|
|
|
þ
|
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, North Billerica, MA
|
|
01862
|
(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
|
|
Large accelerated filer
|
|
☐
|
|
Accelerated filer
|
|
þ
|
|
|
|
|
|||
Non-accelerated filer
|
|
☐
|
|
Smaller reporting company
|
|
☐
|
|
|
|
|
|||
|
|
|
|
Emerging Growth Company
|
|
þ
|
|
|
|
Page
|
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
September 30,
2018 |
|
December 31,
2017 |
||||
Assets
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
104,584
|
|
|
$
|
76,290
|
|
Accounts receivable, net
|
47,135
|
|
|
40,259
|
|
||
Inventory
|
34,572
|
|
|
26,080
|
|
||
Other current assets
|
4,669
|
|
|
5,221
|
|
||
Total current assets
|
190,960
|
|
|
147,850
|
|
||
Property, plant & equipment, net
|
99,407
|
|
|
92,999
|
|
||
Intangibles, net
|
9,727
|
|
|
11,798
|
|
||
Goodwill
|
15,714
|
|
|
15,714
|
|
||
Deferred tax assets, net
|
79,358
|
|
|
87,010
|
|
||
Other long-term assets
|
29,652
|
|
|
28,487
|
|
||
Total assets
|
$
|
424,818
|
|
|
$
|
383,858
|
|
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Current portion of long-term debt
|
$
|
2,750
|
|
|
$
|
2,750
|
|
Revolving line of credit
|
—
|
|
|
—
|
|
||
Accounts payable
|
20,363
|
|
|
17,464
|
|
||
Accrued expenses and other liabilities
|
31,464
|
|
|
26,536
|
|
||
Total current liabilities
|
54,577
|
|
|
46,750
|
|
||
Asset retirement obligations
|
11,282
|
|
|
10,412
|
|
||
Long-term debt, net
|
264,130
|
|
|
265,393
|
|
||
Other long-term liabilities
|
39,321
|
|
|
38,012
|
|
||
Total liabilities
|
369,310
|
|
|
360,567
|
|
||
Commitments and contingencies (See Note 13)
|
|
|
|
||||
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; 38,463 and 37,765 shares issued and outstanding, respectively)
|
385
|
|
|
378
|
|
||
Additional paid-in capital
|
237,587
|
|
|
232,960
|
|
||
Accumulated deficit
|
(181,432
|
)
|
|
(209,013
|
)
|
||
Accumulated other comprehensive loss
|
(1,032
|
)
|
|
(1,034
|
)
|
||
Total stockholders’ equity
|
55,508
|
|
|
23,291
|
|
||
Total liabilities and stockholders’ equity
|
$
|
424,818
|
|
|
$
|
383,858
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Revenues
|
$
|
88,900
|
|
|
$
|
79,941
|
|
|
$
|
257,103
|
|
|
$
|
250,137
|
|
Cost of goods sold
|
44,015
|
|
|
41,414
|
|
|
126,063
|
|
|
125,901
|
|
||||
Gross profit
|
44,885
|
|
|
38,527
|
|
|
131,040
|
|
|
124,236
|
|
||||
Operating expenses
|
|
|
|
|
|
|
|
||||||||
Sales and marketing
|
10,478
|
|
|
10,075
|
|
|
33,248
|
|
|
31,892
|
|
||||
General and administrative
|
13,609
|
|
|
12,076
|
|
|
37,727
|
|
|
35,549
|
|
||||
Research and development
|
4,316
|
|
|
3,554
|
|
|
12,520
|
|
|
14,149
|
|
||||
Total operating expenses
|
28,403
|
|
|
25,705
|
|
|
83,495
|
|
|
81,590
|
|
||||
Operating income
|
16,482
|
|
|
12,822
|
|
|
47,545
|
|
|
42,646
|
|
||||
Interest expense
|
4,446
|
|
|
4,442
|
|
|
12,794
|
|
|
14,147
|
|
||||
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
—
|
|
|
2,161
|
|
||||
Other income
|
(799
|
)
|
|
(908
|
)
|
|
(2,055
|
)
|
|
(2,037
|
)
|
||||
Income before income taxes
|
12,835
|
|
|
9,288
|
|
|
36,806
|
|
|
28,375
|
|
||||
Income tax expense
|
3,566
|
|
|
762
|
|
|
9,581
|
|
|
2,116
|
|
||||
Net income
|
$
|
9,269
|
|
|
$
|
8,526
|
|
|
$
|
27,225
|
|
|
$
|
26,259
|
|
Net income per common share:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
0.24
|
|
|
$
|
0.23
|
|
|
$
|
0.71
|
|
|
$
|
0.71
|
|
Diluted
|
$
|
0.24
|
|
|
$
|
0.22
|
|
|
$
|
0.69
|
|
|
$
|
0.67
|
|
Weighted-average common shares outstanding:
|
|
|
|
|
|
|
|
||||||||
Basic
|
38,342
|
|
|
37,393
|
|
|
38,155
|
|
|
37,174
|
|
||||
Diluted
|
39,402
|
|
|
39,121
|
|
|
39,467
|
|
|
38,971
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Net income
|
$
|
9,269
|
|
|
$
|
8,526
|
|
|
$
|
27,225
|
|
|
$
|
26,259
|
|
Other comprehensive (loss) income:
|
|
|
|
|
|
|
|
||||||||
Foreign currency translation
|
(2
|
)
|
|
(115
|
)
|
|
2
|
|
|
(139
|
)
|
||||
Total other comprehensive (loss) income
|
(2
|
)
|
|
(115
|
)
|
|
2
|
|
|
(139
|
)
|
||||
Comprehensive income
|
$
|
9,267
|
|
|
$
|
8,411
|
|
|
$
|
27,227
|
|
|
$
|
26,120
|
|
|
Nine Months Ended
September 30, |
||||||
|
2018
|
|
2017
|
||||
Operating activities
|
|
|
|
||||
Net income
|
$
|
27,225
|
|
|
$
|
26,259
|
|
Adjustments to reconcile net income to net cash flows from operating activities:
|
|
|
|
||||
Depreciation, amortization and accretion
|
10,544
|
|
|
15,019
|
|
||
Amortization of debt related costs
|
959
|
|
|
1,031
|
|
||
Provision for bad debt
|
288
|
|
|
2
|
|
||
Provision for excess and obsolete inventory
|
2,470
|
|
|
1,002
|
|
||
Stock-based compensation
|
6,419
|
|
|
3,764
|
|
||
Loss on extinguishment of debt and debt retirement costs
|
—
|
|
|
2,161
|
|
||
Deferred taxes
|
7,220
|
|
|
—
|
|
||
Long-term income tax receivable
|
(2,220
|
)
|
|
(1,345
|
)
|
||
Long-term income tax payable and other long-term liabilities
|
2,397
|
|
|
2,120
|
|
||
Other
|
1,001
|
|
|
627
|
|
||
Increases (decreases) in cash from operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
(7,205
|
)
|
|
(4,609
|
)
|
||
Inventory
|
(9,832
|
)
|
|
(6,361
|
)
|
||
Other current assets
|
(49
|
)
|
|
54
|
|
||
Accounts payable
|
2,200
|
|
|
(270
|
)
|
||
Accrued expenses and other liabilities
|
2,470
|
|
|
2,237
|
|
||
Net cash provided by operating activities
|
43,887
|
|
|
41,691
|
|
||
Investing activities
|
|
|
|
||||
Capital expenditures
|
(12,766
|
)
|
|
(11,589
|
)
|
||
Proceeds from sale of assets
|
1,000
|
|
|
1,234
|
|
||
Net cash used in investing activities
|
(11,766
|
)
|
|
(10,355
|
)
|
||
Financing activities
|
|
|
|
||||
Proceeds from issuance of long-term debt
|
—
|
|
|
274,313
|
|
||
Payments on long-term debt
|
(2,146
|
)
|
|
(285,979
|
)
|
||
Deferred financing costs
|
—
|
|
|
(1,576
|
)
|
||
Payments for public offering costs
|
—
|
|
|
(74
|
)
|
||
Proceeds from stock option exercises
|
1,152
|
|
|
1,210
|
|
||
Proceeds from issuance of common stock
|
428
|
|
|
187
|
|
||
Payments for minimum statutory tax withholding related to net share settlement of equity awards
|
(3,168
|
)
|
|
(2,681
|
)
|
||
Net cash used in financing activities
|
(3,734
|
)
|
|
(14,600
|
)
|
||
Effect of foreign exchange rates on cash and cash equivalents
|
(93
|
)
|
|
163
|
|
||
Net increase in cash and cash equivalents
|
28,294
|
|
|
16,899
|
|
||
Cash and cash equivalents, beginning of period
|
76,290
|
|
|
51,178
|
|
||
Cash and cash equivalents, end of period
|
$
|
104,584
|
|
|
$
|
68,077
|
|
Standard
|
Description
|
Effective Date
for Company
|
Effect on the Condensed Consolidated Financial Statements
|
Recently Issued Accounting Standards Not Yet Adopted
|
|||
ASU 2016-02, Leases (Topic 842)
|
This ASU supersedes existing guidance on accounting for leases in “Leases (Topic 840)” and generally requires all leases to be recognized on the balance sheet. The provisions of ASU 2016-02 are effective for annual reporting periods beginning after December 15, 2018; early adoption is permitted. In July 2018, an amendment was made that allows companies the option of using the effective date of the new standard as the initial application date (at the beginning of the period in which it is adopted, rather than at the beginning of the earliest comparative period).
