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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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LANTHEUS HOLDINGS, INC.
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(Exact name of registrant as specified in its charter)
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Delaware
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35-2318913
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(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.)
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331 Treble Cove Road, North Billerica, MA
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01862
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(Address of principal executive offices)
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(Zip Code)
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(978) 671-8001
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(Registrant’s telephone number, including area code)
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Not Applicable
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(Former name, former address and former fiscal year, if changed since last report
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Large accelerated filer
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☐
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Accelerated filer
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þ
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Non-accelerated filer
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☐ (Do not check if a smaller reporting company)
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Smaller reporting company
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☐
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Emerging Growth Company
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þ
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Page
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March 31,
2018 |
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December 31,
2017 |
||||
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Assets
|
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|
||||
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Current assets
|
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|
|
||||
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Cash and cash equivalents
|
$
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73,739
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$
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76,290
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Accounts receivable, net
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47,834
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40,259
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Inventory
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32,086
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26,080
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Other current assets
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5,598
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5,221
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Total current assets
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159,257
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147,850
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Property, plant & equipment, net
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93,777
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92,999
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Intangibles, net
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11,106
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|
11,798
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||
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Goodwill
|
15,714
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15,714
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Deferred tax assets, net
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83,655
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87,010
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Other long-term assets
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29,080
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28,487
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Total assets
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$
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392,589
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$
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383,858
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Liabilities and stockholders’ equity
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||||
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Current liabilities
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||||
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Current portion of long-term debt
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$
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2,750
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$
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2,750
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Revolving line of credit
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—
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—
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Accounts payable
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21,012
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|
17,464
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||
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Accrued expenses and other liabilities
|
21,634
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|
26,536
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||
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Total current liabilities
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45,396
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|
46,750
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|
||
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Asset retirement obligations
|
10,702
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|
10,412
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||
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Long-term debt, net
|
264,972
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|
265,393
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|
||
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Other long-term liabilities
|
37,855
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|
38,012
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||
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Total liabilities
|
358,925
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|
360,567
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||
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Commitments and contingencies (See Note 13)
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||||
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Stockholders’ equity
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||||
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Preferred stock ($0.01 par value, 25,000 shares authorized; no shares issued and outstanding)
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—
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—
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Common stock ($0.01 par value, 250,000 shares authorized; 37,997 and 37,765 shares issued and outstanding, respectively)
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380
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378
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Additional paid-in capital
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234,765
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232,960
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Accumulated deficit
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(200,447
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)
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(209,013
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)
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Accumulated other comprehensive loss
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(1,034
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)
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(1,034
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)
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Total stockholders’ equity
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33,664
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23,291
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Total liabilities and stockholders’ equity
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$
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392,589
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$
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383,858
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Three Months Ended
March 31, |
||||||
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2018
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2017
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||||
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Revenues
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$
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82,630
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$
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81,359
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Cost of goods sold
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40,321
