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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Lantheus Holdings Inc | NASDAQ:LNTH | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.13 | 0.16% | 79.80 | 79.75 | 81.17 | 2,403 | 13:19:34 |
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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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☐
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Non-accelerated filer
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þ
(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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September 30,
2017 |
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December 31,
2016 |
||||
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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$
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68,077
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|
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$
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51,178
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Accounts receivable, net
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41,713
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36,818
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Inventory
|
23,032
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17,640
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|
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Other current assets
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3,789
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5,183
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Total current assets
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136,611
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110,819
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Property, plant & equipment, net
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94,516
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94,187
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Intangibles, net
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12,645
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15,118
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Goodwill
|
15,714
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15,714
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Other long-term assets
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21,535
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20,060
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Total assets
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$
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281,021
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$
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255,898
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Liabilities and Stockholders’ Deficit
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||||
Current liabilities
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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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3,650
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Revolving line of credit
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—
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|
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—
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||
Accounts payable
|
18,756
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|
18,940
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||
Accrued expenses and other liabilities
|
24,581
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|
21,249
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Total current liabilities
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46,087
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|
43,839
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Asset retirement obligations
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10,151
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9,370
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Long-term debt, net
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265,523
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274,460
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Other long-term liabilities
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37,176
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34,745
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Total liabilities
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358,937
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362,414
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Commitments and contingencies (See Note 12)
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Stockholders’ deficit
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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 ($0.01 par value, 250,000 shares authorized; 37,498 and 36,756 shares issued and outstanding, respectively)
|
375
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367
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Additional paid-in capital
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228,934
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226,462
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Accumulated deficit
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(306,139
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)
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(332,398
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)
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Accumulated other comprehensive loss
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(1,086
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)
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(947
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)
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Total stockholders’ deficit
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(77,916
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)
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(106,516
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)
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Total liabilities and stockholders’ deficit
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$
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281,021
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$
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255,898
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Three Months Ended
September 30, |
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Nine Months Ended
September 30, |
||||||||||||
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2017
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2016
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2017
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2016
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||||||||
Revenues
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$
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79,941
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$
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73,063
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$
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250,137
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$
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227,503
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Cost of goods sold
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41,414
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39,382
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125,901
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124,370
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||||
Gross profit
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38,527
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33,681
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124,236
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103,133
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||||
Operating expenses
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||||||||
Sales and marketing
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10,075
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8,706
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31,892
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27,856
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||||
General and administrative
|
12,076
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10,091
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35,549
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28,842
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Research and development
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3,554
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2,849
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14,149
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8,493
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Total operating expenses
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25,705
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21,646
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81,590
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65,191
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Gain on sales of assets
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—
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(560
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)
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—
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(6,505
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)
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Operating income
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12,822
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12,595
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42,646
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44,447
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Interest expense
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4,442
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6,792
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14,147
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20,799
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Debt retirement costs
