairment of intangible assets—  77,358  
Provision for bad debt expense230  (12) 
Amortization of premium/discount on purchased securities42  (51) 
Write-down of inventory616  4,836  
(Gain)/loss on disposal of property & equipment230  —  
Non-cash equity-based compensation expense 5,879  9,407  
Non-cash IPR&D expense—  18,029  
Amortization of debt discount and debt issuance costs8,103  7,513  
Gains on marketable securities, net(10) (270) 
Change in fair value of contingent consideration—  (21) 
Deferred income taxes630  630  
Non-cash lease expense1,279  —  
Gain on sale of assets(15,853) —  
Changes in operating assets and liabilities: 
Accounts receivable, net28,828  (7,825) 
Inventories(872) (3,323) 
Prepaid and other current assets(1,790) (5,562) 
Accounts payable and accrued expenses(53,494) 36,137  
Deferred revenues—  (101) 
Other assets and liabilities(377) 1,283  
Net cash used in operating activities(42,720) (96,452) 
Cash flows from investing activities:  
Proceeds from sales or maturities of marketable securities33,735  46,420  
Purchase of marketable securities(23,345) (14,815) 
Net proceeds from the sale of assets19,344  —  
Capital expenditures(790) (1,907) 
Net cash provided by investing activities28,944  29,698  
Cash flows from financing activities:  
Payments to settle convertible notes—  (21,417) 
Payments of contingent consideration(17) (27) 
Payments for repurchases of common stock—  (13,730) 
Proceeds from the issuance of common stock under the ESPP631  851  
Proceeds from the exercise of common stock options—  30  
Payments of employee tax withholding related to equity-based compensation(1,326) (1,748) 
Net cash used in financing activities(712) (36,041) 
Net decrease in cash, cash equivalents, and restricted cash(14,488) (102,795) 
Cash, cash equivalents, and restricted cash at beginning of the period113,504  253,751  
Cash, cash equivalents, and restricted cash at end of the period$99,016  $150,956  
Supplemental data for cash flow information:
Cash (refunded) paid for taxes$(256) $433  
Cash paid for interest$5,200  $5,467  
Non-cash investing and financing activities:
Milestone payment accrued for FDA approval of Vyleesi$—  $60,000  
Settlement of note receivable in connection with Perosphere acquisition$—  $10,000  
Right-of-use assets obtained in exchange for lease liabilities$—  $918  
8



AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Three Months Ended June 30, 2020
(Unaudited, amounts in thousands)

RevenueCost of product salesResearch & developmentSelling, general & administrativeGain on sale of assetsRestructuringOperating Loss / Adjusted EBITDA
GAAP$52,755  $18,180  $8,263  $39,568  $(14,444) $8,197  $(7,009) 
Depreciation and intangible asset amortization—  (8,961) (74) (438) —  —  
Stock-based compensation—  (104) 48  (2,037) —  —  
Gain on sale of assets—  —  —  —  14,444  —  
Restructuring—  —  —  —  —  (8,197) 
Non-GAAP Adjusted$52,755  $9,115  $8,237  $37,093  $—  $—  $(1,690) 








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)

RevenueCost of product salesResearch & developmentSelling, general & administrativeIntangible asset impairment chargeOperating Loss / Adjusted EBITDA
GAAP$77,767  $24,290  $14,980  $77,324  $77,358  $(116,185) 
Depreciation and intangible asset amortization—  (3,943) (336) (434) —  
Stock-based compensation—  (199) (680) (3,656) —  
Asset impairment—  (4,836) —  —  (77,358) 
Non-GAAP Adjusted$77,767  $15,312  $13,964  $73,234  $—  $(24,743) 

















9





AMAG Pharmaceuticals, Inc.
Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations
Six Months Ended June 30, 2020
(Unaudited, amounts in thousands)


RevenueCost of product salesResearch & developmentSelling, general & administrativeGain on sale of assetsRestructuringOperating Loss / Adjusted EBITDA
GAAP$123,200  $42,539  $19,443  $92,266  $(14,444) $8,197  $(24,801) 
Depreciation and intangible asset amortization—  (18,798) (150) (843) —  —  
Stock-based compensation—  (307) (23) (5,549) —  —  
Gain on sale of assets—  —  —  —  14,444  —  
Restructuring—  —  —  —  —  (8,197) 
Non-GAAP Adjusted$123,200  $23,434  $19,270  $85,874  $—  $—  $(5,378) 




