(Mark One)
|
|
☒
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the quarterly period ended March 31, 2017
|
|
or
|
|
☐
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the transition period from to
|
Delaware
(State or Other Jurisdiction of
Incorporation or Organization)
|
04-2742593
(I.R.S. Employer
Identification No.)
|
1100 Winter Street
Waltham, Massachusetts
(Address of Principal Executive Offices)
|
02451
(Zip Code)
|
Large accelerated filer
|
☒
|
|
Accelerated filer
|
☐
|
Non-accelerated filer
|
☐
|
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
☐
|
|
|
|
Emerging growth company
|
☐
|
|
||
|
||
|
||
|
||
|
||
|
|
|
|
|
|
|
|
March 31, 2017
|
|
December 31, 2016
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
252,854
|
|
|
$
|
274,305
|
|
Investments
|
305,541
|
|
|
304,781
|
|
||
Accounts receivable, net
|
85,233
|
|
|
92,375
|
|
||
Inventories
|
36,927
|
|
|
37,258
|
|
||
Prepaid and other current assets
|
8,316
|
|
|
9,839
|
|
||
Total current assets
|
688,871
|
|
|
718,558
|
|
||
Property, plant and equipment, net
|
22,708
|
|
|
24,460
|
|
||
Goodwill
|
639,484
|
|
|
639,484
|
|
||
Intangible assets, net
|
1,067,329
|
|
|
1,092,178
|
|
||
Restricted cash
|
2,493
|
|
|
2,593
|
|
||
Other long-term assets
|
1,025
|
|
|
1,153
|
|
||
Total assets
|
$
|
2,421,910
|
|
|
$
|
2,478,426
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
7,591
|
|
|
$
|
3,684
|
|
Accrued expenses
|
147,479
|
|
|
156,008
|
|
||
Current portion of long-term debt
|
20,455
|
|
|
21,166
|
|
||
Current portion of acquisition-related contingent consideration
|
97,515
|
|
|
97,068
|
|
||
Deferred revenues
|
34,899
|
|
|
34,951
|
|
||
Total current liabilities
|
307,939
|
|
|
312,877
|
|
||
Long-term liabilities:
|
|
|
|
|
|
||
Long-term debt, net
|
783,333
|
|
|
785,992
|
|
||
Convertible 2.5% notes, net
|
181,566
|
|
|
179,363
|
|
||
Acquisition-related contingent consideration
|
51,440
|
|
|
50,927
|
|
||
Deferred tax liabilities
|
154,225
|
|
|
197,066
|
|
||
Deferred revenues
|
16,970
|
|
|
14,850
|
|
||
Other long-term liabilities
|
2,349
|
|
|
2,962
|
|
||
Total liabilities
|
1,497,822
|
|
|
1,544,037
|
|
||
Commitments and contingencies
|
|
|
|
|
|
||
Stockholders’ equity:
|
|
|
|
|
|
||
Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued
|
—
|
|
|
—
|
|
||
Common stock, par value $0.01 per share, 117,500,000 shares authorized; 34,445,394 and 34,336,147 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively
|
344
|
|
|
343
|
|
||
Additional paid-in capital
|
1,242,640
|
|
|
1,238,031
|
|
||
Accumulated other comprehensive loss
|
(3,746
|
)
|
|
(3,838
|
)
|
||
Accumulated deficit
|
(315,150
|
)
|
|
(300,147
|
)
|
||
Total stockholders’ equity
|
924,088
|
|
|
934,389
|
|
||
Total liabilities and stockholders’ equity
|
$
|
2,421,910
|
|
|
$
|
2,478,426
|
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Revenues:
|
|
|
|
||||
Product sales, net
|
$
|
112,517
|
|
|
$
|
89,564
|
|
Service revenues, net
|
26,931
|
|
|
19,520
|
|
||
License fee, collaboration and other revenues
|
24
|
|
|
216
|
|
||
Total revenues
|
139,472
|
|
|
109,300
|
|
||
Costs and expenses:
|
|
|
|
||||
Cost of product sales
|
27,573
|
|
|
18,300
|
|
||
Cost of services
|
5,010
|
|
|
5,526
|
|
||
Research and development expenses
|
16,489
|
|
|
14,229
|
|
||
Acquired in-process research and development
|
60,000
|
|
|
—
|
|
||
Selling, general and administrative expenses
|
70,424
|
|
|
63,175
|
|
||
Restructuring expenses
|
—
|
|
|
622
|
|
||
Total costs and expenses
|
179,496
|
|
|
101,852
|
|
||
Operating income (loss)
|
(40,024
|
)
|
|
7,448
|
|
||
Other income (expense):
|
|
|
|
||||
Interest expense
|
(18,300
|
)
|
|
(18,443
|
)
|
||
Interest and dividend income
|
1,031
|
|
|
708
|
|
||
Gains on investments, net
|
27
|
|
|
—
|
|
||
Other income (expense)
|
—
|
|
|
220
|
|
||
Total other income (expense)
|
(17,242
|
)
|
|
(17,515
|
)
|
||
Loss before income taxes
|
(57,266
|
)
|
|
(10,067
|
)
|
||
Income tax benefit
|
(20,706
|
)
|
|
(2,540
|
)
|
||
Net loss
|
$
|
(36,560
|
)
|
|
$
|
(7,527
|
)
|
Net loss per share:
|
|
|
|
||||
Basic
|
$
|
(1.06
|
)
|
|
$
|
(0.22
|
)
|
Diluted
|
$
|
(1.06
|
)
|
|
$
|
(0.22
|
)
|
Weighted average shares outstanding used to compute net loss per share:
|
|
|
|
||||
Basic
|
34,378
|
|
|
34,739
|
|
||
Diluted
|
34,378
|
|
|
34,739
|
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Net loss
|
$
|
(36,560
|
)
|
|
$
|
(7,527
|
)
|
Other comprehensive income (loss):
