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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): March 3, 2020

 

 

 

AMAG PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other jurisdiction of incorporation)

 

001-10865   04-2742593
(Commission File Number)   (IRS Employer Identification No.)

 

1100 Winter Street, Waltham, Massachusetts 02451
(Address of Principal Executive Offices) (Zip Code)

 

(617) 498-3300

(Registrant’s telephone number, including area code)

 

 

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

 

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

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, par value $0.01 per share   AMAG   NASDAQ Global Select Market

 

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

 

Emerging growth company  ¨

 

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

 

 

 

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 (the “Exchange Act”), 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 (the “Securities Act”), except as expressly set forth by specific reference in such filing. 

 

On March 4, 2020, AMAG Pharmaceuticals, Inc. (“AMAG”) issued a press release announcing its operating results for the quarter and year ended December 31, 2019 and its intention to hold a conference call to discuss AMAG’s financial results and provide a business update, including an update on recent corporate developments. 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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On March 4, 2020, AMAG also announced that Julie Krop, M.D., AMAG’s Executive Vice President and Chief Medical Officer, will be leaving AMAG, effective March 31, 2020. In exchange for her agreeing to provide support and transition services through March 31, 2020, AMAG has agreed to provide Dr. Krop with a lump-sum payment of $288,000, subject to certain conditions, including that Dr. Krop execute an effective release and waiver of claims for the benefit of AMAG, as provided in a separation letter expected to be entered into on or about the date hereof.

 

The foregoing description of the separation letter is not complete and is qualified in its entirety by reference to the letter, which will be filed as an exhibit to AMAG’s Quarterly Report on Form 10-Q for the quarter ending March 31, 2020.

 

Item 7.01. Regulation FD Disclosure. 

 

The information in this Item 7.01, including Exhibit 99.3 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act, except as expressly set forth by specific reference in such filing.  

 

On March 4, 2020, AMAG issued a press release announcing Dr. Krop’s departure and related matters. A copy of AMAG’s press release is furnished herewith as Exhibit 99.3. 

 

Item 9.01. Financial Statement and Exhibits.

 

(d) Exhibits.

 

Exhibit

No.

  Description
99.1   Press Release of AMAG Pharmaceuticals, Inc., dated March 4, 2020 (furnished herewith)
99.2   Copy of AMAG Pharmaceuticals, Inc.’s presentation slides dated March 4, 2020 (furnished herewith)
99.3   Press Release of AMAG Pharmaceuticals, Inc., dated March 4, 2020 (furnished herewith)

 

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
    Chief Business Officer, General Counsel & Corporate Secretary
     
  Dated:    March 4, 2020

 

3

 

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

AMAG PHARMACEUTICALS REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS

AND PROVIDES CORPORATE UPDATE

 

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

 

WALTHAM, Mass., (March 4, 2020) AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited consolidated financial results for the fourth quarter and full year ended December 31, 2019. Total revenues for the full year of 2019 totaled $327.8 million, including revenue of $167.9 million from Feraheme® (ferumoxytol injection), revenue of $122.1 million from Makena® (hydroxyprogesterone caproate injection), and revenue of $21.4 million from Intrarosa® (prasterone). The company reported an operating loss of $445.5 million and an adjusted EBITDA loss of $65.0 million in 2019.1

 

“Our financial results reported today reflect the successes and challenges of 2019. While we achieved record revenue for Feraheme and gained our third FDA approval in two years, we faced some challenges, namely the readout of the PROLONG study and the October Advisory Committee for Makena,” said William Heiden, AMAG’s president and chief executive officer. “We acknowledged the Makena challenges in our recently-completed strategic review, resulting in our decision to divest Intrarosa and Vyleesi®. We believe this decision will position the company well to focus on the continuing development of ciraparantag and AMAG-423, drive continued growth of Feraheme, and continue our work to retain patient access to Makena. Preparing for the future, the board of directors has initiated a search for my successor to lead the company on the next leg of the AMAG journey, serving shareholders and patients with unmet medical needs.”

 

 

 

 

FINANCIAL RESULTS FOR THE PERIODS ENDED DECEMBER 31

Fourth Quarter Financial Results

 

   Three Months Ended December 31, 
($M)  2019   2018 
Revenues  $89.7   $88.1 
Feraheme   41.7    35.2 
Makena   25.6    46.9 
Intrarosa   6.5    5.9 
Other product revenue   (0.4)   0.1 
Collaboration revenue   16.3     
Costs and expenses  $283.6   $106.9 
Cost of product sales   43.3    28.7 
Research and development   16.5    12.2 
Selling, general and administrative expenses   68.8    66.0 
Impairment of assets   155.0     
Operating loss  $(193.9)  $(18.8)
Adjusted EBITDA1  $(5.8)  $1.5 

____________________________

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

 

Revenues

During the fourth quarter ended December 31, 2019 revenue totaled $89.7 million, compared with $88.1 million for the same period in 2018.

In the fourth quarter of 2019 sales of Feraheme totaled $41.7 million, compared with $35.2 million in the same period in 2018, sales of Makena totaled $25.6 million, compared with $46.9 million in the same period in 2018, and sales of Intrarosa totaled $6.5 million, compared with $5.9 million in the same period in 2018.
Included in revenue for the fourth quarter of 2019 was $16.3 million of collaboration revenue recognized in connection with a termination and settlement agreement entered into with Daiichi Sankyo, Inc. (DSI) related to a clinical trial collaboration agreement that AMAG acquired as part of the Perosphere acquisition. Under the terms of the settlement agreement with DSI, AMAG received $10.0 million in cash and recognized an additional $6.3 million of deferred revenue in December 2019.

 

Costs and Expenses

Costs and expenses in the fourth quarter ended December 31, 2019 totaled $283.6 million, compared with $107.0 million in the same period in 2018.

During the fourth quarter of 2019, the company identified indicators of impairment for the Makena subcutaneous auto-injector, Intrarosa and Vyleesi asset groups related to i) the unfavorable FDA Advisory Committee recommendation for Makena on October 29, 2019 and ii) the completion of a strategic review, which resulted in the company's intention to divest Intrarosa and Vyleesi. Total impairment charges of $155.0 million were recorded in a separate operating expense line in the fourth quarter of 2019.