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—
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1,415
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—
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1,415
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Loss on extinguishment of debt
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—
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—
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2,161
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—
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Other (income) expense
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(908
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)
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148
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(2,037
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)
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(317
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)
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Income before income taxes
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9,288
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4,240
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28,375
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22,550
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Provision for income taxes
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762
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20
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2,116
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657
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Net income
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$
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8,526
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$
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4,220
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$
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26,259
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$
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21,893
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Net income per common share outstanding:
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Basic
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$
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0.23
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$
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0.14
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$
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0.71
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$
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0.71
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Diluted
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$
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0.22
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$
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0.13
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$
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0.67
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$
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0.71
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Weighted-average common shares outstanding:
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||||||||
Basic
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37,393
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31,221
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37,174
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30,658
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Diluted
|
39,121
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32,402
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38,971
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31,049
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Three Months Ended
September 30, |
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Nine Months Ended
September 30, |
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2017
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2016
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2017
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2016
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||||||||
Net income
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$
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8,526
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$
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4,220
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$
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26,259
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$
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21,893
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Other comprehensive (loss) income:
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||||||||
Reclassification adjustment for gains on sales of assets included in net income
|
—
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|
|
435
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|
|
—
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|
435
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|
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Foreign currency translation
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(115
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)
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234
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(139
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)
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|
490
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|
||||
Total other comprehensive (loss) income
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(115
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)
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669
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(139
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)
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925
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|
||||
Total comprehensive income
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$
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8,411
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$
|
4,889
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$
|
26,120
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$
|
22,818
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|
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Nine Months Ended
September 30, |
||||||
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2017
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|
2016
|
||||
Operating activities
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|
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Net income
|
$
|
26,259
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$
|
21,893
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Adjustments to reconcile net income to net cash flows from operating activities:
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||||
Depreciation, amortization and accretion
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15,019
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|
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12,664
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Amortization of debt related costs
|
1,031
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|
|
1,235
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Provision for excess and obsolete inventory
|
1,002
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|
|
982
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|
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Stock-based compensation
|
3,764
|
|
|
1,869
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|
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Gain on sales of assets
|
—
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|
|
(6,505
|
)
|
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Loss on extinguishment of debt and debt retirement costs
|
2,161
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|
|
1,415
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Other
|
1,404
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(254
|
)
|
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Increases (decreases) in cash from operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
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(4,609
|
)
|
|
1,071
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|
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Inventory
|
(6,361
|
)
|
|
(1,658
|
)
|
||
Other current assets
|
54
|
|
|
(1,032
|
)
|
||
Accounts payable
|
(270
|
)
|
|
2,684
|
|
||
Accrued expenses and other liabilities
|
2,237
|
|
|
2,497
|
|
||
Net cash provided by operating activities
|
41,691
|
|
|
36,861
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|
||
Investing activities
|
|
|
|
||||
Proceeds from sales of assets
|
1,234
|
|
|
10,541
|
|
||
Capital expenditures
|
(11,589
|
)
|
|
(4,976
|
)
|
||
Other
|
—
|
|
|
74
|
|
||
Net cash (used in) provided by investing activities
|
(10,355
|
)
|
|
5,639
|
|
||
Financing activities
|
|
|
|
||||
Payments on long-term debt
|
(285,979
|
)
|
|
(57,790
|
)
|
||
Proceeds from issuance of long-term debt
|
274,313
|
|
|
—
|
|
||
Proceeds from issuance of common stock
|
187
|
|
|
41,600
|
|
||
Payments for public offering costs
|
—
|
|
|
(1,266
|
)
|
||
Proceeds from stock option exercises
|
1,210
|
|
|
61
|
|
||
Payments for minimum statutory tax withholding related to net share settlement of equity awards
|
(2,681
|
)
|
|
(552
|
)
|
||
Deferred financing costs
|
(1,576
|
)
|
|
(11
|
)
|
||
Other
|
(74
|
)
|
|
—
|
|
||
Net cash used in financing activities
|
(14,600
|
)
|
|
(17,958
|
)
|
||
Effect of foreign exchange rates on cash and cash equivalents
|
163
|
|
|
57
|
|
||
Net increase in cash and cash equivalents
|
16,899
|
|
|
24,599
|
|
||
Cash and cash equivalents, beginning of period
|
51,178
|
|
|
28,596
|
|
||
Cash and cash equivalents, end of period
|
$
|
68,077
|
|
|
$
|
53,195
|
|
•
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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.
|
•
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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).
|
•
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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.