|
January 1, 2019
|
The Company is currently in the process of performing an assessment on the impact of the standard, including optional practical expedients and transition methods that the Company may elect upon adoption and is progressing with an implementation plan. The implementation plan includes identifying the Company’s lease population, assessing significant leases under the new guidance and identifying changes to processes and controls. The Company is more than halfway through its assessment and implementation plan. At this time, the Company does not anticipate a significant impact to its balance sheet upon adoption of this standard. The Company, in part due to the limited anticipated impact, plans to utilize the prospective approach of adopting the standard.
|
|
|
Three Months Ended September 30, 2018
|
|
Nine Months Ended September 30, 2018
|
||||||||||||||||||||
Major Products/Service Lines (in thousands)
|
|
U.S.
|
|
International
|
|
Total
|
|
U.S.
|
|
International
|
|
Total
|
||||||||||||
Product revenue, net
(1)
|
|
$
|
70,255
|
|
|
$
|
18,069
|
|
|
$
|
88,324
|
|
|
$
|
215,829
|
|
|
$
|
39,567
|
|
|
$
|
255,396
|
|
License and royalty revenues
|
|
—
|
|
|
576
|
|
|
576
|
|
|
—
|
|
|
1,707
|
|
|
1,707
|
|
||||||
Total revenues
|
|
$
|
70,255
|
|
|
$
|
18,645
|
|
|
$
|
88,900
|
|
|
$
|
215,829
|
|
|
$
|
41,274
|
|
|
$
|
257,103
|
|
(1)
|
The Company’s principal products include DEFINITY, TechneLite and Xenon and are categorized within product revenue, net. The Company applies the
|
(in thousands)
|
Rebates and
Allowances
|
||
Balance, January 1, 2018
|
$
|
2,860
|
|
Provision related to current period revenues
|
9,609
|
|
|
Adjustments relating to prior period revenues
|
(291
|
)
|
|
Payments or credits made during the period
|
(7,885
|
)
|
|
Balance, September 30, 2018
|
$
|
4,293
|
|
(in thousands)
|
Three Months Ended September 30, 2018
|
|
Nine Months Ended September 30, 2018
|
||||
Amounts included in the contract liability at the beginning of the period
|
$
|
8
|
|
|
$
|
25
|
|
Performance obligations satisfied (or partially satisfied) in previous periods
|
$
|
—
|
|
|
$
|
—
|
|
•
|
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.
|
|
September 30, 2018
|
||||||||||||||
(in thousands)
|
Total Fair
Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Money market
|
$
|
12,605
|
|
|
$
|
12,605
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total
|
$
|
12,605
|
|
|
$
|
12,605
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
December 31, 2017
|
||||||||||||||
(in thousands)
|
Total Fair
Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Money market
|
$
|
8,700
|
|
|
$
|
8,700
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total
|
$
|
8,700
|
|
|
$
|
8,700
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Income tax expense
|
$
|
3,566
|
|
|
$
|
762
|
|
|
$
|
9,581
|
|
|
$
|
2,116
|
|
(in thousands)
|
September 30,
2018 |
|
December 31,
2017 |
||||
Raw materials
|
$
|
11,896
|
|
|
$
|
10,447
|
|
Work in process
|
7,168
|
|
|
5,509
|
|
||
Finished goods
|
15,508
|
|
|
10,124
|
|
||
Total inventory
|
$
|
34,572
|
|
|
$
|
26,080
|
|
(in thousands)
|
September 30,
2018 |
|
December 31,
2017 |
||||
Land
|
$
|
13,450
|
|
|
$
|
13,450
|
|
Buildings
|
63,647
|
|
|
76,059
|
|
||
Machinery, equipment and fixtures
|
68,966
|
|
|
71,870
|
|
||
Computer software
|
18,365
|
|
|
20,271
|
|
||
Construction in progress
|
15,285
|
|
|
7,622
|
|
||
|
179,713
|
|
|
189,272
|
|
||
Less: accumulated depreciation and amortization
|
(80,306
|
)
|
|
(96,273
|
)
|
||
Total property, plant & equipment, net
|
$
|
99,407
|
|
|
$
|
92,999
|
|
(in thousands)
|
Amount
|
||
Balance at January 1, 2018
|
$
|
10,412
|
|
Accretion expense
|
870
|
|
|
Balance at September 30, 2018
|
$
|
11,282
|
|
(in thousands)
|
Amount
|
||
Remainder of 2018
|
$
|
688
|
|
2019
|
2,750
|
|
|
2020
|
2,750
|
|
|
2021
|
2,750
|
|
|
2022
|
261,937
|
|
|
Total principal outstanding
|
270,875
|
|
|
Unamortized debt discount
|
(1,697
|
)
|
|
Unamortized debt issuance costs
|
(2,298
|
)
|
|
Total
|
266,880
|
|
|
Less: current portion
|
(2,750
|
)
|
|
Total long-term debt
|
$
|
264,130
|
|
Period
|
Consolidated
Leverage Ratio
|
Q4 2018 through Q1 2019
|
4.75 to 1.00
|
Thereafter
|
4.50 to 1.00
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Cost of goods sold
|
$
|
322
|
|
|
$
|
198
|
|
|
$
|
812
|
|
|
$
|
514
|
|
Sales and marketing
|
193
|
|
|
183
|
|
|
892
|
|
|
474
|
|
||||
General and administrative
|
1,540
|
|
|
1,089
|
|
|
3,741
|
|
|
2,315
|
|
||||
Research and development
|
352
|
|
|
187
|
|
|
974
|
|
|
461
|
|
||||
Total stock-based compensation expense
|
$
|
2,407
|
|
|
$
|
1,657
|
|
|
$
|
6,419
|
|
|
$
|
3,764
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(in thousands, except per share amounts)
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Net income
|
$
|
9,269
|
|
|
$
|
8,526
|
|
|
$
|
27,225
|
|
|
$
|
26,259
|
|
|
|
|
|
|
|
|
|
||||||||
Basic weighted-average common shares outstanding
|
38,342
|
|
|
37,393
|
|
|
38,155
|
|
|
37,174
|
|
||||
Effect of dilutive stock options
|
31
|
|
|
318
|
|
|
70
|
|
|
371
|
|
||||
Effect of dilutive restricted stock
|
1,029
|
|
|
1,410
|
|
|
1,242
|
|
|
1,426
|
|
||||
Diluted weighted-average common shares outstanding
|
39,402
|
|
|
39,121
|
|
|
39,467
|
|
|
38,971
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Basic income per common share
|
$
|
0.24
|
|
|
$
|
0.23
|
|
|
$
|
0.71
|
|
|
$
|
0.71
|
|
Diluted income per common share
|
$
|
0.24
|
|
|
$
|
0.22
|
|
|
$
|
0.69
|
|
|
$
|
0.67
|
|
|
|
|
|
|
|
|
|
||||||||
Antidilutive securities excluded from diluted net income per common share
|
355
|
|
|
322
|
|
|
346
|
|
|
378
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Foreign currency gains (losses)
|
$
|
89
|
|
|
$
|
414
|
|
|
$
|
(198
|
)
|
|
$
|
554
|
|
Tax indemnification income
|
692
|
|
|
489
|
|
|
2,220
|
|
|
1,469
|
|
||||
Other
|
18
|
|
|
5
|
|
|
33
|
|
|
14
|
|
||||
Total other income
|
$
|
799
|
|
|
$
|
908
|
|
|
$
|
2,055
|
|
|
$
|
2,037
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Revenues from external customers
|
|
|
|
|
|
|
|
||||||||
U.S.
|
$
|
70,255
|
|
|
$
|
69,579
|
|
|
$
|
215,829
|
|
|
$
|
218,706
|
|
International
|
18,645
|
|
|
10,362
|
|
|
41,274
|
|
|
31,431
|
|
||||
Total revenues from external customers
|
$
|
88,900
|
|
|
$
|
79,941
|
|
|
$
|
257,103
|
|
|
$
|
250,137
|
|
Operating income
|
|
|
|
|
|
|
|
||||||||
U.S.