 

 

 

 

Operating Loss and Adjusted EBITDA

The company reported an operating loss in the fourth quarter ended December 31, 2019 of $193.9 million, which included the $155.0 million of impairment charges discussed above, compared to an operating loss of $18.8 million for the same period last year.
The company reported an adjusted EBITDA loss of $5.8 million in the fourth quarter of 2019, compared with adjusted EBITDA of $1.5 million for the same period last year.1

 

Full Year Financial Results

 

   Twelve Months Ended December 31, 
($M)  2019   2018 
Revenues  $327.8   $474.0 
Feraheme   167.9    135.0 
Makena   122.1    322.3 
Intrarosa   21.4    16.2 
Other product revenue   (0.2)   0.4 
Collaboration and other revenue   16.6    0.1 
Costs and expenses  $773.3   $521.0 
Cost of product sales   107.2    215.9 
Research and development   64.9    44.8 
Acquired in-process research and development   74.9    32.5 
Selling, general and administrative expenses   286.6    227.8 
Impairment of assets   232.3     
Restructuring   7.4     
Operating loss  $(445.5)  $(47.0)
Adjusted EBITDA1  $(65.0)  $120.8 

 

Revenues

Revenues totaled $327.8 million in 2019, compared with $474.0 million in 2018.

Feraheme achieved record revenue of $167.9 million in 2019, an increase of 24% over 2018, and market share of 17.7%. The overall IV iron market grew 12.0% in 2019 from 2018.
Makena revenues totaled $122.1 million in 2019, compared with $322.3 million in 2018. This decrease was primarily due to a decrease in sales of the Makena intramuscular (IM) product caused by IM supply disruptions and generic competition, which resulted in the company ultimately removing the IM product, including its authorized generic, from the market. Partially offsetting the decrease in Makena IM revenues was an increase in Makena subcutaneous auto-injector revenues.
Intrarosa revenues increased 32% to $21.4 million in 2019, compared with $16.2 million in 2018.

 

Costs and Expenses

Costs and expenses in 2019 totaled $773.3 million, compared with $521.0 million in 2018. This increase includes i) impairment charges of $232.3 million related to second quarter impairment charges of $77.4 million and the fourth quarter impairment charges described earlier, ii) a $74.9 million acquired in-process research and development charge related to the acquisition of Perosphere Pharmaceuticals, which closed in the first quarter of 2019, and iii) a restructuring charge of $7.4 million related to combining the Maternal Health and Women's Health sales forces in the first quarter of 2019.

Cost of product sales decreased $108.7 million year-over-year, primarily due to a decrease in amortization related to the Makena IM product that was fully impaired in the second quarter of 2019.
SG&A expenses increased $58.8 million to $286.6 million in 2019, compared with $227.8 million in 2018. SG&A expenses in 2018 included a reversal of $49.6 million related to a Makena sales milestone that the company determined was not likely to be paid. Excluding this expense reversal, SG&A increased by $9.2 million, which was primarily driven by the commercial launch of Vyleesi in September 2019.
Research and development expenses increased $20.0 million to $64.9 million in 2019, primarily related to the development costs for the ciraparantag and AMAG-423 programs.

 

 

 

 

Operating Loss and Adjusted EBITDA

The company reported an operating loss of $445.5 million in 2019, compared with an operating loss of $47.0 million in 2018.
The company reported an adjusted EBITDA loss of $65.0 million in 2019, compared with adjusted EBITDA of $120.8 million in 2018.1

 

Balance Sheet

As of December 31, 2019, the company’s cash and investments totaled $171.8 million.
As of December 31, 2019 long-term debt totaled $320.0 million (representing the principal amount outstanding of the 2022 convertible notes).

 

“Despite the challenges that the company faced throughout 2019, the growth in Feraheme revenues emerged as a bright spot for the year. Even with a soft fourth quarter for Makena, we managed our spend to achieve our adjusted EBITDA financial guidance for the year,” said Ted Myles, AMAG’s chief operating officer and chief financial officer. “For 2020, we have guided to a return to profitability based on revenues of $255 million at the midpoint. We believe that our capital allocation strategy, which includes the divestiture of Intrarosa and Vyleesi and associated expense reductions, positions us well to focus on our core value drivers. AMAG's unique portfolio combines the opportunity to generate positive cash flows from commercial products while advancing a potentially exciting pipeline of development products.”

 

2020 FINANCIAL GUIDANCE2

The company reaffirms the following financial guidance for 2020.

 

($M) 2020 Financial Guidance
Total revenue $230 - $280
Operating income $2 - $32
Non-GAAP adjusted EBITDA $20 - $50

 

2 See reconciliation of 2020 GAAP to non-GAAP financial guidance at conclusion of this press release.

 

2020 KEY PRIORITIES

Complete successful CEO transition 
Divest Intrarosa and Vyleesi to align with the new strategic direction 
Drive continued Feraheme growth 
Work with the FDA to maintain patient access to Makena  
Advance ciraparantag and AMAG-423 development programs  
Pursue ex-U.S. portfolio partnering opportunities 
Meet or exceed financial guidance 

 

 

 

 

CONFERENCE CALL AND WEBCAST ACCESS

AMAG Pharmaceuticals, Inc. will host a conference call and webcast today at 8:00 a.m. EST to discuss the company's fourth quarter and full year 2019 financial results.

 

DIAL-IN NUMBER

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

International Dial-in Number: (702) 495-1202

Conference ID: 5865557

 

Replay Dial-in Number: (855) 859-2056

Replay International Dial-in Number: (404) 537-3406

Conference ID: 5865557

 

A telephone replay will be available from approximately 11:00 a.m. ET on March 4, 2020 through midnight on March 11, 2020.

 

The webcast with slides will be accessible through the Investors section of AMAG’s website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.

 

USE OF NON-GAAP FINANCIAL MEASURES

AMAG has presented certain non-GAAP financial measures, including non-GAAP 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.