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Total Fair
Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
September 30, 2017
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(in thousands)
|
||||||||||||||
Money market funds
|
$
|
6,565
|
|
|
$
|
6,565
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
6,565
|
|
|
$
|
6,565
|
|
|
$
|
—
|
|
|
$
|
—
|
|
December 31, 2016
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
3,565
|
|
|
$
|
3,565
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,565
|
|
|
$
|
3,565
|
|
|
$
|
—
|
|
|
$
|
—
|
|
(in thousands)
|
September 30,
2017 |
|
December 31,
2016 |
||||
Raw materials
|
$
|
10,699
|
|
|
$
|
9,658
|
|
Work in process
|
5,571
|
|
|
3,965
|
|
||
Finished goods
|
6,762
|
|
|
4,017
|
|
||
Total inventory
|
$
|
23,032
|
|
|
$
|
17,640
|
|
(in thousands)
|
September 30,
2017 |
|
December 31,
2016 |
||||
Land
|
$
|
14,950
|
|
|
$
|
14,950
|
|
Buildings
|
74,864
|
|
|
70,628
|
|
||
Machinery, equipment and fixtures
|
69,549
|
|
|
65,407
|
|
||
Computer software
|
18,463
|
|
|
18,482
|
|
||
Construction in progress
|
10,068
|
|
|
7,224
|
|
||
|
187,894
|
|
|
176,691
|
|
||
Less: accumulated depreciation and amortization
|
(93,378
|
)
|
|
(82,504
|
)
|
||
Total property, plant & equipment, net
|
$
|
94,516
|
|
|
$
|
94,187
|
|
(in thousands)
|
Amount
|
||
Balance at January 1, 2017
|
$
|
9,370
|
|
Accretion expense
|
781
|
|
|
Balance at September 30, 2017
|
$
|
10,151
|
|
(in thousands)
|
Amount
|
||
Remainder of 2017
|
$
|
688
|
|
2018
|
2,750
|
|
|
2019
|
2,750
|
|
|
2020
|
2,750
|
|
|
2021
|
2,750
|
|
|
2022
|
261,937
|
|
|
Total principal outstanding
|
273,625
|
|
|
Unamortized debt discount
|
(2,273
|
)
|
|
Unamortized debt issuance costs
|
(3,079
|
)
|
|
Total
|
268,273
|
|
|
Less: current portion
|
(2,750
|
)
|
|
Total long-term debt
|
$
|
265,523
|
|
Period
|
Consolidated
Leverage Ratio
|
Q3 2017 through Q1 2018
|
5.00 to 1.00
|
Q2 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)
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Cost of goods sold
|
$
|
198
|
|
|
$
|
120
|
|
|
$
|
514
|
|
|
$
|
259
|
|
Sales and marketing
|
183
|
|
|
123
|
|
|
474
|
|
|
251
|
|
||||
General and administrative
|
1,089
|
|
|
487
|
|
|
2,315
|
|
|
1,065
|
|
||||
Research and development
|
187
|
|
|
147
|
|
|
461
|
|
|
294
|
|
||||
Total stock-based compensation expense
|
$
|
1,657
|
|
|
$
|
877
|
|
|
$
|
3,764
|
|
|
$
|
1,869
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(in thousands, except per share amounts)
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Net income
|
$
|
8,526
|
|
|
$
|
4,220
|
|
|
$
|
26,259
|
|
|
$
|
21,893
|
|
Basic weighted-average common shares outstanding
|
37,393
|
|
|
31,221
|
|
|
37,174
|
|
|
30,658
|
|
||||
Effect of dilutive stock options
|
318
|
|
|
1,084
|
|
|
371
|
|
|
391
|
|
||||
Effect of dilutive restricted stock awards
|
1,410
|
|
|
97
|
|
|
1,426
|
|
|
—
|
|
||||
Diluted weighted-average common shares outstanding
|
39,121
|
|
|
32,402
|
|
|
38,971
|
|
|
31,049
|
|
||||
Basic income per common share outstanding
|
$
|
0.23
|
|
|
$
|
0.14
|
|
|
$
|
0.71
|
|
|
$
|
0.71
|
|
Diluted income per common share outstanding
|
$
|
0.22
|
|
|
$
|
0.13
|
|
|
$
|
0.67
|
|
|
$
|
0.71
|
|
|
|
|
|
|
|
|
|
||||||||
Antidilutive securities excluded from diluted income per common share
|
322
|
|
|
448
|
|
|
378
|
|
|
1,873
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(in thousands)
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Foreign currency (gains) losses
|
$
|
(414
|
)
|
|
$
|
349
|
|
|
$
|
(554
|
)
|
|
$
|
330
|
|
Tax indemnification income
|
(489
|
