Form 10-Q Lantheus Holdings, Inc. For: Mar 31
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from __________ to __________
Commission File Number
(Exact name of registrant as specified in its charter) |
(State or other jurisdiction of incorporation or organization) |
(IRS Employer Identification No.) |
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(Address of principal executive offices) |
(Zip Code) |
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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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Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging Growth Company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Act) Yes ☐ No
The registrant had
LANTHEUS HOLDINGS, INC.
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Lantheus Holdings, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands, except par value)
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March 31, |
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December 31, |
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2026 |
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2025 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Accounts receivable, net |
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Inventory, net |
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Income tax receivable |
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Other current assets |
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Assets held for sale |
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Total current assets |
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Investment in equity securities |
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Long-term notes receivable |
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Property, plant and equipment, net |
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Intangibles, net |
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Goodwill |
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Deferred tax assets, net |
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Other long-term assets |
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Total assets |
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$ |
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$ |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Current portion of long-term debt and other borrowings |
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$ |
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$ |
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Accounts payable |
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Accrued expenses and other current liabilities |
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Liabilities held for sale |
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Total current liabilities |
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Asset retirement obligations |
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Long-term debt and other borrowings, net of current portion |
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Long-term deferred tax liabilities |
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Long-term contingent consideration liabilities, net of current portion |
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Other long-term liabilities |
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Total liabilities |
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Stockholders' equity: |
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Preferred stock ($ |
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Common stock ($ |
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Additional paid-in capital |
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Treasury stock at cost; |
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Retained earnings |
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Accumulated other comprehensive loss |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
Lantheus Holdings, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)
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Three Months Ended |
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2026 |
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2025 |
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Revenues |
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$ |
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$ |
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Cost of goods sold |
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Gross profit |
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Operating expenses |
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Sales and marketing |
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General and administrative |
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Research and development |
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Total operating expenses |
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Operating income |
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Interest expense |
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Investment in equity securities - unrealized (gain) loss |
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Gain on sale of business, net of transaction costs |
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Other income, net |
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Income before income taxes |
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Income tax expense |
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Net income |
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$ |
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$ |
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Net income per common share: |
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Basic |
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$ |
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$ |
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Diluted |
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$ |
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$ |
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Weighted average common shares outstanding: |
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Basic |
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Diluted |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Lantheus Holdings, Inc.
Condensed Consolidated Statements of Comprehensive Income
(Unaudited)
(in thousands)
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Three Months Ended |
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2026 |
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2025 |
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Net income |
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$ |
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$ |
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Other comprehensive income (loss): |
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Foreign currency translation |
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Comprehensive income |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Lantheus Holdings, Inc.
Condensed Consolidated Statements of Changes in Stockholders’ Equity
(Unaudited)
(in thousands)
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Three Months Ended March 31, 2026 |
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Accumulated |
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Additional |
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Other |
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Total |
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Common Stock |
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Treasury Stock |
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Paid-In |
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Retained |
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Comprehensive |
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Stockholders' |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Earnings |
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Income (Loss) |
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Equity |
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Balance at January 1, 2026 |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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Net income |
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— |
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— |
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— |
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— |
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— |
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— |
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Other comprehensive loss |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
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( |
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Stock option exercises and employee stock plan purchases |
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— |
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— |
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— |
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— |
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Vesting of restricted stock units |
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— |
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— |
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— |
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— |
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Shares withheld to cover taxes |
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( |
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( |
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— |
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— |
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( |
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— |
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— |
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( |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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Balance at March 31, 2026 |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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Three Months Ended March 31, 2025 |
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Accumulated |
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Additional |
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Other |
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Total |
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Common Stock |
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Treasury Stock |
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Paid-In |
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Retained |
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Comprehensive |
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Stockholders' |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Earnings |
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Loss |
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Equity |
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Balance at January 1, 2025 |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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Net income |
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— |
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— |
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— |
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— |
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— |
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— |
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Other comprehensive loss |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
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( |
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Stock option exercises and employee stock plan purchases |
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— |
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— |
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— |
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— |
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Vesting of restricted stock units |
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— |
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— |
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( |
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— |
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— |
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— |
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Shares withheld to cover taxes |
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( |
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( |
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— |
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— |
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( |
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— |
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— |
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( |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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Balance at March 31, 2025 |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Lantheus Holdings, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
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Three Months Ended |
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2026 |
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2025 |
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Cash flows from operating activities: |
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Net income |
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$ |
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$ |
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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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Adjustment to the fair value of asset retirement obligation |
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Amortization of debt-related costs |
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Change in fair value of contingent assets and liabilities |
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( |
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Inventory adjustments |
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Stock-based compensation |
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Unrealized (gain) loss on investment in equity securities |
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( |
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Charges incurred pursuant to acquired in-process research and development |
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Deferred taxes |
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Long-term income tax payable and other long-term liabilities |
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Gain on sale of business, net of transaction costs |
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( |
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Other |
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( |
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Changes in operating assets and liabilities, excluding impact of acquisitions: |
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Accounts receivable |
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( |
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( |
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Inventory |
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Other current and noncurrent assets |
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( |
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Accounts payable |
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Accrued expenses and other current and noncurrent liabilities |
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Net cash provided by operating activities |
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Cash flows from investing activities: |
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Capital expenditures |
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( |
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Proceeds from sale of business, net of transaction costs |
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Proceeds from sale of assets |
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Deposit for acquisition of a business |
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( |
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Purchases of investment in equity securities |
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( |
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Net cash provided by (used in) investing activities |
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( |
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Cash flows from financing activities: |
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Payments of long-term debt and other borrowings |
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( |
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( |
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Proceeds from stock option exercises |
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Proceeds from employee stock purchase plan |
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Payments for minimum statutory tax withholding related to net share settlement of equity awards |
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( |
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Proceeds from issuance of common stock |
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Net cash used in financing activities |
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( |
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( |
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Effect of exchange rate changes on cash, cash equivalents and restricted cash |
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( |
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Net increase in cash, cash equivalents and restricted cash |
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Cash, cash equivalents and restricted cash, beginning of period |
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Cash, cash equivalents and restricted cash, end of period |
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$ |
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$ |
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5
Lantheus Holdings, Inc.
Condensed Consolidated Statements of Cash Flows (Continued)
(Unaudited)
(in thousands)
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Three Months Ended |
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2026 |
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2025 |
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Reconciliation to amounts within the condensed consolidated balance sheets |
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Cash and cash equivalents |
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$ |
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$ |
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Restricted cash included in other long-term assets |
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Cash, cash equivalents and restricted cash at end of period |
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$ |
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$ |
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Three Months Ended |
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2026 |
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2025 |
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Schedule of non-cash investing and financing activities |
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Additions of property, plant and equipment included in liabilities |
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$ |
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$ |
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Modification of lease agreement |
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$ |
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$ |
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Receipt of notes related to sale of business |
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$ |
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$ |
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Contingent consideration assets related to sale of business |
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$ |
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$ |
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Right-of-use asset obtained in exchange for operating lease obligation |
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$ |
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$ |
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Right-of-use asset obtained in exchange for finance lease obligation |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
6
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note Regarding Company References and Trademarks
Unless the context otherwise requires, references to the “Company,” “our Company,” “Lantheus,” “we,” “us” and “our” refer to Lantheus Holdings, Inc. and its direct and indirect wholly-owned subsidiaries; references to “Lantheus Holdings” refer to Lantheus Holdings, Inc. and not to any of its subsidiaries; references to “Lantheus Medical” refer to Lantheus Medical Imaging, Inc., the wholly-owned subsidiary of Lantheus Holdings; references to “Aphelion,” “Lantheus Alpha” and “Meilleur” refer to Aphelion LLC, Lantheus Alpha Therapy, LLC and Meilleur Technologies, Inc., respectively, each a wholly-owned subsidiary of Lantheus Holdings; references to “Cerveau,” “Lantheus Real Estate,” “Progenics,” “Evergreen,” “Lantheus Radiopharm UK”, and “Lantheus Switzerland,” refer to Cerveau Technologies, Inc.; Lantheus MI Real Estate, LLC; Progenics Pharmaceuticals, Inc.; Evergreen Theragnostics, Inc.; Lantheus Radiopharmaceuticals UK Limited and Lantheus Switzerland GmbH, respectively, each a wholly-owned subsidiary of Lantheus Medical, references to “EXINI” refer to EXINI Diagnostics AB, a wholly-owned subsidiary of Progenics, and references to “Lantheus Biosciences” refer to Lantheus Biosciences Ltd. (or to Life Molecular Imaging Limited prior to the Company’s acquisition of it in July 2025 and a name change in February 2026), a wholly-owned subsidiary of Lantheus Radiopharm UK.