|
$
|
12,897
|
|
|
$
|
12,243
|
|
|
$
|
41,345
|
|
|
$
|
40,306
|
|
International
|
3,585
|
|
|
579
|
|
|
6,200
|
|
|
2,340
|
|
||||
Total operating income
|
16,482
|
|
|
12,822
|
|
|
47,545
|
|
|
42,646
|
|
||||
Interest expense
|
4,446
|
|
|
4,442
|
|
|
12,794
|
|
|
14,147
|
|
||||
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
—
|
|
|
2,161
|
|
||||
Other income
|
(799
|
)
|
|
(908
|
)
|
|
(2,055
|
)
|
|
(2,037
|
)
|
||||
Income before income taxes
|
$
|
12,835
|
|
|
$
|
9,288
|
|
|
$
|
36,806
|
|
|
$
|
28,375
|
|
•
|
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 future patent and regulatory exclusivity expirations;
|
•
|
The instability of the global Moly supply, including outages at the NTP Radioisotopes (“NTP”) processing facility in South Africa from late November 2017 until mid-February 2018 and again from early June 2018 through the present, resulting in our inability to fill all of the demand for our TechneLite generators on certain manufacturing days during those periods;
|
•
|
Risks associated with revenues and unit volumes for Xenon in pulmonary studies as a result of increased competition from Curium;
|
•
|
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;
|
•
|
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 Cardinal Health (“Cardinal”), United Pharmacy Partners (“UPPI”), GE Healthcare and Jubilant Drax Image Radiopharmaceuticals (“JDI”) d/b/a Triad Isotopes, Inc. (“Triad”);
|
•
|
Risks associated with the technology transfer programs to secure production of our products at additional contract manufacturer sites, including an alternative microbubble formulation at Samsung BioLogics (“SBL”) in South Korea;
|
•
|
Risks associated with our lead agent in development, flurpiridaz F 18, including:
|
•
|
The ability of GE Healthcare to successfully complete the Phase 3 development program;
|
•
|
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 two current internal clinical development programs - DEFINITY for a left ventricular ejection fraction (“LVEF”) indication, and LMI 1195 for patient populations that would benefit from molecular imaging of the norepinephrine pathway, including risk stratification of ischemic heart failure patients;
|
•
|
Risks associated with the manufacturing and distribution of our products and the regulatory requirements related thereto;
|
•
|
Risks associated with our investment in, and construction of, additional specialized manufacturing capabilities at our North Billerica, Massachusetts facility;
|
•
|
The dependence of certain of our customers upon third-party healthcare payors and the uncertainty of third-party coverage and reimbursement rates;
|
•
|
Uncertainties regarding the impact of on-going U.S. healthcare reform proposals on our business, including related reimbursements for our current and potential future products;
|
•
|
Our being subject to extensive government regulation and our potential inability to comply with those regulations;
|
•
|
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 liability;
|
•
|
The extensive costs, time and uncertainty associated with new product development, including further product development relying on external development partners or potentially developed internally;
|
•
|
Our inability to introduce new products and adapt to an evolving technology and diagnostic landscape;
|
•
|
Our inability to identify and in-license or acquire additional products to grow our business;
|
•
|
Our inability to protect our intellectual property and the risk of claims that we have infringed on the intellectual property of others;
|
•
|
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;
|
•
|
Our inability to adequately operate, maintain and protect our facilities, equipment and technology infrastructure;
|
•
|
Our inability to hire or retain skilled employees and key personnel;
|
•
|
Our inability 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 potentially becoming a large accelerated filer;
|
•
|
Risks related to the ownership of our common stock; 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, 2017.
|
•
|
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 generator that provides the essential nuclear material used by radiopharmacies to radiolabel Cardiolite, Neurolite and other Technetium-based radiopharmaceuticals used in nuclear medicine procedures. TechneLite uses Moly as its active ingredient.
|
•
|
Xenon is a radiopharmaceutical gas that is inhaled and used to assess pulmonary function and also for imaging cerebral blood flow. Xenon is manufactured by a third party and is processed and finished by us.
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||||||||||||||
(in thousands)
|
2018
|
|
% of
Revenues |
|
2017
|
|
% of
Revenues |
|
2018
|
|
% of
Revenues |
|
2017
|
|
% of
Revenues |
||||||||||||
DEFINITY
|
$
|
43,755
|
|
|
49.2
|
%
|
|
$
|
37,729
|
|
|
47.2
|
%
|
|
$
|
134,508
|
|
|
52.3
|
%
|
|
$
|
115,569
|
|
|
46.2
|
%
|
TechneLite
|
30,618
|
|
|
34.4
|
%
|
|
26,356
|
|
|
33.0
|
%
|
|
75,491
|
|
|
29.4
|
%
|
|
79,900
|
|
|
31.9
|
%
|
||||
Xenon
|
7,239
|
|
|
8.2
|
%
|
|
7,726
|
|
|
9.6
|
%
|
|
22,805
|
|
|
8.8
|
%
|
|
23,713
|
|
|
9.5
|
%
|
||||
Other
|
7,288
|
|
|
8.2
|
%
|
|
8,130
|
|
|
10.2
|
%
|
|
24,299
|
|
|
9.5
|
%
|
|
30,955
|
|
|
12.4
|
%
|
||||
Total revenues
|
$
|
88,900
|
|
|
100.0
|
%
|
|
$
|
79,941
|
|
|
100.0
|
%
|
|
$
|
257,103
|
|
|
100.0
|
%
|
|
$
|
250,137
|
|
|
100.0
|
%
|
•
|
Patents -
We continue to actively pursue additional patents in connection with DEFINITY, both in the U.S. and internationally. In the U.S., we now have an Orange Book-listed method of use patent expiring in March 2037. This patent augments an Orange Book-listed composition of matter patent expiring in June 2019, and additional manufacturing patents that are not Orange Book-listed expiring in 2021, 2023 and most recently 2037. Outside of the U.S., our DEFINITY patent protection or regulatory exclusivity currently expires in 2019.
|
•
|
LVEF Indication -
We have reached agreement with the FDA on a special protocol assessment, or SPA, for our Phase 3 LVEF clinical program, designed to demonstrate improved accuracy of LVEF measurements with DEFINITY-enhanced echocardiography. We are conducting two well-controlled studies powered to prove superiority in LVEF measurement accuracy with DEFINITY-enhanced versus unenhanced echocardiography. The truth standard in these studies is cardiac
|
•
|
Modified Formulation -
We are developing at SBL a modified formulation of DEFINITY. We believe this modified formulation will provide an enhanced product profile enabling shipment and storage 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 alternative clinical settings. We were recently granted a composition of matter patent on the modified formulation which runs through December 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 2020. Given its physical characteristics, the modified formulation may also be better suited for inclusion in kits requiring microbubbles for other indications and applications.
|
•
|
New Applications
- As we continue to look for other opportunities to expand our microbubble franchise, we are evaluating new indications and applications beyond echocardiography and contrast imaging generally.
|
•
|
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 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.
|
•
|
increased revenues for DEFINITY in the suboptimal echocardiogram segment as a result of our continued focused sales efforts;
|
•
|
decreased revenues for TechneLite in the U.S. segment primarily as a result of a temporary supplier disruption;
|
•
|
increased revenues for TechneLite in the International segment primarily driven by increased volume as a result of temporary incremental demand;
|
•
|
decreased revenues in other revenue due to the recognition of $5.0 million during the prior year from GE Healthcare in exchange for rights to the continued Phase 3 development and worldwide commercialization of flurpiridaz F 18;
|
•
|
decreased depreciation expense as a result of the decommissioning of certain long-lived assets during the prior year period;
|
•
|
decreases in general and administrative expense of $1.7 million incurred in connection with the refinancing of our debt, as well as a related $2.2 million loss on the extinguishment of debt during the prior year period; and
|
•
|
i
ncreased tax expense due to the profit generated during the three and nine months ended September 30, 2018 and the fact that we no longer record a valuation allowance against our domestic deferred tax assets.