)
|
|
(196
|
)
|
|
(1,469
|
)
|
|
(632
|
)
|
||||
Other income
|
(5
|
)
|
|
(5
|
)
|
|
(14
|
)
|
|
(15
|
)
|
||||
Total other (income) expense
|
$
|
(908
|
)
|
|
$
|
148
|
|
|
$
|
(2,037
|
)
|
|
$
|
(317
|
)
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(in thousands)
|
Transaction Type
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Avista Capital Partners, L.P. and its affiliates*
|
Offering costs paid on behalf of Avista pursuant to registration rights agreement
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
326
|
|
|
$
|
—
|
|
INC Research Holdings, Inc. (“INC”)**
|
Pharmacovigilance services
|
—
|
|
|
293
|
|
|
—
|
|
|
647
|
|
||||
VWR Scientific*
|
Inventory supplies
|
—
|
|
|
60
|
|
|
297
|
|
|
245
|
|
||||
Total related party expenses
|
|
$
|
—
|
|
|
$
|
353
|
|
|
$
|
623
|
|
|
$
|
892
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(in thousands)
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Revenues from external customers
|
|
|
|
|
|
|
|
||||||||
U.S.
|
$
|
69,579
|
|
|
$
|
62,621
|
|
|
$
|
218,706
|
|
|
$
|
192,687
|
|
International
|
10,362
|
|
|
10,442
|
|
|
31,431
|
|
|
34,816
|
|
||||
Total revenues from external customers
|
$
|
79,941
|
|
|
$
|
73,063
|
|
|
$
|
250,137
|
|
|
$
|
227,503
|
|
Operating income
|
|
|
|
|
|
|
|
||||||||
U.S.
|
$
|
12,243
|
|
|
$
|
11,649
|
|
|
$
|
40,306
|
|
|
$
|
35,941
|
|
International
|
579
|
|
|
946
|
|
|
2,340
|
|
|
8,506
|
|
||||
Total operating income
|
12,822
|
|
|
12,595
|
|
|
42,646
|
|
|
44,447
|
|
||||
Interest expense
|
4,442
|
|
|
6,792
|
|
|
14,147
|
|
|
20,799
|
|
||||
Debt retirement costs
|
—
|
|
|
1,415
|
|
|
—
|
|
|
1,415
|
|
||||
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
2,161
|
|
|
—
|
|
||||
Other (income) expense
|
(908
|
)
|
|
148
|
|
|
(2,037
|
)
|
|
(317
|
)
|
||||
Income before income taxes
|
$
|
9,288
|
|
|
$
|
4,240
|
|
|
$
|
28,375
|
|
|
$
|
22,550
|
|
•
|
Our ability to continue to increase segment penetration for 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 future patent and regulatory exclusivity expirations;
|
•
|
Risks associated with revenues and unit volumes for Xenon in pulmonary studies and the potential competition in this generic segment from Curium (formerly known as Mallinckrodt Nuclear Imaging; purchased by IBA Molecular in January 2017 and renamed Curium in April 2017);
|
•
|
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 Triad Isotopes (“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 alternate contract manufacturer sites, including a next generation DEFINITY product at Samsung BioLogics (“SBL”) in South Korea;
|
•
|
Risks associated with the manufacturing and distribution of our products and the regulatory requirements related thereto;
|
•
|
The instability of the global Molybdenum-99 (“Moly”) supply;
|
•
|
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;
|
•
|
Risks associated with our lead agent in development, flurpiridaz F 18, including:
|
▪
|
The ability of GE Healthcare to successfully complete the Phase III development program;
|
▪
|
The ability to obtain Food and Drug Administration (“FDA”) approval; and
|
▪
|
The ability to gain post-approval market acceptance and adequate reimbursement;
|
•
|
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;
|
•
|
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;
|
•
|
Our inability to utilize or limitations in our ability to utilize net operating loss carryforwards to reduce our future tax liability;
|
•
|
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, 2016
and in Part II—Item 1A. “Risk Factors” of this Quarterly Report on Form 10-Q.