Solely for convenience, the Company refers to trademarks, service marks and trade names in this Quarterly Report on Form 10-Q (“Form 10-Q”) without the TM, SM and ® symbols. Those references are not intended to indicate, in any way, that the Company will not assert, to the fullest extent permitted under applicable law, its rights to its trademarks, service marks and trade names. Each trademark, service mark or trade name of any other company appearing in this Form 10-Q, is, to the Company’s knowledge, owned by that other company.
1. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements include the accounts of Lantheus and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) for interim financial information and with the instructions for Form 10-Q and Article 10 of Regulation S-X. Accordingly, these condensed consolidated financial statements do not include all of the information and notes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal and recurring adjustments) considered necessary for a fair statement have been included. The preparation of the Company’s condensed consolidated financial statements requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenue and expenses, and related disclosures. The results of operations for the three months ended March 31, 2026 and 2025 are not necessarily indicative of the results that may be expected for any future period.
The condensed consolidated balance sheet at December 31, 2025 has been derived from the audited consolidated financial statements at that date but does not include all the information and notes required by U.S. GAAP for complete financial statements. These condensed consolidated financial statements and accompanying notes should be read in conjunction with the consolidated financial statements and notes thereto included in Item 8 of the Company’s most recent Annual Report on Form 10-K (“Form 10-K”) for the year ended December 31, 2025 filed with the Securities Exchange Commission (“SEC”) on February 26, 2026.
2. Summary of Significant Accounting Policies
Recent Accounting Pronouncements
The Company has considered all new accounting standards issued by the Financial Accounting Standards Board (“FASB”).
Accounting Pronouncements Adopted During the Period
In July 2025, the FASB issued Accounting Standards Update (“ASU”) 2025-05, “Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets,” which provides a practical expedient related to the estimation of expected credit losses for accounts receivable and current contract assets that arise from transactions accounted for under Accounting Standards Codification (“ASC”) 606, “Revenue Recognition.” ASU 2025-05 requires an entity to disclose whether it has elected to use the practical expedient. An entity that makes the accounting policy election is required to disclose the date through which subsequent cash collections are evaluated. The Company adopted ASU 2025-05 effective January 1, 2026 on a prospective basis and elected the practical expedient for the calculation of expected credit losses for the Company’s current accounts and notes receivables. Adoption of this standard did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures during the first quarter of 2026.
In November 2024, the FASB issued ASU 2024-04, “Debt - Debt with Conversion and Other Options (Subtopic 470-20),” which clarifies the requirements for determining whether certain settlements of convertible debt instruments should be accounted for as an induced conversion
7
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
rather than as extinguishment of debt. The requirements of ASU 2024-04 are effective for the annual periods beginning after December 15, 2025, including interim periods within those fiscal years. The Company prospectively adopted ASU 2024-04 as of January 1, 2026. The adoption did not have a material impact on the Company’s condensed consolidated financial statements during the first quarter of 2026, as the Company has not entered into any exchange-related settlements, modifications, or inducement transactions related to its
Accounting Pronouncements Not Yet Adopted
In December 2025, the FASB issued ASU 2025-11, “Interim Reporting (Topic 270) Narrow-Scope Improvements,” which clarifies that the interim reporting requirements in Topic 270 apply to all entities that issue interim financial statements prepared in accordance with U.S. GAAP and consolidates such requirements within Topic 270. The amendments provide a comprehensive list within Topic 270 of required interim disclosures, establishes a principle requiring disclosure of events or changes occurring after the end of the most recent annual reporting period that have a material impact on interim results and clarifies the form and content requirements applicable to interim financial statements. The requirements of ASU 2025-11 are effective for interim reporting periods within annual reporting periods beginning after December 15, 2027 (for the Company’s Form 10-Q for the three months ending March 31, 2028). The Company is currently in the process of evaluating the effects of this pronouncement on its consolidated financial statements and related disclosures.
In September 2025, the FASB issued ASU 2025-06, “Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software,” which simplifies the capitalization guidance by removing all references to software development project stages so that the guidance is neutral to different software development methods. Entities will now capitalize costs associated with internal-use software only when management has authorized and committed funding, and it is probable that the project will be completed and the software will be used to perform its intended function. ASU 2025-06 is effective for interim and annual periods beginning after December 15, 2027, with early adoption permitted. The Company is currently in the process of evaluating the effects of this pronouncement on its consolidated financial results and related disclosures.
In November 2024, the FASB issued ASU 2024-03, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40),” and in January 2025, the FASB issued ASU 2025-01, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date.” ASU 2024-03 requires additional income statement disclosures, including the disaggregation of specific categories of expenses underlying the line items presented on the income statement. Additionally, ASU 2024-03 requires enhanced disclosure of selling expenses. As clarified by ASU 2025-01, the requirements of the guidance are effective for annual periods beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027. For the Company, annual reporting requirements under ASU 2024-03 will be effective for its Form 10-K for the year ending December 31, 2027 and interim reporting requirements will be effective beginning in the first quarter of 2028. Early adoption is permitted and the amendments should be applied on a prospective basis, however retrospective application is permitted. The Company is currently in the process of evaluating the impact of this pronouncement on its related disclosures.
3. Revenue from Contracts with Customers
Disaggregation of Revenue
The following table summarizes revenue by source as follows:
|
|
Three Months Ended |
|
|||||
(in thousands) |
|
2026 |
|
|
2025 |
|
||
Major Products /Service Lines |
|
|
|
|
|
|
||
Product revenue, net(1) |
|
$ |
|
|
$ |
|
||
License and royalty revenues |
|
|
|
|
|
|
||
Total revenues |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
8
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Prior to January 1, 2026, the Company classified its revenues into
Revenue by product category on a net basis is as follows:
|
|
Three Months Ended |
|
|||||
(in thousands) |
|
2026 |
|
|
2025 |
|
||
PYLARIFY |
|
$ |
|
|
$ |
|
||
Total oncology |
|
|
|
|
|
|
||
Neuraceq |
|
|
|
|
|
|
||
Total neurology |
|
|
|
|
|
|
||
DEFINITY |
|
|
|
|
|
|
||
Total cardiology |
|
|
|
|
|
|
||
Strategic partnerships and other |
|
|
|
|
|
|
||
SPECT |
|
|
|
|
|
|
||
Total revenues |
|
$ |
|
|
$ |
|
||
The following table presents the Company’s revenue by geographic region determined by location of customer or other party for the periods presented:
|
|
For the Three Month Ended March 31, |
|
|||||||||||||
(in thousands) |
|
2026 |
|
|
% of Revenue |
|
|
2025 |
|
|
% of Revenue |
|
||||
United States |
|
$ |
|
|
|
% |
|
$ |
|
|
|
% |
||||
Rest of world |
|
|
|
|
|
% |
|
|
|
|
|
% |
||||
Total revenues |
|
$ |
|
|
|
% |
|
$ |
|
|
|
% |
||||
Product Returns
The Company generally offers customers a limited right of return due to non-conforming product. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company currently estimates product return liabilities using its historical product return information and considers other factors that it believes could significantly impact its expected returns, including product recalls. Reserves for product returns are not significant to the Company due to the nature of its products including radiopharmaceutical products with limited half-lives.
Rebates
Estimates for rebates represent the Company’s estimated obligations under contractual arrangements with third parties. Rebate accruals are recorded in the same period the related revenue is recognized, resulting in a reduction of revenue and the establishment of a liability which is included in accrued expenses and other current liabilities in the Company’s consolidated balance sheets. These rebates result from performance-based offers that are primarily based on attaining contractually specified sales volumes and growth, Medicaid rebate programs for the Company’s products, administrative fees of group purchasing organizations and certain distributor-related commissions. The calculation of the accrual for these rebates is based on an estimate of the third-party’s expected purchases and the resulting applicable contractual rebate to be earned over a contractual period.
