|
|
|
☑
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
LANTHEUS HOLDINGS, INC.
|
(Exact name of registrant as specified in its charter)
|
|
Delaware
|
|
35-2318913
|
|
(State or other jurisdiction of incorporation or organization)
|
|
(IRS Employer Identification No.)
|
|
|
|
|
|
331 Treble Cove Road
|
|
01862
|
|
North Billerica,
|
MA
|
|
|
(Address of principal executive offices)
|
|
(Zip Code)
|
(978)
|
671-8001
|
(Registrant’s telephone number, including area code)
|
|
|
|
Not Applicable
|
|
(Former name, former address and former fiscal year, if changed since last report
|
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common stock, par value $0.01 per share
|
LNTH
|
The Nasdaq Global Market
|
Large accelerated filer
|
|
☑
|
|
Accelerated filer
|
|
☐
|
|
|
|
|
|||
Non-accelerated filer
|
|
☐
|
|
Smaller reporting company
|
|
☐
|
|
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|
|
|||
|
|
|
|
Emerging Growth Company
|
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☐
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Page
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||
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||
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||
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||
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||
|
||
|
||
|
March 31,
2020 |
|
December 31,
2019 |
||||
Assets
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
95,713
|
|
|
$
|
92,919
|
|
Accounts receivable, net
|
44,883
|
|
|
43,529
|
|
||
Inventory
|
30,814
|
|
|
29,180
|
|
||
Other current assets
|
8,967
|
|
|
7,283
|
|
||
Total current assets
|
180,377
|
|
|
172,911
|
|
||
Property, plant and equipment, net
|
108,613
|
|
|
116,497
|
|
||
Intangibles, net
|
6,930
|
|
|
7,336
|
|
||
Goodwill
|
15,714
|
|
|
15,714
|
|
||
Deferred tax assets, net
|
70,454
|
|
|
71,834
|
|
||
Other long-term assets
|
22,037
|
|
|
21,627
|
|
||
Total assets
|
$
|
404,125
|
|
|
$
|
405,919
|
|
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Current portion of long-term debt and other borrowings
|
$
|
10,143
|
|
|
$
|
10,143
|
|
Accounts payable
|
18,980
|
|
|
18,608
|
|
||
Accrued expenses and other liabilities
|
32,836
|
|
|
37,360
|
|
||
Total current liabilities
|
61,959
|
|
|
66,111
|
|
||
Asset retirement obligations
|
13,243
|
|
|
12,883
|
|
||
Long-term debt, net and other borrowings
|
181,488
|
|
|
183,927
|
|
||
Other long-term liabilities
|
29,037
|
|
|
28,397
|
|
||
Total liabilities
|
285,727
|
|
|
291,318
|
|
||
Commitments and contingencies (See Note 15)
|
|
|
|
||||
Stockholders’ equity
|
|
|
|
||||
Preferred stock ($0.01 par value, 25,000 shares authorized; no shares issued and outstanding)
|
—
|
|
|
—
|
|
||
Common stock ($0.01 par value, 250,000 shares authorized; 39,750 and 39,251 shares issued and outstanding, respectively)
|
398
|
|
|
393
|
|
||
Additional paid-in capital
|
253,530
|
|
|
251,641
|
|
||
Accumulated deficit
|
(133,136
|
)
|
|
(136,473
|
)
|
||
Accumulated other comprehensive loss
|
(2,394
|
)
|
|
(960
|
)
|
||
Total stockholders’ equity
|
118,398
|
|
|
114,601
|
|
||
Total liabilities and stockholders’ equity
|
$
|
404,125
|
|
|
$
|
405,919
|
|
|
Three Months Ended
March 31, |
||||||
|
2020
|
|
2019
|
||||
Revenues
|
$
|
90,704
|
|
|
$
|
86,510
|
|
Cost of goods sold
|
52,702
|
|
|
42,426
|
|
||
Gross profit
|
38,002
|
|
|
44,084
|
|
||
Operating expenses
|
|
|
|
||||
Sales and marketing
|
10,130
|
|
|
10,397
|
|
||
General and administrative
|
16,699
|
|
|
12,589
|
|
||
Research and development
|
4,048
|
|
|
4,929
|
|
||
Total operating expenses
|
30,877
|
|
|
27,915
|
|
||
Operating income
|
7,125
|
|
|
16,169
|
|
||
Interest expense
|
1,946
|
|
|
4,592
|
|
||
Other income
|
(350
|
)
|
|
(1,187
|
)
|
||
Income before income taxes
|
5,529
|
|
|
12,764
|
|
||
Income tax expense
|
2,192
|
|
|
2,815
|
|
||
Net income
|
$
|
3,337
|
|
|
$
|
9,949
|
|
Net income per common share:
|
|
|
|
||||
Basic
|
$
|
0.08
|
|
|
$
|
0.26
|
|
Diluted
|
$
|
0.08
|
|
|
$
|
0.25
|
|
Weighted-average common shares outstanding:
|
|
|
|
||||
Basic
|
39,433
|
|
|
38,603
|
|
||
Diluted
|
40,102
|
|
|
39,787
|
|
|
Three Months Ended
March 31, |
||||||
|
2020
|
|
2019
|
||||
Net income
|
$
|
3,337
|
|
|
$
|
9,949
|
|
Other comprehensive (loss) income:
|
|
|
|
||||
Foreign currency translation
|
(446
|
)
|
|
56
|
|
||
Unrealized loss on cash flow hedges, net of tax
|
(988
|
)
|
|
—
|
|
||
Total other comprehensive (loss) income
|
(1,434
|
)
|
|
56
|
|
||
Comprehensive income
|
$
|
1,903
|
|
|
$
|
10,005
|
|
|
|
Three Months Ended March 31, 2020
|
|||||||||||||||||||||
|
|
Common Stock
|
|
Additional
Paid-In Capital |
|
Accumulated
Deficit |
|
Accumulated
Other Comprehensive Loss |
|
Total
Stockholders’ Equity |
|||||||||||||
|
|
Shares
|
|
Amount
|
|
||||||||||||||||||
Balance, January 1, 2020
|
|
39,251
|
|
|
$
|
393
|
|
|
$
|
251,641