|
•
|
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., its composition of matter patent will expire in 2019, its manufacturing patent will expire in 2021, and a new method of use patent will expire in 2037. In numerous foreign jurisdictions, patent protection or regulatory exclusivity will currently expire in 2019. We also have an active next generation development program for this agent including pursuing additional indications, new patent protection, and new formulations, but we can give no assurance that the program will be successful or that additional patents will protect the agent.
|
•
|
TechneLite is a technetium generator which 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)
|
2017
|
|
% of
Revenues
|
|
2016
|
|
% of
Revenues
|
|
2017
|
|
% of
Revenues
|
|
2016
|
|
% of
Revenues
|
||||||||||||
DEFINITY
|
$
|
37,729
|
|
|
47.2
|
%
|
|
$
|
32,604
|
|
|
44.6
|
%
|
|
$
|
115,569
|
|
|
46.2
|
%
|
|
$
|
97,499
|
|
|
42.9
|
%
|
TechneLite
|
26,356
|
|
|
33.0
|
%
|
|
24,533
|
|
|
33.6
|
%
|
|
79,900
|
|
|
31.9
|
%
|
|
74,621
|
|
|
32.8
|
%
|
||||
Xenon
|
7,726
|
|
|
9.6
|
%
|
|
6,677
|
|
|
9.1
|
%
|
|
23,713
|
|
|
9.5
|
%
|
|
21,625
|
|
|
9.5
|
%
|
||||
Other
|
8,130
|
|
|
10.2
|
%
|
|
9,249
|
|
|
12.7
|
%
|
|
30,955
|
|
|
12.4
|
%
|
|
33,758
|
|
|
14.8
|
%
|
||||
Total revenues
|
$
|
79,941
|
|
|
100.0
|
%
|
|
$
|
73,063
|
|
|
100.0
|
%
|
|
$
|
250,137
|
|
|
100.0
|
%
|
|
$
|
227,503
|
|
|
100.0
|
%
|
•
|
increased revenues and segment penetration for DEFINITY in the suboptimal echocardiogram segment as a result of our continued focused sales efforts;
|
•
|
increased revenues for TechneLite, mainly the result of higher contracted volumes from certain customers;
|
•
|
increased revenues of $5.0 million from GE Healthcare for the continued Phase III development and worldwide commercialization of flurpiridaz F 18;
|
•
|
lower international revenues and cost of goods sold as a result of the sales of our Canadian and Australian radiopharmacies in 2016;
|
•
|
increased depreciation expense as a result of the scheduled decommissioning of certain long-lived assets;
|
•
|
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; and
|
•
|
decreased interest expense due to the refinancing of long-term debt and a lower principal balance on our long-term debt.
