001-10865
|
|
04-2742593
|
(Commission File
Number)
|
|
(IRS Employer Identification
No.)
|
1100 Winter St.
|
|
|
Waltham, Massachusetts
|
|
02451
|
(Address of principal executive
offices)
|
|
(Zip Code)
|
|
AMAG PHARMACEUTICALS, INC.
|
|
|
By:
|
/s/ Joseph D. Vittiglio
|
|
|
Joseph D. Vittiglio
Executive Vice President, General Counsel, Quality & Corporate Secretary
|
|
|
|
|
Date: February 7, 2019
|
•
|
Received FDA approval and successfully launched Makena subcutaneous auto-injector
|
•
|
Received FDA approval and launched Feraheme's expanded label, achieving 27% growth in 2018
|
•
|
Established strong healthcare provider support for Intrarosa and initiated direct-to-consumer campaign
|
•
|
Received FDA acceptance of Vyleesi NDA with a June 23, 2019 PDUFA date
|
•
|
Acquired AMAG-423, a late-stage orphan drug candidate in development for the treatment of severe preeclampsia
|
•
|
Acquired Perosphere Pharmaceuticals Inc. (closed in January 2019), including ciraparantag, a development-stage drug candidate to reverse the anticoagulant effects of novel oral anticoagulants (NOACs) and low molecular weight heparin (LMWH)
|
•
|
Divested the Cord Blood Registry (CBR) business and paid off $475 million of senior notes, eliminating cash interest expense of approximately $40 million per year
|
•
|
Achieved top- and bottom-line financial guidance, which was raised three times during 2018
|
($M)
|
2019 Financial Guidance
|
Total revenue
|
$365 - $415
|
Operating loss
|
($131) - ($101)
|
Adjusted EBITDA
|
($65) - ($35)
|
•
|
Build on the success of the Makena SC auto-injector’s 46% fourth quarter 2018 market share (of FDA-approved hydroxyprogesterone caproate products)
|
•
|
Drive Feraheme market growth and market share growth to treat more patients suffering from iron deficiency anemia
|
•
|
Continue successful Intrarosa direct-to-consumer campaign; expanding treatment to more of the 18 million untreated women
|
•
|
Submit results to the FDA from the ambulatory blood pressure study assessing short-term daily use of Vyleesi prior to the June 23, 2019 PDUFA date; prepare for commercial launch in 2H-2019
|
•
|
Target full enrollment in AMAG-423 severe preeclampsia Phase 2b/3a clinical study by year end
|
•
|
Initiate ciraparantag anticoagulant reversal agent Phase 3a clinical studies
|
•
|
Pursue business development opportunities
|
•
|
Meet/exceed financial guidance
|
|
|
Three Months Ended December 31,
|
|
Year Ended December 31,
|
||||||||||||
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Revenues:
|
|
|
|
|
|
|
|
|
||||||||
Makena
|
|
$
|
46,888
|
|
|
$
|
100,388
|
|
|
$
|
322,265
|
|
|
$
|
387,158
|
|
Feraheme/MuGard
|
|
35,271
|
|
|
26,612
|
|
|
135,369
|
|
|
106,671
|
|
||||
Intrarosa
|
|
5,888
|
|
|
1,455
|
|
|
16,218
|
|
|
1,816
|
|
||||
Other revenues
|
|
75
|
|
|
70
|
|
|
150
|
|
|
124
|
|
||||
Total revenues
|
|
88,122
|
|
|
128,525
|
|
|
474,002
|
|
|
495,769