|
|
|
$
|
(136,473
|
)
|
|
$
|
(960
|
)
|
|
$
|
114,601
|
|
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,337
|
|
|
—
|
|
|
3,337
|
|
|||||
Other comprehensive income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,434
|
)
|
|
(1,434
|
)
|
|||||
Stock option exercises and employee stock plan purchases
|
|
33
|
|
|
—
|
|
|
366
|
|
|
—
|
|
|
—
|
|
|
366
|
|
|||||
Vesting of restricted stock awards and units
|
|
563
|
|
|
6
|
|
|
(6
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Shares withheld to cover taxes
|
|
(97
|
)
|
|
(1
|
)
|
|
(1,546
|
)
|
|
—
|
|
|
—
|
|
|
(1,547
|
)
|
|||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
3,075
|
|
|
—
|
|
|
—
|
|
|
3,075
|
|
|||||
Balance, March 31, 2020
|
|
39,750
|
|
|
$
|
398
|
|
|
$
|
253,530
|
|
|
$
|
(133,136
|
)
|
|
$
|
(2,394
|
)
|
|
$
|
118,398
|
|
|
|
Three Months Ended March 31, 2019
|
|||||||||||||||||||||
|
|
Common Stock
|
|
Additional
Paid-In Capital |
|
Accumulated
Deficit |
|
Accumulated
Other Comprehensive Loss |
|
Total
Stockholders’ Equity |
|||||||||||||
|
|
Shares
|
|
Amount
|
|
||||||||||||||||||
Balance, January 1, 2019
|
|
38,466
|
|
|
$
|
385
|
|
|
$
|
239,865
|
|
|
$
|
(168,140
|
)
|
|
$
|
(1,108
|
)
|
|
$
|
71,002
|
|
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9,949
|
|
|
—
|
|
|
9,949
|
|
|||||
Other comprehensive income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
56
|
|
|
56
|
|
|||||
Stock option exercises and employee stock plan purchases
|
|
37
|
|
|
—
|
|
|
606
|
|
|
—
|
|
|
—
|
|
|
606
|
|
|||||
Vesting of restricted stock awards and units
|
|
365
|
|
|
4
|
|
|
(4
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Shares withheld to cover taxes
|
|
(50
|
)
|
|
(1
|
)
|
|
(1,119
|
)
|
|
—
|
|
|
—
|
|
|
(1,120
|
)
|
|||||
Stock-based compensation
|
|
—
|
|
|
—
|
|
|
2,720
|
|
|
—
|
|
|
—
|
|
|
2,720
|
|
|||||
Balance, March 31, 2019
|
|
38,818
|
|
|
$
|
388
|
|
|
$
|
242,068
|
|
|
$
|
(158,191
|
)
|
|
$
|
(1,052
|
)
|
|
$
|
83,213
|
|
|
Three Months Ended
March 31, |
||||||
|
2020
|
|
2019
|
||||
Operating activities
|
|
|
|
||||
Net income
|
$
|
3,337
|
|
|
$
|
9,949
|
|
Adjustments to reconcile net income to net cash flows from operating activities:
|
|
|
|
||||
Depreciation, amortization and accretion
|
3,732
|
|
|
3,323
|
|
||
Impairment of long-lived assets
|
7,275
|
|
|
—
|
|
||
Amortization of debt related costs
|
169
|
|
|
320
|
|
||
Provision for bad debt
|
202
|
|
|
(190
|
)
|
||
Provision for excess and obsolete inventory
|
449
|
|
|
511
|
|
||
Stock-based compensation
|
3,075
|
|
|
2,720
|
|
||
Deferred taxes
|
1,467
|
|
|
1,741
|
|
||
Long-term income tax receivable
|
(554
|
)
|
|
(802
|
)
|
||
Long-term income tax payable and other long-term liabilities
|
705
|
|
|
1,018
|
|
||
Other
|
452
|
|
|
(6
|
)
|
||
Increases (decreases) in cash from operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
(1,750
|
)
|
|
(1,040
|
)
|
||
Inventory
|
(2,098
|
)
|
|
465
|
|
||
Other current assets
|
1,149
|
|
|
(1,152
|
)
|
||
Accounts payable
|
(913
|
)
|
|
1,458
|
|
||
Accrued expenses and other liabilities
|
(7,289
|
)
|
|
(7,847
|
)
|
||
Net cash provided by operating activities
|
9,408
|
|
|
10,468
|
|
||
Investing activities
|
|
|
|
||||
Capital expenditures
|
(2,698
|
)
|
|
(10,550
|
)
|
||
Net cash used in investing activities
|
(2,698
|
)
|
|
(10,550
|
)
|
||
Financing activities
|
|
|
|
||||
Payments on long-term debt and other borrowings
|
(2,551
|
)
|
|
(717
|
)
|
||
Proceeds from stock option exercises
|
—
|
|
|
324
|
|
||
Proceeds from issuance of common stock
|
366
|
|
|
282
|
|
||
Payments for minimum statutory tax withholding related to net share settlement of equity awards
|
(1,547
|
)
|
|
(1,120
|
)
|
||
Net cash used in financing activities
|
(3,732
|
)
|
|
(1,231
|
)
|
||
Effect of foreign exchange rates on cash and cash equivalents
|
(184
|
)
|
|
(27
|
)
|
||
Net increase (decrease) in cash and cash equivalents
|
2,794
|
|
|
(1,340
|
)
|
||
Cash and cash equivalents, beginning of period
|
92,919
|
|
|
113,401
|
|
||
Cash and cash equivalents, end of period
|
$
|
95,713
|
|
|
$
|
112,061
|
|
|
|
Three Months Ended
March 31, |
||||||
Major Products/Service Lines by Segment (in thousands)
|
|
2020
|
|
2019
|
||||
U.S.
|
|
|
|
|
|
|
||
Product revenue, net(1)
|
|
$
|
78,745
|
|
|
$
|
75,434
|
|
Total U.S. revenues
|
|
78,745
|
|
|
75,434
|
|
||
International
|
|
|
|
|
||||
Product revenue, net(1)
|
|
11,468
|
|
|
10,549
|
|
||
License and royalty revenues
|
|
491
|
|
|
527
|
|
||
Total International revenues
|
|
11,959
|
|
|
11,076
|
|
||
Total revenues
|
|
$
|
90,704
|
|
|
$
|
86,510
|
|
(1)
|
The Company’s principal products include DEFINITY and TechneLite and are categorized within product revenue, net. The Company applies the
|
•
|
Level 1 — Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
|
•
|
Level 2 — Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).