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(in thousands)
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Revenues
|
$
|
88,900
|
|
|
$
|
79,941
|
|
|
$
|
257,103
|
|
|
$
|
250,137
|
|
Cost of goods sold
|
44,015
|
|
|
41,414
|
|
|
126,063
|
|
|
125,901
|
|
||||
Gross profit
|
44,885
|
|
|
38,527
|
|
|
131,040
|
|
|
124,236
|
|
||||
Operating expenses
|
|
|
|
|
|
|
|
||||||||
Sales and marketing
|
10,478
|
|
|
10,075
|
|
|
33,248
|
|
|
31,892
|
|
||||
General and administrative
|
13,609
|
|
|
12,076
|
|
|
37,727
|
|
|
35,549
|
|
||||
Research and development
|
4,316
|
|
|
3,554
|
|
|
12,520
|
|
|
14,149
|
|
||||
Total operating expenses
|
28,403
|
|
|
25,705
|
|
|
83,495
|
|
|
81,590
|
|
||||
Operating income
|
16,482
|
|
|
12,822
|
|
|
47,545
|
|
|
42,646
|
|
||||
Interest expense
|
4,446
|
|
|
4,442
|
|
|
12,794
|
|
|
14,147
|
|
||||
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
—
|
|
|
2,161
|
|
||||
Other income
|
(799
|
)
|
|
(908
|
)
|
|
(2,055
|
)
|
|
(2,037
|
)
|
||||
Income before income taxes
|
12,835
|
|
|
9,288
|
|
|
36,806
|
|
|
28,375
|
|
||||
Income tax expense
|
3,566
|
|
|
762
|
|
|
9,581
|
|
|
2,116
|
|
||||
Net income
|
$
|
9,269
|
|
|
$
|
8,526
|
|
|
$
|
27,225
|
|
|
$
|
26,259
|
|
(in thousands)
|
Rebates and
Allowances
|
||
Balance, January 1, 2018
|
$
|
2,860
|
|
Provision related to current period revenues
|
9,609
|
|
|
Adjustments relating to prior period revenues
|
(291
|
)
|
|
Payments or credits made during the period
|
(7,885
|
)
|
|
Balance, September 30, 2018
|
$
|
4,293
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||||||||||||||||
(in thousands)
|
|
2018
|
|
2017
|
|
Change
$ |
|
Change
% |
|
2018
|
|
2017
|
|
Change
$ |
|
Change
% |
||||||||||||||
U.S.
|
|
$
|
40,193
|
|
|
$
|
36,820
|
|
|
$
|
3,373
|
|
|
9.2
|
%
|
|
$
|
121,163
|
|
|
$
|
118,481
|
|
|
$
|
2,682
|
|
|
2.3
|
%
|
International
|
|
4,692
|
|
|
1,707
|
|
|
2,985
|
|
|
174.9
|
%
|
|
9,877
|
|
|
5,755
|
|
|
4,122
|
|
|
71.6
|
%
|
||||||
Total gross profit
|
|
$
|
44,885
|
|
|
$
|
38,527
|
|
|
$
|
6,358
|
|
|
16.5
|
%
|
|
$
|
131,040
|
|
|
$
|
124,236
|
|
|
$
|
6,804
|
|
|
5.5
|
%
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||||||||||||||||
(in thousands)
|
2018
|
|
2017
|
|
Change
$ |
|
Change
% |
|
2018
|
|
2017
|
|
Change
$ |
|
Change
% |
||||||||||||||
U.S.
|
$
|
13,339
|
|
|
$
|
11,901
|
|
|
$
|
1,438
|
|
|
12.1
|
%
|
|
$
|
37,175
|
|
|
$
|
35,055
|
|
|
$
|
2,120
|
|
|
6.0
|
%
|
International
|
270
|
|
|
175
|
|
|
95
|
|
|
54.3
|
%
|
|
552
|
|
|
494
|
|
|
58
|
|
|
11.7
|
%
|
||||||
Total general and administrative
|
$
|
13,609
|
|
|
$
|
12,076
|
|
|
$
|
1,533
|
|
|
12.7
|
%
|
|
$
|
37,727
|
|
|
$
|
35,549
|
|
|
$
|
2,178
|
|
|
6.1
|
%
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||||||||||||||||
(in thousands)
|
2018
|
|
2017
|
|
Change
$ |
|
Change
% |
|
2018
|
|
2017
|
|
Change
$ |
|
Change
% |
||||||||||||||
U.S.
|
$
|
4,095
|
|
|
$
|
3,196
|
|
|
$
|
899
|
|
|
28.1
|
%
|
|
$
|
11,300
|
|
|
$
|
13,265
|
|
|
$
|
(1,965
|
)
|
|
(14.8
|
)%
|
International
|
221
|
|
|
358
|
|
|
(137
|
)
|
|
(38.3
|
)%
|
|
1,220
|
|
|
884
|
|
|
336
|
|
|
38.0
|
%
|
||||||
Total research and development
|
$
|
4,316
|
|
|
$
|
3,554
|
|
|
$
|
762
|
|
|
21.4
|
%
|
|
$
|
12,520
|
|
|
$
|
14,149
|
|
|
$
|
(1,629
|
)
|
|
(11.5
|
)%
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||||||||||||||||
(in thousands)
|
2018
|
|
2017
|
|
Change
$ |
|
Change
% |
|
2018
|
|
2017
|
|
Change
$ |
|
Change
% |
||||||||||||||
Income tax expense
|
$
|
3,566
|
|
|
$
|
762
|
|
|
$
|
2,804
|
|
|
368.0
|
%
|
|
$
|
9,581
|
|
|
$
|
2,116
|
|
|
$
|
7,465
|
|
|
352.8
|
%
|
|
|
Nine Months Ended
September 30, |
||
|
|
2018
|
|
2017
|
Effective tax rate
|
|
26.0%
|
|
7.5%
|
|
Nine Months Ended
September 30, |
||||||
(in thousands)
|
2018
|
|
2017
|
||||
Net cash provided by operating activities
|
$
|
43,887
|
|
|
$
|
41,691
|
|
Net cash used in investing activities
|
$
|
(11,766
|
)
|
|
$
|
(10,355
|
)
|
Net cash used in financing activities
|
$
|
(3,734
|
)
|
|
$
|
(14,600
|
)
|
Period
|
Consolidated
Leverage Ratio
|
Q4 2018 through Q1 2019
|
4.75 to 1.00
|
Thereafter
|
4.50 to 1.00
|
•
|
The pricing environment and the level of product sales of our currently marketed products, particularly DEFINITY and any additional products that we may market in the future;
|
•
|
Revenue mix shifts and associated volume and selling price changes that could result from contractual status changes with key customers and additional competition;
|
•
|
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 extent to which we acquire or invest in new products, businesses and technologies;
|
•
|
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.
|
•
|
We might not have been the first to make the inventions covered by each of our pending patent applications and issued patents, and we could lose our patent rights as a result;
|
•
|
We might not have been the first to file patent applications for these inventions or our patent applications may not have been timely filed, and we could lose our patent rights as a result;
|
•
|
Others may independently develop similar or alternative technologies or duplicate any of our technologies;
|
•
|
It is possible that none of our pending patent applications will result in any further issued patents;
|
•
|
Our issued patents may not provide a basis for commercially viable drugs, may not provide us with any protection from unauthorized use of our intellectual property by third parties, and may not provide us with any competitive advantages;
|
•
|
Our patent applications or patents may be subject to interferences, oppositions, post-grant review, ex-parte re-examinations, inter-partes review or similar administrative proceedings;
|
•
|
While we generally apply for patents in those countries where we intend to make, have made, use or sell patented products, we may not be able to accurately predict all of the countries where patent protection will ultimately be desirable and may be precluded from doing so at a later date;
|
•
|
We may choose not to seek patent protection in certain countries where the actual cost outweighs the perceived benefit at a certain time;
|
•
|
Patents issued in foreign jurisdictions may have different scopes of coverage as our U.S. patents and so our products may not receive the same degree of protection in foreign countries as they would in the U.S.;
|
•
|
We may not develop additional proprietary technologies that are patentable; or
|
•
|
The patents of others may have an adverse effect on our business.
|
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
|
|||
July 2018**
|
|
—
|
|
|
$
|
—
|
|
|
*
|
|
*
|
August 2018**
|
|
11,283
|
|
|
$
|
15.94
|
|
|
*
|
|
*
|
September 2018**
|
|
48,954
|
|
|
$
|
15.39
|
|
|
*
|
|
*
|
Total
|
|
60,237
|
|
|
|
|
*
|
|
|
*
|
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
|
10.1*
|
|
|
|
|
|
|
|
|
|
|
10.2*
|
|
|
|
|
|
|
|
|
|
|
31.1*
|
|
|
|
|
|
|
|
|
|
|
31.2*
|
|
|
|
|
|
|
|
|
|
|
32.1**
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
*
|
Filed herewith
|
**
|
Furnished herewith
|
|
|
|
LANTHEUS HOLDINGS, INC.
|
||
|
|
|
By:
|
|
/s/ MARY ANNE HEINO
|
Name:
|
|
Mary Anne Heino
|
Title:
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
Date:
|
|
October 30, 2018
|
|
||
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:
|
|
October 30, 2018
|
1.
|
Resignations.
On the Separation Date, you will be deemed to have resigned from your position as Senior Vice President, Commercial and from any and all (i) officer positions you hold with the Company or any of its Affiliates (as defined below); (ii) memberships you hold on any boards of directors, boards of managers or other governing boards or bodies of the Company or any of its Affiliates; and (iii) memberships you hold on any of the committees of any of those boards or bodies. For purposes of this Agreement, “
Affiliates
” means all persons and entities directly or indirectly controlling, controlled by or under common control with the Company, whether control by management authority, equity interest or otherwise.
|
2.
|
Final Compensation.