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)


RevenueCost of product salesResearch & developmentSelling, general & administrativeAcquired IPR&DIntangible asset impairment chargeRestructuringOperating Loss / Adjusted EBITDA
GAAP$153,255  $42,767  $33,046  $152,006  $74,856  $77,358  $7,420  $(234,198) 
Depreciation and intangible asset amortization—  (7,886) (345) (858) —  —  —  
Stock-based compensation—  (401) (1,360) (6,981) —  —  —  
Acquisition-related costs—  —  —  (270) —  —  —  
Asset impairment—  (4,836) —  —  —  (77,358) —  
Restructuring—  —  —  —  —  —  (7,420) 
Acquired IPR&D—  —  —  —  (74,856) —  —  
Non-GAAP Adjusted$153,255  $29,644  $31,341  $143,897  $—  $—  $—  $(51,627) 









10


AMAG Pharmaceuticals, Inc.
Reconciliation of GAAP to Non-GAAP 2020 Financial Guidance
(Unaudited, amounts in thousands)


2020 Financial Guidance
Operating loss$(40) - $(15)
Depreciation30.0
Stock-based compensation11.0
Gain on sale of assets(14.4)
Restructuring8.2
Non-GAAP adjusted EBITDA$(5) - $20




CONTACT:
Rushmie Nofsinger
781-530-6838

11
q22020ex992
AMAG Pharmaceuticals Second Quarter 2020 Financial Results August 6, 2020 © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 1


 
Forward-Looking Statements This presentation contains forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, expectations that AMAG can return to adjusted EBITDA positive in 2020; anticipated impacts of recent organizational changes; plans to focus on future value drivers and advance assets with the highest potential and probability of success; expectations as to COVID‐19 and its impact on revenues, operations and corporate functions; beliefs and expectations for the Makena retrospective study and interactions with the FDA; beliefs about market share; statements regarding 2020 financial guidance, including the impact of recent events on such guidance, such as the termination of the Palatin license agreement and costs associated with discontinuing the AMAG‐423 program, and beliefs about ciraparantag’s ability to act as a broad‐spectrum reversal agent , 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, risks and uncertainties related to the scale and scope of the COVID‐19 pandemic and its impact on AMAG’s revenues and operations, including clinical trials, as well as COVID‐19’s impact on AMAG’s business partners, healthcare providers, patients, employees and the health care industry and worldwide economies generally, risks related to AMAG’s ability to manage the recently streamlined business and achieve anticipated results in a timely manner or at all, including any unintended consequences from such efforts; the possibility that AMAG’s independent auditors will identify a material weakness as part of their review stemming from the immaterial accounting errors, or that they will identify other errors or corrections, including errors or corrections that could materially impact our financial statements; the accounting impact of our recent business development activity could have a material impact on our guidance; revenue expectations and estimates may be inaccurate, including as a result of regulatory action with respect to Makena or due to COVID‐19; AMAG may not successfully develop and obtain approval for ciraparantag or may face challenges in supporting its relationship with Norgine, 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, 2019, its Current Reports on Form 8‐K, its Quarterly Reports on Form 10‐Q, including for the quarter ended March 31, 2020, and in any subsequent filings with the SEC, including AMAG’s upcoming Form 10‐Q for the quarter ended June 30, 2020, 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. Makena® is a registered trademark of AMAG Pharma USA, Inc. Other trademarks referred to in this report are the property of their respective owners. © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 2


 
1 Making Progress Against our Strategic Evolution 2 Managing our Core Business AGENDA 3 Financial Update 4 Q&A © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 3