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|
41,597
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|
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Gross profit
|
42,309
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39,762
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||
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Operating expenses
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||||
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Sales and marketing
|
10,640
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10,214
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General and administrative
|
12,543
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|
12,270
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Research and development
|
3,989
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5,351
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Total operating expenses
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27,172
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27,835
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Operating income
|
15,137
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|
11,927
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Interest expense
|
4,050
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|
5,420
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Loss on extinguishment of debt
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—
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2,161
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Other income
|
(920
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)
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(577
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)
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Income before income taxes
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12,007
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4,923
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Income tax expense
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3,796
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|
785
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Net income
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$
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8,211
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$
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4,138
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Net income per common share:
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||||
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Basic
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$
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0.22
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$
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0.11
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Diluted
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$
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0.21
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$
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0.11
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Weighted-average common shares outstanding:
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||||
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Basic
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37,886
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36,889
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Diluted
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39,493
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38,601
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Three Months Ended
March 31, |
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2018
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2017
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||||
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Net income
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$
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8,211
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$
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4,138
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Other comprehensive loss:
|
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||||
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Foreign currency translation
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—
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(4
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)
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Total other comprehensive loss
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—
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(4
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)
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Comprehensive income
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$
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8,211
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$
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4,134
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|
|
Three Months Ended
March 31, |
||||||
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2018
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2017
|
||||
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Operating activities
|
|
|
|
||||
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Net income
|
$
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8,211
|
|
|
$
|
4,138
|
|
|
Adjustments to reconcile net income to net cash flows from operating activities:
|
|
|
|
||||
|
Depreciation, amortization and accretion
|
3,596
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|
|
6,160
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|
||
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Amortization of debt related costs
|
320
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|
|
360
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|
||
|
Provision for bad debt
|
195
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|
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62
|
|
||
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Provision for excess and obsolete inventory
|
1,220
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|
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285
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|
||
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Stock-based compensation
|
1,796
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|
|
945
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|
||
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Loss on extinguishment of debt and debt retirement costs
|
—
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|
|
2,161
|
|
||
|
Deferred taxes
|
2,923
|
|
|
—
|
|
||
|
Long-term income tax receivable
|
(841
|
)
|
|
(490
|
)
|
||
|
Long-term income tax payable and other long-term liabilities
|
854
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|
|
769
|
|
||
|
Other
|
(46
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)
|
|
(58
|
)
|
||
|
Increases (decreases) in cash from operating assets and liabilities:
|
|
|
|
||||
|
Accounts receivable
|
(7,816
|
)
|
|
(3,135
|
)
|
||
|
Inventory
|
(6,579
|
)
|
|
(2,427
|
)
|
||
|
Other current assets
|
(1,003
|
)
|
|
(1,250
|
)
|
||
|
Accounts payable
|
2,160
|
|
|
1,200
|
|
||
|
Accrued expenses and other liabilities
|
(5,656
|
)
|
|
(3,196
|
)
|
||
|
Net cash (used in) provided by operating activities
|
(666
|
)
|
|
5,524
|
|
||
|
Investing activities
|
|
|
|
||||
|
Capital expenditures
|
(2,135
|
)
|
|
(4,899
|
)
|
||
|
Proceeds from sale of assets
|
1,000
|
|
|
335
|
|
||
|
Net cash used in investing activities
|
(1,135
|
)
|
|
(4,564
|
)
|
||
|
Financing activities
|
|
|
|
||||
|
Proceeds from issuance of long-term debt
|
—
|
|
|
274,313
|
|
||
|
Payments on long-term debt
|
(715
|
)
|
|
(284,551
|
)
|
||
|
Deferred financing costs
|
—
|
|
|
(1,219
|
)
|
||
|
Payments for public offering costs
|
—
|
|
|
(74
|
)
|
||
|
Proceeds from stock option exercises
|
514
|
|
|
632
|
|
||
|
Proceeds from issuance of common stock
|
206
|
|
|
—
|
|
||
|
Payments for minimum statutory tax withholding related to net share settlement of equity awards
|
(709
|
)
|
|
(355
|
)
|
||
|
Net cash used in financing activities
|
(704
|
)
|
|
(11,254
|
)
|
||
|
Effect of foreign exchange rates on cash and cash equivalents
|
(46
|
)
|
|
(2
|
)
|
||
|
Net decrease in cash and cash equivalents
|
(2,551
|
)
|
|
(10,296
|
)
|
||
|
Cash and cash equivalents, beginning of period
|
76,290
|
|
|
51,178
|
|
||
|
Cash and cash equivalents, end of period
|
$
|
73,739
|
|
|
$
|
40,882
|
|
|
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 in the statement of financial position. The provisions of ASU 2016-02 are effective for annual reporting periods beginning after December 15, 2018; early adoption is permitted. The provisions of this ASU are to be applied using a modified retrospective approach.
|
January 1, 2019
|
The Company is currently assessing the impact that this standard will have on its consolidated financial statements.
|
|
Standard
|
Description
|
Effective Date
for Company
|
Effect on the Condensed Consolidated Financial Statements
|
|
Accounting Standards Adopted During the Three Months Ended March 31, 2018
|
|||
|
ASU 2017-09, Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting
|
This ASU clarifies when to account for a change to the terms or conditions of a share–based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, vesting conditions or classification of the award (as equity or liability) changes as a result of the change in terms or conditions.