|
|
|
|
||||
Unrealized gains (losses) on securities:
|
|
|
|
||||
Holding gains arising during period, net of tax
|
92
|
|
|
932
|
|
||
Net unrealized gains on securities
|
92
|
|
|
932
|
|
||
Total comprehensive loss
|
$
|
(36,468
|
)
|
|
$
|
(6,595
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net loss
|
$
|
(36,560
|
)
|
|
$
|
(7,527
|
)
|
Adjustments to reconcile net loss to net cash provided by operating activities:
|
|
|
|
||||
Depreciation and amortization
|
27,994
|
|
|
19,644
|
|
||
Provision for bad debt expense
|
590
|
|
|
2,209
|
|
||
Amortization of premium/discount on purchased securities
|
113
|
|
|
177
|
|
||
Non-cash equity-based compensation expense
|
5,778
|
|
|
6,160
|
|
||
Amortization of debt discount and debt issuance costs
|
3,209
|
|
|
2,937
|
|
||
Gains on investments, net
|
(143
|
)
|
|
—
|
|
||
Change in fair value of contingent consideration
|
1,043
|
|
|
5,056
|
|
||
Deferred income taxes
|
(21,192
|
)
|
|
(1,469
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable, net
|
6,553
|
|
|
715
|
|
||
Inventories
|
(403
|
)
|
|
(2,157
|
)
|
||
Receivable from collaboration
|
—
|
|
|
246
|
|
||
Prepaid and other current assets
|
1,523
|
|
|
(3,078
|
)
|
||
Accounts payable and accrued expenses
|
(4,622
|
)
|
|
(6,647
|
)
|
||
Deferred revenues
|
2,067
|
|
|
9,717
|
|
||
Other assets and liabilities
|
(486
|
)
|
|
593
|
|
||
Net cash (used in) provided by operating activities
|
(14,536
|
)
|
|
26,576
|
|
||
Cash flows from investing activities:
|
|
|
|
||||
Proceeds from sales or maturities of investments
|
128,512
|
|
|
25,500
|
|
||
Purchase of investments
|
(129,241
|
)
|
|
(63,413
|
)
|
||
Change in restricted cash
|
100
|
|
|
—
|
|
||
Capital expenditures
|
(658
|
)
|
|
(681
|
)
|
||
Net cash used in investing activities
|
(1,287
|
)
|
|
(38,594
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Long-term debt principal payments
|
(4,375
|
)
|
|
(4,375
|
)
|
||
Payment of contingent consideration
|
(83
|
)
|
|
(65
|
)
|
||
Payments for repurchases of common stock
|
—
|
|
|
(7,562
|
)
|
||
Proceeds from the exercise of stock options
|
152
|
|
|
400
|
|
||
Payments of employee tax withholding related to equity-based compensation
|
(1,322
|
)
|
|
(1,696
|
)
|
||
Net cash used in financing activities
|
(5,628
|
)
|
|
(13,298
|
)
|
||
Net decrease in cash and cash equivalents
|
(21,451
|
)
|
|
(25,316
|
)
|
||
Cash and cash equivalents at beginning of the period
|
274,305
|
|
|
228,705
|
|
||
Cash and cash equivalents at end of the period
|
$
|
252,854
|
|
|
$
|
203,389
|
|
Supplemental data for cash flow information:
|
|
|
|
||||
Cash paid for taxes
|
$
|
208
|
|
|
$
|
2,400
|
|
Cash paid for interest
|
$
|
26,195
|
|
|
$
|
27,964
|
|
|
Three Months Ended March 31,
|
||||
|
2017
|
|
2016
|
||
AmerisourceBergen Drug Corporation
|
22
|
%
|
|
24
|
%
|
McKesson Corporation
|
14
|
%
|
|
<10
|
%
|
|
March 31, 2017
|
|
December 31, 2016
|
||
AmerisourceBergen Drug Corporation
|
31
|
%
|
|
13
|
%
|
McKesson Corporation
|
21
|
%
|
|
32
|
%
|
•
|
Persuasive evidence of an arrangement exists;
|
•
|
Delivery of product has occurred or services have been rendered;
|
•
|
The sales price charged is fixed or determinable; and
|
•
|
Collection is reasonably assured.
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Gross product sales
|
$
|
206,724
|
|
|
$
|
152,192
|
|
Provision for product sales allowances and accruals:
|
|
|
|
|
|||
Contractual adjustments
|
69,829
|
|
|
45,581
|
|
||
Governmental rebates
|
24,378
|
|
|
17,047
|
|
||
Total
|
94,207
|
|
|
62,628
|
|
||
Product sales, net
|
$
|
112,517
|
|
|
$
|
89,564
|
|
|
March 31, 2017
|
||||||||||||||
|
|
|
Gross
|
|
Gross
|
|
Estimated
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Corporate debt securities
|
|
|
|
|
|
|
|
||||||||
Due in one year or less
|
$
|
137,390
|
|
|
$
|
8
|
|
|
$
|
(86
|
)
|
|
$
|
137,312
|
|
Due in one to three years
|
111,161
|
|
|
36
|
|
|
(135
|
)
|
|
111,062
|
|
||||
U.S. treasury and government agency securities
|
|
|
|
|
|
|
|
|
|||||||
Due in one year or less
|
2,513
|
|
|
—
|
|
|
(1
|
)
|
|
2,512
|
|
||||
Due in one to three years
|
14,373
|
|
|
4
|
|
|
(49
|
)
|
|
14,328
|
|
||||
Commercial paper
|
|
|
|
|
|
|
|
|
|||||||
Due in one year or less
|
26,875
|
|
|
—
|
|
|
—
|
|
|
26,875
|
|
||||
Certificates of deposit
|
|
|
|
|
|
|
|
||||||||
Due in one year or less
|
12,000
|
|
|
—
|
|
|
—
|
|
|
12,000
|
|
||||
Due in one to three years
|
1,452