An analysis of the amount of, and change in, accruals for rebate liabilities is summarized as follows:
(in thousands) |
|
Rebates |
|
|
Balance at January 1, 2026 |
|
$ |
|
|
Provision related to current period revenues |
|
|
|
|
Payments or credits made during the period |
|
|
( |
) |
Balance at March 31, 2026 |
|
$ |
|
|
9
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Contract Assets and Liabilities
The Company recognizes an asset for incremental costs of obtaining a contract with a customer if it expects to recover those costs. The Company’s sales incentive compensation plans qualify for capitalization since these plans are directly related to sales achieved during a period of time. However, the Company has elected the practical expedient to expense the costs as they are incurred, within sales and marketing expenses, since the amortization period is less than one year.
The following table provides a roll forward of deferred revenue:
(in thousands) |
|
Deferred Revenue |
|
|
Balance at January 1, 2026 |
|
$ |
|
|
Revenue recognized in relation to the beginning of the year contract liability balance |
|
|
( |
) |
Revenue deferred |
|
|
|
|
Balance at March 31, 2026 |
|
$ |
|
|
The Company is required to allocate a portion of its revenue received from commercial contracts to future reporting periods to the extent the Company had performance obligations that extended beyond one year. However, the Company’s performance obligations are typically part of contracts that have an original expected duration of one year or less. Therefore, since the Company elected the practical expedient under ASC 606-10-50-14, it does not disclose information regarding remaining performance obligations which are part of contracts that have an original expected duration of one year or less.
4. Fair Value of Financial Instruments
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability of fair value measurements, financial instruments are categorized based on a hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:
The Company’s financial assets and liabilities that are measured at fair value on a recurring basis consist of money market funds, deferred compensation plan liabilities, contingent consideration liabilities and equity investments. The Company invests excess cash from its operating cash accounts in overnight investments and reflects these amounts in cash and cash equivalents in the condensed consolidated balance sheets at fair value using quoted prices in active markets for identical assets. Investment in equity securities resulting from the Perspective Therapeutics, Inc. (“Perspective”) and Radiopharm Theranostics Limited (“Radiopharm”) strategic agreements were recorded at fair value by the Company and are adjusted for price changes observable in the market each quarter. The Company recorded the contingent consideration liabilities resulting from the acquisitions of Progenics, Evergreen and Lantheus Biosciences at fair value based on inputs that are not observable in the market. Consideration received from the sale of the SPECT business on January 1, 2026 was initially measured at fair value. See Note 8, “SPECT Business” for more information about the sale of the SPECT business in the first quarter of 2026.
10
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The tables below present information about the Company’s assets and liabilities measured at fair value on a recurring basis:
|
|
|
|
|
March 31, 2026 |
|
||||||||||
|
|
Total Fair |
|
|
|
|
|
|
|
|
|
|
||||
(in thousands) |
|
Value |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Investment securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total assets |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Deferred compensation plan liabilities |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Contingent consideration liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total liabilities |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
December 31, 2025 |
|
||||||||||
|
|
Total Fair |
|
|
|
|
|
|
|
|
|
|
||||
(in thousands) |
|
Value |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Investment securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total assets |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Deferred compensation plan liabilities |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Contingent consideration liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total liabilities |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Nonqualified Deferred Compensation Plan
The Company maintains the Lantheus Nonqualified Deferred Compensation Plan (the “LDCP”) for the benefit of certain key, highly-compensated employees and non-employee directors. The assets of the LDCP are invested in corporate-owned life insurance (“COLI”) and mutual funds at March 31, 2026. The mutual funds are classified as Level 1 of the fair value hierarchy because they are valued using quoted market prices. The liabilities of the LDCP are presented in other long-term liabilities in the Company’s condensed consolidated balance sheets. See Note 16, “Benefit Plans” for more information on the LDCP.
Perspective Therapeutics Inc. Equity Securities
At March 31, 2026, the Company held
Radiopharm Theranostics Limited Equity Securities
The Company held
See Note 17, “Acquisitions” for further discussion of the Radiopharm transaction.
Contingent Consideration Liabilities
11
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Progenics
The Company assumed contingent consideration liabilities related to a previous acquisition completed by Progenics in 2013 (“2013 Acquisition”). These contingent consideration liabilities include potential payments of up to $
Significant changes in any of the probabilities of success, the probabilities as to the periods in which sales targets and milestones will be achieved, discount rates or underlying revenue forecasts would result in a higher fair value measurement. The Company records the contingent consideration liabilities at fair value with changes in estimated fair values recorded in general and administrative expenses in the condensed consolidated statements of operations. The Company can give no assurance that the actual amounts paid, if any, in connection with the contingent consideration liabilities, will be consistent with any recurring fair value estimate of such contingent consideration liabilities. The Company estimated that the probability of successfully meeting the sales targets and commercialization milestones described above was zero, as the Company discontinued the production of AZEDRA in the first quarter of 2024 and the Company is not actively advancing 1095. As a result of this assessment, the Company determined the value of the contingent consideration liabilities to be $
Evergreen Theragnostics, Inc.
Pursuant to the terms of the Agreement and Plan of Merger (the “Evergreen Merger Agreement”) with Evergreen and Shareholder Representative Services LLC governing the Company's acquisition of Evergreen in April 2025 (see Note 17, “Acquisitions”), the Company is required to pay up to $
Lantheus Biosciences Ltd.
Pursuant to the terms of the Sale and Purchase Agreement (the “LMI Purchase Agreement”) with Life Medical Group Limited (“Life Medical”) in connection with the Company’s acquisition of Lantheus Biosciences in July 2025 (see Note 17, “Acquisitions”), the Company is required to make certain earn-out and milestone payments as a percentage of and upon achievement of specified net sales thresholds, respectively, of Neuraceq and certain other imaging agents in Lantheus Bioscience’s pipeline. These contingent cash earn-out and milestone payments total up to $
In addition to the net sales earn-out and milestone payments, the Company also assumed a contingent consideration liability owed to Piramal Holdings SA (“Piramal”), pursuant to an assumed contract (the “Piramal SPA”). The Company is required to make cash payments of up to $
The Company estimated the fair value of the contingent consideration liabilities using a Monte Carlo simulation model in a risk-neutral framework, whereby the achievement of the future revenue and other specified earnings metrics associated with the contingent payments were simulated using a geometric Brownian motion model. The most significant unobservable inputs with respect to Neuraceq and other imaging
12
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
agents in Lantheus Biosciences’s pipeline include revenue volatility and the probability of commercial success. A significant change in the revenue volatility or forecasted commercial revenue could result in a material fluctuation in the value of the contingent consideration liability.
The following table reflects the activity for the Company’s contingent consideration measured at fair value using Level 3 inputs for the three months ended March 31, 2026:
|
|
Level 3 |
|
|
|
|
Accrued Contingent |
|
|
(in thousands) |
|
Consideration |
|
|
Balance at January 1, 2026 |
|
$ |
|
|
Changes in fair value included in net income |
|
|
( |
) |
Balance at March 31, 2026 |
|
$ |
|
|
Significant changes in any of the probabilities of success, the probabilities as to the periods in which sales targets and milestones will be achieved, discount rates or underlying revenue forecasts would result in a higher or lower fair value measurement. The Company records the contingent consideration liabilities at fair value with changes in estimated fair values recorded within operating expenses in the condensed consolidated statements of operations. The Company can give no assurance that the actual amounts paid, if any, in connection with the contingent consideration liabilities, will be consistent with any recurring fair value estimate of such contingent consideration liabilities. As a result of this assessment, the Company determined the value of the contingent consideration liabilities to be $
The recurring Level 3 fair value measurements of the Company's contingent consideration liabilities include the following significant unobservable inputs (in thousands, except percent data):
|
|
Fair Value at |
|
|
|
|
|
|
|
|
|
|
|||||
Contingent Consideration Liability |
|
March 31, |
|
|
December 31, |
|
|
|
Valuation Technique |
|
Unobservable Inputs |
|
Range |
|
Weighted Average |
||
Development and commercialization milestones |
|
$ |
|
|
$ |
|
|
|
Discounted cash flow |
|
Payment discount rate |
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
Probability of payment |
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
Range of expected payment dates |
|
2026 - 2037 |
|
N/A |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Sales milestones |
|
|
|
|
|
|
|
|
Scenario analysis |
|
Revenue volatility |
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
Revenue discount rate |
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Assumed contingent consideration from Piramal SPA |
|
|
|
|
|
|
|
|
Scenario analysis |
|
EBITDA volatility |
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
EBITDA discount rate |
|
|
||||
Total contingent consideration liabilities |
|
$ |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Consideration Received From the Sale of the SPECT Business
On January 1, 2026 as a result of the sale of the Company’s SPECT business pursuant to the Equity and Asset Purchase Agreement, by and among Lantheus Medical, Lantheus MI Canada, Inc., Lantheus EU Limited, and Illuminated, SHINE SPECT, LLC, SHINE SPECT Medical Products, Ltd., and SHINE SPECT Limited (collectively referred to as “SHINE SPECT”), dated as of May 1, 2025 (the “SHINE SPECT Agreement”), the Company received consideration consisting of cash, notes receivable that may be settled in equity of Illuminated or in cash depending on their specific terms, a right to receive additional cash on the earlier of January 1, 2030 or upon the occurrence of certain specified events, and the right to certain contingent consideration, as described below.