The new guidance will be applied prospectively to awards modified on or after the adoption date. The guidance is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017 for all entities. |
January 1, 2018
|
The adoption of this standard did not have a material impact on the Company’s condensed consolidated financial statements.
|
|
ASU 2014-09, Revenue from Contracts with Customers (Topic 606) and related amendments
|
This ASU and related amendments affect any entity that either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets, unless those contracts are within the scope of other standards. The guidance in this ASU supersedes the revenue recognition requirements in Topic 605, Revenue Recognition and most industry-specific guidance. The core principle of the guidance is that an entity should recognize revenue upon the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.
|
January 1, 2018
|
See Note 3, "Revenue from Contracts with Customers" for the required disclosures related to the impact of adopting this standard.
The adoption of this standard did not have a material impact on the Company’s condensed consolidated balance sheets and statements of operations.
|
|
|
|
Reportable Segments
|
||||||||||
|
Major Products/Service Lines (in thousands)
|
|
U.S.
|
|
International
|
|
Total
|
||||||
|
Product revenue, net
(1)
|
|
$
|
71,488
|
|
|
$
|
10,580
|
|
|
$
|
82,068
|
|
|
License and royalty revenues
|
|
—
|
|
|
562
|
|
|
562
|
|
|||
|
Total revenues
|
|
$
|
71,488
|
|
|
$
|
11,142
|
|
|
$
|
82,630
|
|
|
(1)
|
The Company’s principal products include DEFINITY, TechneLite and Xenon and are categorized within product revenue, net. The Company applies the same revenue recognition policies and judgments for all of its principal products.
|
|
(in thousands)
|
Rebates and
Allowances
|
||
|
Balance, January 1, 2018
|
$
|
2,860
|
|
|
Provision related to current period revenues
|
3,027
|
|
|
|
Adjustments relating to prior period revenues
|
(121
|
)
|
|
|
Payments or credits made during the period
|
(2,776
|
)
|
|
|
Balance, March 31, 2018
|
$
|
2,990
|
|
|
(in thousands)
|
Amount
|
||
|
Remainder of amounts included in the contract liability at the beginning of the period
|
$
|
8
|
|
|
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.
|
|
|
March 31, 2018
|
||||||||||||||
|
(in thousands)
|
Total Fair
Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
|
Money market
|
$
|
10,624
|
|
|
$
|
10,624
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Total
|
$
|
10,624
|
|
|
$
|
10,624
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
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
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
(in thousands)
|
March 31,
2018 |
|
December 31,
2017 |
||||
|
Raw materials
|
$
|
11,178
|
|
|
$
|
10,447
|
|
|
Work in process
|
10,310
|
|
|
5,509
|
|
||
|
Finished goods
|
10,598
|
|
|
10,124
