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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q
(Mark One) 
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2020
or
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from                        to                       
Commission file number 001-10865
https://cdn.kscope.io/99e5831e49f55948f26854d79a1b003d-amag-20200630_g1.jpg
AMAG Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware04-2742593
(State or Other Jurisdiction of
Incorporation or Organization)
(I.R.S. Employer
Identification No.)
1100 Winter Street,Waltham,Massachusetts02451
(Address of Principal Executive Offices)(Zip Code)
(617498-3300
(Registrant’s Telephone Number, Including Area Code)

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 share
AMAGNASDAQ Global Select Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes   No 
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes   No 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Accelerated filer
Non-accelerated filer
Smaller reporting company
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.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes   No 
As of August 12, 2020, there were 34,479,646 shares of the registrant’s Common Stock, par value $0.01 per share, outstanding.


Table of Contents
AMAG PHARMACEUTICALS, INC.
FORM 10-Q
FOR THE QUARTER ENDED JUNE 30, 2020
TABLE OF CONTENTS
 
 
 
 
 
  
  
 

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Table of Contents
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements:
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AMAG PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)
(Unaudited)
 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 (Note O)
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, respectively
344  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  
The accompanying notes are an integral part of these condensed consolidated financial statements.
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AMAG PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(Unaudited)
 
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Revenues:
Product sales, net$52,729  $77,634  $123,142  $153,047  
Other revenues26  133  58  208  
Total revenues52,755  77,767  123,200  153,255  
Costs and expenses:    
Cost of product sales18,180  24,290  42,539  42,767  
Research and development expenses8,263  14,980  19,443  33,046  
Acquired in-process research and development      74,856  
Selling, general and administrative expenses39,568  77,324  92,266  152,006  
Impairment of intangible assets  77,358    77,358  
Gain on sale of assets(14,444)   (14,444)   
Restructuring expenses8,197    8,197  7,420  
Total costs and expenses59,764  193,952  148,001  387,453  
Operating loss (7,009) (116,185) (24,801) (234,198) 
Other income (expense):    
Interest expense(6,700) (6,330) (13,303) (12,780) 
Interest and dividend income327  1,224  804  2,810  
Other income (expense)(22) 2  1,288  342  
Total other expense, net(6,395) (5,104) (11,211) (9,628) 
Loss before income taxes(13,404) (121,289) (36,012) (243,826) 
Income tax benefit(160) (120) (60) (257) 
Net loss$(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  

The accompanying notes are an integral part of these condensed consolidated financial statements.
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AMAG PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(IN THOUSANDS)
(Unaudited)

 Three Months Ended June 30,Six Months Ended June 30,
 2020201920202019
Net loss$(13,244) $(121,169) $(35,952) $(243,569) 
Other comprehensive loss:    
Holding (losses) gains associated with marketable securities arising during period, net of tax823  344  275  953  
Total comprehensive loss$(12,421) $(120,825) $(35,677) $(242,616) 

The accompanying notes are an integral part of these condensed consolidated financial statements.
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AMAG PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(IN THOUSANDS, EXCEPT SHARES)
(Unaudited)



Common Stock
SharesAmountAdditional Paid-in CapitalAccumulated Other Comprehensive LossAccumulated DeficitTotal Stockholders' Equity
Balance at April 1, 202034,266,256  $342  $1,300,572  $(3,787) $(1,037,909) $259,218  
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings100,915  1  (117) —  —  (116) 
Issuance of common stock under employee stock purchase plan96,202  1  630  —  —  631  
Non-cash equity based compensation—  —  2,010  —  —  2,010  
Unrealized losses on securities, net of tax—  —  —  823  —  823  
Net loss—  —  —  —  (13,244) (13,244) 
Balance at June 30, 202034,463,373  $344  $1,303,095  $(2,964) $(1,051,153) $249,322  





Common Stock    
SharesAmountAdditional Paid-in CapitalAccumulated Other Comprehensive LossAccumulated DeficitTotal Stockholders' Equity
Balance at January 1, 202033,999,081  $339  $1,297,917  $(3,239) $(1,015,201) $279,816  
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings368,090  4  (1,331) —  —  (1,327) 
Issuance of common stock under employee stock purchase plan96,202  1  630  —  —  631  
Non-cash equity based compensation—  —  5,879  —  —  5,879  
Unrealized losses on securities, net of tax—  —  —  275  —  275  
Net loss—  —  —  —  (35,952) (35,952) 
Balance at June 30, 202034,463,373  $344  $1,303,095  $(2,964) $(1,051,153) $249,322  

The accompanying notes are an integral part of these condensed consolidated financial statements.
