|
|
|
—
|
|
|
—
|
|
|
1,452
|
|
||||
Total investments
|
$
|
305,764
|
|
|
$
|
48
|
|
|
$
|
(271
|
)
|
|
$
|
305,541
|
|
|
December 31, 2016
|
||||||||||||||
|
|
|
Gross
|
|
Gross
|
|
Estimated
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Corporate debt securities
|
|
|
|
|
|
|
|
||||||||
Due in one year or less
|
$
|
106,430
|
|
|
$
|
3
|
|
|
$
|
(69
|
)
|
|
$
|
106,364
|
|
Due in one to three years
|
139,742
|
|
|
32
|
|
|
(281
|
)
|
|
139,493
|
|
||||
U.S. treasury and government agency securities
|
|
|
|
|
|
|
|
|
|||||||
Due in one year or less
|
1,021
|
|
|
—
|
|
|
—
|
|
|
1,021
|
|
||||
Due in one to three years
|
11,395
|
|
|
—
|
|
|
(52
|
)
|
|
11,343
|
|
||||
Commercial paper
|
|
|
|
|
|
|
|
|
|
|
|
||||
Due in one year or less
|
40,560
|
|
|
—
|
|
|
—
|
|
|
40,560
|
|
||||
Certificates of deposit
|
|
|
|
|
|
|
|
|
|
|
|
||||
Due in one year or less
|
6,000
|
|
|
—
|
|
|
—
|
|
|
6,000
|
|
||||
Total investments
|
$
|
305,148
|
|
|
$
|
35
|
|
|
$
|
(402
|
)
|
|
$
|
304,781
|
|
|
Fair Value Measurements at March 31, 2017 Using:
|
||||||||||||||
|
|
|
Quoted Prices in
|
|
|
|
Significant
|
||||||||
|
|
|
Active Markets for
|
|
Significant Other
|
|
Unobservable
|
||||||||
|
|
|
Identical Assets
|
|
Observable Inputs
|
|
Inputs
|
||||||||
|
Total
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
9,932
|
|
|
$
|
9,932
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Corporate debt securities
|
248,374
|
|
|
—
|
|
|
248,374
|
|
|
—
|
|
||||
U.S. treasury and government agency securities
|
16,840
|
|
|
—
|
|
|
16,840
|
|
|
—
|
|
||||
Commercial paper
|
26,875
|
|
|
—
|
|
|
26,875
|
|
|
—
|
|
||||
Certificates of deposit
|
13,452
|
|
|
—
|
|
|
13,452
|
|
|
—
|
|
||||
Total Assets
|
$
|
315,473
|
|
|
$
|
9,932
|
|
|
$
|
305,541
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Contingent consideration - Lumara Health
|
$
|
146,973
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
146,973
|
|
Contingent consideration - MuGard
|
1,982
|
|
|
—
|
|
|
—
|
|
|
1,982
|
|
||||
Total Liabilities
|
$
|
148,955
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
148,955
|
|
Balance as of December 31, 2016
|
$
|
147,995
|
|
Payments made
|
(83
|
)
|
|
Adjustments to fair value of contingent consideration
|
1,043
|
|
|
Balance as of March 31, 2017
|
$
|
148,955
|
|
|
March 31, 2017
|
|
December 31, 2016
|
||||
Raw materials
|
$
|
14,721
|
|
|
$
|
14,382
|
|
Work in process
|
3,250
|
|
|
3,924
|
|
||
Finished goods
|
18,956
|
|
|
18,952
|
|
||
Total inventories
|
$
|
36,927
|
|
|
$
|
37,258
|
|
|
March 31, 2017
|
|
December 31, 2016
|
||||
Land
|
$
|
700
|
|
|
$
|
700
|
|
Land improvements
|
300
|
|
|
300
|
|
||
Building and improvements
|
9,500
|
|
|
9,500
|
|
||
Computer equipment and software
|
14,190
|
|
|
13,866
|
|
||
Furniture and fixtures
|
2,401
|
|
|
2,401
|
|
||
Leasehold improvements
|
3,718
|
|
|
3,718
|
|
||
Laboratory and production equipment
|
6,638
|
|
|
6,449
|
|
||
Construction in progress
|
1,765
|
|
|
1,619
|
|
||
|
39,212
|
|
|
38,553
|
|
||
Less: accumulated depreciation
|
(16,504
|
)
|
|
(14,093
|
)
|
||
Property, plant and equipment, net
|
$
|
22,708
|
|
|
$
|
24,460
|
|
|
March 31, 2017
|
|
December 31, 2016
|
||||||||||||||||||||||||||||
|
|
|
Accumulated
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
||||||||||||||||
|
Cost
|
|
Amortization
|
|
Impairments
|
|
Net
|
|
Cost
|
|
Amortization
|
|
Impairments
|
|
Net
|
||||||||||||||||
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Makena base technology
|
$
|
797,100
|
|
|
$
|
149,652
|
|
|
$
|
—
|
|
|
$
|
647,448
|
|
|
$
|
797,100
|
|
|
$
|
128,732
|
|
|
$
|
—
|
|
|
$
|
668,368
|
|
CBR customer relationships
|
297,000
|
|
|
17,519
|
|
|
—
|
|
|
279,481
|
|
|
297,000
|
|
|
13,590
|
|
|
—
|
|
|
283,410
|
|
||||||||
|
1,094,100
|
|
|
167,171
|
|
|
—
|
|
|
926,929
|
|
|
1,094,100
|
|
|
142,322
|
|
|
—
|
|
|
951,778
|
|
||||||||
Indefinite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Makena IPR&D
|
79,100
|
|
|
—
|
|
|
—
|
|
|
79,100
|
|
|
79,100
|
|
|
—
|
|
|
—
|
|
|
79,100
|
|
||||||||
CBR trade names and trademarks
|
65,000
|
|
|
—
|
|
|
3,700
|
|
|
61,300
|
|
|
65,000
|
|
|
—
|
|
|
3,700
|
|
|
61,300
|
|
||||||||
Total intangible assets
|
$
|
1,238,200
|
|
|
$
|
167,171
|
|
|
$
|
3,700
|
|
|
$
|
1,067,329
|
|
|
$
|
1,238,200
|
|
|
$
|
142,322
|
|
|
$
|
3,700
|
|
|
$
|
1,092,178
|
|
|
|
Estimated
|
||
|
|
Amortization
|
||
Period
|
|
Expense
|
||
Remainder of Year Ending December 31, 2017