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(in thousands)
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Revenues
|
$
|
79,941
|
|
|
$
|
73,063
|
|
|
$
|
250,137
|
|
|
$
|
227,503
|
|
Cost of goods sold
|
41,414
|
|
|
39,382
|
|
|
125,901
|
|
|
124,370
|
|
||||
Gross profit
|
38,527
|
|
|
33,681
|
|
|
124,236
|
|
|
103,133
|
|
||||
Operating expenses
|
|
|
|
|
|
|
|
||||||||
Sales and marketing
|
10,075
|
|
|
8,706
|
|
|
31,892
|
|
|
27,856
|
|
||||
General and administrative
|
12,076
|
|
|
10,091
|
|
|
35,549
|
|
|
28,842
|
|
||||
Research and development
|
3,554
|
|
|
2,849
|
|
|
14,149
|
|
|
8,493
|
|
||||
Total operating expenses
|
25,705
|
|
|
21,646
|
|
|
81,590
|
|
|
65,191
|
|
||||
Gain on sales of assets
|
—
|
|
|
(560
|
)
|
|
—
|
|
|
(6,505
|
)
|
||||
Operating income
|
12,822
|
|
|
12,595
|
|
|
42,646
|
|
|
44,447
|
|
||||
Interest expense
|
4,442
|
|
|
6,792
|
|
|
14,147
|
|
|
20,799
|
|
||||
Debt retirement costs
|
—
|
|
|
1,415
|
|
|
—
|
|
|
1,415
|
|
||||
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
2,161
|
|
|
—
|
|
||||
Other (income) expense
|
(908
|
)
|
|
148
|
|
|
(2,037
|
)
|
|
(317
|
)
|
||||
Income before income taxes
|
9,288
|
|
|
4,240
|
|
|
28,375
|
|
|
22,550
|
|
||||
Provision for income taxes
|
762
|
|
|
20
|
|
|
2,116
|
|
|
657
|
|
||||
Net income
|
$
|
8,526
|
|
|
$
|
4,220
|
|
|
$
|
26,259
|
|
|
$
|
21,893
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||||||||||||||||
(in thousands)
|
|
2017
|
|
2016
|
|
Change
$
|
|
Change
%
|
|
2017
|
|
2016
|
|
Change
$
|
|
Change
%
|
||||||||||||||
U.S.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
DEFINITY
|
|
$
|
36,901
|
|
|
$
|
32,007
|
|
|
$
|
4,894
|
|
|
15.3
|
%
|
|
$
|
113,035
|
|
|
$
|
95,497
|
|
|
$
|
17,538
|
|
|
18.4
|
%
|
TechneLite
|
|
22,621
|
|
|
20,906
|
|
|
1,715
|
|
|
8.2
|
%
|
|
69,150
|
|
|
64,282
|
|
|
4,868
|
|
|
7.6
|
%
|
||||||
Xenon
|
|
7,726
|
|
|
6,675
|
|
|
1,051
|
|
|
15.7
|
%
|
|
23,709
|
|
|
21,620
|
|
|
2,089
|
|
|
9.7
|
%
|
||||||
Other
|
|
2,331
|
|
|
3,033
|
|
|
(702
|
)
|
|
(23.1
|
)%
|
|
12,812
|
|
|
11,288
|
|
|
1,524
|
|
|
13.5
|
%
|
||||||
Total U.S. revenues
|
|
69,579
|
|
|
62,621
|
|
|
6,958
|
|
|
11.1
|
%
|
|
218,706
|
|
|
192,687
|
|
|
26,019
|
|
|
13.5
|
%
|
||||||
International
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
DEFINITY
|
|
828
|
|
|
597
|
|
|
231
|
|
|
38.7
|
%
|
|
2,534
|
|
|
2,002
|
|
|
532
|
|
|
26.6
|
%
|
||||||
TechneLite
|
|
3,735
|
|
|
3,627
|
|
|
108
|
|
|
3.0
|
%
|
|
10,750
|
|
|
10,339
|
|
|
411
|
|
|
4.0
|
%
|
||||||
Xenon
|
|
—
|
|
|
2
|
|
|
(2
|
)
|
|
(100.0
|
)%
|
|
4
|
|
|
5
|
|
|
(1
|
)
|
|
(20.0
|
)%
|
||||||
Other
|
|
5,799
|
|
|
6,216
|
|
|
(417
|
)
|
|
(6.7
|
)%
|
|
18,143
|
|
|
22,470
|
|
|
(4,327
|
)
|
|
(19.3
|
)%
|
||||||
Total International revenues
|
|
10,362
|
|
|
10,442
|
|
|
(80
|
)
|
|
(0.8
|
)%
|
|
31,431
|
|
|
34,816
|
|
|
(3,385
|
)
|
|
(9.7
|
)%
|
||||||
Total revenues
|
|
$
|
79,941
|
|
|
$
|
73,063
|
|
|
$
|
6,878
|
|
|
9.4
|
%
|
|
$
|
250,137
|
|
|
$
|
227,503
|
|
|
$
|
22,634
|
|
|
9.9
|
%
|
(in thousands)
|
Rebates and
Allowances |
||
Balance, as of January 1, 2017
|
$
|
2,297
|
|
Current provisions relating to revenues in current year
|
6,864
|
|
|
Adjustments relating to prior years’ estimate
|
(154
|
)
|
|
Payments/credits relating to revenues in current year
|
(4,658
|
)
|
|
Payments/credits relating to revenues in prior years
|
(1,474
|
)
|
|
Balance, as of September 30, 2017
|
$
|
2,875
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||||||||||||||||
(in thousands)
|
|
2017
|
|
2016
|
|
Change
$ |
|
Change
% |
|
2017
|
|
2016
|
|
Change
$ |
|
Change
% |
||||||||||||||
U.S.