|
|
||||
Costs and expenses:
|
|
|
|
|
|
|
|
|
||||||||
Cost of product sales
|
|
28,716
|
|
|
70,587
|
|
|
215,892
|
|
|
161,349
|
|
||||
Research and development expenses
|
|
12,211
|
|
|
11,996
|
|
|
44,846
|
|
|
75,017
|
|
||||
Acquired in-process research and development
|
|
—
|
|
|
—
|
|
|
32,500
|
|
|
65,845
|
|
||||
Selling, general and administrative expenses
|
|
66,030
|
|
|
58,667
|
|
|
227,810
|
|
|
178,151
|
|
||||
Impairment of intangible assets
|
|
—
|
|
|
—
|
|
|
—
|
|
|
319,246
|
|
||||
Restructuring expenses
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Total costs and expenses
|
|
106,957
|
|
|
141,250
|
|
|
521,048
|
|
|
799,608
|
|
||||
Operating (loss) income
|
|
(18,835
|
)
|
|
(12,725
|
)
|
|
(47,046
|
)
|
|
(303,839
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
|
||||||||
Interest expense
|
|
(6,571
|
)
|
|
(15,978
|
)
|
|
(51,971
|
)
|
|
(68,382
|
)
|
||||
Loss on debt extinguishment
|
|
—
|
|
|
(1,096
|
)
|
|
(35,922
|
)
|
|
(10,926
|
)
|
||||
Interest and dividend income
|
|
2,120
|
|
|
628
|
|
|
5,328
|
|
|
2,810
|
|
||||
Other (expense) income
|
|
(10
|
)
|
|
(27
|
)
|
|
(74
|
)
|
|
(70
|
)
|
||||
Total other expense, net
|
|
(4,461
|
)
|
|
(16,473
|
)
|
|
(82,639
|
)
|
|
(76,568
|
)
|
||||
(Loss) income from continuing operations before income taxes
|
|
(23,296
|
)
|
|
(29,198
|
)
|
|
(129,685
|
)
|
|
(380,407
|
)
|
||||
Income tax expense (benefit)
|
|
(2,550
|
)
|
|
(29,936
|
)
|
|
39,654
|
|
|
(175,254
|
)
|
||||
Net (loss) income from continuing operations
|
|
(20,746
|
)
|
|
738
|
|
|
(169,339
|
)
|
|
(205,153
|
)
|
||||
|
|
|
|
|
|
|
|
|
||||||||
Discontinued operations:
|
|
|
|
|
|
|
|
|
||||||||
Income (loss) from discontinued operations
|
|
—
|
|
|
5,314
|
|
|
18,873
|
|
|
10,313
|
|
||||
Gain on sale of CBR business
|
|
(2,506
|
)
|
|
—
|
|
|
87,076
|
|
|
—
|
|
||||
Income tax expense (benefit)
|
|
(975
|
)
|
|
2,592
|
|
|
2,371
|
|
|
4,388
|
|
||||
Net income (loss) from discontinued operations
|
|
(1,531
|
)
|
|
2,722
|
|
|
103,578
|
|
|
5,925
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
Net loss
|
|
$
|
(22,277
|
)
|
|
$
|
3,460
|
|
|
$
|
(65,761
|
)
|
|
$
|
(199,228
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
Basic net (loss) income per share:
|
|
|
|
|
|
|
|
|
||||||||
(Loss) income from continuing operations
|
|
$
|
(0.60
|
)
|
|
$
|
0.02
|
|
|
$
|
(4.92
|
)
|
|
$
|
(5.88
|
)
|
Income (loss) from discontinued operations
|
|
(0.04
|
)
|
|
0.08
|
|
|
3.01
|
|
|
0.17
|
|
||||
Total
|
|
$
|
(0.64
|
)
|
|
$
|
0.10
|
|
|
$
|
(1.91
|
)
|
|
$
|
(5.71
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
Diluted net (loss) income per share:
|
|
|
|
|
|
|
|
|
||||||||
(Loss) income from continuing operations
|
|
$
|
(0.60
|
)
|
|
$
|
0.02
|
|
|
$
|
(4.92
|
)
|
|
$
|
(5.88
|
)
|
Income (loss) from discontinued operations
|
|
(0.04
|
)
|
|
0.08
|
|
|
3.01
|
|
|
0.17
|
|
||||
Total
|
|
$
|
(0.64
|
)