You will receive, on or as soon as reasonably practicable following the Separation Date, in the form of one or more payroll checks, (i) your base salary for the final, unpaid payroll period(s) of your employment through the Separation Date; (ii) compensation at the rate of your base salary for any vacation time accrued but not used as of the Separation Date; (iii) any contributions that you have made under any employee stock purchase plan of Lantheus Holdings, Inc. (“
Parent
”) or any of its Affiliates that are refundable to you under its respective terms and conditions; and (iv) reimbursement for business expenses incurred by you but not yet paid to you as of the Separation Date;
provided
that you submit all expenses and supporting documentation required within thirty (30) days of the Separation Date and that those expenses are reimbursable under Company policies in effect as of the Separation Date.
|
3.
|
Employee Benefits.
Except for any right you may have to continue your participation and that of your eligible dependents in the Company’s group health plans under the Consolidated Omnibus Budget Reconciliation Act of 1985 (“
COBRA
”) or similar state law, your participation in all employee benefit plans and programs of the Company and its Affiliates will end as of the last day of the month in which the Separation Date occurs. You will receive information about your COBRA continuation rights under separate cover.
|
4.
|
Equity Awards.
You hold certain equity awards granted to you by Lantheus Holdings, Inc. (“
Parent
”), an Affiliate of the Company, under its 2008 Equity Incentive Plan, 2013 Equity Incentive Plan and/or 2015 Equity Incentive Plan, each as amended, and the equity incentive agreements evidencing those grants entered into between you and Parent under those plans (collectively, the “
Equity Agreements
” and those equity awards, collectively, the “
Equity Awards
”). You acknowledge and agree that all Equity Awards that are unvested as of the Separation Date are being forfeited for no consideration due to you in accordance with the Equity Agreements, and all of your then-vested Equity Awards will continue to be subject to the terms and conditions of the applicable Equity Agreements, including the post-termination of employment exercise provisions thereof.
|
5.
|
Severance Payments.
Subject to your execution of this Agreement within fifty (50) days following the Separation Date and your not revoking this Agreement within the seven (7)-day period immediately thereafter, and subject to your meeting in full your obligations under this Agreement and the Continuing Obligations (as defined in Section 8(a) below), the Company will provide you with the following:
|
(a)
|
an amount equal to the sum of (x) $228,589.04, representing a pro rata portion of an amount equal to forty-five percent (45%) of your annual base salary on the Separation Date, based upon the percentage of the fiscal year elapsed through Separation Date, plus (y) $407,000.00, representing your annual base salary, which amount (i.e., the sum of clauses (x) and (y)) will be paid in substantially equal installments over a period of twelve (12)
|
(b)
|
provided that you timely and properly elect to purchase continued healthcare coverage under COBRA, Company-subsidized COBRA benefits (in an amount representing the Company’s contribution level for active employees at the time of payment) for the period ending on the earliest of (i) the expiration of the Severance Period, (ii) the date on which you become covered under another employer’s health plan and (iii) the expiration of the maximum COBRA continuation coverage period for which you are eligible under federal law (for the avoidance of doubt, during this subsidized period, you will be responsible for paying a COBRA premium equal to the active employee contribution rate directly to the Company’s COBRA administrator, and you will be responsible for paying the entirety of the COBRA premium directly to the Company’s COBRA administrator after this period).
|
6.
|
Acknowledgement of Full Payment.
You acknowledge and agree that the payments and other benefits provided under this Agreement are in complete satisfaction of any and all compensation and benefits due to you from the Company or any of its Affiliates, whether for services provided to the Company or otherwise, through the Separation Date. You further acknowledge that, except as expressly provided under this Agreement, no further compensation or benefits are owed or will be provided to you by the Company or any of its Affiliates.
|
7.
|
Taxes and Withholding.
All payments made by the Company under this Agreement will be reduced by any tax or other amounts required to be withheld by the Company under applicable law. This Agreement and the payments and benefits provided under this Agreement are intended to be exempt from the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (“
Section 409A
”), and this Agreement will be construed consistently with that intent. Without limiting the foregoing, the severance payments set forth in Section 5 of this Agreement are intended to be exempt from Section 409A as “separation pay” within the meaning of Section 1.409A-1(b)(9)(iii) of the Treasury Regulations. Notwithstanding anything to the contrary, in no event will the Company have any liability relating to the failure or alleged failure of any payment or benefit under this Agreement to be exempt from the requirements of Section 409A.
|
8.
|
Continuing Obligations.
|
(a)
|
You acknowledge and recognize the highly competitive nature of the businesses of the Company and its Affiliates and, accordingly, in consideration of the severance pay and benefits set forth in Section 5 and other valuable consideration, you acknowledge and agree that you will continue to be bound by your obligations relating to confidentiality, non-competition, non-solicitation, no-hire, invention assignment, non-disparagement and/or any other restrictive covenant set forth in any agreement by and between you and the Company or any of its Affiliates, including, without limitation, those set forth in Sections 10-13 of the employment agreement, dated November 16, 2015, between you and the Company (the “
Employment Agreement
”) (all such obligations, collectively, the “
Continuing Obligations
”). Each of the Continuing Obligations is an individual right, separately enforceable by the Company and/or its applicable Affiliate(s), notwithstanding any conflict or other inconsistency among any provisions (or any parts of any provisions) of any of the Continuing Obligations, and no such conflict or other inconsistency will have the effect of superseding, restricting or otherwise limiting any of the Continuing Obligations. The obligation of the Company to make payments to you under Section 5, and your right to retain those payments, are expressly conditioned upon your continued full performance of your obligations under this Agreement and of the Continuing Obligations.
|
(b)
|
You agree not to disclose to any individual or entity any of the terms of, or amounts paid under, this Agreement; provided, however, that you will not be prohibited from making disclosures to your spouse or domestic partner, attorney or tax advisor.
|
(c)
|
You hereby assign to the Company all right, title and interest that you have in any discovery, invention or innovation conceived or reduced to practice by you in the performance of your employment with the Company (including all intellectual property rights related to any discovery, invention or innovation), which you acknowledge and agree is solely and exclusively owned by the Company. You will cooperate and assist the Company (at the Company’s expense) in obtaining patent protection for any such discovery, invention or innovation, including executing all documents required for such purpose, and you hereby irrevocably appoint the Company as your lawful attorney-in-fact for such purpose. This Agreement will also be deemed a transfer
|
(d)
|
For the avoidance of doubt, (i) nothing contained in the Employment Agreement or this Agreement, or any of the Continuing Obligations, limits, restricts or in any other way affects your communicating with any governmental agency or entity, or communicating with any official or staff person of any governmental agency or entity, concerning matters relevant to that governmental agency or entity; and (ii) you will not be held criminally or civilly liable under any federal or state trade secret law for disclosing a trade secret (y) in confidence to a federal, state or local government official, either directly or indirectly, or to an attorney, solely for the purpose of reporting or investigating a suspected violation of law, or (z) in a complaint or other document filed under seal in a lawsuit or other proceeding;
provided
,
however
, that notwithstanding this immunity from liability, you may be held liable if you unlawfully access trade secrets by unauthorized means or disclose (except as permitted above) or use any trade secrets.
|
9.
|
Return of Company Documents and Other Property.
In signing this Agreement, you represent, warrant and covenant that you have returned to the Company any and all documents, materials and information (whether in hardcopy, on electronic media or otherwise) related to the business of the Company and its Affiliates (whether present or otherwise), and all keys, access cards, credit cards, computer hardware and software, telephones and telephone-related equipment and all other property of the Company or any of its Affiliates in your possession or control. Further, you represent, warrant and covenant that you have not retained any copy or derivation of any documents, materials or information (whether in hardcopy, on electronic media or otherwise) of the Company or any of its Affiliates. Further, you represent, warrant and covenant that you have disclosed to the Company all passwords necessary or desirable to obtain access to, or that would assist in obtaining access to, all information which you have password-protected on any computer equipment, network or system of the Company or any of its Affiliates.
|
10.
|
General Release and Waiver of Claims.
|
(a)
|
You agree to and do waive any claims you may have for employment by the Company. You, on your own behalf and on behalf of your heirs, estate and beneficiaries, further do hereby release the Company, and in those capacities, any of its Affiliates, and each of their respective past, present and future officers, directors, agents, employees, shareholders, investors, employee benefit plans and their administrators, trustees or fiduciaries, insurers of any of those entities, and its and their successors and assigns and others related to those entities (collectively, the “
Released Parties
”) from any and all claims made, to be made, or which might have been made of whatever nature, whether known or unknown, from the beginning of time, including those that arose as a consequence of your employment with the Company, or arising out of the termination of your employment with the Company, or any act committed or omitted during or after the existence of that employment relationship, all up through and including the date on which this Agreement is executed, including, but not limited to, those which were, could have been or could be the subject of an administrative or judicial proceeding filed by you or on your behalf under federal, state or local law, whether by statute, regulation, in contract or tort, and including, but not limited to, for front pay, back pay, wages, bonus, fringe benefit, any form of discrimination, wrongful termination, tort, emotional distress, pain and suffering, breach of contract, fraud, defamation, compensatory or punitive damages, interest, attorney’s fees, reinstatement or reemployment, and any rights or claims under the Civil Rights Act of 1866, the Age Discrimination in Employment Act of 1967, 29 U.S.C. sec. 621,
et seq.