 
Making Progress Against Strategic Evolution Recent accomplishments help sharpen focus on future value drivers Building • Scott Myers appointed President & CEO on April 28, 2020 • Tony Casciano promoted to Chief Operating Officer Management Team • Brian Piekos promoted to Chief Financial Officer to Lead Evolution • Additional organizational changes to help create focused, biotech culture Advancing Assets with Highest Potential and Probability of Success Entered into exclusive licensing Completed divestment of women’s Decided to stop AMAG-423 trial agreement with Norgine to develop health assets and commercialize ciraparantag Independent Data Safety and Monitoring • Allows company to reduce operating expenses Board conducted interim analysis across Europe, Australia and New and return focus to core business and • Initiated interim analysis in light of extended Zealand opportunities in pipeline delays caused by COVID‐19 and ongoing • Provides AMAG with $30 million upfront • Intrarosa® rights sold to Millicent Pharma difficulties in enrolling trial payment and eligibility to receive up to $260 Limited for approximately $20.9 million upfront • No safety concerns million in development and commercial fixed consideration milestones1 in addition to sales royalties • Vyleesi® returned to Palatin Technologies • Norgine has committed to contribute one‐third of the costs of the Phase 3 clinical program 1 40.0 million of such milestones will be paid to the former equity holders of Perosphere Pharmaceuticals Inc. pursuant to the Agreement and Plan of Merger with Perosphere © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 4


 
Engagement During COVID-19 Protect the health of our employees AMAG’s Guiding Principles Do our part to stop the spread of COVID-19 During COVID-19 Support our customers and providers by helping them to focus on direct patient care Corporate Functions Remain Engaged • Supply chain remains intact • Regulatory interactions have continued © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 5


 
Makena Update: FDA Still Reviewing Pertinent Information AMAG is committed to generating additional information on efficacy Earlier this spring, AMAG submitted a proposal to the FDA to 1. RETROSPECTIVE STUDY generate additional data. The company proposed two Using secondary data sources observational studies that would support further defining the patient populations that most benefit from 17P as well as predictors of benefit in women with a singleton pregnancy with 2. PROSPECTIVE STUDY history of a spontaneous preterm birth. Primary data collection In mid-July, the FDA indicated they are still reviewing the Makena situation. AMAG has proactively initiated the first part of the retrospective study, which will be important in evaluating the baseline characteristics in patients overall and by treatment status (treated vs. untreated). © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 6


 
Managing Our Core Business Makena Revenue Slightly Impacted by COVID in the Quarter SECOND QUARTER REVENUE EXFACTORY TRENDS (doses) • Q2‐2020 ExFactory volume • Q2‐2020 Revenue of $22.3M $30.6 was 27% below Q2‐2019 was 5% below Q1 20201 $22.3 • Q2‐2020 Market Share of 66% • Q2 ‐2020 Average share was 3% above Q2 20191 above Q1‐20201 Q2-2019 Q2-2020 JAN FEB MAR APR MAY JUN • Limited impact to Makena revenue in the quarter due to COVID‐191 COVID-19 • Some softening of patient enrollments observed following field restructuring in May2 1 AMAG estimates market share and market growth using IQVIA data and internal analytics 2Source: MCC enrollment data © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 7


 
Managing Our Core Business Feraheme Revenue Impacted by COVID; Returned to Growth in June SECOND QUARTER REVENUE EXFACTORY TRENDS (grams) $42.1 • Q2‐2020 Revenue of $29.6M • $29.6 Q2 –2020 ExFactory volume was 30% below Q2‐2019 was 26% below Q1‐ 20201 • Q2 ‐2020 Market share of 17.3% • June 2020 ExFactory 1 was 0.1% above Q2‐2019 volume and market share above Pre COVID Levels1 Q2-2019 Q2-2020 JAN FEB MAR APR MAY JUN • Feraheme volumes disproportionately impacted to start the quarter as patient visits to HCPs declined2 COVID-19 • Monthly market share and exFactory volume record highs in June 20201 1 AMAG estimates market share and market growth using IQVIA data and internal analytics. 2 Source: IQVIA: Medical Claims Data Analysis, 2020 © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 8