 

ABOUT AMAG

AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging our 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 contained herein which do not describe historical facts, including, among others, beliefs about the performance of AMAG’s commercially available products; beliefs regarding AMAG’s ability to drive continued Feraheme growth; expectations for ciraparantag and AMAG-423 studies, including development timelines; AMAG’s expectations regarding its ability to successfully divest Intrarosa and Vyleesi and the effect and amount of associated expense reductions; AMAG’s expectations regarding its ability to ensure continued patient access to Makena and the associated effect on cash flow; beliefs regarding AMAG’s ability to return to profitability; expectations that AMAG remains on track to return to positive adjusted EBITDA in 2020 and other 2020 financial guidance; plans to search for a successor to AMAG’s president and chief executive officer, and the ability to affect a smooth transition William Heiden and the ability to effect a successful transition; plans to pursue ex-U.S. portfolio partnering opportunities; 2020 financial guidance, including forecasted GAAP revenue and operating loss and non-GAAP adjusted EBITDA; and beliefs regarding AMAG's ability to optimize the value of its portfolio to maximize shareholder value are based on management’s current expectations and beliefs and are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.

 

Such risks and uncertainties include, among others, risks that the FDA will withdraw approval of Makena in line with the recommendation of the Advisory Committee; the FDA could take other adverse action related to Makena given the findings and recommendation of the Advisory Committee; AMAG may not be able to generate additional efficacy data that will be satisfactory to the FDA (if the FDA permits AMAG to submit additional data to support or as a condition to the continued commercialization of Makena); healthcare providers may be reluctant to continue to prescribe the Makena auto-injector or the FDA may require that the Makena label include information on the PROLONG study, restrictions to the current indication or the insertion of new warnings or precautions; AMAG is unable to generate sufficient cash to satisfy its debt obligations and could face challenges undertaking fundraising, restructuring or strategic transactions in order to meet these obligations, including under convertible notes due June 1, 2022; AMAG will be significantly dependent on sales of Feraheme to support its ongoing operations, including its development pipeline, and Feraheme could face increased competition in the near term, including as a result of the recent approval of Monoferric® or if Sandoz’s ANDA is approved; that AMAG will face difficulties or delays in appointing a chief executive officer to succeed Mr. Heiden or otherwise be unable to successfully transition to a new CEO; AMAG will not be able to divest Intrarosa or Vyleesi in the expected timeframe, or at all, or that any transaction will be on terms that are favorable to AMAG or that yield any value for its shareholders; that the anticipated benefits of such a divestiture, including anticipated expense reductions, will not be realized at expected levels, or at all; that AMAG may be unable to gain approval of its product candidates, including AMAG-423 and ciraparantag, on a timely basis, or at all; that such approvals, if obtained, will include unanticipated restrictions or warnings and that the costs and time investments for AMAG’s development efforts will be higher than anticipated, or that AMAG has over-estimated the market and potential revenues for its products and product candidates, if approved, including AMAG-423 and ciraparantag; that AMAG will be unable to successfully identify and enter into partnerships with out-licensees for its product candidates in ex-U.S. territories, which could delay the commercialization of those product candidates in certain geographies, as well as those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2018, its Quarterly Report on Form 10-Q for the quarters ended March 31, 2019, June 30, 2019 and September 30, 2019, and subsequent filings with the SEC (including its upcoming Annual Report on Form 10-K for the year ended December 31, 2019), 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, Feraheme® and Vyleesi ® are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc. Other trademarks referred to in this report are the property of their respective owners.

 

 

 

- Tables Follow -

 

 

 

 

AMAG Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(unaudited, amounts in thousands, except for per share data)

 

   Three Months Ended December 31,  Year Ended December 31, 
   2019   2018  2019   2018 
Revenues:                   
Feraheme  $41,653   $35,204  $167,947   $135,001 
Makena   25,601    46,888   122,064    322,265 
Intrarosa   6,520    5,888   21,417    16,218 
Other   (395)   67   (238)   368 
Total product sales, net   73,379    88,047   311,190    473,852 
Collaboration revenue   16,299       16,400     
Other revenue   31    75   161    150 
Total revenues   89,709    88,122   327,751    474,002 
Costs and expenses:                   
Cost of product sales   43,322    28,716   107,193    215,892 
Research and development expenses   16,476    12,211   64,853    44,846 
Acquired in-process research and development          74,856    32,500 
Selling, general and administrative expenses   68,873    66,030   286,600    227,810 
Impairment of assets   154,978       232,336     
Restructuring expenses          7,420     
Total costs and expenses   283,649    106,957   773,258    521,048 
Operating loss   (193,940)   (18,835)  (445,507)   (47,046)
Other income (expense):                   
Interest expense   (6,510)   (6,571)  (25,709)   (51,971)
Loss on debt extinguishment              (35,922)
Interest and dividend income   636    2,120   4,285    5,328 
Other (expense) income   (134)   (10)  428    (74)
Total other expense, net   (6,008)   (4,461)  (20,996)   (82,639)
Loss from continuing operations before income taxes   (199,948)   (23,296)  (466,503)   (129,685)
Income tax (benefit) expense   (21)   (2,550)  (47)   39,654 
Net loss from continuing operations   (199,927)   (20,746)  (466,456)   (169,339)
                    
Discontinued operations:                   
Income from discontinued operations              18,873 
Gain on sale of CBR business       (2,506)      87,076 
Income tax expense       (975)      2,371 
Net (loss) income from discontinued operations       (1,531)      103,578 
                    
Net loss  $(199,927)  $(22,277) $(466,456)  $(65,761)
                    
Basic and diluted earnings per share:                   
Loss from continuing operations  $(5.89)  $(0.60) $(13.71)  $(4.92)
Income from discontinued operations       (0.04)      3.01 
Total  $(5.89)  $(0.64) $(13.71)  $(1.91)
                    
Weighted average shares outstanding used to compute earnings per share (basic and diluted):   33,945    34,560   34,030    34,394 

 

 

 

 

AMAG Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(unaudited, amounts in thousands)

 