|
•
|
Level 3 — Unobservable inputs that reflect a Company’s estimates about the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data.
|
|
March 31, 2020
|
||||||||||||||
(in thousands)
|
Total Fair
Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Money market
|
$
|
42,051
|
|
|
$
|
42,051
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Interest rate swaps
|
1,330
|
|
|
—
|
|
|
1,330
|
|
|
—
|
|
||||
Total
|
$
|
43,381
|
|
|
$
|
42,051
|
|
|
$
|
1,330
|
|
|
$
|
—
|
|
|
December 31, 2019
|
||||||||||||||
(in thousands)
|
Total Fair
Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Money market
|
$
|
39,530
|
|
|
$
|
39,530
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total
|
$
|
39,530
|
|
|
$
|
39,530
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Three Months Ended
March 31, |
||||||
(in thousands)
|
2020
|
|
2019
|
||||
Income tax expense
|
$
|
2,192
|
|
|
$
|
2,815
|
|
(in thousands)
|
March 31,
2020 |
|
December 31,
2019 |
||||
Raw materials
|
$
|
11,607
|
|
|
$
|
11,417
|
|
Work in process
|
12,445
|
|
|
9,450
|
|
||
Finished goods
|
6,762
|
|
|
8,313
|
|
||
Total inventory
|
$
|
30,814
|
|
|
$
|
29,180
|
|
(in thousands)
|
March 31,
2020 |
|
December 31,
2019 |
||||
Land
|
$
|
13,450
|
|
|
$
|
13,450
|
|
Buildings
|
69,622
|
|
|
75,654
|
|
||
Machinery, equipment and fixtures
|
76,251
|
|
|
87,763
|
|
||
Computer software
|
20,768
|
|
|
20,739
|
|
||
Construction in progress
|
11,165
|
|
|
10,546
|
|
||
|
191,256
|
|
|
208,152
|
|
||
Less: accumulated depreciation and amortization
|
(82,643
|
)
|
|
(91,655
|
)
|
||
Total property, plant and equipment, net
|
$
|
108,613
|
|
|
$
|
116,497
|
|
(in thousands)
|
Amount
|
||
Balance at January 1, 2020
|
$
|
12,883
|
|
Accretion expense
|
360
|
|
|
Balance at March 31, 2020
|
$
|
13,243
|
|
(in thousands)
|
Amount
|
||
Remainder of 2020
|
$
|
7,500
|
|
2021
|
10,000
|
|
|
2022
|
11,250
|
|
|
2023
|
15,000
|
|
|
2024
|
148,750
|
|
|
Total principal outstanding
|
192,500
|
|
|
Unamortized debt discount
|
(458
|
)
|
|
Unamortized debt issuance costs
|
(730
|
)
|
|
Finance lease liabilities
|
319
|
|
|
Total
|
191,631
|
|
|
Less: current portion
|
(10,143
|
)
|
|
Total long-term debt, net and other borrowings
|
$
|
181,488
|
|
(in thousands)
|
|
March 31, 2020
|
|
December 31, 2019
|
||||
Derivatives type
|
Classification
|
|
|
|
||||
Liabilities:
|
|
|
|
|
|
|
||
Interest rate swap
|
Accrued expenses and other liabilities
|
$
|
1,330
|
|
|
$
|
—
|
|
(in thousands)
|
Foreign currency translation
|
|
Unrealized loss on cash flow hedges
|
|
Accumulated other comprehensive loss
|
||||||
Balance at January 1, 2020
|
$
|
(960
|
)
|
|
$
|
—
|
|
|
$
|
(960
|
)
|
Other comprehensive loss before reclassifications
|
(446
|
)
|
|
(988
|
)
|
|
(1,434
|
)
|
|||
Amounts reclassified to earnings
|
—
|
|
|
—
|
|
|
—
|
|
|||
Balance at March 31, 2020
|
$
|
(1,406
|
)
|
|
$
|
(988
|
)
|
|
$
|
(2,394
|
)
|
|
|
|
|
|
|
||||||
Balance at January 1, 2019
|
$
|
(1,108
|
)
|
|
$
|
—
|
|
|
$
|
(1,108
|
)
|
Other comprehensive income before reclassifications
|
56
|
|
|
—
|
|
|
56
|
|
|||
Amounts reclassified to earnings
|
—
|
|
|
—
|
|
|
—
|
|
|||
Balance at March 31, 2019
|
$
|
(1,052
|
)
|
|
$
|
—
|
|
|
$
|
(1,052
|
)
|
|
Three Months Ended
March 31, |
||||||
(in thousands)
|
2020
|
|
2019
|
||||
Cost of goods sold
|
$
|
618
|
|
|
$
|
440
|
|
Sales and marketing
|
253
|
|
|
451
|
|
||
General and administrative
|
1,815
|
|
|
1,574
|
|
||
Research and development
|
389
|
|
|
255
|
|
||
Total stock-based compensation expense
|
$
|
3,075
|
|
|
$
|
2,720
|
|
|
Three Months Ended
March 31, |
||||||
(in thousands, except per share amounts)
|
2020
|
|
2019
|
||||
Net income
|
$
|
3,337
|
|
|
$
|
9,949
|
|
|
|
|
|
||||
Basic weighted-average common shares outstanding
|
39,433
|
|
|
38,603
|
|
||
Effect of dilutive stock options
|
28
|
|
|
58
|
|
||
Effect of dilutive restricted stock
|
641
|
|
|
1,126
|
|
||
Diluted weighted-average common shares outstanding
|
40,102
|
|
|
39,787
|
|
||
|
|
|
|
||||
Basic income per common share
|
$
|
0.08
|
|
|
$
|
0.26
|
|
Diluted income per common share
|
$
|
0.08
|
|
|
$
|
0.25
|
|
|
|
|
|
||||
Antidilutive securities excluded from diluted net income per common share
|
604
|
|
|
222
|
|
|
Three Months Ended
March 31, |
||||||
(in thousands)
|
2020
|
|
2019
|
||||
Foreign currency (losses) gains
|
$
|
(314
|
)
|
|
$
|
42
|
|
Tax indemnification income, net
|
555
|
|
|
802
|
|
||
Interest income
|
109
|
|
|
283
|
|
||
Other
|
—
|
|
|
60
|
|
||
Total other income
|
$
|
350
|
|
|
$
|
1,187
|
|
|
Three Months Ended
March 31, |
||||||
(in thousands)
|
2020
|
|
2019
|
||||
Revenue by product from external customers
|
|
|
|
||||
U.S.