 
Second Quarter Financial Results $M Q2-2020 Q2-2019 Feraheme $29.6 $42.1 Makena 22.3 30.6 • Revenues Intrarosa 1.2 4.9 – Decrease primarily due to negative impact of Other (0.4) 0.2 COVID‐19 during quarter and the October 2019 unfavorable FDA Advisory Committee Total revenues $52.8 $77.8 recommendation on Makena Cost of product sales $18.2 $24.2 Research and development 8.3 15.0 Selling, general and administrative 39.6 77.3 Gain on sale off assets (14.4) ‐‐ • Operating Expenses Restructuring 8.2 ‐‐ – R&D decline due to COVID‐driven delays and 2Q‐19 Impairment of intangible assets ‐‐ 77.4 Vyleesi expenses Total costs and expenses $59.8 $194.0 – S, G&A ~50% decline driven by exit of Women’s Health business and associated restructuring GAAP operating loss ($7.0) ($116.2) Non-GAAP adjusted EBITDA(1) ($1.7) ($24.7) 1 See slide 14 for a reconciliation of GAAP to non‐GAAP financial results. © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 9


 
Reissued Guidance Confirms a Return to Positive Adjusted EBITDA 2020 FINANCIAL GUIDANCE1 ($M) Total revenue $225 ‐ $255 Operating loss $(40) ‐ $(15) Adjusted EBITDA2 $(5) ‐ $20 Risk‐adjusted topline view S, G&A expenses reduced by R&D expenses reduced due to given uncertainty caused by: ~$100M vs. 2019 discontinuation of AMAG‐423 program and COVID‐driven delays • COVID related business • Driven by Women’s Health disruption product divestitures and in ciraparantag development • Makena FDA Advisory associated restructuring Committee outcome 1 2020 Operating Loss financial guidance excludes the accounting impact of the following subsequent events announced in July: termination of the Vyleesi license agreement with Palatin and costs associated with discontinuing the AMAG‐423 program. 2 See slide 15 for a reconciliation of GAAP to non‐GAAP financial guidance. FINANCIAL © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 10


 
2020: Goals and Key Areas of Focus for AMAG GOALS Successful CEO transition COMPLETED Divest Intrarosa® and Vyleesi® to align with the new strategic direction Completed exclusive licensing agreement with Norgine for ciraparantag Advance AMAG-423 and Drive continued Maintain patient access to ciraparantag development Reach adjusted EBITDA Feraheme growth Makena programs positive UPDATE UPDATE AMAG-423 UPDATE Strong recovery during Q2 Initiating retrospective data Stopped Phase 2b/3a trial Reissued guidance includes amidst COVID‐19 pandemic analysis as part of our following recommendation EBITDA‐positive projection in commitment to generate from DSMB 2H‐20 additional data on efficacy Field teams continue to promote CIRAPARANTAG Advancing and educate on product preparations for use of coagulometer in Phase 2b studies © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 11


 
AMAG Pharmaceuticals Q&A © 2019 AMAG Pharmaceuticals, Inc. All© rights 2020 reservedAMAG Pharmaceuticals, Inc. All rights reserved 12


 
Appendix 13


 
Reconciliation of GAAP to Non-GAAP Financial Results ($M) YTD-2020 YTD-2019 Q2-2020 Q2-2019 GAAP operatingloss ($24.8) ($234.2) ($7.0) ($116.2) Depreciation andintangible asset amortization 19.7 9.1 9.4 4.7 Stock‐based compensation 5.9 8.7 2.1 4.5 Restructuring 8.2 7.4 8.2 ‐‐ Gain on Asset Sale (14.4) ‐‐ (14.4) ‐‐ Transaction / acquisition‐related costs ‐‐ 0.3 ‐‐ ‐‐ AcquiredIPR&D ‐‐ 74.9 ‐‐ ‐‐ Asset impairment charges ‐‐ 82.2 ‐‐ 82.2 Non-GAAP adjusted EBITDA ($5.4) ($51.6) ($1.7) ($24.7) © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 14


 
Reconciliation of GAAP to Non-GAAP 2020 Financial Guidance ($M) 2020 Financial Guidance GAAP operating income $(40) - $(15) Depreciation & intangible asset amortization 30 Stock‐based compensation 11 Restructuring 8.2 Gain on sale of assets (14.4) Non-GAAP adjusted EBITDA $(5) - $20 APPENDIX © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 15


 
AMAG Pharmaceuticals Second Quarter 2020 Financial Results August 6, 2020 © 2019 AMAG Pharmaceuticals, Inc. All© rights 2020 reservedAMAG Pharmaceuticals, Inc. All rights reserved 16