   December 31, 2019   December 31, 2018 
ASSETS          
Current assets:          
Cash and cash equivalents  $113,009   $253,256 
Marketable securities   58,742    140,915 
Accounts receivable, net   94,163    75,347 
Inventories   31,553    26,691 
Prepaid and other current assets   19,100    18,961 
Note receivable       10,000 
Total current assets   316,567    525,170 
Property and equipment, net   4,116    7,521 
Goodwill   422,513    422,513 
Intangible assets, net   23,620    217,033 
Operating lease right-of-use asset   23,286     
Deferred tax assets   630    1,260 
Restricted cash   495    495 
Other long-term assets       1,467 
Total assets  $791,227   $1,175,459 
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable  $27,021   $14,487 
Accrued expenses   177,079    129,537 
Current portion of convertible notes, net       21,276 
Current portion of operating lease liability   4,077     
Current portion of acquisition-related contingent consideration   17    144 
Total current liabilities   208,194    165,444 
Long-term liabilities:          
Convertible notes, net   277,034    261,933 
Long-term operating lease liability   19,791     
Long-term acquisition-related contingent consideration       215 
Other long-term liabilities   89    1,212 
Total liabilities   505,108    428,804 
           
Commitments and Contingencies (Note P)          
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; 33,999,081 and 34,606,760 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively   339    346 
Additional paid-in capital   1,297,917    1,292,736 
Accumulated other comprehensive loss   (3,239)   (3,985)
Accumulated deficit   (1,008,898)   (542,442)
Total stockholders’ equity   286,119    746,655 
Total liabilities and stockholders’ equity  $791,227   $1,175,459 

 

 

 

 

AMAG Pharmaceuticals, Inc.

Condensed Consolidated Statements of Cash Flows

(unaudited, amounts in thousands, except for per share data)

 

   Years Ended December 31, 
   2019   2018 
Cash flows from operating activities:          
Net loss  $(466,456)  $(65,761)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:          
Depreciation and amortization   27,324    172,223 
Impairment of long-lived assets   232,336     
Provision for bad debt expense       678 
Amortization of premium/discount on purchased securities   (95)   87 
Write-down of inventory   19,767    5,176 
(Gain) loss on disposal of fixed assets       (99)
Non-cash equity-based compensation expense   19,198    19,916 
Non-cash IPR&D expense   18,029     
Loss on debt extinguishment       35,922 
Amortization of debt discount and debt issuance costs   15,242    15,658 
(Gain) loss on sale of marketable securities, net   (265)   (1)
Change in fair value of contingent consideration   (270)   (49,607)
Deferred income taxes   404    41,166 
Non-cash lease expense   2,725     
Gain on sale of the CBR business       (87,076)
Transaction costs       (14,111)
Changes in operating assets and liabilities:          
Accounts receivable, net   (18,816)   16,995 
Inventories   (19,253)   (454)
Prepaid and other current assets   (113)   (6,097)
Accounts payable and accrued expenses   52,747    (32,568)
Deferred revenues   (6,400)   8,658 
Other assets and liabilities   (1,800)   95 
Net cash (used in) provided by operating activities   (125,696)   60,800 
Cash flows from investing activities:          
Proceeds from sales or maturities of marketable securities   98,321    85,342 
Purchases of marketable securities   (14,815)   (89,956)
Milestone payment for Vyleesi developed technology   (60,000)    
Proceeds from the sale of the CBR business       519,303 
Note receivable       (10,000)
Capital expenditures   (2,544)   (2,534)
Net cash provided by investing activities   20,962    502,155 
Cash flows from financing activities:          
Long-term debt principal payments       (475,000)
Payments to repurchase 2019 Convertible Notes   (21,417)    
Payment of premium on debt extinguishment       (28,054)
Payment of contingent consideration   (72)   (119)
Payments for repurchases of common stock   (13,730)    
Proceeds from the issuance of common stock under the ESPP   1,506     
Proceeds from the exercise of common stock options   30    3,881 
Payments of employee tax withholding related to equity-based compensation   (1,830)   (2,682)
Net cash used in financing activities   (35,513)   (501,974)
Net (decrease) increase in cash, cash equivalents and restricted cash   (140,247)   60,981 
Cash, cash equivalents and restricted cash at beginning of the year   253,751    192,770 
Cash, cash equivalents and restricted cash at end of the year  $113,504   $253,751 
           
Supplemental data of cash flow information:          
Cash (refunded) paid for taxes  $(202)  $5,345 
Cash paid for interest  $10,667   $48,757 
Non-cash investing and financing activities:          
Right-of-use assets obtained in exchange for lease obligations  $18,455   $ 
Settlement of note receivable in connection with Perosphere acquisition  $10,000   $ 

 

 

 

 

AMAG Pharmaceuticals, Inc.

Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations

Three Months Ended December 31, 2019

(unaudited, amounts in thousands)

 

   Revenue   Cost of
product
sales
   Research &
development
   Selling,
general &
administrative
   Asset
impairment
charges
   Operating
Loss /
Adjusted
EBITDA
 
GAAP  $89,709   $43,322   $16,476   $68,873   $154,978   $(193,940)
Depreciation and intangible asset amortization       (12,666)   (101)   (684)         
Stock-based compensation       (245)   (793)   (3,779)         
Charges related to impairment       (14,893)           (154,978)     
Non-GAAP Adjusted  $89,709   $15,518   $15,582   $64,410   $   $(5,801)

 

AMAG Pharmaceuticals, Inc.

Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations

Three Months Ended December 31, 2018

(unaudited, amounts in thousands)

 

   Revenue   Cost of
product
sales
   Research &
development
   Selling,
general &
administrative
   Operating
Loss /
Adjusted
EBITDA
 
GAAP  $88,122   $28,716   $12,211   $66,030   $(18,835)
Depreciation and intangible asset amortization       (13,714)   (9)   (372)     
Non-cash inventory step-up adjustments       (126)             
Stock-based compensation       (215)   (637)   (4,465)     
Adjustments to contingent consideration               432      
Acquisition related costs               (1,257)     
Non-GAAP Adjusted  $88,122   $14,661   $11,565   $60,368   $1,528 

 

 

 

 

AMAG Pharmaceuticals, Inc.

Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations

Twelve Months Ended December 31, 2019

(unaudited, amounts in thousands)

 

   Revenue   Cost of
product
sales
   Research &
development
   Selling,
general &
administrative
   Asset
impairment
charges
   Acquired IPR&D   Restructuring   Operating
Loss /
Adjusted
EBITDA
 
GAAP  $327,751   $107,193   $64,853   $286,600   $232,336   $74,856   $7,420   $(445,507)
Depreciation and intangible asset amortization       (24,764)   (572)   (1,988)                 
Stock-based compensation       (871)   (2,844)   (14,818)                 
Acquired IPR&D                       (74,856)         
Charges related to impairment       (19,729)           (232,336)             
Restructuring charges                           (7,420)     
Acquisition related costs               (270)                 
Non-GAAP Adjusted  $327,751   $61,829   $61,437   $269,524   $   $   $   $(65,039)

 

AMAG Pharmaceuticals, Inc.