|
|
|
|
||||
DEFINITY
|
$
|
55,010
|
|
|
$
|
49,716
|
|
TechneLite
|
19,356
|
|
|
20,058
|
|
||
Other nuclear
|
9,062
|
|
|
9,524
|
|
||
Rebates and allowances
|
(4,683
|
)
|
|
(3,864
|
)
|
||
Total U.S. Revenues
|
78,745
|
|
|
75,434
|
|
||
International
|
|
|
|
||||
DEFINITY
|
1,781
|
|
|
1,395
|
|
||
TechneLite
|
3,742
|
|
|
4,087
|
|
||
Other nuclear
|
6,438
|
|
|
5,596
|
|
||
Rebates and allowances
|
(2
|
)
|
|
(2
|
)
|
||
Total International Revenues
|
11,959
|
|
|
11,076
|
|
||
Worldwide
|
|
|
|
||||
DEFINITY
|
56,791
|
|
|
51,111
|
|
||
TechneLite
|
23,098
|
|
|
24,145
|
|
||
Other nuclear
|
15,500
|
|
|
15,120
|
|
||
Rebates and allowances
|
(4,685
|
)
|
|
(3,866
|
)
|
||
Total Revenues
|
$
|
90,704
|
|
|
$
|
86,510
|
|
|
Three Months Ended
March 31, |
||||||
(in thousands)
|
2020
|
|
2019
|
||||
Operating income
|
|
|
|
||||
U.S.
|
$
|
4,988
|
|
|
$
|
14,584
|
|
International
|
2,137
|
|
|
1,585
|
|
||
Total operating income
|
7,125
|
|
|
16,169
|
|
||
Interest expense
|
1,946
|
|
|
4,592
|
|
||
Other income
|
(350
|
)
|
|
(1,187
|
)
|
||
Income before income taxes
|
$
|
5,529
|
|
|
$
|
12,764
|
|
•
|
The impact of the global COVID-19 pandemic on our business, financial condition or prospects, including a decline in the volume of procedures using our products, potential delays and disruptions to global supply chains, manufacturing activities, logistics, operations, employees and contractors, the business activities of our suppliers, distributors, customers and other business partners, as well as the effects on worldwide economies, financial markets, social institutions, labor markets and healthcare systems;
|
•
|
Our ability to continue to grow the appropriate use of DEFINITY in suboptimal echocardiograms in the face of segment competition from other echocardiography contrast agents, including Optison from GE Healthcare Limited (“GE Healthcare”) and Lumason from Bracco Diagnostics Inc. (“Bracco”), and potential generic competition as a result of patent and regulatory exclusivity expirations;
|
•
|
The instability of the global Mo-99 supply, including (i) periodic outages at the NTP Radioisotopes (“NTP”) processing facility in South Africa in 2017, 2018 and 2019, and (ii) a recently resolved production volume limitations at the Australian Nuclear Science and Technology Organisation’s (“ANSTO”) new Mo-99 processing facility in Australia, in each case resulting in our inability to fill some or all of the demand for our TechneLite generators on certain manufacturing days during the outage periods;
|
•
|
Our dependence upon third parties for the manufacture and supply of a substantial portion of our products, raw materials and components, including DEFINITY at JHS;
|
•
|
The extensive costs, time and uncertainty associated with new product development, including further product development relying on external development partners or developing internally;
|
•
|
Our ability to identify and acquire or in-license additional products, businesses or technologies to drive our future growth;
|
•
|
Our ability to protect our intellectual property and the risk of claims that we have infringed on the intellectual property of others;
|
•
|
Risks associated with the technology transfer programs to secure production of our products at additional contract manufacturer sites, including a modified formulation of DEFINITY at Samsung BioLogics (“SBL”) in South Korea;
|
•
|
Risks associated with our investment in, and construction of, additional specialized manufacturing capabilities at our North Billerica, Massachusetts facility, including our ability to bring the new capabilities online by 2021;
|
•
|
Our dependence on key customers for our medical imaging products, and our ability to maintain and profitably renew our contracts with those key customers, including GE Healthcare, Cardinal Health (“Cardinal”), United Pharmacy Partners (“UPPI”), Jubilant Radiopharma formerly known as Triad Isotopes, Inc. (“Jubilant Radiopharma”) and PharmaLogic Holdings Corp (“PharmaLogic”);
|
•
|
Risks associated with our lead agent in development, flurpiridaz F 18, which in 2017 we out-licensed to GE Healthcare, including:
|
•
|
The ability to successfully complete the Phase 3 development program, including delays in enrollment that will result from the COVID-19 pandemic;
|
•
|
The ability to obtain Food and Drug Administration (“FDA”) approval; and
|
•
|
The ability to gain post-approval market acceptance and adequate reimbursement;
|
•
|
Risks associated with our development agent, LMI 1195, for patient populations that would benefit from molecular imaging of the norepinephrine pathway, including designing and timely completing two Phase 3 clinical trials for the diagnosis and management of neuroendocrine tumors in pediatric and adult populations, respectively;
|
•
|
Risks associated with the manufacturing and distribution of our products and the regulatory requirements related thereto;
|
•
|
The dependence of certain of our customers upon third-party healthcare payors and the uncertainty of third-party coverage and reimbursement rates;
|
•
|
The existence and market success of competitor products;
|
•
|
Uncertainties regarding the impact of U.S. and state healthcare reform measures and proposals on our business, including measures and proposals related to reimbursement for our current and potential future products, controls over drug pricing, drug pricing transparency and generic drug competition;
|
•
|
Our being subject to extensive government regulation and oversight, our ability to comply with those regulations and the costs of compliance;
|
•
|
Potential liability associated with our marketing and sales practices;
|
•
|
The occurrence of any serious or unanticipated side effects with our products;
|
•
|
Our exposure to potential product liability claims and environmental, health and safety liability;
|
•
|
Our ability to introduce new products and adapt to an evolving technology and medical practice landscape;
|
•
|
Risks associated with prevailing economic or political conditions and events and financial, business and other factors beyond our control;
|
•
|
Risks associated with our international operations, including potential global disruptions in air transport due to COVID-19, which could adversely affect our international supply chains for radioisotopes and other critical materials as well as international distribution channels for our commercial products;
|
•
|
Our ability to adequately qualify, operate, maintain and protect our facilities, equipment and technology infrastructure;
|
•
|
Our ability to hire or retain skilled employees and key personnel;
|
•
|
Our ability to utilize, or limitations in our ability to utilize, net operating loss carryforwards to reduce our future tax liability;
|
•
|