Installment Note
The Company received a promissory note from Illuminated, with a principal amount of $
13
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
of preferred stock upon a qualified financing or shares of common stock on completion of an initial public offering by Illuminated (a “SHINE IPO”) or the merger or acquisition with a special purpose acquisition company, at the conversion price. If a Non-Qualified Financing (as defined in the Installment Note) occurs prior to the maturity date, the Company has the option to convert the outstanding principal amount into shares of preferred stock at the conversion price. If a change-in-control event occurs on or prior to the maturity date, the Company has the option to either (i) settle the principal balance in cash or (ii) convert the outstanding principal amount into shares of common stock of Illuminated at the conversion price. The Company estimated the fair value of the Installment Note issued on January 1, 2026 using a probability weight discounted cash flow model. The discount upon issuance of the Installment Note is being recognized into other income, net in the Company’s condensed consolidated statements of operations for the periods in which the instrument remains outstanding. Illuminated completed a qualified financing on February 17, 2026, resulting in the conversion of the Installment Note into Series E preferred shares of Illuminated, which were issued to the Company on April 6, 2026.
Seller Note
The Company received an unsecured promissory note from SHINE SPECT (the “Seller Note”), with a principal amount of $
Deferred Cash Purchase Price
The Company will receive $
Net Contingent Consideration
The Company may earn up to $
14
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
revenue associated with the sales milestones was simulated using a geometric Brownian motion model. The Company estimated the fair value of the Contingent Consideration Receivable to be $
A contingent consideration payable of $
All components of net consideration received were measured at fair value on January 1, 2026 in computing the gain on sale of business.
(in thousands) |
|
|
|
|
Cash consideration received |
|
$ |
|
|
Installment Note |
|
|
|
|
Seller Note |
|
|
|
|
Deferred Cash Purchase Price |
|
|
|
|
Net contingent consideration receivable |
|
|
|
|
Total net consideration received |
|
$ |
|
|
|
|
|
|
|
5. Income Taxes
The Company calculates income taxes at the end of each reporting period based on the estimated effective tax rate for the full year, adjusted for any discrete events which are recorded in the period they occur. Cumulative adjustments to the tax provision are recorded in the reporting period in which a change in the estimated annual effective tax rate is determined.
|
|
Three Months Ended |
|
|||||
(in thousands) |
|
2026 |
|
|
2025 |
|
||
Income tax expense |
|
$ |
|
|
$ |
|
||
Effective tax rate |
|
|
% |
|
|
% |
||
The decrease in the effective income tax rate for the three months ended March 31, 2026 is primarily due to the change in valuation allowance related to the fluctuation in value of the Company’s investment in equity securities balance, partially offset by the decrease in excess tax benefits associated with the Company’s payment of stock-based compensation.
6. Inventory, Net
Inventory, net of related reserves, consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
(in thousands) |
|
2026 |
|
|
2025 |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work in process |
|
|
|
|
|
|
||
Finished goods |
|
|
|
|
|
|
||
Total inventory, net |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
The majority of the value of the inventory relates to non-radioactive products. With respect to the Company’s products that are radiopharmaceuticals, due to the limited shelf life of such products, they are generally not held as finished goods.
15
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
7. Property, Plant and Equipment, Net
Property, plant and equipment, net, consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
(in thousands) |
|
2026 |
|
|
2025 |
|
||
Land |
|
$ |
|
|
$ |
|
||
Buildings |
|
|
|
|
|
|
||
Machinery, equipment and fixtures |
|
|
|
|
|
|
||
Computer software |
|
|
|
|
|
|
||
Construction in progress |
|
|
|
|
|
|
||
Total gross property, plant and equipment |
|
|
|
|
|
|
||
Less - accumulated depreciation and amortization |
|
|
( |
) |
|
|
( |
) |
Total property, plant and equipment, net |
|
$ |
|
|
$ |
|
||
Depreciation and amortization expense related to property, plant and equipment, net, was $
8. SPECT Business
Sale of SPECT Business
On January 1, 2026 (the “Disposition Date”), the Company completed the sale of its SPECT business to SHINE SPECT (the “Disposition”). Upon completion of the Disposition, the Company did not retain an equity interest in the SPECT entities sold in connection with the Disposition and concluded that it no longer held a controlling financial interest in the SPECT business. Accordingly, all previously recognized assets and liabilities of the SPECT business that were conveyed to SHINE SPECT were deconsolidated. Assets and liabilities derecognized upon the Disposition included those relating to the Company’s approved SPECT products (TechneLite, NEUROLITE, Xenon Xe-133 Gas, and Cardiolite), the portion of the North Billerica, Massachusetts campus that manufactures the SPECT products and specified assets and liabilities of the Company’s Canada-based SPECT operations. The Company has concluded that following the Disposition, SHINE SPECT and the Company are not related parties.
Consideration received from SHINE SPECT on the Disposition Date consisted of cash, the Installment Note, the Seller Note, the Deferred Cash Purchase Price and the right to certain contingent consideration. All components of consideration received were measured at fair value on the Disposition Date in computing the gain on sale of business. The fair value of total net consideration received on the Disposition Date was approximately $
The Company recognized a gain on sale of the SPECT business, net of transaction costs of $
Assets and Liabilities Held for Sale
As of December 31, 2025, assets and liabilities associated with the Company’s SPECT business were presented in the Company’s consolidated balance sheet as assets and liabilities held for sale since it was determined that those assets and liabilities met the criteria of held-for-sale under ASC 360, “Impairment or disposal of long-lived assets.”
The Company does not believe the sale represented a strategic shift that had a major effect on the Company's consolidated financial results and therefore did not meet the criteria for classification as discontinued operations.