Reconciliation of Condensed Consolidated Statements of Operations to Non-GAAP Statements of Operations

Twelve Months Ended December 31, 2018

(unaudited, amounts in thousands)

 

   Revenue   Cost of
product
sales
   Research &
development
   Selling,
general &
administrative
   Acquired IPR&D   Operating
Loss /
Adjusted
EBITDA
 
GAAP  $474,002   $215,892   $44,846   $227,810   $32,500   $(47,046)
Depreciation and intangible asset amortization       (158,446)   (21)   (1,592)         
Non-cash inventory step-up adjustments       (3,728)                 
Stock-based compensation       (802)   (2,533)   (16,614)         
Adjustments to contingent consideration               49,607          
Acquired IPR&D                   (32,500)     
Acquisition related costs               (1,257)         
Non-GAAP Adjusted  $474,002   $52,916   $42,292   $257,954   $   $120,840 

 

 

 

 

AMAG Pharmaceuticals, Inc.

Reconciliation of 2019 Financial Guidance of Non-GAAP Adjusted EBITDA

(Unaudited, amounts in millions)

 

Operating income  $2 - $32 
Depreciation   2 
Stock-based compensation   16 
Adjusted EBITDA   $20 - $50 

 

AMAG Pharmaceuticals, Inc.

Share Count Reconciliation

(unaudited, amounts in millions)

 

   Three Months Ended December 31,   Twelve Months Ended December 31, 
   2019   2018   2019   2018 
Weighted average basic shares outstanding   33.9    34.6    34.0    34.4 
Employee equity incentive awards   3   3   3   3
GAAP diluted shares outstanding   33.9    34.6    34.0    34.4 
Employee equity incentive awards   4   0.34   4   0.34
Non-GAAP diluted shares outstanding   33.9    34.9    34.0    34.7 

3 Employee equity incentive awards would be anti-dilutive in this period.

4 Reflects the non-GAAP dilutive impact of employee equity incentive awards.

 

CONTACTS:

Investors:

Linda Lennox

908-627-3424

 

Media:

Sarah Connors

781-296-0722

 

 

 

 

Exhibit 99.2

 

1 © 2020 AMAG Pharmaceuticals, Inc. All rights reserved AMAG Pharmaceuticals Fourth Quarter / Full Year 2019 Financial Results March 4, 2020

 

 

© 2020 AMAG Pharmaceuticals, Inc. All rights reserved This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1 995 (PSLRA) and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, expectations related to the time to complete a CEO search the ability to effect a suc cessful transition; AMAG’s expectations regarding its ability to successfully divest Intrarosa and Vyleesi and the effect and amount of associated expense reductions; plans to reduce operating expenses; beliefs that a streamlined po rtf olio and infrastructure will position AMAG for near - and long - term profitability; AMAG’s expectations regarding its ability to drive continued Feraheme growth and that Feraheme will provide positive cash flow to fund its development programs; AMAG’s expectations regarding its ability to ensure continu ed patient access to Makena and the associated effect on cash flow; AMAG’s expectations for its product and product candidate portfolio, including belief s a bout the assumptions regarding market share and commercial potential of AMAG’s key commercial and product candidates; plans to continue to invest in late - stage development programs and the results thereof; beliefs about the be haviors of patients and prescribers of Makena and the associated risks; beliefs about the NOAC market and that ciraparantag’s characteristics may offer a more optimal reversal agent; beliefs that AMAG will be able to work collaboratively with the FDA on a path forward that would allow for continued patient access to Makena; AMAG’s expectations regarding the potential for ex - U.S. out - licensing and partnership opportunities; 2020 financial guid ance, including forecasted GAAP revenue and operating loss and non - GAAP adjusted EBITDA; and AMAG’s 2020 goals and key areas of focus, including expectations and beliefs regarding ( i ) AMAG’s ability to successfully achieve benefits from its leadership transition plan, including managing the search for and tra nsition to a new chief executive officer, (ii) AMAG’s ability to successfully divest Intrarosa and Vyleesi and the effect and amount of associated expense reductions; (iii) AMAG’s ability to drive continued Feraheme growth sufficient to support AMAG’s development programs, (iv) AMAG’s ability to ensure continued patient access to Makena and that Makena is cash flow po sit ive in 2020, (v) AMAG’s pipeline, including AMAG - 423 and ciraparantag, (vi) AMAG’s ability to successfully out - license its products or product candidates in ex - U.S. territories and (vii) AMAG’s ability to meet or exceed it s 2020 financial guidance 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 AMAG will be unable to divest Intrarosa and Vyleesi in the expected timeframe, or at all, or that any transaction will be on terms that are favorable to AMAG or that yield any value for its shareholders; the risk that the anticipated benefits of such a divestiture, including anticipated exp ens e reductions, will not be realized at expected levels or at all or that cash expenditures will be greater than anticipated; the risk that the FDA will recommend that Makena be removed from the market, in line with the recommendation of the Advisory Committee; the risk that the FDA could take other adverse action related to Makena given the findings and recommendation of the Advisory Committee; the risk that, even if the FDA does not recommend that Maken a b e removed from the market, sales of Makena will continue to be negatively impacted, including as a result of the recommendation of the Advisory Committee; the risk that AMAG may not be able to generate additional effica cy data that will be satisfactory to the FDA (if the FDA permits AMAG to submit additional data to support or as a condition to the continued commercialization of Makena); the risk that healthcare providers may be reluctant to continue to prescribe the Makena auto - injector or the FDA may require that the Makena label may include restrictions to the current indication or the insertion of new warnings or precautions; the risk that AMAG will face dif ficulties or delays in appointing a chief executive officer to succeed Mr. Heiden or otherwise be unable to successfully transition to a new CEO or be unable to successfully achieve the anticipated benefits from its leadership transi tio n plan; the possibility that AMAG will encounter challenges retaining or attracting talent; the risk that AMAG may be unable to gain approval of its product candidates, including AMAG - 423 and ciraparantag, on a timely basis, or at all ; the risk that such approvals, if obtained, will include unanticipated restrictions or warnings; the risk that the costs and time investments for AMAG’s development efforts will be higher than anticipated; the possibility that AMAG ha s over - estimated the market and potential revenues for its products and product candidates, if approved, including AMAG - 423 and ciraparantag; the risk that AMAG is unable to generate sufficient cash to satisfy its debt obli gations and could face challenges undertaking fundraising, restructuring or strategic transactions in order to meet these obligations, including under convertible notes due June 1, 2022; the risk that AMAG will be significantly de pendent on sales of Feraheme to support its ongoing operations, including its development pipeline, and Feraheme could face increased competition in the near term, including as a result of the recent approval of Monoferric ® or if Sandoz’s ANDA is approved; the risk that AMAG will be unable to successfully identify and enter into partnerships with out - licensees for its product candidates in ex - U.S. territories, which could delay the commercialization of th ose product candidates in certain geographies; the risk that AMAG will not be able to continue to execute on its business plan; the speculative nature of AMAG’s estimates as to market share for its products and potential market sha re for its product candidates and the risk that such estimates are inaccurate and those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the ye ar ended December 31, 2018, its Quarterly Reports on Form 10 - Q for the quarters ended March 31, 2019, June 30, 2019 and September 30, 2019, 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 pr ice. 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 ev ent s, 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, Feraheme ® and Vyleesi ® are registered trademarks of AMAG Pharmaceuticals, Inc. Makena ® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa ® is a registered trademark of Endoceutics , Inc. Other trademarks referred to in this report are the property of their respective owners. Forward - Looking Statements 2