|
|
$
|
95,051
|
|
Year Ending December 31, 2018
|
|
81,433
|
|
|
Year Ending December 31, 2019
|
|
48,283
|
|
|
Year Ending December 31, 2020
|
|
46,845
|
|
|
Year Ending December 31, 2021
|
|
46,767
|
|
|
Thereafter
|
|
608,550
|
|
|
Total
|
|
$
|
926,929
|
|
|
March 31, 2017
|
|
December 31, 2016
|
||||
Commercial rebates, fees and returns
|
$
|
96,280
|
|
|
$
|
89,466
|
|
Professional, license, and other fees and expenses
|
24,630
|
|
|
24,248
|
|
||
Research and development expenses
|
9,901
|
|
|
10,714
|
|
||
Interest expense
|
5,507
|
|
|
16,683
|
|
||
Salaries, bonuses, and other compensation
|
11,161
|
|
|
14,823
|
|
||
Restructuring expense
|
—
|
|
|
74
|
|
||
Total accrued expenses
|
$
|
147,479
|
|
|
$
|
156,008
|
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Beginning balance
|
$
|
(3,838
|
)
|
|
$
|
(4,205
|
)
|
Other comprehensive income before reclassifications
|
92
|
|
|
932
|
|
||
Ending balance
|
$
|
(3,746
|
)
|
|
$
|
(3,273
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Net loss
|
$
|
(36,560
|
)
|
|
$
|
(7,527
|
)
|
|
|
|
|
||||
Weighted average shares outstanding used to compute net loss per share:
|
|
|
|
||||
Basic
|
34,378
|
|
|
34,739
|
|
||
Diluted
|
34,378
|
|
|
34,739
|
|
||
|
|
|
|
||||
Net loss per share:
|
|
|
|
|
|
||
Basic
|
$
|
(1.06
|
)
|
|
$
|
(0.22
|
)
|
Diluted
|
$
|
(1.06
|
)
|
|
$
|
(0.22
|
)
|
|
Three Months Ended March 31,
|
||||
|
2017
|
|
2016
|
||
Options to purchase shares of common stock
|
2,406
|
|
|
2,455
|
|
Shares of common stock issuable upon the vesting of RSUs
|
775
|
|
|
904
|
|
Warrants
|
7,382
|
|
|
7,382
|
|
Convertible 2.5% notes
|
7,382
|
|
|
7,382
|
|
Total
|
17,945
|
|
|
18,123
|
|
|
2007 Equity
|
|
2000 Equity
|
|
2013 Lumara
|
|
Inducement
|
|
|
|||||
|
Plan
|
|
Plan
|
|
Equity Plan
|
|
Grants
|
|
Total
|
|||||
Outstanding at December 31, 2016
|
2,158,822
|
|
|
5,200
|
|
|
134,181
|
|
|
814,975
|
|
|
3,113,178
|
|
Granted
|
322,210
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
322,210
|
|
Exercised
|
(9,065
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(9,065
|
)
|
Expired or terminated
|
(50,696
|
)
|
|
—
|
|
|
(281
|
)
|
|
(27,625
|
)
|
|
(78,602
|
)
|
Outstanding at March 31, 2017
|
2,421,271
|
|
|
5,200
|
|
|
133,900
|
|
|
787,350
|
|
|
3,347,721
|
|
|
2007 Equity
|
|
2000 Equity
|
|
2013 Lumara
|
|
Inducement
|
|
|
|||||
|
Plan
|
|
Plan
|
|
Equity Plan
|
|
Grants
|
|
Total
|
|||||
Outstanding at December 31, 2016
|
773,804
|
|
|
—
|
|
|
27,694
|
|
|
135,456
|
|
|
936,954
|
|
Granted
|
732,956
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
732,956
|
|
Vested
|
(143,056
|
)
|
|
—
|
|
|
(11,664
|
)
|
|
(1,000
|
)
|
|
(155,720
|
)
|
Expired or terminated
|
(26,957
|
)
|
|
—
|
|
|
(501
|
)
|
|
(5,318
|
)
|
|
(32,776
|
)
|
Outstanding at March 31, 2017
|
1,336,747
|
|
|
—
|
|
|
15,529
|
|
|
129,138
|
|
|
1,481,414
|
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Cost of product sales
|
$
|
129
|
|
|
$
|
320
|
|
Research and development
|
756
|
|
|
756
|
|
||
Selling, general and administrative
|
4,893
|
|
|
5,084
|
|
||
Total equity-based compensation expense
|
5,778
|
|
|
6,160
|
|
||
Income tax effect
|
(1,605
|
)
|
|
(1,674
|
)
|
||
After-tax effect of equity-based compensation expense
|
$
|
4,173
|
|
|
$
|
4,486
|
|
|
March 31, 2017
|
|
December 31, 2016
|
||||
2023 Senior Notes
|
$
|
489,907
|
|
|
$
|
489,612
|
|
2015 Term Loan Facility
|
313,881
|
|
|
317,546
|
|
||
Convertible Notes
|
181,566
|
|
|
179,363
|
|
||
Total long-term debt
|
985,354
|
|
|
986,521
|
|
||
Less: current maturities
|
20,455
|
|
|
21,166
|
|
||
Long-term debt, net of current maturities
|
$
|
964,899
|
|
|
$
|
965,355
|
|
1)
|
during any calendar quarter (and only during such calendar quarter), if the last reported sale price of our common stock for at least
20
trading days (whether or not consecutive) during a period of
30
consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to
130%
of the conversion price on each applicable trading day;
|
2)
|
during the
five
business day period after any
five
consecutive trading day period (the “measurement period”) in which the trading price per
$1,000
principal amount of the Convertible Notes for each trading day of the measurement period was less than
98%
of the product of the last reported sale price of our common stock and the conversion rate on each such trading day; or
|
3)
|
upon the occurrence of specified corporate event.