16
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The table below presents the estimated carrying amounts of assets and liabilities held for sale related to the SPECT transaction as of December 31, 2025:
|
|
December 31, |
|
|
(in thousands) |
|
2025 |
|
|
Assets: |
|
|
|
|
Accounts receivable, net |
|
$ |
|
|
Inventory |
|
|
|
|
Other current assets |
|
|
|
|
Property, plant and equipment, net |
|
|
|
|
Intangible assets, net |
|
|
|
|
Goodwill |
|
|
|
|
Total assets held-for-sale |
|
$ |
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
Accounts payable |
|
|
|
|
Accrued expenses and other liabilities |
|
|
|
|
Asset retirement obligation |
|
|
|
|
Total liabilities held-for-sale |
|
$ |
|
|
9. Accrued Expenses, and Other Current and Long-Term Liabilities
Accrued expenses, and other current and long-term liabilities are comprised of the following:
|
|
March 31, |
|
|
December 31, |
|
||
(in thousands) |
|
2026 |
|
|
2025 |
|
||
Compensation and benefits |
|
$ |
|
|
$ |
|
||
Freight, distribution and operations |
|
|
|
|
|
|
||
Accrued rebates and discounts |
|
|
|
|
|
|
||
Accrued professional fees |
|
|
|
|
|
|
||
Accrued research and development expenses |
|
|
|
|
|
|
||
Income taxes payable |
|
|
|
|
|
|
||
Short-term contingent consideration |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total accrued expenses and other current liabilities |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Operating lease liabilities |
|
$ |
|
|
$ |
|
||
Other long-term liabilities |
|
|
|
|
|
|
||
Total other long-term liabilities |
|
$ |
|
|
$ |
|
||
10. Goodwill and Intangibles, Net
Goodwill
The following table represents the change in the carrying value of goodwill for the three months ended March 31, 2026:
(in thousands) |
|
Amount |
|
|
Balance at January 1, 2026 |
|
$ |
|
|
Foreign currency translation adjustments |
|
|
( |
) |
Balance at March 31, 2026 |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Intangibles, net, consisted of the following:
|
|
March 31, 2026 |
|
|||||||||||||
(in thousands) |
|
Useful Lives |
|
Amortization Method |
|
Gross |
|
|
Accumulated |
|
|
Net |
|
|||
Amortizable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Trademarks |
|
|
Straight-line |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Customer relationships |
|
|
Accelerated |
|
|
|
|
|
( |
) |
|
|
|
|||
Currently marketed products |
|
|
Straight-line |
|
|
|
|
|
( |
) |
|
|
|
|||
Licenses |
|
|
Straight-line |
|
|
|
|
|
( |
) |
|
|
|
|||
Developed technology |
|
|
Straight-line |
|
|
|
|
|
( |
) |
|
|
|
|||
Total amortizable intangibles |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
||
Non-amortizable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
In-process research and development |
|
Indefinite |
|
|
|
|
|
|
|
— |
|
|
|
|
||
Total intangibles, net |
|
|
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
|
|
December 31, 2025 |
|
|||||||||||||
(in thousands) |
|
Useful Lives |
|
Amortization Method |
|
Gross |
|
|
Accumulated |
|
|
Net |
|
|||
Amortizable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Trademarks |
|
|
Straight-line |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Customer relationships |
|
|
Accelerated |
|
|
|
|
|
( |
) |
|
|
|
|||
Currently marketed products |
|
|
Straight-line |
|
|
|
|
|
( |
) |
|
|
|
|||
Licenses |
|
|
Straight-line |
|
|
|
|
|
( |
) |
|
|
|
|||
Developed technology |
|
|
Straight-line |
|
|
|
|
|
( |
) |
|
|
|
|||
Total amortizable intangibles |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
||
Non-amortizable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
In-process research and development |
|
Indefinite |
|
|
|
|
|
|
|
— |
|
|
|
|
||
Total intangibles, net |
|
|
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
The Company recorded amortization expense for its intangible assets of $
The table below summarizes the estimated aggregate amortization expense expected to be recognized on the above intangible assets:
(in thousands) |
|
Amount |
|
|
Remainder of 2026 |
|
$ |
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
2030 |
|
|
|
|
2031 and thereafter |
|
|
|
|
Total |
|
$ |
|
|
18
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
11. Long-Term Debt, and Other Borrowings, Net of Current Portion
The carrying value of the Company’s long-term debt and other borrowings, net of current portion is comprised of the following:
|
|
March 31, |
|
|
December 31, |
|
||
(in thousands) |
|
2026 |
|
|
2025 |
|
||
Principal amount |
|
$ |
|
|
$ |
|
||
Unamortized debt issuance costs |
|
|
( |
) |
|
|
( |
) |
Finance lease liabilities |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
Less: current portion of long-term debt and other borrowings |
|
|
( |
) |
|
|
( |
) |
Total long-term debt and other borrowings, net of current portion |
|
$ |
|
|
$ |
|
||
2022 Revolving Facility
In December 2024, the Company entered into an amendment to its $
The Revolving Loans bear interest, with pricing based from time to time at the Company’s election, at (i) the secured overnight financing rate as published by the Federal Reserve Bank of New York on its website plus an applicable margin that ranges from
The Company is permitted to voluntarily prepay the Revolving Loans, in whole or in part, or reduce or terminate the Revolving Commitment, in each case, without premium or penalty. On any business day on which the total amount of outstanding Revolving Loans, Letters of Credit, and Swingline Loans exceeds the total Revolving Commitment, the Company must prepay the Revolving Loans in an amount equal to such excess. The Company is not required to make mandatory prepayments under the 2022 Revolving Facility. As of March 31, 2026, there were
The Company has the right to request an increase to the Revolving Commitment in an aggregate principal amount of up to the greater of $
2022 Revolving Facility Covenants
The 2022 Revolving Facility contains a number of affirmative, negative and reporting covenants, as well as financial maintenance covenants pursuant to which the Company is required to be in quarterly compliance, measured on a trailing four quarter basis, with
19
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
covenant is
The 2022 Revolving Facility contains usual and customary restrictions on the ability of the Company and its subsidiaries to: (i) incur additional indebtedness (ii) create liens; (iii) consolidate, merge, sell or otherwise dispose of all or substantially all of its assets; (iv) sell certain assets; (v) pay dividends on, repurchase or make distributions in respect of capital stock or make other restricted payments; (vi) make certain investments; (vii) repay subordinated indebtedness prior to stated maturity; and (viii) enter into certain transactions with its affiliates.
Upon an event of default, the Administrative Agent (as defined in the 2022 Revolving Facility) will have the right to declare the loans and other obligations outstanding under the 2022 Revolving Facility immediately due and payable and all commitments immediately terminated.
The 2022 Revolving Facility is guaranteed by Lantheus Holdings, and certain subsidiaries of Lantheus Medical, including Progenics and Lantheus Real Estate, and obligations under the 2022 Revolving Facility are generally secured by first priority liens over substantially all of the assets of each of Lantheus Medical, Lantheus Holdings, and certain subsidiaries of Lantheus Medical, including Progenics and Lantheus Real Estate (subject to customary exclusions set forth in the transaction documents) owned as of December 2, 2022 or thereafter acquired.