 

 

© 2020 AMAG Pharmaceuticals, Inc. All rights reserved Agenda 2019 in review 2019 financial overview Core Value Drivers: 2020 and beyond 2020 financial guidance 2020 goals Q&A 4 6 2 3 1 5 3

 

 

© 2020 AMAG Pharmaceuticals, Inc. All rights reserved Option 4 2019 In Review 1) Feraheme market share is based on IQVIA data and internal analytics. Completed acquisition of Perosphere Pharmaceuticals and added ciraparantag to development portfolio Steadily grew Intrarosa revenue and market share 2019 YEAR IN REVIEW Advanced enrollment in Phase 2b/3a trial for orphan drug candidate AMAG - 423 for severe preeclampsia Gained FDA approval of Vyleesi and commercially launched in September Grew Feraheme revenue 24% over 2018 to record revenue of $168M and achieved Q4 market share of 17.7% 1 Mixed year for Makena • IM supply disruptions resulted in removal of both brand and authorized generic • PROLONG study results and AdCom meeting challenges brand durability • Maintained strong Q4 market share of 63% for subcutaneous auto - injector, but experienced market contraction and price erosion post AdCom meeting 4

 

 

© 2020 AMAG Pharmaceuticals, Inc. All rights reserved For the 3 - month and 12 - month periods ended December 31 2019 Financial Results FINANCIAL 1) Includes the recognition of $16.4M of collaboration revenue during the year due to the termination and settlement agreement e ntered in to with Daiichi Sankyo, Inc. (DSI) in December 2019 related to a clinical trial collaboration agreement that AMAG acquired as part of the Perosphere acquisition. As part of the settlement, AMAG received $10M in cash from DSI in December 2019. The company also recognized an additional $6.3M of deferred revenue in December 2019 of the total $6.4M of deferred revenue that was acquired fro m Perosphere related to the original agreement. 2) 2019 operating loss financial guidance did not include the impact of material impairment charges or the associated acceleration of amortization , which were recognized in the in the fourth quarter of 2019. 3) See slide 15 for a reconciliation of GAAP to non - GAAP financials. ($M) Q4 - 2019 Q4 - 2018 FY 2019 FY 2018 FY 2019 Guidance Revenue $89.7 $88.1 $327.8 $474.0 $320 - $330 Feraheme $41.7 $35.2 $167.9 $ 135.0 -- Makena 25.6 46.9 122.1 322.3 -- Intrarosa 6.5 5.9 21.4 16.2 -- Other revenue (0.4) 0.1 -- 0.5 -- Collaboration revenue 1 16.3 -- 16.4 -- -- Costs and expenses $283.6 $106.9 $773.3 $521.0 -- Cost of product sales $43.3 $28.7 $107.2 $ 215.9 -- Research & development (R&D) 16.5 12.2 64.9 44.8 -- Acquired in - process R&D -- -- 74.9 32.5 -- Selling, general & administrative 68.8 66.0 286.6 227.8 -- Impairment of assets 155.0 -- 232.3 -- -- Restructuring -- -- 7.4 -- -- Operating loss ($193.9) ($18.8) ($445.5) ($47.0) ($278) - ($268) 2 Adjusted EBITDA 3 ($5.8) $1.5 ($65.0) 120.8 ($75) - ($65) 5

 

 

© 2020 AMAG Pharmaceuticals, Inc. All rights reserved Hematology COMMERCIAL Maternal Health PIPELINE PHYSICIAN DRIVEN Ciraparantag AMAG - 423 Streamlined Portfolio and Infrastructure Positions AMAG for Near - and Long - term Profitability Focus on Core Value Drivers Feraheme • Provides continued growth and positive cash flow ‒ Sufficient to fund pipeline assets • Exploring new opportunities for future growth Makena • Risk profile heightened with PROLONG study results and FDA AdCom meeting ‒ Soft Q4 - 2019 results inform view of 2020 ‒ Proactively managing product to be cash - flow positive Development Assets • Continue to invest in pipeline programs that have opportunities to address significant unmet medical needs ‒ Development assets provide opportunity for next chapter of long - term revenue growth PORTFOLIO SNAPSHOT 2020 Divest Women’s Health PHYSICIAN/CONSUMER(DTC) DRIVEN 6

 

 