|
|
$
|
0.10
|
|
|
$
|
(1.91
|
)
|
|
$
|
(5.71
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
Weighted average shares outstanding used to compute net income (loss) per share:
|
|
|
|
|
|
|
|
|
||||||||
Basic
|
|
34,560
|
|
|
34,783
|
|
|
34,394
|
|
|
34,907
|
|
||||
Diluted
|
|
34,560
|
|
|
34,879
|
|
|
34,394
|
|
|
34,907
|
|
|
December 31, 2018
|
|
December 31, 2017
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
253,256
|
|
|
$
|
162,855
|
|
Marketable securities
|
140,915
|
|
|
136,593
|
|
||
Accounts receivable, net
|
75,347
|
|
|
91,460
|
|
||
Inventories
|
26,691
|
|
|
34,443
|
|
||
Prepaid and other current assets
|
18,961
|
|
|
11,009
|
|
||
Note receivable
|
10,000
|
|
|
—
|
|
||
Assets held for sale
|
—
|
|
|
45,508
|
|
||
Total current assets
|
525,170
|
|
|
481,868
|
|
||
Property and equipment, net
|
7,521
|
|
|
7,904
|
|
||
Goodwill
|
422,513
|
|
|
422,513
|
|
||
Intangible assets, net
|
217,033
|
|
|
375,479
|
|
||
Deferred tax assets
|
1,260
|
|
|
47,120
|
|
||
Restricted cash
|
495
|
|
|
495
|
|
||
Other long-term assets
|
1,467
|
|
|
266
|
|
||
Assets held for sale, net of current portion
|
—
|
|
|
564,711
|
|
||
Total assets
|
$
|
1,175,459
|
|
|
$
|
1,900,356
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
14,487
|
|
|
$
|
7,717
|
|
Accrued expenses
|
129,537
|
|
|
166,732
|
|
||
Current portion of convertible notes, net
|
21,276
|
|
|
—
|
|
||
Current portion of acquisition-related contingent consideration
|
144
|
|
|
49,399
|
|
||
Liabilities held for sale
|
—
|
|
|
53,870
|
|
||
Total current liabilities
|
165,444
|
|
|
277,718
|
|
||
Long-term liabilities:
|
|
|
|
|
|
||
Long-term debt, net
|
—
|
|
|
466,291
|
|
||
Convertible notes, net
|
261,933
|
|
|
268,392
|
|
||
Acquisition-related contingent consideration
|
215
|
|
|
686
|
|
||
Other long-term liabilities
|
1,212
|
|
|
1,204
|
|
||
Liabilities held for sale, net of current portion
|
—
|
|
|
95,821
|
|
||
Total liabilities
|
428,804
|
|
|
1,110,112
|
|
||
|
|
|
|
||||
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; 34,606,760 and 34,083,112 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively
|
346
|
|
|
341
|
|
||
Additional paid-in capital
|
1,292,736
|
|
|
1,271,628
|
|
||
Accumulated other comprehensive loss
|
(3,985
|
)
|
|
(3,908
|
)
|
||
Accumulated deficit
|
(542,442
|
)
|
|
(477,817
|
)
|
||
Total stockholders’ equity
|
746,655
|
|
|
790,244
|
|
||
Total liabilities and stockholders’ equity
|
$
|
1,175,459
|
|
|
$
|
1,900,356
|
|
|
Years Ended December 31,
|
||||||
|
2018
|
|
2017
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net loss
|
$
|
(65,761
|
)
|
|
$
|
(199,228
|
)
|
Adjustments to reconcile net loss to net cash provided by operating activities:
|
|
|
|
||||
Depreciation and amortization
|
172,223
|
|
|
155,538
|
|
||
Impairment of intangible assets
|
—
|
|
|
319,246
|
|
||
Provision for bad debt expense
|
678
|
|
|
3,852
|
|
||