On December 8, 2022, the Company issued $
The Notes are senior unsecured obligations of the Company. The Notes are fully and unconditionally guaranteed on a senior unsecured basis by the Guarantor. The Notes bear interest at a rate of
The Company evaluated the Notes upon completion of the sale and concluded on the following features:
20
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Holders of the Notes may require the Company to repurchase their Notes upon the occurrence of a fundamental change prior to the maturity at a repurchase price equal to
During the first quarter of 2026, the closing price of the Company’s common stock did not exceed
As of March 31, 2026, the carrying value of the Notes was $
21
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
12. Stockholders' Equity and Stock-Based Compensation
Common Stock Repurchases
On July 31, 2025, the Company’s Board of Directors (“Board”) authorized a program to repurchase up to $
Employee Stock Purchase Plan
The Lantheus Holdings, Inc. 2023 Employee Stock Purchase Plan, (the “2023 ESPP”) provides for the granting of up to
Stock-Based Compensation Expense
The following table presents stock-based compensation expense recognized in the Company’s accompanying condensed consolidated statements of operations:
|
|
Three Months Ended |
|
|||||
(in thousands) |
|
2026 |
|
|
2025 |
|
||
Cost of goods sold |
|
$ |
|
|
$ |
|
||
Sales and marketing |
|
|
|
|
|
|
||
General and administrative |
|
|
|
|
|
|
||
Research and development |
|
|
|
|
|
|
||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
||
22
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
13. Net Income Per Common Share
A summary of net income per common share is presented below:
|
|
Three Months Ended |
|
|||||
(in thousands, except per share amounts) |
|
2026 |
|
|
2025 |
|
||
Net income |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Basic weighted-average common shares outstanding |
|
|
|
|
|
|
||
Effect of dilutive stock options |
|
|
|
|
|
|
||
Effect of dilutive restricted stock |
|
|
|
|
|
|
||
Effect of convertible notes |
|
|
|
|
|
|
||
Diluted weighted-average common shares outstanding |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Net income per common share: |
|
|
|
|
|
|
||
Basic |
|
$ |
|
|
$ |
|
||
Diluted |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Antidilutive securities excluded from diluted net income per common share |
|
|
|
|
|
|
||
Impact of the Convertible Notes
The Company considers shares issuable upon conversion of the Notes to be common stock equivalents and are only included in the calculation of diluted net income per share when their effect is dilutive. The Company has the option to settle the Notes through cash settlement or a combination of cash and share settlement provided that the principal is settled in cash and the conversion spread is settled in cash or shares as elected by the Company. The Company considers the Notes to be participating securities through the two-class method. Per the terms of the Indenture, the Company determined that if a cash dividend is paid that is greater than the stock price at the time such dividend is declared, the holders of the Notes will receive cash on an if-converted basis. While this feature is considered to be a participating right, basic income attributable to common shareholders is only impacted if the Company’s earnings per share exceeds the current share price, regardless of whether such dividend is declared. During the three months ended March 31, 2026 and 2025, no such dividend was declared, and the Company’s earnings per share did not exceed its share price. The Company is required to settle the principal amount of the Notes in cash upon conversion, and convertibility of the Notes is dependent upon the Company’s share price. Therefore, the Company used the if-converted method for calculating the dilutive effect of the conversion option on diluted net income per share. The conversion option will have a dilutive impact on net income per share of Common Stock when the average price per share of the Company's common stock for a given period exceeds the conversion price of the Notes of $
23
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
14. Other Income
Other income consisted of the following:
|
|
Three Months Ended |
|
|||||
(in thousands) |
|
2026 |
|
|
2025 |
|
||
Foreign currency (gain) loss |
|
$ |
( |
) |
|
$ |
|
|
Interest income |
|
|
( |
) |
|
|
( |
) |
Revision of estimated decommissioning costs related to asset retirement obligation(1) |
|
|
|
|
|
( |
) |
|
Other |
|
|
|
|
|
|
||
Total other income, net |
|
$ |
( |
) |
|
$ |
( |
) |
15. Commitments and Contingencies
Legal Proceedings
From time to time, the Company is a party to various legal proceedings arising in the ordinary course of business. In addition, the Company has in the past been, and may in the future be, subject to investigations by governmental and regulatory authorities, which expose it to greater risks associated with litigation, regulatory or other proceedings, as a result of which the Company could be required to pay significant fines or penalties. The costs and outcome of litigation, regulatory or other proceedings cannot be predicted with certainty, and some lawsuits, claims, actions or proceedings may be disposed of unfavorably to the Company and could have a material adverse effect on the Company’s business, financial condition, results of operations and cash flows. In addition, intellectual property disputes often have a risk of injunctive relief which, if imposed against the Company, could materially and adversely affect its financial condition or results of operations. If a matter is both probable to result in material liability and the amount of loss can be reasonably estimated, the Company estimates and discloses the possible material loss or range of loss. If such loss is not probable or cannot be reasonably estimated, a liability is not recorded in its condensed consolidated financial statements.
On January 26, 2024, the Company was sued in the United States District Court for the District of Delaware by Advanced Accelerator Applications USA, Inc. and Advanced Accelerator Applications SA, each a Novartis entity, for patent infringement in response to the filing of our Abbreviated New Drug Application and Paragraph IV certification in connection with PNT2003, consistent with the process established by the Hatch-Waxman Act. In December 2025, the court conducted its trial. As of the date of this Form 10-Q, the Company is currently waiting for the court to issue its decision. Because the outcome of litigation is uncertain, the Company cannot predict how or when this matter will ultimately be resolved.
On February 23, 2024, the Company filed a patent infringement lawsuit against a healthcare-related imaging software developer. The Company settled this lawsuit in February 2026 and received an immaterial amount in settlement.
On September 9, 2025, an alleged stockholder initiated a putative securities class action against the Company in the United States District Court for the Southern District of New York, styled Margolis v. Lantheus Holdings, Inc., et al. The operative complaint also asserts claims against certain of the Company’s named executives. A related action, styled Indiana Pub. Ret. Sys. v. Lantheus Holdings, Inc., et al., was filed in the same court on November 5, 2025. Those actions are now consolidated into a single putative securities class action (captioned In re Lantheus Holdings, Inc. Secs. Litig.), the theory of which is that the defendants made materially false or misleading statements (or omitted material facts) in violation of the Exchange Act. The lead plaintiff filed an amended complaint on March 13, 2026. Under the operative scheduling order in the case, the Company and its executives may move to dismiss the amended complaint by May 11, 2026. Additionally, on December 17, 2025, another alleged stockholder of the Company filed a shareholder derivative action in the same court, styled Lelchuk v. Heino et al., nominally on behalf of the Company and naming as defendants the current directors of the Board and the same officers named in the consolidated securities class action described above (a similar derivative complaint styled Jones v. Markison et al., was previously filed on October 31, 2025 but was voluntarily withdrawn without prejudice). The derivative complaint largely repeats the allegations asserted in the consolidated securities class action, and asserts claims for alleged breaches of fiduciary duties, aiding and abetting breach of fiduciary duty, unjust enrichment, waste of corporate assets, and violations of the Exchange Act. The plaintiff seeks damages and other relief on behalf of the Company. The derivative action is stayed pending one or more of the following events: (i) a public announcement of any settlement of the
24
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
putative securities class action; (ii) a ruling on the defendants’ anticipated motion to dismiss; or (iii) a dismissal with prejudice of the putative securities class action and exhaustion of all related appeals. Because the outcome of litigation is uncertain, the Company cannot predict how or when these matters will ultimately be resolved.
As of March 31, 2026, the Company was not a party to any other material ongoing legal proceedings and has determined that the aforementioned matters are not expected to have a material adverse effect on its business or consolidated financial results.
Technology License and Other Commitments
The Company has licensed from third parties the rights to use certain technologies in its research and development (“R&D”) processes as well as in other products it may develop, commercialize, or sell. In accordance with the related license or sublicense agreements, the Company is contractually required to make certain future payments to these third parties contingent upon (i) the achievement of specified regulatory, development and/or commercialization milestones and (ii) future sales of specified products in the form of royalty payments. Milestone payments are generally recognized in the period in which the achievement of the underlying milestone becomes probable, which is generally the period in which it is actually achieved. Royalty payments are generally recognized in the period in which the associated revenue is recognized.
25
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
16. Benefit Plans
Nonqualified Deferred Compensation Plan
In October 2024, the Company adopted the LDCP to provide key, highly-compensated employees and non-employee directors an additional opportunity for personal financial planning by allowing an option to defer a portion of their base salary and variable compensation each year. Under the LDCP, which is an elective nonqualified deferred compensation plan, employee participants are eligible to defer up to
As of March 31, 2026, assets and liabilities held by the Trust were $
17. Acquisitions
Acquisition of Businesses
Evergreen Theragnostics, Inc.
On April 1, 2025 (the “ Evergreen Closing Date”), the Company acquired all the issued and outstanding shares of Evergreen by means of a statutory merger of a subsidiary of the Company with and into Evergreen, with Evergreen surviving as the Company’s wholly-owned subsidiary (the “Evergreen Merger”), pursuant to the terms of the Evergreen Merger Agreement. Evergreen is a clinical-stage radiopharmaceutical company engaged in contract development and manufacturing organization services as well as drug discovery and commercialization of proprietary products.
As consideration for the Evergreen Merger, the Company made an upfront payment of $
In the event of achievement of specified milestones, the Company would be required to pay up to an additional $
26
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
development and commercialization milestones. The fair value of the total contingent consideration is included in other long-term liabilities in the Company’s condensed consolidated balance sheets at March 31, 2026.
The acquisition date fair value of the consideration transferred in the Evergreen Merger consisted of the following (in thousands):
(in thousands) |
|
|
|
|
Cash consideration |
|
$ |
|
|
Fair value of contingent consideration |
|
|
|
|
Total purchase consideration |
|
$ |
|
|
The Evergreen Merger was accounted for as an acquisition of a business under ASC 805, “Business Combinations (“ASC 805”),” which requires that assets acquired and liabilities assumed on the acquisition date be recognized at their fair values as of the acquisition date. While the Company uses its best estimates and assumptions as part of the purchase price allocation process to value the assets acquired and liabilities assumed, its estimates and assumptions are subject to change during the measurement period, which is up to one year from the acquisition date. Fair value estimates are based on a complex series of judgments about future events and uncertainties and relies on estimates and assumptions. The judgments used to determine the estimated fair value assigned to each class of assets acquired and liabilities assumed, as well as asset lives, can materially impact the Company’s condensed consolidated statements of operations.