© 2020 AMAG Pharmaceuticals, Inc. All rights reserved Continued strong performance FERAHEME 1) AMAG estimates Feraheme’s average market share and IV iron market growth using IQVIA data and internal analytics. • Build on strong performance of past years, including record annual 2019 revenues • Strong IV iron market growth of approximately ~12% over 2018 1 • Feraheme to fund development of pipeline assets • Potential competitive dynamics • Exploring new opportunities for future growth Consistent Volume Growth Ex - factory Grams 0 100,000 200,000 300,000 2017 2018 2019 $0 $100 $200 2017 2018 2019 Consistent Revenue Growth Revenue ($M) 0% 5% 10% 15% 20% 2017 2018 2019 Growing Market Share Avg. Market Share 1 Core Value Drivers: 2020 and Beyond - Feraheme 7

 

 

© 2020 AMAG Pharmaceuticals, Inc. All rights reserved Preterm birth is a significant public health issue in the U.S. 1) Hydroxyprogesterone caproate injection ACOG and SMFM reiterated continued support (post - PROLONG) for the use of Makena in at - risk pregnant women Today, Makena (and generic 17 P 1 ) is the only FDA - approved therapy to reduce the risk of preterm birth If Makena is no longer available, those committed to the use of 17P would likely seek compounded drug, which could create a potential safety risk AMAG is committed to working collaboratively with the FDA on a path forward that could allow at - risk pregnant women to continue to have access to Makena MEIS TRIAL PROLONG TRIAL Conducted in U.S. patient population which had a high rate of preterm birth Demonstrated a 30% reduction in preterm birth rates Conducted primarily in non - U.S. patient population Did not show a reduction in preterm birth rates MA KENA Lower risk patient population with significantly lower preterm birth rates than Meis trial (in both the treatment and placebo arms) Confirmed strong safety profile of Makena Core Value Drivers: 2020 and Beyond - Makena 8

 

 

© 2020 AMAG Pharmaceuticals, Inc. All rights reserved Large unmet medical need with significant global commercial potential AMAG - 423 1) Ananth, C. V., Keyes, K. M., & Wapner , R. J. (2013). Pre - eclampsia rates in the United States, 1980 - 2010: age - period - cohort analysis. The BMJ, 347, f6564. http://doi.org/10.1136/bmj.f6564 . 2) AMAG Phase 2b/3a clinical trial population is a subset of the severe preeclampsia population. 3) Illustrative of commercial opportuni ty for overall severe preeclampsia market. Price reference : $140,000/patient average annual cost for orphan drug, EvaluatePharma ®, Orphan Drug Report 2017. Every 1% of patients in U.S. with severe preeclampsia = $70M 3 / Year ~50,000 pregnant women 1,2 Annual U.S. incidence of SEVERE preeclampsia ~140,000 pregnant women 1 preeclampsia Annual U.S. incidence of Potential ex - U.S. opportunities Large unmet medical need Core Value Drivers: 2020 and Beyond – AMAG - 423 9

 

 

© 2020 AMAG Pharmaceuticals, Inc. All rights reserved Large unmet medical need with s ignificant global commercial potential Core Value Drivers: 2020 and Beyond - Ciraparantag CIRAPARANTAG 1) Perosphere sponsored commercial assessment report conducted by a third party in May 2016. 2) AMAG estimate based on the following: ( i ) Zhu J., Alexander GC, et al. Pharmacotherapy 2018 September; 38(9): 907 - 920. (ii) Sindet - Pedersen C, et al. European Heart Journal - Cardiovascular Pharmacotherapy (2018) 4, 220 – 227. (iii) Garcia D, Alexander JH, et al. Blood 2014 124: 3692 - 3698. (iv) www.aha - org/statistics/fast - facts - us - hospitals . (v) Balakrishna, P, et al. Blood 2017 130:5585. (vi) www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.hem . 3) Illustrative of commercial opportunity for overall NOAC/LMWH market. Price reference: The c urrently approved reversal agent (coagulation factor Xa recombinant, inactivated - zhzo ) price of ~$24,000. Large unmet medical need • Opportunity to provide an improved reversal agent to NOACs Numerous characteristics suggest ciraparantag may offer a more optimal reversal agent • Ready to use • Potential for a fixed dose for all Xa inhibitors • Demonstrates sustained effect over 24 hours after one IV dose ‒ Opportunity to include patients requiring emergent surgery • No prothrombotic signal to date Potential ex - U.S. partnership opportunities Every 1% of patients in U.S. requiring reversal treatment = $36M 3 / Year ~150,000 2 ~6 Million Patients on NOAC / LMWH therapy 1 U.S. market opportunity NOAC / LMWH patients per year requiring a reversal agent 10

 

 

© 2020 AMAG Pharmaceuticals, Inc. All rights reserved 2020 Financial Guidance Reflects a Return to Positive Adjusted EBITDA FINANCIAL 1) 2020 financial guidance reflects management’s current assumptions about the range of potential impact of multiple scenario s a cross our product portfolio, including ( i ) various potential regulatory outcomes related to Makena and (ii) that the divestitures of Intrarosa and Vyleesi will be reported in discontinued operations for accounting purposes in 2020. Therefore, 2020 financial guidance excludes revenue and expenses related to Intrarosa and Vyleesi . 2) Operating income does not include the GAAP impact of the planned divestitures of Intrarosa and Vyleesi . 3) See slide 16 for a reconciliation of GAAP to non - GAAP financial guidance. 2020 FINANCIAL GUIDANCE 1 ($M) Total revenue $230 - $280 Operating income 2 $2 - $32 Adjusted EBITDA 3 $20 - $50 Continued growth of Feraheme to fund the development of pipeline assets Risk - adjusted topline view of Makena given the uncertainty caused by: • FDA Advisory Committee outcome • Soft Q4 - 2019 enrollments and revenue Significant reduction in operating expenses (>$100M) vs. 2019 • Driven by divestiture of Intrarosa and Vyleesi 11

 

 

© 2020 AMAG Pharmaceuticals, Inc. All rights reserved 2020: Goals and Key Areas of Focus for AMAG Drive continued Feraheme growth Divest Intrarosa and Vyleesi to align with new strategic direction Work with the FDA to maintain patient access to Makena Advance ciraparantag and AMAG - 423 development programs Meet/exceed financial guidance Pursue ex - U.S. portfolio partnering opportunities Complete successful CEO transition 12

 

 

© 2019 AMAG Pharmaceuticals, Inc. All rights reserved © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 13 AMAG Pharmaceuticals Q&A

 

 