|
|
$
|
32,759
|
|
|
$
|
31,133
|
|
|
$
|
1,626
|
|
|
5.2
|
%
|
|
$
|
100,225
|
|
|
$
|
96,791
|
|
|
$
|
3,434
|
|
|
3.5
|
%
|
International
|
|
8,655
|
|
|
8,249
|
|
|
406
|
|
|
4.9
|
%
|
|
25,676
|
|
|
27,579
|
|
|
(1,903
|
)
|
|
(6.9
|
)%
|
||||||
Total cost of goods sold
|
|
$
|
41,414
|
|
|
$
|
39,382
|
|
|
$
|
2,032
|
|
|
5.2
|
%
|
|
$
|
125,901
|
|
|
$
|
124,370
|
|
|
$
|
1,531
|
|
|
1.2
|
%
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||||||||||||||||
(in thousands)
|
2017
|
|
2016
|
|
Change
$
|
|
Change
%
|
|
2017
|
|
2016
|
|
Change
$
|
|
Change
%
|
||||||||||||||
U.S.
|
$
|
11,901
|
|
|
$
|
9,693
|
|
|
$
|
2,208
|
|
|
22.8
|
%
|
|
$
|
35,055
|
|
|
$
|
27,629
|
|
|
$
|
7,426
|
|
|
26.9
|
%
|
International
|
175
|
|
|
398
|
|
|
(223
|
)
|
|
(56.0
|
)%
|
|
494
|
|
|
1,213
|
|
|
(719
|
)
|
|
(59.3
|
)%
|
||||||
Total general and administrative
|
$
|
12,076
|
|
|
$
|
10,091
|
|
|
$
|
1,985
|
|
|
19.7
|
%
|
|
$
|
35,549
|
|
|
$
|
28,842
|
|
|
$
|
6,707
|
|
|
23.3
|
%
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||||||||||||||||
(in thousands)
|
2017
|
|
2016
|
|
Change
$
|
|
Change
%
|
|
2017
|
|
2016
|
|
Change
$
|
|
Change
%
|
||||||||||||||
U.S.
|
$
|
3,196
|
|
|
$
|
2,685
|
|
|
$
|
511
|
|
|
19.0
|
%
|
|
$
|
13,265
|
|
|
$
|
7,985
|
|
|
$
|
5,280
|
|
|
66.1
|
%
|
International
|
358
|
|
|
164
|
|
|
194
|
|
|
118.3
|
%
|
|
884
|
|
|
508
|
|
|
376
|
|
|
74.0
|
%
|
||||||
Total research and development
|
$
|
3,554
|
|
|
$
|
2,849
|
|
|
$
|
705
|
|
|
24.7
|
%
|
|
$
|
14,149
|
|
|
$
|
8,493
|
|
|
$
|
5,656
|
|
|
66.6
|
%
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|||||||||||||||||||||||||
(in thousands)
|
2017
|
|
2016
|
|
Change
$
|
|
Change
%
|
|
2017
|
|
2016
|
|
Change
$
|
|
Change
%
|
|||||||||||||
Provision for income taxes
|
$
|
762
|
|
|
$
|
20
|
|
|
$
|
742
|
|
|
>1,000%
|
|
$
|
2,116
|
|
|
$
|
657
|
|
|
$
|
1,459
|
|
|
222.1
|
%
|
|
|
Nine Months Ended September 30,
|
||
|
|
2017
|
|
2016
|
Effective tax rate
|
|
7.5%
|
|
2.9%
|
|
Nine Months Ended
September 30, |
||||||
(in thousands)
|
2017
|
|
2016
|
||||
Net cash provided by operating activities
|
$
|
41,691
|
|
|
$
|
36,861
|
|
Net cash (used in) provided by investing activities
|
$
|
(10,355
|
)
|
|
$
|
5,639
|
|
Net cash used in financing activities
|
$
|
(14,600
|
)
|
|
$
|
(17,958
|
)
|
Period
|
Consolidated
Leverage Ratio
|
Q3 2017 through Q1 2018
|
5.00 to 1.00
|
Q2 2018 through Q1 2019
|
4.75 to 1.00
|
Thereafter
|
4.50 to 1.00
|
•
|
Our ability to have product manufactured and released from JHS and other manufacturing sites in a timely manner in the future;
|
•
|
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;
|
•
|
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 costs of investing in our facilities, equipment and technology infrastructure;
|
•
|
The costs and timing of establishing manufacturing and supply arrangements for commercial supplies of our products;