|
|
March 31, 2017
|
||
Liability component:
|
|
|
|
Principal
|
$
|
199,998
|
|
Less: debt discount and issuance costs, net
|
(18,432
|
)
|
|
Net carrying amount
|
$
|
181,566
|
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Contractual interest expense
|
$
|
1,250
|
|
|
$
|
1,250
|
|
Amortization of debt issuance costs
|
274
|
|
|
258
|
|
||
Amortization of debt discount
|
1,929
|
|
|
1,815
|
|
||
Total interest expense
|
$
|
3,453
|
|
|
$
|
3,323
|
|
|
Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Accrued restructuring, beginning of period
|
$
|
74
|
|
|
$
|
2,883
|
|
Employee severance, benefits and related costs
|
—
|
|
|
809
|
|
||
Payments
|
(74
|
)
|
|
(1,599
|
)
|
||
Accrued restructuring, end of period
|
$
|
—
|
|
|
$
|
2,093
|
|
|
Three Months Ended March 31,
|
|
2017 to 2016
|
|||||||||||
|
2017
|
|
2016
|
|
$ Change
|
|
% Change
|
|||||||
Product sales, net
|
|
|
|
|
|
|
|
|
|
|
||||
Makena
|
$
|
86,455
|
|
|
$
|
65,032
|
|
|
$
|
21,423
|
|
|
33
|
%
|
Feraheme
|
25,922
|
|
|
24,195
|
|
|
1,727
|
|
|
7
|
%
|
|||
MuGard
|
140
|
|
|
337
|
|
|
(197
|
)
|
|
(58
|
)%
|
|||
Total
|
112,517
|
|
|
89,564
|
|
|
22,953
|
|
|
26
|
%
|
|||
Service revenues, net
|
26,931
|
|
|
19,520
|
|
|
7,411
|
|
|
38
|
%
|
|||
License fee, collaboration and other revenues
|
24
|
|
|
216
|
|
|
(192
|
)
|
|
(89
|
)%
|
|||
Total Revenues
|
$
|
139,472
|
|
|
$
|
109,300
|
|
|
$
|
30,172
|
|
|
28
|
%
|
|
Three Months Ended March 31,
|
|
2017 to 2016
|
|||||||||||||||||
|
2017
|
|
Percent of
gross product sales |
|
2016
|
|
Percent of
gross
product sales
|
|
$ Change
|
|
% Change
|
|||||||||
Gross product sales
|
$
|
206,724
|
|
|
|
|
$
|
152,192
|
|
|
|
|
$
|
54,532
|
|
|
36
|
%
|
||
Provision for product sales allowances and accruals:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Contractual adjustments
|
69,829
|
|
|
34
|
%
|
|
45,581
|
|
|
30
|
%
|
|
|
|
|
|
|
|||
Governmental rebates
|
24,378
|
|
|
12
|
%
|
|
17,047
|
|
|
11
|
%
|
|
|
|
|
|
|
|||
Total
|
94,207
|
|
|
46
|
%
|
|
62,628
|
|
|
41
|
%
|
|
|
|
|
|
|
|||
Product sales, net
|
$
|
112,517
|
|
|
|
|
$
|
89,564
|
|
|
|
|
$
|
22,953
|
|
|
26
|
%
|
|
Three Months Ended March 31,
|
|
2017 to 2016
|
|||||||||||
|
2017
|
|
2016
|
|
$ Change
|
|
% Change
|
|||||||
Cost of product sales
|
$
|
27,573
|
|
|
$
|
18,300
|
|
|
$
|
9,273
|
|
|
51
|
%
|
Percentage of net product sales
|
25
|
%
|
|
20
|
%
|
|
|
|
|
|
Three Months Ended March 31,
|
|
2017 to 2016
|
|||||||||||
|
2017
|
|
2016
|
|
$ Change
|
|
% Change
|
|||||||
Cost of services
|
$
|
5,010
|
|
|
$
|
5,526
|
|
|
$
|
(516
|
)
|
|
(9
|
)%
|
Percentage of service revenues
|
19
|
%
|
|
28
|
%
|
|
|
|
|
|
Three Months Ended March 31,
|
|
2017 to 2016
|
|||||||||||
|
2017
|
|
2016
|
|
$ Change
|
|
% Change
|
|||||||
External research and development expenses
|
|
|
|
|
|
|
|
|||||||
Feraheme-related costs
|
$
|
2,492
|
|
|
$
|
5,891
|
|
|
$
|
(3,399
|
)
|
|
(58
|
)%
|
Makena-related costs
|
4,365
|
|
|
3,608
|
|
|
757
|
|
|
21
|
%
|
|||
Bremelanotide-related costs
|
4,369
|
|
|
—
|
|
|
4,369
|
|
|
N/A
|
|
|||
Other external costs
|
972
|
|
|
844
|
|
|
128
|
|
|
15
|
%
|
|||
Total
|
12,198
|
|
|
10,343
|
|
|
1,855
|
|
|
18
|
%
|
|||
Internal research and development expenses
|
4,291
|
|
|
3,886
|
|
|
405
|
|
|
10
|
%
|
|||
Total research and development expenses
|
$
|
16,489
|
|
|
$
|
14,229
|
|
|
$
|
2,260
|
|
|
16
|
%
|
•
|
Bremelanotide:
Under the terms of the Palatin License Agreement we will reimburse Palatin up to an aggregate amount of
$25.0 million
for all reasonable, documented, out-of-pocket expenses incurred by Palatin in connection with the development and regulatory activities necessary to submit an NDA in the U.S. for bremelanotide for the treatment of HSDD in pre-menopausal women. In addition, we expect to incur supply chain costs to support the ultimate commercialization of bremelanotide;
|
•
|
Makena
: This project currently includes studies conducted as part of the post-approval commitments under the provisions of the FDA’s “Subpart H” Accelerated Approval regulations including: (a) an ongoing efficacy and safety clinical study of Makena; (b) an ongoing follow-up study of the children born to mothers from the efficacy and safety clinical study; and (c) a completed PK trial of women taking Makena. In addition, this project includes studies conducted as part of our Makena auto-injector development program, including completion of the definitive PK study in support of the sNDA we filed with the FDA in April 2017;
|
•
|
Feraheme to treat IDA in CKD patients
: This project currently includes the following: (a) a completed clinical study evaluating Feraheme treatment as compared to treatment to another IV iron and (b) a completed global multi-center randomized clinical trial to determine the safety and efficacy of repeat doses of Feraheme as compared to iron sucrose for the treatment of IDA in patients with hemodialysis dependent CKD. This project also includes a pediatric program as part of our post-approval Pediatric Research Equity Act requirement to support pediatric CKD labeling of Feraheme
,
which we suspended in 2015 due to difficulty in enrollment. In December 2016, we met with the FDA to advance our development of a plan forward in order to satisfy this post-approval commitment for Feraheme and recently proposed a protocol to the FDA for a new pediatric study; and
|
•
|
Feraheme to treat IDA regardless of the underlying cause
: This project currently includes the randomized, double-blind multicenter non-inferiority trial evaluating the incidences of moderate-to-severe hypersensitivity reactions (including anaphylaxis) and moderate-to-severe hypotension with Feraheme compared to Injectafer
®
(ferric carboxymaltose infusion) in adults with IDA, which was completed in December 2016. We announced positive topline data in May 2017 and expect to file an sNDA for this broader indication in mid-2017.