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AMAG PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(IN THOUSANDS, EXCEPT SHARES)
(Unaudited)



Common Stock
SharesAmountAdditional Paid-in CapitalAccumulated Other Comprehensive LossAccumulated DeficitTotal Stockholders' Equity
Balance at April 1, 201933,746,828  $337  $1,282,284  $(3,376) $(669,940) $609,305  
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings48,051  1  (115) —  —  (114) 
Issuance of common stock under employee stock purchase plan105,075  1  850  —  —  851  
Non-cash equity based compensation—  —  4,534  —  —  4,534  
Unrealized gains on securities, net of tax—  —  —  344  —  344  
Net loss—  —  —  —  (121,169) (121,169) 
Balance at June 30, 201933,899,954  $339  $1,287,553  $(3,032) $(791,109) $493,751  




Common Stock    
SharesAmountAdditional Paid-in CapitalAccumulated Other Comprehensive LossAccumulated DeficitTotal Stockholders' Equity
Balance at January 1, 201934,606,760  $346  $1,292,736  $(3,985) $(547,540) $741,557  
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings262,919  3  (1,721) —  —  (1,718) 
Issuance of common stock under employee stock purchase plan105,075  1  850  —  —  851  
Repurchase of common stock pursuant to the share repurchase program(1,074,800) (11) (13,719) —  —  (13,730) 
Non-cash equity based compensation—  —  9,407  —  —  9,407  
Unrealized gains on securities, net of tax—  —  —  953  —  953  
Net loss—  —  —  —  (243,569) (243,569) 
Balance at June 30, 201933,899,954  $339  $1,287,553  $(3,032) $(791,109) $493,751  

The accompanying notes are an integral part of these condensed consolidated financial statements.

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AMAG PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(Unaudited)
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(54,216) 36,137  
Deferred revenues  (101) 
Other assets and liabilities(377) 1,283  
Net cash used in operating activities(43,442) (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(68) (1,907) 
Net cash provided by investing activities29,666  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  
The accompanying notes are an integral part of these condensed consolidated financial statements.
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AMAG PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
A.  DESCRIPTION OF BUSINESS
AMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. We are a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs by leveraging our development and commercial expertise to invest in and grow our pharmaceutical products and product candidates across a range of therapeutic areas. As of June 30, 2020, we marketed products that support the health of patients in the areas of hematology and maternal and women’s health, including Feraheme® (ferumoxytol injection) for intravenous use, Makena® (hydroxyprogesterone caproate injection) auto-injector and Vyleesi® (bremelanotide injection). In addition to our approved products, our portfolio includes two product candidates, ciraparantag, which is being studied as an anticoagulant reversal agent and AMAG-423 (digoxin immune fab (ovine)), which is being studied for the treatment of severe preeclampsia (although we have suspended research and development efforts as discussed elsewhere in this report).

In December 2019, we completed a review of our product portfolio and strategy. This strategic review resulted in our intention to divest Intrarosa® (prasterone) and Vyleesi® (bremelanotide injection), as announced in January 2020. In May 2020, we completed the divestiture of Intrarosa, resulting in a gain on sale of $14.4 million recognized during the three and six months ended June 30, 2020. We determined that the divestiture of Intrarosa did not meet the criteria for presentation as a discontinued operation, as it did not represent a strategic shift to our business as described above. Additionally, we determined that the anticipated divestiture of Vyleesi did not result in the related assets meeting the criteria to be recorded as held for sale at June 30, 2020.

In July 2020, we completed the divestiture of Vyleesi and decided to stop the AMAG-423 Phase 2b/3a study based, primarily, on the results of an interim analysis conducted by the study’s independent Data Safety Monitoring Board (“DSMB”). Refer to Note U, “Subsequent Events” for further detail.

Throughout this Quarterly Report on Form 10-Q, AMAG Pharmaceuticals, Inc. and our consolidated subsidiaries are collectively referred to as “the Company,” “AMAG,” “we,” “us,” or “our.”
COVID-19
The global spread of COVID-19 has created significant volatility, uncertainty and economic disruption on a global scale, including in the United States, where we market our products, where our operations and employees reside and where we conduct clinical trials, as well as in Europe and other countries where we have been conducting our AMAG-423 Phase 2b/3a study. The COVID-19 pandemic negatively impacted our financial results during the three months ended June 30, 2020 and is expected to continue to negatively impact our financial results in future periods in 2020. The extent to which the COVID-19 pandemic impacts our business, operations and financial results will depend on numerous evolving factors that we may not be able to accurately predict. While there have been no material impairments to date, any prolonged material disruptions to our sales, supply, research and development efforts and/or operations could negatively impact the Company’s business, operations and/or financial results.