Appendix 14

 

 

© 2020 AMAG Pharmaceuticals, Inc. All rights reserved Reconciliation of GAAP to Non - GAAP Preliminary Financial Results APPENDIX ($M) Q4 - 2019 Q4 - 2018 FY 2019 FY 2018 GAAP operating loss ($193.9) ($18.8) ($445.5) ($47.0) Depreciation and intangible asset amortization 13.5 14.0 27.3 160.0 Non - cash inventory step - up adjustments -- 0.1 -- 3.7 Stock - based compensation 4.8 5.3 18.5 19.9 Adjustments to contingent consideration -- (0.4) -- (49.6) Restructuring -- -- 7.4 -- Transaction/acquisition - related costs -- 1.3 0.3 1.3 Acquired IPR&D -- -- 74.9 32.5 Asset impairment charges 169.8 -- 252.1 -- Non - GAAP adjusted EBITDA ($5.8) $1.5 ($65.0) $120.8 15

 

 

© 2020 AMAG Pharmaceuticals, Inc. All rights reserved Reconciliation of GAAP to Non - GAAP 2020 Financial Guidance APPENDIX ($M) 2020 Financial Guidance GAAP operating income $2 - $32 Depreciation 2 Stock - based compensation 16 Non - GAAP a djusted EBITDA $20 - $50 16

 

 

© 2019 AMAG Pharmaceuticals, Inc. All rights reserved © 2020 AMAG Pharmaceuticals, Inc. All rights reserved 17 AMAG Pharmaceuticals Fourth Quarter / Full Year 2019 Financial Results March 4, 2020

 

 

 

 

Exhibit 99.3 

 

 

 

NOT FOR IMMEDIATE RELEASE

 

AMAG Pharmaceuticals Announces Changes to Medical Development Organization

 

WALTHAM, Mass., March 4, 2020 – AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced changes to its medical development organization. Effective March 31, 2020, Julie Krop, M.D., Executive Vice President and Chief Medical Officer, will be leaving the Company. As AMAG initiates a search for a permanent Chief Medical Officer, the Board of Directors and management will continue to work closely with the medical development organization on key priorities, including working with the U.S. Food and Drug Administration (FDA) to find a path to retain patient and provider access to Makena® and advancing the ciraparantag and AMAG-423 clinical development programs.

 

“Tenured leadership across our medical development organization has helped us achieve our most recent regulatory approvals and the team remains focused on supporting our portfolio of products to address unmet medical needs,” said William Heiden, AMAG’s President and Chief Executive Officer. “We appreciate all the contributions that Dr. Krop has made to our organization and wish her well in her future endeavors.”

 

Over the past several years, AMAG has built out a fully integrated development organization to support the Company’s pipeline of development-stage products. The Company will leverage the team’s expertise and experience across clinical operations, medical affairs, biostatistics, regulatory affairs and pharmacovigilance as it works with the FDA to retain patient access to Makena and advance the ciraparantag and AMAG-423 clinical development programs.

 

Additionally, former board member Lesley Russell, MBChB, MRCP will provide further, interim expertise as Clinical Consultant, effective immediately. Dr. Russell has three decades of experience in clinical development and regulatory affairs, and will advise the company during the transition to a new CMO.

 

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. 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: AMAG’s expectations for the leadership transition, including the planned timing for the search for a new chief medical officer; expectations that AMAG’s Board of Directors, remaining management team and Dr. Russell will continue to work with the company’s medical development organization on the company’s key priorities during the search for a new chief medical officer and successfully support AMAG’s products; AMAG’s expectations regarding continued patient and provider access to Makena and the advancement of its clinical development programs for ciraparantag and AMAG-423; and expectations and beliefs regarding AMAG’s ability to successfully achieve benefits from its leadership transition plan, including managing the search for and transition to a new chief medical officer, 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 that the FDA will withdraw approval of Makena in line with the recommendation of the Advisory Committee; that the FDA could take other adverse action related to Makena given the findings and recommendation of the Advisory Committee; that AMAG may not be able to generate additional efficacy data that will be satisfactory to the FDA (if the FDA permits AMAG to submit additional data to support or as a condition to the continued commercialization of Makena); that healthcare providers may be reluctant to continue to prescribe the Makena auto-injector or the FDA may require that the Makena label include information on the PROLONG study, restrictions to the current indication or the insertion of new warnings or precautions; that AMAG is unlikely generate sufficient cash to satisfy its debt obligations and could face challenges undertaking fundraising, restructuring or strategic transactions in order to meet these obligations, including under convertible notes due June 1, 2022; that AMAG will be significantly dependent on sales of Feraheme to support its ongoing operations, including its development pipeline, and Feraheme could face increased competition in the near term, including as a result of the recent approval of Monoferric® or if Sandoz’s ANDA is approved; that AMAG will face difficulties or delays in appointing a chief executive officer to succeed Mr. Heiden or a chief medical officer to succeed Dr. Krop or otherwise be unable to successfully execute its leadership transition plan; that AMAG will not be able to identify or effect any transaction to divest Intrarosa or Vyleesi in the expected timeframe, or at all, or that any transaction will be on terms that are favorable to AMAG or that yield any value for its shareholders; that the anticipated benefits of such a divestiture, including anticipated expense reductions, will not be realized at expected levels, or at all; that AMAG may be unable to gain approval of its product candidates, including AMAG-423 and ciraparantag, on a timely basis, or at all; that such approvals, if obtained, will include unanticipated restrictions or warnings and that the costs and time investments for AMAG’s development efforts will be higher than anticipated, or that AMAG has over-estimated the market and potential revenues for its products and product candidates, if approved, including AMAG-423 and ciraparantag; that AMAG will be unable to successfully identify and enter into partnerships with out-licensees for its product candidates in ex-U.S. territories, which could delay the commercialization of those product candidates in certain geographies, as well as those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2018, its Quarterly Report on Form 10-Q for the quarters ended March 31, 2019, June 30, 2019 and September 30, 2019, and subsequent filings with the SEC (including its upcoming Annual Report on Form 10-K for the year ended December 31, 2019), 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, are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc.

 

AMAG CONTACTS:

Investors:
Linda Lennox

908-627-3424

 

Media:
Sarah Connors

(781) 296-0722

 

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