|
|
||
|
Total inventory
|
$
|
32,086
|
|
|
$
|
26,080
|
|
|
(in thousands)
|
March 31,
2018 |
|
December 31,
2017 |
||||
|
Land
|
$
|
13,450
|
|
|
$
|
13,450
|
|
|
Buildings
|
63,689
|
|
|
76,059
|
|
||
|
Machinery, equipment and fixtures
|
69,330
|
|
|
71,870
|
|
||
|
Computer software
|
20,280
|
|
|
20,271
|
|
||
|
Construction in progress
|
9,816
|
|
|
7,622
|
|
||
|
|
176,565
|
|
|
189,272
|
|
||
|
Less: accumulated depreciation and amortization
|
(82,788
|
)
|
|
(96,273
|
)
|
||
|
Total property, plant & equipment, net
|
$
|
93,777
|
|
|
$
|
92,999
|
|
|
(in thousands)
|
Amount
|
||
|
Balance at December 31, 2017
|
$
|
10,412
|
|
|
Accretion expense
|
290
|
|
|
|
Balance at March 31, 2018
|
$
|
10,702
|
|
|
(in thousands)
|
Amount
|
||
|
Remainder of 2018
|
$
|
2,063
|
|
|
2019
|
2,750
|
|
|
|
2020
|
2,750
|
|
|
|
2021
|
2,750
|
|
|
|
2022
|
261,937
|
|
|
|
Total principal outstanding
|
272,250
|
|
|
|
Unamortized debt discount
|
(1,923
|
)
|
|
|
Unamortized debt issuance costs
|
(2,605
|
)
|
|
|
Total
|
267,722
|
|
|
|
Less: current portion
|
(2,750
|
)
|
|
|
Total long-term debt
|
$
|
264,972
|
|
|
Period
|
Consolidated
Leverage Ratio
|
|
Q2 2018 through Q1 2019
|
4.75 to 1.00
|
|
Thereafter
|
4.50 to 1.00
|
|
|
Three Months Ended
March 31, |
||||||
|
(in thousands)
|
2018
|
|
2017
|
||||
|
Cost of goods sold
|
$
|
229
|
|
|
$
|
139
|
|
|
Sales and marketing
|
302
|
|
|
124
|
|
||
|
General and administrative
|
980
|
|
|
551
|
|
||
|
Research and development
|
285
|
|
|
131
|
|
||
|
Total stock-based compensation expense
|
$
|
1,796
|
|
|
$
|
945
|
|
|
|
Three Months Ended
March 31, |
||||||
|
(in thousands, except per share amounts)
|
2018
|
|
2017
|
||||
|
Net income
|
$
|
8,211
|
|
|
$
|
4,138
|
|
|
|
|
|
|
||||
|
Basic weighted-average common shares outstanding
|
37,886
|
|
|
36,889
|
|
||
|
Effect of dilutive stock options
|
150
|
|
|
303
|
|
||
|
Effect of dilutive restricted stock
|
1,457
|
|
|
1,409
|
|
||
|
Diluted weighted-average common shares outstanding
|
39,493
|
|
|
38,601
|
|
||
|
|
|
|
|
||||
|
Basic income per common share
|
$
|
0.22
|
|
|
$
|
0.11
|
|
|
Diluted income per common share
|
$
|
0.21
|
|
|
$
|
0.11
|
|
|
|
|
|
|
||||
|
Antidilutive securities excluded from diluted net income per common share
|
86
|
|
|
387
|
|
||
|
|
Three Months Ended
March 31, |
||||||
|
(in thousands)
|
2018
|
|
2017
|
||||
|
Foreign currency gains
|
$
|
72
|
|
|
$
|
85
|
|
|
Tax indemnification income
|
841
|
|
|
490
|
|
||
|
Other
|
7
|
|
|
2
|
|
||
|
Total other income
|
$
|
920
|
|
|
$
|
577
|
|
|
|
Three Months Ended
March 31, |
|||||||
|
(in thousands)
|
2018
|
|
2017
|
|||||
|
Revenues from external customers
|
|
|
|
|||||
|
U.S.
|
$
|
71,488
|
|
|
$
|
71,027
|
|
|
|
International
|
11,142
|
|
|
10,332
|
|
|||
|
Total revenues from external customers
|
$
|
82,630
|
|
—
|
|
$
|
81,359
|
|
|
Operating income
|
|
|
|
|||||
|
U.S.