Amortization of premium/discount on purchased securities
|
87
|
|
|
302
|
|
||
(Gain) loss on disposal of fixed assets
|
(99
|
)
|
|
265
|
|
||
Non-cash equity-based compensation expense
|
19,916
|
|
|
23,664
|
|
||
Non-cash IPR&D expense
|
—
|
|
|
945
|
|
||
Loss on debt extinguishment
|
35,922
|
|
|
10,301
|
|
||
Amortization of debt discount and debt issuance costs
|
15,658
|
|
|
14,395
|
|
||
(Gain) loss on sale of investments, net
|
(1
|
)
|
|
70
|
|
||
Change in fair value of contingent consideration
|
(49,607
|
)
|
|
(47,686
|
)
|
||
Deferred income taxes
|
41,166
|
|
|
(178,421
|
)
|
||
Gain on sale of the CBR business
|
(87,076
|
)
|
|
—
|
|
||
Transaction costs
|
(14,111
|
)
|
|
—
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable, net
|
16,995
|
|
|
(14,978
|
)
|
||
Inventories
|
4,722
|
|
|
(2,331
|
)
|
||
Receivable from collaboration
|
—
|
|
|
—
|
|
||
Prepaid and other current assets
|
(16,097
|
)
|
|
(2,222
|
)
|
||
Accounts payable and accrued expenses
|
(32,568
|
)
|
|
16,834
|
|
||
Deferred revenues
|
8,658
|
|
|
17,080
|
|
||
Payment of contingent consideration in excess of acquisition date fair value
|
—
|
|
|
(10,432
|
)
|
||
Other assets and liabilities
|
95
|
|
|
(1,223
|
)
|
||
Net cash provided by operating activities
|
50,800
|
|
|
105,971
|
|
||
Cash flows from investing activities:
|
|
|
|
||||
Proceeds from sales or maturities of marketable securities
|
85,342
|
|
|
294,957
|
|
||
Purchase of marketable securities
|
(89,956
|
)
|
|
(127,249
|
)
|
||
Acquisition of Intrarosa intangible asset
|
—
|
|
|
(55,800
|
)
|
||
Proceeds from the sale of the CBR business
|
519,303
|
|
|
—
|
|
||
Capital expenditures
|
(2,534
|
)
|
|
(8,988
|
)
|
||
Net cash provided by (used in) investing activities
|
512,155
|
|
|
102,920
|
|
||
Cash flows from financing activities:
|
|
|
|
||||
Long-term debt principal payments
|
(475,000
|
)
|
|
(353,125
|
)
|
||
Proceeds from 2022 Convertible Notes
|
—
|
|
|
320,000
|
|
||
Payments to repurchase 2019 Convertible Notes
|
—
|
|
|
(191,730
|
)
|
||
Payment of premium on debt extinguishment
|
(28,054
|
)
|
|
—
|
|
||
Proceeds to settle warrants
|
—
|
|
|
323
|
|
||
Payment of convertible debt issuance costs
|
—
|
|
|
(9,553
|
)
|
||
Payment of contingent consideration
|
(119
|
)
|
|
(39,793
|
)
|
||
Payments for repurchases of common stock
|
—
|
|
|
(19,466
|
)
|
||
Proceeds from the exercise of common stock options
|
3,881
|
|
|
3,021
|
|
||
Payments of employee tax withholding related to equity-based compensation
|
(2,682
|
)
|
|
(2,696
|
)
|
||
Net cash used in financing activities
|
(501,974
|
)
|
|
(293,019
|
)
|
||
Net increase (decrease) in cash, cash equivalents and restricted cash
|
60,981
|
|
|
(84,128
|
)
|
||
Cash, cash equivalents and restricted cash at beginning of the year
|
192,770
|
|
|
276,898
|
|
||
Cash, cash equivalents and restricted cash at end of the year
|
$
|
253,751
|
|
|
$
|
192,770