As of March 31, 2026, the purchase accounting for the Evergreen Merger has been finalized.
(in thousands) |
|
Estimated Fair Value |
|
|
Assets acquired: |
|
|
|
|
Cash and cash equivalents |
|
$ |
|
|
Accounts receivable, other(1) |
|
|
|
|
Prepaid expenses and other current assets |
|
|
|
|
Property, plant and equipment, net |
|
|
|
|
Intangibles(2) |
|
|
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Total identifiable assets acquired |
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Liabilities assumed: |
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Accounts payable |
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Accrued expenses and other current liabilities |
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Total liabilities assumed |
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Net assets acquired |
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$ |
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Purchase consideration |
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$ |
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Goodwill(3) |
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$ |
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Acquisition-related costs are not included as a component of consideration transferred but are expensed in the periods in which costs are incurred. The Company incurred $
27
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
arrangements and other related fees in the three months ended March 31, 2026. The Company incurred $
Lantheus Biosciences Ltd.
On July 21, 2025, Lantheus Radiopharm UK acquired the entire issued share capital of Lantheus Biosciences pursuant to the LMI Purchase Agreement with Life Medical, Life Healthcare Group Holdings Limited and Lantheus Medical as Lantheus Radiopharm UK’s guarantor (such acquisition, the “LMI Acquisition”). Lantheus Biosciences possesses an Alzheimer’s disease radiodiagnostic commercial infrastructure, R&D capabilities, and an established international footprint. The LMI Acquisition includes Neuraceq, an Alzheimer’s disease radiodiagnostic. Neuraceq is commercially approved in the United States, Canada, the European Union, the United Kingdom, Switzerland, China, Japan, South Korea, and Taiwan. As consideration for the LMI Acquisition, the Company remitted an upfront payment of $
In connection with the LMI Acquisition, the Company could be required to pay up to an additional $
The potential remaining earn-out and milestone payments are accounted for as contingent consideration, the fair value of which is determined using a Monte-Carlo simulation in a risk-neutral framework. The fair value of the total contingent consideration is included in other long-term liabilities in the Company’s condensed consolidated balance sheets at March 31, 2026.
The acquisition date fair value of the provisional consideration transferred in the LMI Acquisition consisted of the following:
(in thousands) |
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Preliminary Estimate |
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Measurement Period Adjustment |
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Final |
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Cash consideration |
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$ |
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Fair value of contingent consideration |
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Total purchase consideration |
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$ |
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) |
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$ |
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The LMI Acquisition was accounted for as an acquisition of a business under ASC 805, which requires that assets acquired and liabilities assumed be recognized at their fair values as of the acquisition date. While the Company uses its best estimates and assumptions as part of the purchase price allocation process to value the assets acquired and liabilities assumed, its estimates and assumptions are subject to change during the measurement period, which is up to one year from the date of acquisition. Fair value estimates are based on a complex series of judgments about future events and uncertainties and rely heavily on estimates and assumptions. The judgments used to determine the estimated fair value assigned to each class of assets acquired and liabilities assumed, as well as asset lives, can materially impact the Company’s condensed consolidated statements of operations.
As of March 31, 2026, the purchase accounting for the LMI Acquisition has not been finalized. As additional information becomes available, the Company may further revise its preliminary purchase price allocation during the remainder of the measurement period. Besides
28
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
tax implications of the purchase price allocation, the final allocation may result in additional changes to other assets and liabilities.
(in thousands) |
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Estimated Fair Value |
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Assets acquired: |
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Accounts receivable, other(1) |
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Inventory |
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Property, plant and equipment, net |
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Intangibles(2) |
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Other long-term assets |
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Total identifiable assets acquired |
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$ |
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Liabilities assumed: |
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Accounts payable |
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$ |
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Accrued expenses and other current liabilities |
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Total liabilities assumed |
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( |
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Net assets acquired |
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$ |
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Purchase consideration |
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$ |
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Goodwill(3) |
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$ |
|
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Acquisition-related costs are not included as a component of consideration transferred but are expensed in the periods in which costs are incurred. The Company incurred $
Acquisition of Assets
Strategic Agreements with Perspective Therapeutics, Inc.
On January 8, 2024, the Company entered into an agreement with Perspective to participate in Perspective’s next qualified financing to purchase Perspective Shares. On January 22, 2024, the Company purchased
29
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
$
Also effective January 8, 2024, the Company obtained certain options and rights from Perspective for an aggregate upfront payment of $
None of these options and rights have been exercised as of March 31, 2026.
Exclusive License for Radiopharm Theranostics Limited
On June 15, 2024, the Company entered into an agreement with Radiopharm to acquire all of Radiopharm’s rights to
In connection with this acquisition, the Company assumed the underlying license agreements related to the two preclinical assets, together with their respective milestone and royalty payment obligations. The Company could pay up to an additional $
During the third quarter of 2024, the Company purchased
RM2 Asset Purchase
On July 3, 2024, the Company acquired from Lantheus Biosciences the global rights to RM2, a gastrin-releasing peptide receptor-targeting agent, including the associated novel, clinical-stage radiotherapeutic and radiodiagnostic pair, referred to as 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2 (and which the Company now refers to as LNTH-2401 and LNTH-2402, respectively), for an upfront payment of $
30
Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
clinical trial thresholds and approvals in different regions, up to €
Costs of IPR&D projects acquired as part of an asset acquisition that have no alternative future use are expensed when incurred, and therefore, charges of $
In connection with the LMI Acquisition, the RM2 Sublicense Agreement was amended to (i) reduce the contingent regulatory and development milestones by €
18. Segment Information
The Company operates as
Significant segment expenses reviewed by the CODM on a monthly basis include sales and marketing, general and administrative and R&D expenses as reported in the Company’s condensed consolidated statements of operations. However, the CODM reviews R&D expenses in more detail for certain expenses related to the Company’s development of new products and clinical programs.
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Geographic Information
See Note 3, “Revenue from Contracts with Customers” for a disaggregation of revenue by geographic region. Long-lived assets by geographic region, which are based on asset location, are not presented because it is impracticable to do so.