Risks related to our outstanding indebtedness and our ability to satisfy those obligations;
|
•
|
Costs and other risks associated with the Sarbanes-Oxley Act and the Dodd-Frank Act, including in connection with becoming a large accelerated filer as of December 31, 2019;
|
•
|
Risks related to the ownership of our common stock;
|
•
|
Risks related to the Progenics Transaction, including:
|
•
|
We or Progenics may be unable to obtain stockholder approval as required;
|
•
|
Conditions to the closing of the Progenics Transaction may not be satisfied;
|
•
|
The Progenics Transaction may involve unexpected costs, liabilities or delays;
|
•
|
The ability of our or Progenics’ business to retain and hire key personnel and maintain relationships with customers, suppliers and others with whom we or Progenics do business, or on our or Progenics’ operating results and business generally;
|
•
|
Our or Progenics’ respective businesses may suffer as a result of uncertainty surrounding the Progenics Transaction and disruption of management’s attention due to the Progenics Transaction;
|
•
|
The occurrence of any event, change or other circumstances that could give rise to the termination of our agreement with Progenics;
|
•
|
Unanticipated risks to our integration plan including in connection with timing, talent, and the potential need for additional resources;
|
•
|
New or previously unidentified manufacturing, regulatory, or research and development issues in the Progenics business;
|
•
|
Risks that the anticipated benefits of the Progenics Transaction or other commercial opportunities may otherwise not be fully realized or may take longer to realize than expected;
|
•
|
Risks relating to the COVID-19 pandemic and its effect on each company’s business and on the combined entity;
|
•
|
Risks that contractual contingent value rights (“CVRs”) we will issue as part of the Progenics Transaction may result in substantial future payments and could divert the attention of our management;
|
•
|
Risks that in connection with the Progenics Transaction, the exercise of appraisal rights by dissenting stockholders could increase the aggregate amount we have to pay for Progenics;
|
•
|
We or Progenics may be adversely affected by other economic, business, and/or competitive factors;
|
•
|
The impact of legislative, regulatory, competitive and technological changes;
|
•
|
Other risks to the consummation of the Progenics Transaction, including the risk that the Progenics Transaction will not be consummated within the expected time period or at all; and
|
•
|
Other factors that are described in Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019 and in Part II, Item 1A. “Risk Factors” in this Quarterly Report on Form 10-Q.
|
•
|
U.S. Segment produces and markets our medical imaging agents and products throughout the U.S. In the U.S., we primarily sell our products to radiopharmacies, integrated delivery networks, hospitals, clinics and group practices.
|
•
|
International Segment operations consist of production and distribution activities in Puerto Rico and some direct distribution activities in Canada. Additionally, within our International Segment, we have established and maintain third-party distribution relationships under which our products are marketed and sold in Europe, Canada, Australia, Asia-Pacific and Latin America.
|
•
|
DEFINITY is a microbubble contrast agent used in ultrasound exams of the heart, also known as echocardiography exams. DEFINITY contains perflutren-containing lipid microspheres and is indicated in the U.S. for use in patients with suboptimal echocardiograms to assist in imaging the left ventricular chamber and left endocardial border of the heart in ultrasound procedures.
|
•
|
TechneLite is a Technetium (“Tc-99m”) generator that provides the essential nuclear material used by radiopharmacies to radiolabel Cardiolite, Neurolite and other Tc-99m-based radiopharmaceuticals used in nuclear medicine procedures. TechneLite uses Mo-99 as its active ingredient.
|
•
|
Patents - We continue to actively pursue additional patents in connection with DEFINITY, both in the U.S. and internationally. In the U.S., three of our recently issued method of use patents covering DEFINITY were listed in the Orange Book. We now have a total of four Orange Book-listed method of use patents, one of which expires in 2035 and three of which expire in 2037, as well as additional manufacturing patents that are not Orange Book-listed expiring in 2021, 2023 and 2037. Outside of the U.S., while our DEFINITY patent protection and regulatory exclusivity have generally expired, we are currently prosecuting additional patents to try to obtain similar method of use and manufacturing patent protection as granted in the U.S.
|
•
|
Modified Formulation - We are developing at SBL a modified formulation of DEFINITY. We believe this modified formulation will provide an enhanced product profile enabling storage as well as shipment at room temperature (DEFINITY’s current formulation requires refrigerated storage), will give clinicians additional choice, and will allow for greater utility of this formulation in broader clinical settings. We were recently granted a composition of matter patent on the modified formulation which runs through 2035. If the modified formulation is approved by the FDA, then this patent would be eligible to be listed in the Orange Book. We currently believe that, if approved by the FDA, the modified formulation could become commercially available in early 2021, although that timing cannot be assured. Given its physical characteristics, the modified formulation may also be well suited for inclusion in kits requiring microbubbles for other indications and applications (including in kits developed by third parties of the type described in the next paragraph).
|
•
|
New Clinical Applications - As we continue to look for other opportunities to expand our microbubble franchise, we are evaluating new indications and clinical applications beyond echocardiography and contrast imaging generally. For example, in April 2019, we announced a strategic development and commercial collaboration with Cerevast Medical, Inc. (“Cerevast”) in which our microbubble will be used in connection with Cerevast’s ocular ultrasound device to target improving blood flow in occluded retinal veins in the eye. Retinal vein occlusion is one of the most common causes of vision loss worldwide. In December 2019, we announced a strategic commercial supply agreement with CarThera for the use of our microbubbles in combination with SonoCloud, a proprietary implantable device in development for the treatment of recurrent glioblastoma. Glioblastoma is a lethal and devastating form of brain cancer with median survival of 15 months after diagnosis.