|
|
Three Months Ended March 31,
|
|
2017 to 2016
|
|||||||||||
|
2017
|
|
2016
|
|
$ Change
|
|
% Change
|
|||||||
Compensation, payroll taxes and benefits
|
$
|
21,694
|
|
|
$
|
20,760
|
|
|
$
|
934
|
|
|
4
|
%
|
Professional, consulting and other outside services
|
38,864
|
|
|
29,137
|
|
|
9,727
|
|
|
33
|
%
|
|||
Fair value of contingent consideration liability
|
1,043
|
|
|
5,056
|
|
|
(4,013
|
)
|
|
(79
|
)%
|
|||
Amortization expense related to customer relationship intangible
|
3,930
|
|
|
3,132
|
|
|
798
|
|
|
25
|
%
|
|||
Equity-based compensation expense
|
4,893
|
|
|
5,090
|
|
|
(197
|
)
|
|
(4
|
)%
|
|||
Total selling, general and administrative expenses
|
$
|
70,424
|
|
|
$
|
63,175
|
|
|
$
|
7,249
|
|
|
11
|
%
|
•
|
$10.6 million increase in sales and marketing, consulting, professional fees, and other expenses due to marketing and other activities related to Makena, CBR and Feraheme,
partially offset by an $0.8 million decrease in general and administrative, consulting, professional fees and other expenses; and
|
•
|
$4.0 million
decrease to the contingent consideration liability expense primarily as a result of the reduction in the remaining contingent consideration balance related to Makena following the $100.0 million milestone payment made in 2016 and a revision of the expected timing for the next milestone payment.
|
|
March 31, 2017
|
|
December 31, 2016
|
|
$ Change
|
|
% Change
|
|||||||
Cash and cash equivalents
|
$
|
252,854
|
|
|
$
|
274,305
|
|
|
$
|
(21,451
|
)
|
|
(8
|
)%
|
Investments
|
305,541
|
|
|
304,781
|
|
|
760
|
|
|
—
|
%
|
|||
Total
|
$
|
558,395
|
|
|
$
|
579,086
|
|
|
$
|
(20,691
|
)
|
|
(4
|
)%
|
|
|
|
|
|
|
|
|
|||||||
Outstanding principal on 2023 Senior Notes
|
$
|
500,000
|
|
|
$
|
500,000
|
|
|
$
|
—
|
|
|
—
|
%
|
Outstanding principal on Convertible Notes
|
199,998
|
|
|
199,998
|
|
|
—
|
|
|
—
|
%
|
|||
Outstanding principal on 2015 Term Loan Facility
|
323,750
|
|
|
328,125
|
|
|
(4,375
|
)
|
|
(1
|
)%
|
|||
Total
|
$
|
1,023,748
|
|
|
$
|
1,028,123
|
|
|
$
|
(4,375
|
)
|
|
—
|
%
|
•
|
The FDA may determine that bremelanotide
does not demonstrate safety and efficacy in accordance with regulatory agency standards based on the results of the Phase 3 trial, including the co-primary and secondary endpoints and safety results;
|
•
|
The FDA may determine that the magnitude of efficacy demonstrated in the bremelanotide studies does not amount to a clinically meaningful benefit to pre-menopausal women with HSDD and thus that the product cannot be approved despite statically significant efficacy results;
|
•
|
The FDA could analyze and/or interpret data from pre-clinical testing and clinical trials in different ways than we or Palatin interpret it, such as the calculation of effect size in our Phase 3 studies or the sufficiency of data to determine the timing of onset and the dosing of the product;
|
•
|
The initiation, conduct or results of the remaining drug interaction, safety pharmacology and other ancillary studies may be delayed or unsuccessful;
|
•
|
The auto-injector device, supplied by an unaffiliated third party, that we plan to use to administer bremelanotide may not be adequate or may not be approved by the FDA;
|
•
|
Palatin or we may be unable to establish, and obtain FDA approval for, a commercially viable manufacturing process for bremelanotide in a timely manner, or at all;
|
•
|
Adverse medical events reported during the trials, including increases in blood pressure noted in prior clinical trials and a serious adverse event of hepatitis of unknown etiology;
|
•
|
The failure of clinical investigational sites and the records kept at such sites, including the clinical trial data, to be in compliance with the FDA’s GCP, including the failure to pass FDA inspections of clinical trial sites; and
|
•
|
The FDA may change their approval policies or adopt new regulations.
|
Period
|
Total Number
of Shares Purchased(1) |
|
Average Price
Paid Per Share |
|
Total Number of
Shares Purchased as Part of Publicly Announced Plans or Programs (2) |
|
Maximum Number
of Shares (or approximate dollar value) That May Yet Be Purchased Under the Plans or Programs (2) |
|||||
January 1, 2017 through January 31, 2017
|
949
|
|
|
$
|
34.80
|
|
|
—
|
|
|
1,659,751
|
|
February 1, 2017 through February 28, 2017
|
38,386
|
|
|
23.74
|
|
|
—
|
|
|
1,781,737
|
|
|
March 1, 2017 through March 31, 2017
|
16,203
|
|
|
23.27
|
|
|
—
|
|
|
1,773,836
|
|
|
Total
|
55,538
|
|
|
$
|
23.79
|
|
|
—
|
|
|
|
(1)
|
Represents the surrender of shares of our common stock withheld by us to satisfy the minimum tax withholding obligations in connection with the vesting of restricted stock units held by our employees.