|
$
|
14,156
|
|
|
$
|
11,168
|
|
|
|
International
|
981
|
|
|
759
|
|
|||
|
Total operating income
|
15,137
|
|
|
11,927
|
|
|||
|
Interest expense
|
4,050
|
|
|
5,420
|
|
|||
|
Loss on extinguishment of debt
|
—
|
|
|
2,161
|
|
|||
|
Other income
|
(920
|
)
|
|
(577
|
)
|
|||
|
Income before income taxes
|
$
|
12,007
|
|
|
$
|
4,923
|
|
|
|
•
|
Our ability to continue to grow the appropriate use of DEFINITY in suboptimal echocardiograms in the face of increased 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;
|
|
•
|
Risks associated with revenues and unit volumes for Xenon in pulmonary studies as a result of competition from Curium and potentially others;
|
|
•
|
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”);
|
|
•
|
Our dependence upon third parties for the manufacture and supply of a substantial portion of our products, including DEFINITY at JHS;
|
|
•
|
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;
|
|
•
|
The instability of the global Molybdenum-99 (“Moly”) supply, including recent regulatory issues at the NTP Radioisotopes (“NTP”) processing facility in South Africa, resulting in our inability to fill all of the demand for our TechneLite generators on certain manufacturing days;
|
|
•
|
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 new internal clinical development programs - DEFINITY for an ejection fraction (“EF”) indication and LMI 1195 for heart failure patient risk stratification;
|
|
•
|
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 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 an ultrasound 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. We launched DEFINITY in 2001, and in the U.S., an Orange Book-listed composition of matter patent will expire in 2019, a manufacturing patent will expire in 2021, a new Orange Book-listed method of use patent will expire in 2037 and another manufacturing patent will expire in 2037. In numerous foreign jurisdictions, patent protection or regulatory exclusivity will currently expire in 2019.
|
|
•
|
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
March 31, |
||||||||||||
|
(in thousands)
|
2018
|
|
% of
Revenues
|
|
2017
|
|
% of
Revenues
|
||||||
|
DEFINITY
|
$
|
44,655
|
|
|
54.0
|
%
|
|
$
|
37,712
|
|
|
46.4
|
%
|
|
TechneLite
|
21,395
|
|
|
25.9
|
%
|
|
26,825
|
|
|
33.0
|
%
|
||
|
Xenon
|
7,927
|
|
|
9.6
|
%
|
|
8,060
|
|
|
9.9
|
%
|
||
|
Other
|
8,653
|
|
|
10.5
|
%
|
|
8,762
|
|
|
10.7
|
%
|
||
|
Total revenues
|
$
|
82,630
|
|
|
100.0
|
%
|
|
$
|
81,359
|
|
|
100.0
|
%
|
|
•
|
increased revenues for DEFINITY in the suboptimal echocardiogram segment as a result of our continued focused sales efforts;
|
|
•
|
decreased revenues for TechneLite primarily as a result of a temporary supplier disruption;
|
|
•
|
decreased depreciation expense as a result of the scheduled 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;
|
|
•
|
decreased interest expense of
$1.4 million
due to the refinancing, and subsequent repricing, of our debt; and
|
|
•
|
i
ncreased tax expense due to the profit generated during the three months ended March 31, 2018 and the fact that we no longer record a valuation allowance against our domestic deferred tax assets.
|
|
|
Three Months Ended
March 31, |
||||||
|
(in thousands)
|
2018
|
|
2017
|
||||
|
Revenues
|
$
|
82,630
|
|
|
$
|
81,359
|
|
|
Cost of goods sold
|
40,321
|
|
|
41,597
|
|
||
|
Gross profit
|
42,309
|
|
|
39,762
|
|
||
|
Operating expenses
|
|
|
|
||||
|
Sales and marketing
|
10,640
|
|
|
10,214
|
|
||
|
General and administrative
|
12,543
|
|
|
12,270
|
|
||
|
Research and development
|
3,989
|
|
|
5,351
|
|
||
|
Total operating expenses
|
27,172
|
|
|
27,835
|
|
||
|
Operating income
|
15,137
|
|
|
11,927
|
|
||
|
Interest expense
|
4,050
|
|
|
5,420
|
|
||
|
Loss on extinguishment of debt
|
—
|
|
|
2,161
|
|
||
|
Other income
|
(920
|
)
|
|
(577
|
)
|
||
|
Income before income taxes
|
12,007
|
|
|
4,923
|
|
||
|
Income tax expense
|
3,796
|
|
|
785
|
|
||
|
Net income
|
$
|
8,211
|
|
|
$
|
4,138
|
|
|
|
|
Three Months Ended
March 31, |
|||||||||||||
|
(in thousands)
|
|
2018
|
|
2017
|
|
Change
$
|
|
Change
%
|
|||||||
|
U.S.