|
•
|
The extent to which we acquire or invest in (i) new products, businesses and technologies, or (ii) the further clinical development or commercialization of existing development candidates or products;
|
•
|
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.
|
•
|
Less stable political and economic environments and changes in a specific country’s or region’s political or economic conditions, including on-going political and military tensions on the Korean peninsula which could adversely affect our next generation DEFINITY program at SBL;
|
•
|
Entering into or renewing commercial agreements with international governments or provincial authorities or entities directly or indirectly controlled by such governments or authorities, such as our Chinese partner Double-Crane Pharmaceutical Company;
|
•
|
International customers which are agencies or institutions of foreign governments;
|
•
|
Local business practices which may be in conflict with the U.S. Foreign Corrupt Practices Act and U.K. Bribery Act;
|
•
|
Currency fluctuations;
|
•
|
Potential negative consequences from changes in tax laws affecting our ability to repatriate profits;
|
•
|
Unfavorable labor regulations;
|
•
|
Greater difficulties in relying on non-U.S. courts to enforce either local or U.S. laws, particularly with respect to intellectual property;
|
•
|
Greater potential for intellectual property piracy;
|
•
|
Greater difficulties in managing and staffing non-U.S. operations;
|
•
|
The need to ensure compliance with the numerous in-country and international regulatory and legal requirements applicable to our business in each of these jurisdictions and to maintain an effective compliance program to ensure compliance with these requirements;
|
•
|
Changes in public attitudes about the perceived safety of nuclear facilities;
|
•
|
Changes in trade policies, regulatory requirements and other barriers;
|
•
|
Civil unrest or other catastrophic events, including Hurricane Maria in Puerto Rico; and
|
•
|
Longer payment cycles of non-U.S. customers and difficulty collecting receivables in non-U.S. jurisdictions.
|
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 2017**
|
|
—
|
|
|
$
|
—
|
|
|
*
|
|
*
|
August 2017**
|
|
27,918
|
|
|
$
|
17.48
|
|
|
*
|
|
*
|
September 2017**
|
|
37,860
|
|
|
$
|
16.80
|
|
|
*
|
|
*
|
Total
|
|
65,778
|
|
|
|
|
*
|
|
|
|
|
|
|
INCORPORATED BY REFERENCE
|
||||||
EXHIBIT
NUMBER
|
|
DESCRIPTION OF EXHIBITS
|
|
FORM
|
|
FILE
NUMBER
|
|
EXHIBIT
|
|
FILING
DATE
|
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
|
|
|
|
LANTHEUS HOLDINGS, INC.
|
||
|
|
|
By:
|
|
/s/ MARY ANNE HEINO
|
Name:
|
|
Mary Anne Heino
|
Title:
|
|
President and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
Date:
|
|
November 2, 2017
|
|
||
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:
|
|
November 2, 2017
|
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