, the Older Workers Benefit Protection Act, the Americans with Disabilities Act, the Family and Medical Leave Act, the Civil Rights Act of 1964, Title VII, the Civil Rights Act of 1991, the Employee Retirement Income Security Act of 1974, the Equal Pay Act, the Worker Adjustment and Retraining Notification Act, the Massachusetts Fair Employment Practices Act (M.G.L. c.151B), the Massachusetts Civil Rights Act, the Massachusetts Equal Pay and Maternity Benefits Law, the Massachusetts Equal Rights for Elderly and Disabled Law, the Massachusetts Small Necessities Leave Act, the Massachusetts Age Discrimination Law, the Massachusetts Wage Payment Statutes (M.G.L. c.149, 148, 150), the Massachusetts Earned Sick Tim Law (MGL Ch. 149, Section 148C) and any other federal, state or local law, in each case, as amended, relating to employment, discrimination in employment, termination of employment, wages, benefits or otherwise. You acknowledge and agree that even though claims and facts in addition to those now known or believed by you to exist may subsequently be discovered, it is your intention to fully settle and release all claims you may have against the Company and the Released Parties, whether known, unknown or suspected. The Released Parties who are not party to this Agreement will be third-party beneficiaries of this Section 10(a).
|
(b)
|
Notwithstanding the generality of the foregoing, you do not waive your right to (i) have a complaint, charge or related lawsuit filed with the Equal Employment Opportunity Commission (“
EEOC
”) or any similar state or
|
(c)
|
The Company and you acknowledge and agree that the release contained in Section 10(a) above does not, and will not be construed to, release or limit the scope of any existing obligation of the Company and/or any of its Affiliates (i) if and as applicable, to indemnify you for your acts as an officer or director of the Company and/or its Affiliates in accordance with their respective charters or bylaws or under an indemnification agreement to which you and the Company or any of its Affiliates are parties or under any applicable Directors and Officers insurance policies or under any applicable law; or (ii) to you and your eligible, participating dependents or beneficiaries under the terms of any existing group welfare (excluding severance) or retirement plan of the Company in which you and/or any of those dependents or beneficiaries are participants.
|
(d)
|
You acknowledge and agree that before entering into this Agreement, you have had the opportunity to consult with any attorney or other advisor of your choice, and you are hereby advised to consult with an attorney. You further acknowledge and agree that by signing this Agreement, you do so of your own free will and act, that it is your intention to be legally bound by its terms, and that no promises or representations have been made to you by any person to induce you to enter into this Agreement other than the express terms set forth herein. You further acknowledge and agree that you have carefully read this Agreement, know and understand its contents and its binding legal effect, including the waiver and release of claims set forth in Section 10(a) above.
|
11.
|
Unemployment Benefits.
To the extent permitted by applicable law, the Company will not actively contest any application you make for unemployment benefits. However, the Company will respond truthfully, completely, and timely to any inquiries by the Massachusetts Department of Unemployment Assistance or any other governmental agency or court concerning the termination of your employment.
|
12.
|
Cooperation.
Upon reasonable prior request, you agree to cooperate with the Company or its Affiliates in connection with any present or future litigation or regulatory proceeding brought against the Company or any of its Affiliates, to the extent the Company or its Affiliate deems your cooperation necessary. This cooperation may include, but will not be limited to, meeting with the Company’s or its Affiliate’s counsel and providing testimony if so requested. The Company or its Affiliate will reimburse you for reasonable pre-approved out-of-pocket expenses incurred by you as a result of this cooperation.
|
13.
|
No Admission; Affirmations.
Neither by offering to make nor by making this Agreement does the Company or you admit any failure of performance, wrongdoing or violation of law. You also affirm that you have not filed, caused to be filed, nor are you presently a party to any claim against the Company, unless noted below under your signature. You also affirm that you have been paid and/or have received all compensation, wages, bonuses, commissions and/or benefits to which you may be entitled from the Company. You further affirm that you have been granted by the Company any leave to which you were entitled under the Family and Medical Leave Act or related state or local leave or disability accommodation laws. You further affirm that you have no known workplace injuries or occupational diseases regarding your employment at the Company, unless previously reported to the Company in writing. You also affirm that you have not divulged any proprietary or confidential information of the Company and that you have disclosed to the Company any discovery, invention or innovation conceived or reduced to practice by you in the performance of your employment with the Company. You further affirm that you have not been retaliated against for reporting any allegations of wrongdoing by the Company or its officers, including any allegations of corporate fraud. You also affirm by your signature below that you are not aware of any wrongdoing, regulatory violations or corporate fraud committed by the Company, its Affiliates or any employees or independent contractors of any of the foregoing, unless previously reported to the Company in writing.
|
14.
|
Miscellaneous.
|
(a)
|
This Agreement constitutes the entire agreement between you and the Company or any of its Affiliates, and supersedes all prior and contemporaneous communications, agreements and understandings, whether written or oral, with respect to your employment, its termination and all related matters, excluding only the Continuing Obligations, which will remain in full force and effect in accordance with their terms.
|
(b)
|
This Agreement is a Massachusetts contract, and this Agreement (and all claims, controversies and causes of action arising under or otherwise relating to this Agreement) will be governed and construed in accordance with the laws of the Commonwealth of Massachusetts, without regard to any conflict of laws principles that would result in the application of the laws of another jurisdiction. Each party agrees to submit to the exclusive jurisdiction of the courts of the Commonwealth of Massachusetts in connection with any dispute arising out of or otherwise relating to this Agreement.
|
(c)
|
This Agreement may not be modified or amended, and no breach will be deemed to be waived, unless agreed to in writing by you and an expressly authorized representative of the Company. The captions and headings in this Agreement are for convenience only, and in no way define or describe the scope or content of any provision of this Agreement.
|
(d)
|
In the event that any one or more of the provisions of this Agreement is held to be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions will not in any way be affected or impaired thereby. Moreover, if any one or more of the provisions contained in this Agreement is held to be excessively broad as to duration, scope or activity or subject, those provisions will be construed by limiting and reducing them so as to be enforceable to the maximum extent compatible with applicable law.
|
(e)
|
This Agreement will inure to the benefit of and be binding upon personal or legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees.
|
(f)
|
This Agreement, and all of your rights and duties under this Agreement, will not be assignable or delegable by you. Any purported assignment or delegation by you in violation of the foregoing will be null and void and of no force and effect. This Agreement may be assigned by the Company to an individual or entity which is an Affiliate or a successor in interest to substantially all of the business operations of the Company. Upon any assignment, the rights and obligations of the Company under this Agreement will become the rights and obligations of that Affiliate or successor individual or entity.
|
(g)
|
The Company’s obligation to pay you the amounts set forth under this Agreement and to make the arrangements provided under this agreement are subject to set-off, counterclaim and recoupment of amounts owed by you to the Company or its Affiliates.
|
(h)
|
This Agreement may be executed in separate counterparts (including by electronically delivered .pdf files or copies of manually signed signature pages), each of which will be deemed to be an original and all of which taken together will constitute one and the same agreement.
|
|
|
|
|
|
/s/ MARY ANNE HEINO
|
Name:
|
|
Mary Anne Heino
|
Title:
|
|
President and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
/s/ TIMOTHY HEALEY
|
Name:
|
|
Timothy Healey
|
Date:
|
|
9/12/2018
|
1.
|
Resignations.
On the Separation Date, you will be deemed to have resigned from your position as Chief Financial Officer and Treasurer and from any and all (i) officer positions you hold with the Company or any of its Affiliates (as defined below); (ii) memberships you hold on any boards of directors, boards of managers or other governing boards or bodies of the Company or any of its Affiliates; and (iii) memberships you hold on any of the committees of any of those boards or bodies. For purposes of this Agreement, “
Affiliates
” means all persons and entities directly or indirectly controlling, controlled by or under common control with the Company, whether control by management authority, equity interest or otherwise.
|
2.
|
Advisory Period
. In consideration of the terms of this Agreement, you agree to be engaged by the Company as an employee beginning on the Separation Date and continuing through September 28, 2018 (the “
Advisory Period
”)
.