|
|
|
|
|
|
|
|
|
|||||||
|
DEFINITY
|
|
$
|
43,506
|
|
|
$
|
36,923
|
|
|
$
|
6,583
|
|
|
17.8
|
%
|
|
TechneLite
|
|
18,063
|
|
|
23,308
|
|
|
(5,245
|
)
|
|
(22.5
|
)%
|
|||
|
Xenon
|
|
7,927
|
|
|
8,058
|
|
|
(131
|
)
|
|
(1.6
|
)%
|
|||
|
Other
|
|
1,992
|
|
|
2,738
|
|
|
(746
|
)
|
|
(27.2
|
)%
|
|||
|
Total U.S. revenues
|
|
71,488
|
|
|
71,027
|
|
|
461
|
|
|
0.6
|
%
|
|||
|
International
|
|
|
|
|
|
|
|
|
|||||||
|
DEFINITY
|
|
1,149
|
|
|
789
|
|
|
360
|
|
|
45.6
|
%
|
|||
|
TechneLite
|
|
3,332
|
|
|
3,517
|
|
|
(185
|
)
|
|
(5.3
|
)%
|
|||
|
Xenon
|
|
—
|
|
|
2
|
|
|
(2
|
)
|
|
(100.0
|
)%
|
|||
|
Other
|
|
6,661
|
|
|
6,024
|
|
|
637
|
|
|
10.6
|
%
|
|||
|
Total International revenues
|
|
11,142
|
|
|
10,332
|
|
|
810
|
|
|
7.8
|
%
|
|||
|
Total revenues
|
|
$
|
82,630
|
|
|
$
|
81,359
|
|
|
$
|
1,271
|
|
|
1.6
|
%
|
|
(in thousands)
|
Rebates and
Allowances
|
||
|
Balance, January 1, 2018
|
$
|
2,860
|
|
|
Provision related to current period revenues
|
3,027
|
|
|
|
Adjustments relating to prior period revenues
|
(121
|
)
|
|
|
Payments or credits made during the period
|
(2,776
|
)
|
|
|
Balance, March 31, 2018
|
$
|
2,990
|
|
|
|
|
Three Months Ended
March 31, |
|||||||||||||
|
(in thousands)
|
|
2018
|
|
2017
|
|
Change
$
|
|
Change
%
|
|||||||
|
U.S.
|
|
$
|
39,873
|
|
|
$
|
37,969
|
|
|
$
|
1,904
|
|
|
5.0
|
%
|
|
International
|
|
2,436
|
|
|
1,793
|
|
|
643
|
|
|
35.9
|
%
|
|||
|
Total gross profit
|
|
$
|
42,309
|
|
|
$
|
39,762
|
|
|
$
|
2,547
|
|
|
6.4
|
%
|
|
|
Three Months Ended
March 31, |
|||||||||||||
|
(in thousands)
|
2018
|
|
2017
|
|
Change
$ |
|
Change
% |
|||||||
|
U.S.
|
$
|
9,987
|
|
|
$
|
9,566
|
|
|
$
|
421
|
|
|
4.4
|
%
|
|
International
|
653
|
|
|
648
|
|
|
5
|
|
|
0.8
|
%
|
|||
|
Total sales and marketing
|
$
|
10,640
|
|
|
$
|
10,214
|
|
|
$
|
426
|
|
|
4.2
|
%
|
|
|
Three Months Ended
March 31, |
|||||||||||||
|
(in thousands)
|
2018
|
|
2017
|
|
Change
$ |
|
Change
% |
|||||||
|
U.S.