|
(2)
|
We did not repurchase any of our common stock during the
first
quarter of
2017
. We have repurchased and retired $20.0 million of our common stock under the share repurchase program through
March 31, 2017
. These shares were purchased pursuant to a repurchase program authorized by our board of directors that was announced in January 2016 to repurchase up to $60.0 million of our common stock, of which
$40.0 million
remains outstanding as of
March 31, 2017
. The repurchase program does not have an expiration date and may be suspended for periods or discontinued at any time.
|
Exhibit
Number
|
|
Description
|
10.1
|
|
License Agreement, by and between AMAG Pharmaceuticals, Inc. and Palatin Technologies, Inc., dated January 8, 2017 (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed February 3, 2017, File No. 001-10865) (Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***]. This exhibit has been filed separately with the SEC without any redactions pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended)
|
10.2
|
|
License Agreement, by and between AMAG Pharmaceuticals, Inc. and Endoceutics, Inc., dated February 13, 2017(incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed April 5, 2017, File No. 001-10865) (Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***]. This exhibit has been filed separately with the SEC without any redactions pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended)
|
10.3
|
|
Manufacturing and Supply Agreement, by and between AMAG Pharmaceuticals, Inc. and Endoceutics, Inc., dated April 5, 2017 (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed April 5, 2017, File No. 001-10865) (Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***]. This exhibit has been filed separately with the SEC without any redactions pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended)
|
10.4+
|
|
AMAG Pharmaceuticals, Inc. Long-Term Incentive Plan (included as Exhibit A to the Form of Award Notice under the AMAG Pharmaceuticals, Inc. Long-term Incentive Plan filed as Exhibit 10.5 to this Quarterly Report on Form 10-Q)
|
10.5+
|
|
Form of Award Notice under the AMAG Pharmaceuticals, Inc. Long-term Incentive Plan
|
10.6+
|
|
AMAG Pharmaceuticals, Inc.’s Non-Employee Director Compensation Policy
|
31.1+
|
|
Certification Pursuant to Rule 13a‑14(a)/15d‑14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
31.2+
|
|
Certification Pursuant to Rule 13a‑14(a)/15d‑14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
32.1++
|
|
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
32.2++
|
|
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
101.INS+
|
|
XBRL Instance Document
|
101.SCH+
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL+
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF+
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB+
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE+
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
+
|
Exhibits marked with a plus sign (“+”) are filed herewith.
|
++
|
Exhibits marked with a double plus sign (“++”) are furnished herewith.
|
|
|
|
|
|
AMAG PHARMACEUTICALS, INC.
|
||
|
|
|
|
|
By:
|
/s/ William K. Heiden
|
|
|
|
William K. Heiden
|
|
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
|
|
Date:
|
May 3, 2017
|
|
|
|
|
|
|
AMAG PHARMACEUTICALS, INC.
|
||
|
|
|
|
|
By:
|
/s/ Edward Myles
|
|
|
|
Edward Myles
|
|
|
|
Senior Vice President of Finance, Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
|
Date:
|
May 3, 2017
|
Exhibit
Number
|
|
Description
|
10.1
|
|
License Agreement, by and between AMAG Pharmaceuticals, Inc. and Palatin Technologies, Inc., dated January 8, 2017 (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed February 3, 2017, File No. 001-10865) (Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***]. This exhibit has been filed separately with the SEC without any redactions pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended)
|
10.2
|
|
License Agreement, by and between AMAG Pharmaceuticals, Inc. and Endoceutics, Inc., dated February 13, 2017(incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed April 5, 2017, File No. 001-10865) (Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***]. This exhibit has been filed separately with the SEC without any redactions pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended)
|
10.3
|
|
Manufacturing and Supply Agreement, by and between AMAG Pharmaceuticals, Inc. and Endoceutics, Inc., dated April 5, 2017 (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed April 5, 2017, File No. 001-10865) (Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***]. This exhibit has been filed separately with the SEC without any redactions pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended)
|
10.4+
|
|
AMAG Pharmaceuticals, Inc. Long-Term Incentive Plan (included as Exhibit A to the Form of Award Notice under the AMAG Pharmaceuticals, Inc. Long-term Incentive Plan filed as Exhibit 10.5 to this Quarterly Report on Form 10-Q)
|
10.5+
|
|
Form of Award Notice under the AMAG Pharmaceuticals, Inc. Long-term Incentive Plan
|
10.6+
|
|
AMAG Pharmaceuticals, Inc.’s Non-Employee Director Compensation Policy
|
31.1+
|
|
Certification Pursuant to Rule 13a‑14(a)/15d‑14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes‑Oxley Act of 2002
|
31.2+
|
|
Certification Pursuant to Rule 13a‑14(a)/15d‑14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes‑Oxley Act of 2002
|
32.1++
|
|
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes‑Oxley Act of 2002
|
32.2++
|
|
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes‑Oxley Act of 2002
|
101.INS+
|
|
XBRL Instance Document
|
101.SCH+
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL+
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF+
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB+
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE+
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
+
|
Exhibits marked with a plus sign (“+”) are filed herewith.
|
++
|
Exhibits marked with a double plus sign (“++”) are furnished herewith.
|
|
AMAG PHARMACEUTICALS, INC.
|
|
|
|
By:
|
|
Name: William K. Heiden
|
|
Title: President and Chief Executive Officer
|
Dated:
|
|
|
|
|
|
|
Participant's Signature
|
|
|
|
|
|
|
|
Participant's name and address:
|
|
|
|
|
|
|
|
|
|
|
|
|
(a)
|
“
Administrator
” means the Compensation Committee of the Board.
|
(b)
|
“
Award
” means a grant to a Participant hereunder.