B.  BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
These condensed consolidated financial statements are unaudited and, in the opinion of management, include all adjustments necessary for a fair statement of our financial position and results of operations for the interim periods presented. Such adjustments consisted only of normal recurring items. The year-end condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States of America (“GAAP”).
In accordance with GAAP for interim financial reports and the instructions for Form 10-Q and the rules of the Securities and Exchange Commission, certain information and footnote disclosures normally included in annual financial statements have been condensed or omitted. Our accounting policies are described in the Notes to the Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2019 (our “Annual Report”). Interim results are not necessarily indicative of the results of operations for the full year. These interim financial statements should be read in conjunction with our Annual Report.
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Principles of Consolidation
The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates and Assumptions
The preparation of our condensed consolidated financial statements in conformity with GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent liabilities. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity and the amount of revenues and expenses. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including product sales revenue; product sales allowances and accruals; allowance for expected credit losses; marketable securities; inventory; fair value estimates used to assess impairment of long-lived assets, including goodwill and other intangible assets; debt obligations; certain accrued liabilities, including clinical trial accruals; equity-based compensation expense; and income taxes, inclusive of valuation allowances, will depend on future developments that are highly uncertain, including new information that may emerge concerning COVID-19 and the actions taken to contain or treat its impact, as well as the economic impact on local, regional and national customers and markets. We have made estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods. Actual results could differ materially from these estimates.
Concentrations and Significant Customer Information
Financial instruments which potentially subject us to concentrations of credit risk consist principally of cash and cash equivalents, marketable securities, and accounts receivable. We currently hold our excess cash primarily in institutional money market funds, corporate debt securities, U.S. treasury and government agency securities and certificates of deposit. As of June 30, 2020, we did not have a material concentration in any single investment.

Our operations are located entirely within the U.S. We focus primarily on developing, manufacturing, and commercializing our products and product candidates. The following table sets forth customers who represented 10% or more of our total revenues for the three and six months ended June 30, 2020 and 2019:
Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
McKesson Corporation31 %35 %36 %36 %
AmerisourceBergen Drug Corporation37 %28 %33 %27 %
Cardinal Health<10%11 %11 %12 %
 
Our net accounts receivable primarily represent amounts due for products sold directly to wholesalers, distributors and specialty pharmacies. Accounts receivable for our products are recorded net of reserves for estimated chargeback obligations, prompt payment discounts and any allowance for expected credit losses. At June 30, 2020 and December 31, 2019, three customers accounted for 10% or more of our accounts receivable balances, representing approximately 84% and 85% in the aggregate of our total accounts receivable, respectively.
We are currently dependent on a single supplier for certain of our manufacturing processes, including for Feraheme drug substance (produced in two separate facilities) and for our Makena auto-injector product. We have been and may continue to be exposed to a significant loss of revenue from the sale of our products in the event that our suppliers and/or manufacturers are not able to fulfill demand for any reason.
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Recently Adopted Accounting Pronouncements
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“Topic 326”). We adopted Topic 326 effective January 1, 2020 using a modified retrospective approach. The adoption of Topic 326 did not have a material impact on our condensed consolidated financial statements and accordingly, no transition adjustment was recorded at the adoption date. Under Topic 326, we estimate expected credit losses for our trade receivables held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. We also evaluate any impaired marketable securities against the new impairment model within Topic 326 to determine whether any loss or allowance for credit loss should be recorded at the reporting date.

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”) as part of its Simplification Initiative to reduce the cost and complexity in accounting for income taxes. ASU 2019-12 removes certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. ASU 2019-12 also amends other aspects of the guidance to help simplify and promote consistent application of GAAP. The guidance is effective for interim and annual periods beginning after December 15, 2020, with early adoption permitted. We adopted ASU 2019-12 effective January 1, 2020. The adoption of ASU 2019-12 did not have a material impact on our condensed consolidated financial statements.

Immaterial Revision of Prior Period Financial Information

Prior period amounts, specifically net product sales and accrued expenses have been revised to correct a prior period error related to gross-to-net (“GTN”) adjustments for governmental rebates and the related accrual for a certain state program. Refer to Note S, “Revision of Prior Period Financial Statements” for further detail.


C.  REVENUE RECOGNITION
Product Revenue and Allowances and Accruals

The following table provides information about disaggregated revenue by product for the three and six months ended June 30, 2020 and 2019 (in thousands):
 Three Months Ended June 30,Six Months Ended June 30,
2020201920202019
Product sales, net  
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 sales, net$52,729  $77,634  $123,142  $153,047  

Total gross product sales were offset by product sales allowances and accruals for the three and six months ended June 30, 2020 and 2019 as follows (in thousands):
 Three Months Ended June 30,Six Months Ended June 30,
 2020201920202019
Gross product sales$181,995  $239,185  $414,735  $450,904  
Provision for product sales allowances and accruals:    
Contractual adjustments109,861  128,641  253,036  237,526  
Governmental rebates19,405  32,910  38,557  60,331  
Total129,266  161,551  291,593  297,857  
Product sales, net$52,729  $77,634