|
$
|
12,387
|
|
|
$
|
12,106
|
|
|
$
|
281
|
|
|
2.3
|
%
|
|
International
|
156
|
|
|
164
|
|
|
(8
|
)
|
|
(4.9
|
)%
|
|||
|
Total general and administrative
|
$
|
12,543
|
|
|
$
|
12,270
|
|
|
$
|
273
|
|
|
2.2
|
%
|
|
|
Three Months Ended
March 31, |
|||||||||||||
|
(in thousands)
|
2018
|
|
2017
|
|
Change
$ |
|
Change
% |
|||||||
|
U.S.
|
$
|
3,343
|
|
|
$
|
5,129
|
|
|
$
|
(1,786
|
)
|
|
(34.8
|
)%
|
|
International
|
646
|
|
|
222
|
|
|
424
|
|
|
191.0
|
%
|
|||
|
Total research and development
|
$
|
3,989
|
|
|
$
|
5,351
|
|
|
$
|
(1,362
|
)
|
|
(25.5
|
)%
|
|
|
Three Months Ended
March 31, |
|||||||||||||
|
(in thousands)
|
2018
|
|
2017
|
|
Change
$ |
|
Change
% |
|||||||
|
Income tax expense
|
$
|
3,796
|
|
|
$
|
785
|
|
|
$
|
3,011
|
|
|
383.6
|
%
|
|
|
|
Three Months Ended
March 31, |
||
|
|
|
2018
|
|
2017
|
|
Effective tax rate
|
|
31.6%
|
|
15.9%
|
|
|
Three Months Ended
March 31, |
||||||
|
(in thousands)
|
2018
|
|
2017
|
||||
|
Net cash (used in) provided by operating activities
|
$
|
(666
|
)
|
|
$
|
5,524
|
|
|
Net cash used in investing activities
|
$
|
(1,135
|
)
|
|
$
|
(4,564
|
)
|
|
Net cash used in financing activities
|
$
|
(704
|
)
|
|
$
|
(11,254
|
)
|
|
Period
|
Consolidated
Leverage Ratio
|
|
Q2 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;
|
|
•
|
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.
|
|
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 2018**
|
|
2,384
|
|
|
$
|
23.38
|
|
|
*
|
|
*
|
|
February 2018**
|
|
32,923
|
|
|
$
|
19.80
|
|
|
*
|
|
*
|
|
March 2018**
|
|
556
|
|
|
$
|
16.30
|
|
|
*
|
|
*
|
|
Total
|
|
35,863
|
|
|
|
|
*
|
|
|
||
|
**
|
Reflects shares withheld to satisfy minimum statutory tax withholding amounts due from employees related to the receipt of stock, which resulted from the exercise of vesting of equity awards.
|
|
|
|
|
|
INCORPORATED BY REFERENCE
|
||||||
|
EXHIBIT
NUMBER
|
|
DESCRIPTION OF EXHIBITS
|
|
FORM
|
|
FILE
NUMBER
|
|
EXHIBIT
|
|
FILING
DATE
|
|
31.1*
|
|
|
|
|
|
|
|
|
|
|
|
31.2*
|
|
|
|
|
|
|
|
|
|
|
|
32.1**
|
|
|
|
|
|
|
|
|
|
|
|
10.1***
|
|
|
|
|
|
|
|
|
|
|
|
10.2***
|
|
|
|
|
|
|
|
|
|
|
|
10.3***
|
|
|
|
|
|
|
|
|
|
|
|
10.4***
|
|
|
|
|
|
|
|
|
|
|
|
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:
|
|
May 2, 2018
|
|
|
||
|
LANTHEUS HOLDINGS, INC.
|
||
|
|
|
|
|
By:
|
|
/s/ JOHN W. CROWLEY
|
|
Name:
|
|
John W. Crowley
|
|
Title:
|
|
Chief Financial Officer and Treasurer
(Principal Financial Officer and Principal Accounting Officer)
|
|
Date:
|
|
May 2, 2018
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|