|
(c)
|
“
Award Notice
” means a notice or agreement provided to a Participant that sets forth the terms, conditions and limitations of the Participant’s participation in this Plan, including, without limitation, the Participant’s Target Award.
|
(d)
|
“
Board
” means the Board of Directors of the Company.
|
(e)
|
“
Closing Stock Price
” means the Stock Price as of the last day of any Performance Measurement Period.
|
(f)
|
“
Code
” means Internal Revenue Code of 1986, as amended.
|
(g)
|
“
Dividend Value
” shall mean the aggregate amount of dividends and other distributions paid on one share of Stock for which the record date occurred on or after the first day of the Performance Measurement Period and prior to the Issuance Date for the Performance Measurement Period (excluding dividends and distributions paid in the form of additional shares).
|
(h)
|
“
Effective Date
” means February 23, 2017.
|
(i)
|
“
Employment Agreement
” means any applicable agreement between a Participant and the Company governing employment matters.
|
(j)
|
“
Fair Market Value
” means, as of any given date, the fair market value of a security which shall be the closing sale price reported for such security on the principal stock exchange or, if applicable, any other national exchange on which the security is traded or admitted to trading on such date on which a sale was reported. If there are no market quotations for such date, the determination shall be made by reference to the last date preceding such date for which there are market quotations.
|
(k)
|
“
Grant Date
” means the date that the Administrator designates in its approval of an Award in accordance with applicable law as the date on which the Award is granted.
|
(l)
|
“
Index Companies
” means the companies included in the NASDAQ Biotechnology
Index, but specifically excluding the Company, as of the first day of the applicable Performance Period.
|
(m)
|
“
Index Relative TSR Return
” means the Company’s Total Shareholder Return during the Performance Measurement Period compared to the Total Shareholder Return of the Index Companies during the Performance Measurement Period. Relative performance will be determined by numerical ranking the Company and the Index Companies according to their respective Total Shareholder Return, with a rank of #1 for the company with the highest Total Shareholder Return through the bottom ranking equal to the total number of companies in the comparison. After this ranking, the percentile ranking of the Company relative to the Index Companies will be determined as follows:
|
where:
|
“P” represents the percentile ranking which will be rounded, if necessary, to the nearest whole percentile by application of regular rounding.
|
(n)
|
“
Initial Stock Price
” means the Stock Price as of the first day of any Performance Measurement Period.
|
(o)
|
“
Participant
” means an executive or senior management of the Company selected by the Administrator to participate in the Plan.
|
(p)
|
“
Performance Measurement Period
” means, unless otherwise specified by the Administrator at the time an Award is granted, the period commencing on the Grant Date and ending on the earlier of (i) the date immediately preceding the third anniversary thereafter or (ii) the date upon which a Sale Event (as defined in the 2007 Plan) shall occur (the earlier of such dates, the “
Valuation Date
”). There shall be overlapping Performance Measurement Periods.
|
(q)
|
“
Restricted Stock Units”
means the restricted stock units of the Company.
|
(r)
|
“
Stock
” means the Company’s common stock.
|
(s)
|
“
Stock Price
” for each of the Company and the Index Companies means, as of a particular date, the VWAP (volume weighted average price), as determined by Bloomberg, of the common stock of such company for the 20 trading days ending on, and including, such date; provided however, that in the event of a Sale Event, the Company’s Stock Price shall equal the Fair Market Value, as determined by the Administrator in its discretion, of the total consideration paid or payable in the transaction resulting in the Sale Event, for one share of Stock.
|
(t)
|
“
Target Award
” means the target number of Restricted Stock Units that comprise a Participant’s Award for each Performance Measurement Period, as set forth in the Participant’s Award Notice.
|
(u)
|
“
Total Shareholder Return
” means for each of the Company and the Index Companies, with respect to the Performance Measurement Period, the total return (expressed as a percentage) that would have been realized by a shareholder who (a) bought one share of common stock of such company at the Initial Stock Price on the first day of the Performance Measurement Period, (b) reinvested each dividend and other distribution declared during the Performance Measurement Period with respect to such share (and any other shares, or fractions thereof, previously received upon reinvestment of dividends or other distributions or on account of stock dividends), without deduction for any taxes with respect to such dividends or other distributions or any charges in connection with such reinvestment, in additional shares of common stock of such company at a price per share equal to (i) the Fair Market Value on the trading day immediately preceding the ex-dividend date for such dividend or other distribution less (ii) the amount of such dividend or other distribution, and (c) sold such shares on the Valuation Date at the Fair Market Value of such shares on the Valuation Date, without deduction for any taxes with respect to any gain on such sale or any charges in connection with such sale. As set forth in, and pursuant to, Section 3(b) of this Plan, appropriate adjustments to the Total Shareholder Return shall be made to take into account all stock dividends, stock splits, reverse stock splits and
|
Audit Committee:
|
|
$
|
12,500
|
|
Compensation Committee:
|
|
$
|
10,000
|
|
Governance & Risk Committee:
|
|
$
|
7,500
|
|
Audit Committee:
|
|
$
|
25,000
|
|
Compensation Committee:
|
|
$
|
20,000
|
|
Governance & Risk Committee:
|
|
$
|
15,000
|
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of AMAG Pharmaceuticals, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
|
|
Date:
|
May 3, 2017
|
|
|
|
|
|
|
/s/ William K. Heiden
|
|
|
William K. Heiden
|
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of AMAG Pharmaceuticals, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c.
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d.
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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a.
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date:
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May 3, 2017
|
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/s/ Edward Myles
|
|
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Edward Myles
|
|
|
Senior Vice President of Finance, Chief Financial Officer and Treasurer
(Principal Financial Officer)
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1.
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
2.
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
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/s/ William K. Heiden
|
|
William K. Heiden
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
|
|
|
May 3, 2017
|
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(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
|
|
/s/ Edward Myles
|
|
Edward Myles
|
|
Senior Vice President of Finance, Chief Financial Officer and Treasurer
|
|
(Principal Financial Officer)
|
|
|
|
|
May 3, 2017
|
|