During the Advisory Period, you will provide services on an as-requested basis and will be compensated at the same rate as your salary in effect as of immediately prior to the Separation Date.
Such services will be performed at mutually agreeable times. You will not be required to be present at the Company’s offices unless requested by the Company.
|
3.
|
Final Compensation.
You will receive, on or as soon as reasonably practicable following the Separation Date, in the form of one or more payroll checks, (i) your base salary for the final, unpaid payroll period(s) of your employment through the Separation Date; (ii) compensation at the rate of your base salary for any vacation time accrued but not used as of the Separation Date; (iii) any contributions that you have made under the Lantheus Holdings, Inc. 2017 Employee Stock Purchase Plan that are refundable to you under its terms and conditions; and (iv) reimbursement for business expenses incurred by you but not yet paid to you as of the Separation Date;
provided
that you submit all expenses and supporting documentation required within thirty (30) days of the Separation Date and that those expenses are reimbursable under Company policies in effect as of the Separation Date.
|
4.
|
Employee Benefits.
Except for any right you may have to continue your participation and that of your eligible dependents in the Company’s group health plans under the Consolidated Omnibus Budget Reconciliation Act of 1985 (“
COBRA
”) or similar state law, your participation in all employee benefit plans and programs of the Company and its Affiliates will end as of the Separation Date, except for participation in the Company’s group health plans, which will end as of the last day of the month in which the Separation Date occurs. You will receive information about your COBRA continuation rights under separate cover.
|
5.
|
Equity Awards.
You hold certain equity awards granted to you by Lantheus Holdings, Inc. (“
Parent
”), an Affiliate of the Company, under its 2013 Equity Incentive Plan and/or 2015 Equity Incentive Plan, each as amended, and the equity incentive agreements evidencing those grants entered into between you and Parent under those plans (collectively, the “
Equity Agreements
” and those equity awards, collectively, the “
Equity Awards
”). Subject to your execution of this Agreement within twenty-one (21) days following the Separation Date and your not revoking this Agreement within the seven (7)-day period immediately thereafter, and subject to your meeting in full your obligations under this Agreement and the Continuing Obligations (as defined in Section 9(a) below), the restricted stock awards set forth on
Schedule A
attached hereto will remain outstanding as to that number of shares, and will become freely transferable on the dates, in each case, set forth on
Schedule A
. You acknowledge and agree that all Equity Awards that are unvested as of the Separation Date will be forfeited (with the exception of the restricted stock awards set forth on
Schedule A
) for no consideration due to you on the Separation Date, and all of your then-vested Equity Awards will continue to be subject
|
6.
|
Severance Payments.
Subject to your execution of this Agreement within twenty-one (21) days following the Separation Date and your not revoking this Agreement within the seven (7)-day period immediately thereafter, and subject to your meeting in full your obligations under this Agreement and the Continuing Obligations (as defined in Section 9(a) below), the Company will provide you with the following:
|
(a)
|
an amount equal to the sum of (x) $209,550, representing an amount equal to fifty-five percent (55%) of your annual base salary on the Separation Date, plus (y) $381,000, representing your annual base salary, which amount (i.e., the sum of clauses (x) and (y)) will be paid in substantially equal installments over a period of twelve (12) months following the Separation Date (the “
Severance Period
”) in accordance with the Company’s regular payroll practices, with the first payment commencing on the Company’s first payroll date after the thirtieth (30
th
) day following the Separation Date, and with the first payment including any of those amounts that would otherwise have been paid prior thereto; and
|
(b)
|
an amount equal to $66,000, representing the cash portion of the long-term incentive plan that has been achieved based on performance through the Separation Date, which amount will be payable at the same time it is payable to the other participants in the long-term incentive plan, which is currently expected to be March 31, 2019 but in no event will be later than December 31, 2019; and
|
(c)
|
provided that you timely and properly elect to purchase continued healthcare coverage under COBRA, reimbursement for COBRA benefits, in an amount representing the Company’s contribution level for active employees at the time of payment, for the period ending on the earliest of (i) the expiration of the Severance Period, (ii) the date on which you become covered under another employer’s health plan and (iii) the expiration of the maximum COBRA continuation coverage period for which you are eligible under federal law; provided that you submit supporting documentation of your payment of COBRA premiums, as provided for below, within thirty (30) days of paying such premiums (for the avoidance of doubt, you will be responsible for paying the applicable COBRA premiums directly to the Company’s COBRA administrator); and
|
(d)
|
reimbursement for outplacement executive services incurred by you during the twelve (12) months following the Separation Date in an amount up to $25,000;
provided
that you submit such expenses and supporting documentation required within thirty (30) days of incurring such expenses.
|
7.
|
Acknowledgement of Full Payment.
You acknowledge and agree that the payments and other benefits provided under this Agreement are in complete satisfaction of any and all compensation and benefits due to you from the Company or any of its Affiliates, whether for services provided to the Company or otherwise, through the Separation Date. You further acknowledge that, except as expressly provided under this Agreement, no further compensation or benefits are owed or will be provided to you by the Company or any of its Affiliates.
|
8.
|
Taxes and Withholding.
All payments made by the Company under this Agreement will be reduced by any tax or other amounts required to be withheld by the Company under applicable law. In addition, on the Separation Date, the Company will withhold from the restricted stock awards that remain outstanding as set forth on Schedule A that number of shares of Parent common stock having a fair market value equal to the minimum statutory amount required by law to be withheld to satisfy the Company’s withholding obligations with respect to such restricted stock (it being understood that no such withholding shall relieve you of any tax obligations you may have with respect to such restricted stock awards). This Agreement and the payments and benefits provided under this Agreement are intended to be exempt from the requirements of Section 409A of the Internal Revenue Code of 1986, as amended (“
Section 409A
”), and this Agreement will be construed consistently with that intent. Without limiting the foregoing, the severance payments set forth in Section 6 of this Agreement are intended to be exempt from Section 409A as “separation pay” within the meaning of Section 1.409A-1(b)(9)(iii) of the Treasury Regulations and/or “short-term deferrals” within the meaning of Section 1.409A-1(b)(4) of the Treasury Regulations. Your right to receive any installments payments pursuant to this Agreement shall be treated as a right to receive a series of separate and distinct payments. Notwithstanding anything to the contrary, in no event will the Company have any liability relating to the failure or alleged failure of any payment or benefit under this Agreement to be exempt from the requirements of Section 409A.
|
9.
|
Continuing Obligations.
|
(a)
|
You acknowledge and recognize the highly competitive nature of the businesses of the Company and its Affiliates and, accordingly, in consideration of the severance pay and benefits set forth in Section 5 and 6 and other valuable consideration, you acknowledge and agree that you will continue to be bound by your obligations relating to confidentiality, non-competition, non-solicitation, no-hire, invention assignment, non-disparagement and/or any other restrictive covenant set forth in any agreement by and between you and the Company or any of its Affiliates, including, without limitation, those set forth in Sections 9-11 of the employment agreement, effective as of August 12, 2013, between you and the Company (as amended, the “
Employment Agreement
”) (all such obligations, collectively, the “
Continuing Obligations
”). Each of the Continuing Obligations is an individual right, separately enforceable by the Company and/or its applicable Affiliate(s), notwithstanding any conflict or other inconsistency among any provisions (or any parts of any provisions) of any of the Continuing Obligations, and no such conflict or other inconsistency will have the effect of superseding, restricting or otherwise limiting any of the Continuing Obligations. The obligation of the Company to make payments and provide the benefits described under Sections 5 and 6, and your right to retain those payments and benefits, are expressly conditioned upon your continued full performance of your obligations under this Agreement and of the Continuing Obligations.
|
(b)
|
You hereby assign to the Company all right, title and interest that you have in any discovery, invention or innovation conceived or reduced to practice by you in the performance of your employment with the Company (including all intellectual property rights related to any discovery, invention or innovation), which you acknowledge and agree is solely and exclusively owned by the Company. You will cooperate and assist the Company (at the Company’s expense) in obtaining patent protection for any such discovery, invention or innovation, including executing all documents required for such purpose, and you hereby irrevocably appoint the Company as your lawful attorney-in-fact for such purpose. This Agreement will also be deemed a transfer to the Company of, and you hereby assign to the Company, the copyright of any copyrightable subject matter created by you in the performance of your employment with the Company.
|
(c)
|
For the avoidance of doubt, (i) nothing contained in the Employment Agreement or this Agreement, or any of the Continuing Obligations, limits, restricts or in any other way affects your communicating with any governmental agency or entity, or communicating with any official or staff person of any governmental agency or entity, concerning matters relevant to that governmental agency or entity; and (ii) you will not be held criminally or civilly liable under any federal or state trade secret law for disclosing a trade secret (y) in confidence to a federal, state or local government official, either directly or indirectly, or to an attorney, solely for the purpose of reporting or investigating a suspected violation of law, or (z) in a complaint or other document filed under seal in a lawsuit or other proceeding;
provided
,
however
, that notwithstanding this immunity from liability, you may be held liable if you unlawfully access trade secrets by unauthorized means or disclose (except as permitted above) or use any trade secrets.
|
10.
|
Return of Company Documents and Other Property.