|
•
|
In-House Manufacturing - We are currently building specialized in-house manufacturing capabilities at our North Billerica, Massachusetts facility for DEFINITY and, potentially, other sterile vial products. We believe the investment in these efforts will allow us to better control DEFINITY manufacturing and inventory, reduce our costs in a potentially more price competitive environment, and provide us with supply chain redundancy. We currently expect to be in a position to use this in-house manufacturing capability by early 2021, although that timing cannot be assured.
|
•
|
DEFINITY in China - On March 19, 2020 in connection with our Chinese development and distribution arrangement with Double Crane Pharmaceutical Company, we filed an Import Drug License application with the NMPA, or National Medical Products Administration, for the use of DEFINITY for the echocardiography indication. Our application is now undergoing initial review by the NMPA. We believe this is an important milestone in our efforts to commercialize DEFINITY in China. Double Crane is also in the process of analyzing the clinical results relating to the liver and kidney indications and will also work with us to prepare an Import Drug License application for those indications.
|
|
Three Months Ended
March 31, |
||||||
(in thousands)
|
2020
|
|
2019
|
||||
Revenues
|
$
|
90,704
|
|
|
$
|
86,510
|
|
Cost of goods sold
|
52,702
|
|
|
42,426
|
|
||
Gross profit
|
38,002
|
|
|
44,084
|
|
||
Operating expenses
|
|
|
|
||||
Sales and marketing
|
10,130
|
|
|
10,397
|
|
||
General and administrative
|
16,699
|
|
|
12,589
|
|
||
Research and development
|
4,048
|
|
|
4,929
|
|
||
Total operating expenses
|
30,877
|
|
|
27,915
|
|
||
Operating income
|
7,125
|
|
|
16,169
|
|
||
Interest expense
|
1,946
|
|
|
4,592
|
|
||
Other income
|
(350
|
)
|
|
(1,187
|
)
|
||
Income before income taxes
|
5,529
|
|
|
12,764
|
|
||
Income tax expense
|
2,192
|
|
|
2,815
|
|
||
Net income
|
$
|
3,337
|
|
|
$
|
9,949
|
|
|
|
Three Months Ended
March 31, |
|||||||||||||
(in thousands)
|
|
2020
|
|
2019
|
|
Change
$ |
|
Change
% |
|||||||
U.S.
|
|
|
|
|
|
|
|
|
|||||||
DEFINITY
|
|
$
|
55,010
|
|
|
$
|
49,716
|
|
|
$
|
5,294
|
|
|
10.6
|
%
|
TechneLite
|
|
19,356
|
|
|
20,058
|
|
|
(702
|
)
|
|
(3.5
|
)%
|
|||
Other nuclear
|
|
9,062
|
|
|
9,524
|
|
|
(462
|
)
|
|
(4.9
|
)%
|
|||
Rebates and allowances
|
|
(4,683
|
)
|
|
(3,864
|
)
|
|
(819
|
)
|
|
21.2
|
%
|
|||
Total U.S. revenues
|
|
78,745
|
|
|
75,434
|
|
|
3,311
|
|
|
4.4
|
%
|
|||
International
|
|
|
|
|
|
|
|
|
|
||||||
DEFINITY
|
|
1,781
|
|
|
1,395
|
|
|
386
|
|
|
27.7
|
%
|
|||
TechneLite
|
|
3,742
|
|
|
4,087
|
|
|
(345
|
)
|
|
(8.4
|
)%
|
|||
Other nuclear
|
|
6,438
|
|
|
5,596
|
|
|
842
|
|
|
15.0
|
%
|
|||
Rebates and allowances
|
|
(2
|
)
|
|
(2
|
)
|
|
—
|
|
|
—
|
%
|
|||
Total International revenues
|
|
11,959
|
|
|
11,076
|
|
|
883
|
|
|
8.0
|
%
|
|||
Worldwide
|
|
|
|
|
|
|
|
|
|||||||
DEFINITY
|
|
56,791
|
|
|
51,111
|
|
|
5,680
|
|
|
11.1
|
%
|
|||
TechneLite
|
|
23,098
|
|
|
24,145
|
|
|
(1,047
|
)
|
|
(4.3
|
)%
|
|||
Other nuclear
|
|
15,500
|
|
|
15,120
|
|
|
380
|
|
|
2.5
|
%
|
|||
Rebates and allowances
|
|
(4,685
|
)
|
|
(3,866
|
)
|
|
(819
|
)
|
|
21.2
|
%
|
|||
Total revenues
|
|
$
|
90,704
|
|
|
$
|
86,510
|
|
|
$
|
4,194
|
|
|
4.8
|
%
|
(in thousands)
|
Rebates and
Allowances
|
||
Balance, January 1, 2020
|
$
|
6,985
|
|
Provision related to current period revenues
|
4,650
|
|
|
Adjustments relating to prior period revenues
|
35
|
|
|
Payments or credits made during the period
|
(6,070
|
)
|
|
Balance, March 31, 2020
|
$
|
5,600
|
|
|
|
Three Months Ended
March 31, |
|||||||||||||
(in thousands)
|
|
2020
|
|
2019
|
|
Change
$ |
|
Change
% |
|||||||
U.S.
|
|
$
|
35,063
|
|
|
$
|
41,551
|
|
|
$
|
(6,488
|
)
|
|
(15.6
|
)%
|
International
|
|
2,939
|
|
|
2,533
|
|
|
406
|
|
|
16.0
|
%
|
|||
Total gross profit
|
|
$
|
38,002
|
|
|
$
|
44,084
|
|
|
$
|
(6,082
|
)
|
|
(13.8
|
)%
|
|
Three Months Ended
March 31, |
|||||||||||||
(in thousands)
|
2020
|
|
2019
|
|
Change
$ |
|
Change
% |
|||||||
U.S.