|
|
|
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
|
|
|
Revenue
|
|
Cost of product sales
|
|
Research & development
|
|
Selling, general & administrative
|
|
Operating Loss / Adjusted EBITDA
|
||||||||||
GAAP
|
$
|
128,525
|
|
|
$
|
70,587
|
|
|
$
|
11,996
|
|
|
$
|
58,667
|
|
|
$
|
(12,725
|
)
|
Depreciation and intangible asset amortization
|
—
|
|
|
(60,818
|
)
|
|
(63
|
)
|
|
(181
|
)
|
|
|
||||||
Non-cash inventory step-up adjustments
|
—
|
|
|
(919
|
)
|
|
—
|
|
|
—
|
|
|
|
||||||
Stock-based compensation
|
—
|
|
|
(194
|
)
|
|
(575
|
)
|
|
(4,150
|
)
|
|
|
||||||
Adjustments to contingent consideration
|
—
|
|
|
—
|
|
|
—
|
|
|
543
|
|
|
|
||||||
Non-GAAP Adjusted
|
$
|
128,525
|
|
|
$
|
8,656
|
|
|
$
|
11,358
|
|
|
$
|
54,879
|
|
|
$
|
53,632
|
|
|
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
|
|
|
Revenue
|
|
Cost of product sales
|
|
Research & development
|
|
Selling, general & administrative
|
|
Intangible asset impairment charges
|
|
Acquired IPR&D
|
|
Operating Loss / Adjusted EBITDA
|
||||||||||||||
GAAP
|
$
|
495,769
|
|
|
$
|
161,349
|
|
|
$
|
75,017
|
|
|
$
|
178,151
|
|
|
$
|
319,246
|
|
|
$
|
65,845
|
|
|
$
|
(303,839
|
)
|
Depreciation and intangible asset amortization
|
—
|
|
|
(130,518
|
)
|
|
(180
|
)
|
|
(876
|
)
|
|
—
|
|
|
—
|
|
|
|
||||||||
Non-cash inventory step-up adjustments
|
—
|
|
|
(2,146
|
)
|
|
(103
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
||||||||
Stock-based compensation
|
—
|
|
|
(882
|
)
|
|
(3,225
|
)
|
|
(16,187
|
)
|
|
—
|
|
|
—
|
|
|
|
||||||||
Adjustments to contingent consideration
|
—
|
|
|
—
|
|
|
—
|
|
|
47,686
|
|
|
—
|
|
|
—
|
|
|
|
||||||||
Acquired IPR&D
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(65,845
|
)
|
|
|
||||||||
Impairment charges of intangible assets
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(319,246
|
)
|
|
—
|
|
|
|
||||||||
Acquisition related costs
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,462
|
)
|
|
—
|
|
|
—
|
|
|
|
||||||||
Non-GAAP Adjusted
|
$
|
495,769
|
|
|
$
|
27,803
|
|
|
$
|
71,509
|
|
|
$
|
207,312
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
189,145
|
|
Operating loss
|
($131) - ($101)
|
Depreciation and intangible asset amortization
|
43
|
Stock-based compensation
|
22
|
Non-cash inventory step up and adjustments to contingent consideration
|
1
|
Adjusted EBITDA
|
($65) - ($35)
|
|
Three Months Ended December 31,
|
|
Twelve Months Ended December 31,
|
|
||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
||||
Weighted average basic shares outstanding
|
34.6
|
|
|
34.8
|
|
|
34.4
|
|
|
34.9
|
|
|
Employee equity incentive awards
|
—
|
|
3
|
0.1
|
|
3
|
—
|
|
3
|
—
|
|
3
|
GAAP diluted shares outstanding
|
34.6
|
|
|
34.9
|
|
|
34.4
|
|
|
34.9
|
|
|
Employee equity incentive awards
|
0.3
|
|
4
|
—
|
|
4
|
0.3
|
|
4
|
0.3
|
|
4
|
Non-GAAP diluted shares outstanding
|
34.9
|
|
|
34.9
|
|
|
34.7
|
|
|
35.2
|
|
|