In signing this Agreement, you represent, warrant and covenant that you have returned to the Company any and all documents, materials and information (whether in hardcopy, on electronic media or otherwise) related to the business of the Company and its Affiliates (whether present or otherwise), and all keys, access cards, credit cards, computer hardware and software, telephones and telephone-related equipment and all other property of the Company or any of its Affiliates in your possession or control. Further, you represent, warrant and covenant that you have not retained any copy or derivation of any documents, materials or information (whether in hardcopy, on electronic media or otherwise) of the Company or any of its Affiliates. Further, you represent, warrant and covenant that you have disclosed to the Company all passwords necessary or desirable to obtain access to, or that would assist in obtaining access to, all information which you have password-protected on any computer equipment, network or system of the Company or any of its Affiliates.
|
11.
|
General Release and Waiver of Claims.
|
(a)
|
You agree to and do waive any claims you may have for employment by the Company. You, on your own behalf and on behalf of your heirs, estate and beneficiaries, further do hereby release the Company, and in those capacities, any of its Affiliates, and each of their respective past, present and future officers, directors, agents, employees, shareholders, investors, employee benefit plans and their administrators, trustees or fiduciaries, insurers of any of those entities, and its and their successors and assigns and others related to those entities (collectively, the “
Released Parties
”) from any and all claims made, to be made, or which might have been made of whatever nature, whether known or unknown, from the beginning of time, including those that arose as a
|
(b)
|
Notwithstanding the generality of the foregoing, you do not waive your right to (i) have a complaint, charge or related lawsuit filed with the Equal Employment Opportunity Commission (“
EEOC
”) or any similar state or local governmental agency by you or by anyone on your behalf or to participate in an investigation conducted by the EEOC or any similar state or local governmental agency; however, you expressly waive your right to recover any personal relief, recovery or monies should you or anyone on your behalf pursue any of those complaints, claims or related lawsuits; or (ii) pursue a claim that cannot be waived by law, such as a claim for unemployment benefit rights.
|
(c)
|
The Company and you acknowledge and agree that the release contained in Section 11(a) above does not, and will not be construed to, release or limit the scope of any existing obligation of the Company and/or any of its Affiliates (i) if and as applicable, to indemnify you for your acts as an officer or director of the Company and/or its Affiliates in accordance with their respective charters or bylaws or under an indemnification agreement to which you and the Company or any of its Affiliates are parties or under any applicable Directors and Officers insurance policies or under any applicable law; or (ii) to you and your eligible, participating dependents or beneficiaries under the terms of any existing group welfare (excluding severance) or retirement plan of the Company in which you and/or any of those dependents or beneficiaries are participants with respect vested benefits under such plans.
|
(d)
|
You acknowledge and agree that before entering into this Agreement, you have had the opportunity to consult with any attorney or other advisor of your choice, and you are hereby advised to consult with an attorney. You further acknowledge and agree that by signing this Agreement, you do so of your own free will and act, that it is your intention to be legally bound by its terms, and that no promises or representations have been made to you by any person to induce you to enter into this Agreement other than the express terms set forth herein. You further acknowledge and agree that you have carefully read this Agreement, know and understand its contents and its binding legal effect, including the waiver and release of claims set forth in Section 11(a) above.
|
12.
|
Unemployment Benefits.
To the extent permitted by applicable law, the Company will not actively contest any application you make for unemployment benefits. However, the Company will respond truthfully, completely, and timely to any inquiries by the Massachusetts Department of Unemployment Assistance or any other governmental agency or court concerning the termination of your employment.
|
13.
|
Cooperation.
Upon reasonable prior request, you agree to cooperate with the Company or its Affiliates in connection with any present or future litigation or regulatory proceeding brought against the Company or any of its Affiliates, to the extent the Company or its Affiliate deems your cooperation necessary. This cooperation may include, but will not be limited to, meeting with the Company’s or its Affiliate’s counsel and providing testimony if so requested. The Company
|
14.
|
No Admission; Affirmations.
Neither by offering to make nor by making this Agreement does the Company or you admit any failure of performance, wrongdoing or violation of law. You also affirm that you have been paid and/or have received all compensation, wages, bonuses, commissions and/or benefits to which you may be entitled from the Company. You further affirm that you have been granted by the Company any leave to which you were entitled under the Family and Medical Leave Act or related state or local leave or disability accommodation laws. You further affirm that you have no known workplace injuries or occupational diseases regarding your employment at the Company, unless previously reported to the Company in writing. You also affirm that you have not divulged any proprietary or confidential information of the Company and that you have disclosed to the Company any discovery, invention or innovation conceived or reduced to practice by you in the performance of your employment with the Company. You further affirm that you have not been retaliated against for reporting any allegations of wrongdoing by the Company or its officers, including any allegations of corporate fraud. You also affirm by your signature below that you are not aware of any wrongdoing, regulatory violations or corporate fraud committed by the Company, its Affiliates or any employees or independent contractors of any of the foregoing, unless previously reported to the Company in writing.
|
15.
|
Miscellaneous.
|
(a)
|
This Agreement constitutes the entire agreement between you and the Company or any of its Affiliates, and supersedes all prior and contemporaneous communications, agreements and understandings, whether written or oral, with respect to your employment, its termination and all related matters, excluding only the Continuing Obligations, which will remain in full force and effect in accordance with their terms.
|
(b)
|
This Agreement is a Massachusetts contract, and this Agreement (and all claims, controversies and causes of action arising under or otherwise relating to this Agreement) will be governed and construed in accordance with the laws of the Commonwealth of Massachusetts, without regard to any conflict of laws principles that would result in the application of the laws of another jurisdiction. Each party agrees to submit to the exclusive jurisdiction of the courts of the Commonwealth of Massachusetts in connection with any dispute arising out of or otherwise relating to this Agreement.
|
(c)
|
This Agreement may not be modified or amended, and no breach will be deemed to be waived, unless agreed to in writing by you and an expressly authorized representative of the Company. The captions and headings in this Agreement are for convenience only, and in no way define or describe the scope or content of any provision of this Agreement.
|
(d)
|
In the event that any one or more of the provisions of this Agreement is held to be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions will not in any way be affected or impaired thereby. Moreover, if any one or more of the provisions contained in this Agreement is held to be excessively broad as to duration, scope or activity or subject, those provisions will be construed by limiting and reducing them so as to be enforceable to the maximum extent compatible with applicable law.
|
(e)
|
This Agreement (including, without limitation, the Company’s obligation to make severance payments and restricted stock awards as specifically provided herein) will remain and inure to the benefit of and be binding upon personal or legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees.
|
(f)
|
This Agreement, and all of your rights and duties under this Agreement, will not be assignable or delegable by you. Any purported assignment or delegation by you in violation of the foregoing will be null and void and of no force and effect. This Agreement may be assigned by the Company to an individual or entity which is an Affiliate or a successor in interest to substantially all of the business operations of the Company. Upon any assignment, the rights and obligations of the Company under this Agreement will become the rights and obligations of that Affiliate or successor individual or entity.
|
(g)
|
The Company’s obligation to pay you the amounts set forth under this Agreement and to make the arrangements provided under this agreement are subject to set-off, counterclaim and recoupment of amounts owed by you to the Company or its Affiliates.
|
(h)
|
This Agreement may be executed in separate counterparts (including by electronically delivered .pdf files or copies of manually signed signature pages), each of which will be deemed to be an original and all of which taken together will constitute one and the same agreement.
|
|
|
|
|
|
/s/ MARY ANNE HEINO
|
Name:
|
|
Mary Anne Heino
|
Title:
|
|
President and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
|
|
|
/s/ JOHN W. CROWLEY
|
Name:
|
|
John W. Crowley
|
Date:
|
|
9/2018
|
Equity Award
|
Grant Date
|
Grant ID
|
Date on Which Restrictions on Transferability Lapse*
|
Number of Shares
|
Unvested restricted stock
|
09/01/2015
|
[LRSA15]
|
09/01/2018
|
10,000
|
Unvested restricted stock
|
09/01/2015
|
[LRSA15]
|
09/01/2019
|
10,000
|
Unvested restricted stock
|
04/06/2015
|
[LRSA15]
|
01/30/2019
|
5,338
|
Unvested restricted stock
|
04/26/2016
|
[LRSA15]
|
04/26/2019
|
15,500
|
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
September 30, 2018
(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)
|