|
$
|
9,607
|
|
|
$
|
9,969
|
|
|
$
|
(362
|
)
|
|
(3.6
|
)%
|
International
|
523
|
|
|
428
|
|
|
95
|
|
|
22.2
|
%
|
|||
Total sales and marketing
|
$
|
10,130
|
|
|
$
|
10,397
|
|
|
$
|
(267
|
)
|
|
(2.6
|
)%
|
|
Three Months Ended
March 31, |
|||||||||||||
(in thousands)
|
2020
|
|
2019
|
|
Change
$ |
|
Change
% |
|||||||
U.S.
|
$
|
16,555
|
|
|
$
|
12,348
|
|
|
$
|
4,207
|
|
|
34.1
|
%
|
International
|
144
|
|
|
241
|
|
|
(97
|
)
|
|
(40.2
|
)%
|
|||
Total general and administrative
|
$
|
16,699
|
|
|
$
|
12,589
|
|
|
$
|
4,110
|
|
|
32.6
|
%
|
|
Three Months Ended
March 31, |
|||||||||||||
(in thousands)
|
2020
|
|
2019
|
|
Change
$ |
|
Change
% |
|||||||
U.S.
|
$
|
3,913
|
|
|
$
|
4,650
|
|
|
$
|
(737
|
)
|
|
(15.8
|
)%
|
International
|
135
|
|
|
279
|
|
|
(144
|
)
|
|
(51.6
|
)%
|
|||
Total research and development
|
$
|
4,048
|
|
|
$
|
4,929
|
|
|
$
|
(881
|
)
|
|
(17.9
|
)%
|
|
Three Months Ended
March 31, |
|||||||||||||
(in thousands)
|
2020
|
|
2019
|
|
Change
$ |
|
Change
% |
|||||||
Income tax expense
|
$
|
2,192
|
|
|
$
|
2,815
|
|
|
$
|
(623
|
)
|
|
(22.1
|
)%
|
|
|
Three Months Ended
March 31, |
||
|
|
2020
|
|
2019
|
Effective tax rate
|
|
39.6%
|
|
22.1%
|
|
Three Months Ended
March 31, |
||||||
(in thousands)
|
2020
|
|
2019
|
||||
Net cash provided by operating activities
|
$
|
9,408
|
|
|
$
|
10,468
|
|
Net cash used in investing activities
|
$
|
(2,698
|
)
|
|
$
|
(10,550
|
)
|
Net cash used in financing activities
|
$
|
(3,732
|
)
|
|
$
|
(1,231
|
)
|
•
|
The level of product sales and the pricing environment of our currently marketed products, particularly DEFINITY and any additional products that we may market in the future, including decreased product sales resulting from the COVID-19 pandemic;
|
•
|
Revenue mix shifts and associated volume and selling price changes that could result from contractual status changes with key customers and additional competition;
|
•
|
The costs of acquiring or in-licensing, developing, obtaining regulatory approval for, and commercializing, new products, businesses or technologies, together with the costs of pursuing opportunities that are not eventually consummated;
|
•
|
Our investment in the further clinical development and commercialization of existing products and development candidates;
|
•
|
The costs of investing in our facilities, equipment and technology infrastructure;
|
•
|
The costs and timing of establishing manufacturing and supply arrangements for commercial supplies of our products and raw materials and components;
|
•
|
Our ability to have product manufactured and released from JHS and other manufacturing sites in a timely manner in the future;
|
•
|
The costs of further commercialization of our existing products, particularly in international markets, including product marketing, sales and distribution and whether we obtain local partners to help share such commercialization costs;
|
•
|
The extent to which we choose to establish collaboration, co-promotion, distribution or other similar arrangements for our marketed products;
|
•
|
The legal costs relating to maintaining, expanding and enforcing our intellectual property portfolio, pursuing insurance or other claims and defending against product liability, regulatory compliance or other claims; and
|
•
|
The cost of interest on any additional borrowings which we may incur under our financing arrangements.
|
•
|
The delay or cancellation by hospitals and clinics of the elective procedures in which our products are used as a result of their COVID-19 response efforts and the duration of such effects, thereby reducing sales of our products for an unknown period of time;
|
•
|
The inability or unwillingness of some patients to visit hospitals or clinics in order to undergo elective procedures in which our products are used, thereby reducing sales of our products for an unknown period of time;
|
•
|
The inability of some patients to pay for elective procedures and/or the co-pay associated with those procedures in which our products are used due to job loss or lack of insurance, thereby reducing sales of our products for an unknown period of time;
|
•
|
The inability of our distributors, radiopharmacy customers, hospitals, clinics and other customers to conduct their normal operations, including supplying or conducting procedures in which our products are used, because of their COVID-19 response efforts, or the reduced capacity or productivity of their employees and contractors as a result of possible illness, quarantine or other inability to work, thereby reducing sales of our products for an unknown period of time;
|
•
|
The reduction in pulmonary ventilation studies in which our Xenon-133 gas is used because of institutional concerns about a hospital’s ability to adequately decontaminate equipment used to administer those studies during the COVID-19 pandemic, thereby reducing Xenon-133 sales for an unknown period of time;
|
•
|
The inability of global suppliers of raw materials or components used in the manufacture of our products, or contract manufacturers of our products, to supply and/or transport those raw materials, components and products to us in a timely and cost effective manner due to shutdowns, interruptions or delays, limiting and precluding the production of our finished products, impacting our ability to supply customers, reducing our sales, increasing our costs of goods sold, and reducing our absorption of overhead;
|
•
|
The partial or complete delay or cancellation of international or domestic flights by our airfreight carriers, resulting in our inability to receive raw materials, components and products from our global suppliers or to ship and deliver our finished products to our domestic and international customers in a timely or cost effective manner, thereby potentially increasing our freight costs as we seek alternate, potentially more expensive, methods to ship raw materials, components or products, and negatively impacting our sales;
|
•
|
The reduced capacity or productivity of our complex, on-campus operations as a result of possible illness, quarantine or other inability of our employees and contractors to work, despite all of the preventative measures we continue to undertake to protect the health and safety of our workforce;
|
•
|
The illiquidity or insolvency of our suppliers, contract manufacturers and freight carriers whose business activities could be shut down, interrupted or delayed;
|
•
|
The illiquidity or insolvency of our distributors and customers, or their inability to pay our invoices in full or in a timely manner, due to the reduction in their revenues caused by the cancellation or delay of procedures and other factors, which could potentially reduce our cash flow, reduce our liquidity and increase our bad debt reserves;
|
•
|
A portion of our raw materials or finished product inventory may expire due to reduced demand for our drugs;
|
•
|
Delays in our ability, and the ability of our development partners to conduct, enroll and complete clinical development programs such as the flurpiridaz F 18 Phase 3 clinical development program currently being conducted by GE Healthcare;
|
•
|
Delays of regulatory reviews and approvals, including with respect to our product candidates, by the FDA or other health or regulatory authorities;
|
•
|
Decreased sales of those of our products that are promotionally sensitive, like DEFINITY, due to the reduction of in-person sales and marketing activities and training caused by travel restrictions, quarantines, other similar social distancing measures and more restrictive hospital access policies;
|
•
|
Our ability to maintain employee morale and motivate and retain management personnel and other key employees as a result of our recent work week and salary reductions;
|
•
|
A disruption or delay in regulatory approval for, and operation of, our new, on-campus manufacturing facility, which would delay implementation of our supply diversification strategy for certain of our key products and impact our ability to benefit from a lower cost of goods for those products;
|
•
|
A reduction in revenue with continued incurrence of high fixed costs relating to our already-existing, complex and expensive nuclear manufacturing facility could adversely affect our cash flows, liquidity and ability to comply with the financial covenants in our 2019 Facility, and there can be no assurance that any required waiver or consent related to any such failure to comply would be granted by our current lenders;
|
•
|
A delay in the stockholder approval and consummation of our acquisition of Progenics and the delay in achieving, or inability to achieve, successful integration of the two companies, or the synergies, cost savings, innovation and other anticipated benefits of the acquisition due to impact of the COVID-19 pandemic on the operations, financial condition and prospects of our Company and Progenics;
|
•
|
The instability to worldwide economies, financial markets, social institutions, labor markets and the healthcare systems as a result of the COVID-19 pandemic, which could result in an economic downturn that could adversely impact our
|
•
|
A recurrence of the COVID-19 pandemic after social distancing and other similar measures have been relaxed.
|
Period
|
|
Total Number of
Shares Purchased
|
|
Average Price Paid
per Share
|
|
Total Number of
Shares Purchased as
Part of Publicly
Announced Programs
|
|
Approximate Dollar
Value of Shares that
May Yet Be Purchased Under
the Program
|
|||
January 2020**
|
|
—
|
|
|
$
|
—
|
|
|
*
|
|
*
|
February 2020**
|
|
72,520
|
|
|
$
|
16.16
|
|
|
*
|
|
*
|
March 2020**
|
|
24,914
|
|
|
$
|
15.04
|
|
|
*
|
|
*
|
Total
|
|
97,434
|
|
|
|
|
*
|
|
|
*
|
These amounts are not applicable as the Company does not have a share repurchase program in effect.
|
**
|
Reflects shares withheld to satisfy minimum statutory tax withholding amounts due from employees related to the receipt of stock which resulted from the exercise or vesting of equity awards.
|
|
|
|
|
INCORPORATED BY REFERENCE
|
||||||
EXHIBIT
NUMBER
|
|
DESCRIPTION OF EXHIBITS
|
|
FORM
|
|
FILE
NUMBER
|
|
EXHIBIT
|
|
FILING
DATE
|
2.1
|
|
|
8-K
|
|
001-36569
|
|
2.1
|
|
2/20/2020
|
|
10.1
|
|
|
8-K
|
|
001-36569
|
|
10.1
|
|
2/20/2020
|
|
10.2
|
|
|
S-4/A
|
|
333-234627
|
|
10.2
|
|
3/16/2020
|
|
31.1*
|
|
|
|
|
|
|
|
|
|
|
31.2*
|
|
|
|
|
|
|
|
|
|
|
32.1**
|
|
|
|
|
|
|
|
|
|
|
101.INS*
|
|
Inline XBRL Instance Document
|
|
|
|
|
|
|
|
|
101.SCH*
|
|
Inline XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
|
|
|
101.CAL*
|
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
|
|
|
101.DEF*
|
|
Inline XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
|
|
|
|
|
101.LAB*
|
|
Inline XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
|
|
|
|
|
101.PRE*
|
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
|
|
104*
|
|
Cover Page Interactive Data File (embedded within the Inline XBRL document)
|
|
|
|
|
|
|
|
|
|
|
*
|
Filed herewith.
|
**
|
Furnished herewith.
|
+
|
Indicates management contract or compensatory plan or arrangement.
|
|
|
|
LANTHEUS HOLDINGS, INC.
|
||
|
|
|
By:
|
|
/s/ MARY ANNE HEINO
|
Name:
|
|
Mary Anne Heino
|
Title:
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
Date:
|
|
April 30, 2020
|
|
||
LANTHEUS HOLDINGS, INC.
|
||
|
|
|
By:
|
|
/s/ ROBERT J. MARSHALL, JR.
|
Name:
|
|
Robert J. Marshall, Jr.
|
Title:
|
|
Chief Financial Officer and Treasurer
(Principal Financial Officer and Principal Accounting Officer)
|
Date:
|
|
April 30, 2020
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Lantheus Holdings, 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 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 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 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.
|
|
|
|
|
|
/s/ MARY ANNE HEINO
|
Name:
|
|
Mary Anne Heino
|
Title:
|
|
President and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Lantheus Holdings, 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 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 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 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.
|
|
|
|
|
|
/s/ ROBERT J. MARSHALL, JR.
|
Name:
|
|
Robert J. Marshall, Jr.
|
Title:
|
|
Chief Financial Officer and Treasurer
|
|
|
(Principal Financial Officer and Principal Accounting Officer)
|
1.
|
The Quarterly Report on Form 10-Q for the period ended March 31, 2020 (the “Report”) of the Company 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/ MARY ANNE HEINO
|
Name:
|
|
Mary Anne Heino
|
Title:
|
|
President and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
/s/ ROBERT J. MARSHALL, JR.
|
Name:
|
|
Robert J. Marshall, Jr.
|
Title:
|
|
Chief Financial Officer and Treasurer
|
|
|
(Principal Financial Officer and Principal Accounting Officer)
|