31
19. Subsequent Events
On April 6, 2026, the Company entered into an Adoption Agreement with Illuminated, the parent company of SHINE, pursuant to which the Company acquired
32
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Cautionary Note Regarding Forward-Looking Statements
Some of the statements contained in this Quarterly Report on Form 10-Q (“Form 10-Q”) are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements, including, in particular, statements about our plans, strategies, prospects and industry estimates, are subject to risks and uncertainties. These statements identify prospective information and can generally be identified by words such as “anticipates,” “believes,” “can,” “commitment,” “could,” “designed,” “ensuring,” “estimates,” “expects,” “generate,” “impact,” “increasing,” “hopes,” “intends,” “launch,” “likely,” “long-term,” “maintain,” “may,” “pipeline,” “plans,” “potential,” “predict,” “remain,” “seek,” “should,” “sustain,” “target,” “will,” “would” and similar expressions, or by express or implied discussions regarding potential or pending acquisitions, dispositions, collaborations, development and commercialization plans described in this Form 10-Q, or regarding potential future revenues and expenses related to such acquisitions, collaborations, development and commercialization plans. Examples of forward-looking statements include statements we make relating to our outlook and expectations including, without limitation, in connection with: (i) continued market expansion, penetration and reimbursement for our established commercial products, particularly PYLARIFY, DEFINITY and Neuraceq, in a competitive environment and our ability to clinically and commercially differentiate our products; (ii) our ability to complete the technology transfer across our positron emission tomography (“PET”) manufacturing facilities (“PMF”) network for PYLARIFY TruVu, the new formulation of our F-18 prostate-specific membrane antigen (“PSMA”) PET imaging agent approved by the U.S. Food and Drug Administration (“FDA”) on March 6, 2026, to obtain FDA approval for each PMF to manufacture PYLARIFY TruVu, to obtain adequate coding, coverage and payment, including transitional pass-through payment status (“TPT Status”), for PYLARIFY TruVu and to have customers adopt PYLARIFY TruVu; (iii) the availability of raw materials, key components, equipment, manufacturing time slots, either used in the production of our products and product candidates, or by customers of our products and product candidates, including, but not limited to PET scanners for PYLARIFY, PYLARIFY TruVu, Neuraceq, MK-6240, LNTH-2501 and NAV-4694; (iv) our ability to have third parties manufacture our products and product candidates and our ability to manufacture DEFINITY in our in-house manufacturing facility, in amounts and at the times needed; (v) our ability to satisfy our obligations under our existing clinical development partnerships using Neuraceq, MK-6240 or NAV-4694 and other assets as a research tool and under the license agreements through which we have rights to those assets, and to further develop and commercialize MK-6240 and NAV-4694 as approved products; (vi) our ability to continue to successfully integrate acquisitions, including of Lantheus Biosciences and Evergreen Theragnostics, Inc. (“Evergreen”), which could be impacted by unforeseen expenses related to integration activities, the potential for unforeseen liabilities within those businesses, the ability to integrate disparate information technology systems, retain key talent and create a merged corporate culture that successfully realizes the full potential of the combined organization; (vii) our ability to obtain FDA approval for LNTH-2501, our investigational kit for the preparation of Gallium-68 edotreotide injection, which has been studied for use in conjunction with a PET scan to stage and localize neuroendocrine tumors in adult and pediatric patients and to successfully commercialize LNTH-2501 if approved; (viii) our ability to obtain final FDA approval for PNT2003, which received FDA tentative approval in March 2026, to be successful in the patent litigation associated with PNT2003 and to successfully commercialize PNT2003 if approved; (ix) the cost, efforts and timing for clinical development, manufacturing, regulatory approval, adequate coding, coverage and payment and successful commercialization of our newly approved products, product candidates and new clinical applications and territories for our products, in each case, that we or our strategic partners may undertake, including those investigational assets for which FDA approval has been obtained or is anticipated to be obtained this year; (x) our ability to identify opportunities to collaborate with strategic partners and to acquire or in-license additional diagnostic and therapeutic product opportunities in oncology, neurology and other strategic areas and continue to grow and advance our pipeline of products; and (xi) the effect that changes to management, including the recent turnover in our leadership and senior management team, could have on our business.
Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, such statements are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. These statements are neither statements of historical fact nor guarantees or assurances of future performance. The matters referred to in the forward-looking statements contained in this Form 10-Q may not in fact occur. We caution you, therefore, against relying on any of these forward-looking statements. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on February 26, 2026 (our “Form 10-K”), and in Part II, Item 1A. “Risk Factors” in this Form 10-Q.
Any forward-looking statement made by us in this Form 10-Q speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
33
Available Information
Our global Internet site is www.lantheus.com. We routinely make available important information, including copies of our Form 10-K, Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after those reports are electronically filed with, or furnished to, the SEC, free of charge on our website at investor.lantheus.com. We recognize our website as a key channel of distribution to reach public investors and as a means of disclosing material non-public information to comply with our disclosure obligations under SEC Regulation FD. Information contained on our website shall not be deemed incorporated into, or to be part of this Form 10-Q, and any website references are not intended to be made through active hyperlinks.
Our reports filed with, or furnished to, the SEC are also available on the SEC’s website at www.sec.gov, and for Form 10-Ks and Form 10-Qs, in an Inline Extensible Business Reporting Language (“iXBRL”) format. iXBRL is an electronic coding language used to create interactive financial statement data over the Internet. The information on our website is neither part of nor incorporated by reference into this Form 10-Q.
The following discussion and analysis of our financial condition and results of operations should be read together with the condensed consolidated financial statements and the related notes included in Item 1 of this Form 10-Q as well as the other factors described in Part I, Item 1A. “Risk Factors” in our Form 10-K, and in Part II, Item 1A. “Risk Factors” in this Form 10-Q.
Overview
Our Business
We are the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Prior to January 1, 2026, we classified our revenues into three product categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Other Revenue. Following our sale of our SPECT business on January 1, 2026, we classify our revenues into four product categories: Oncology, Neurology, Cardiology, and Strategic Partnerships and Other Revenue, reflecting the evolution of our commercial portfolio and strategic focus. We have presented the prior year numbers for revenues to conform with our current year presentation, including the disaggregation of revenue related to the single-photon emission computerized tomography (“SPECT”) business which was divested to SHINE Technologies, LLC (“SHINE”), a wholly-owned subsidiary of Illuminated Holdings, Inc. (“Illuminated”), on January 1, 2026. Our Strategic Partnerships and Other Revenue category includes biomarkers and digital solutions supporting our partners’ therapeutic development, out-licensing agreements for non-core assets and geographically-focused commercialization strategies and contract development and manufacturing organization (“CDMO”) revenue generated by Evergreen. We are headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Switzerland, Sweden and the United Kingdom.
Our commercial products are used by cardiologists, internists, neurologists, nuclear medicine physicians, oncologists, radiologists, sonographers, technologists, and urologists across a range of clinical care settings. We believe our diagnostic products provide information that enables healthcare professionals (“HCPs”) to better detect, characterize, or rule out disease, with the potential to improve patient management and clinical decision-making.
We produce and market our products throughout the United States (the “United States” or “U.S.”), selling primarily to hospitals, independent imaging centers and government facilities. Outside the United States, we generally sell our products through a combination of direct distribution in Canada, third-party distribution relationships in Europe, Australia, Asia-Pacific, Central America, and South America and through licensing agreements granting exclusive rights to develop and commercialize certain products.
Recent Developments
In February 2026, we announced an updated strategic focus on innovative PET radiodiagnostics, informed by our capabilities and customer relationships. Over the past year, we took purposeful, disciplined actions to optimize our portfolio and continue to strengthen our commercial and development capabilities, including strategic transactions that expanded our presence across oncology, neurology and cardiology while diversifying our pipeline. Some of our recent developments include the following:
Extension of LNTH-2501 New Drug Application (“NDA”) Review
On March 17, 2026, we announced that the FDA has extended its review of the NDA for LNTH-2501, moving the Prescription Drug User Fee Act (“PDUFA”) target action date from March 29, 2026 to June 29, 2026. LNTH-2501 is a diagnostic kit for the preparation of Gallium-68 (“Ga-68”) edotreotide injection, which has been studied for use with PET imaging for localization of somatostatin receptor-positive neuroendocrine tumors in adult and pediatric patients. The revised PDUFA target action date will allow the FDA additional time to review and
34
consider further manufacturing-related information we submitted. This standard review extension is not related to the efficacy or safety data of LNTH-2501.
Approval of PYLARIFY TruVu
On March 6, 2026, we announced that the FDA approved PYLARIFY TruVu (piflufolastat F18), a new formulation of our F-18 PSMA PET imaging agent. PYLARIFY TruVu is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, or suspected recurrence based on elevated serum prostate-specific antigen (“PSA”). PYLARIFY TruVu is designed to enhance product stability at higher radioactive concentrations, supporting more efficient manufacturing and distribution, including the potential to increase batch sizes and enable certain manufacturing sites to reach more patients and serve broader geographic markets. As a result, PYLARIFY TruVu has the potential to enhance supply flexibility and improve operating leverage across the network of PET manufacturing facilities (“PMFs”) that will manufacture and distribute the product. PYLARIFY TruVu is expected to become commercially available beginning in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, with the intent to transition customers from PYLARIFY to the PYLARIFY TruVu. We plan to work closely with clinicians and PMF sites to support a smooth transition, including providing guidance on ordering, handling, and clinical use to support continuity of care. We also plan to pursue reimbursement for the new formulation from the Centers for Medicare and Medicaid Services (“CMS”), including seeking three years of TPT Status.
Tentative Approval of ANDA for PNT2003
On March 2, 2026, we announced that the FDA issued tentative approval of our Abbreviated New Drug Application (“ANDA”) for Lutetium Lu 177 Dotatate, also referred to as PNT2003, a radioequivalent version of LUTATHERA® (lutetium Lu 177 dotatate). LUTATHERA is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (“GEP-NETs”), including foregut, midgut, and hindgut neuroendocrine tumors. This tentative approval from the FDA indicates that the FDA has completed its review of the ANDA and determined that it meets the requirements for approval under the Federal Food, Drug and Cosmetics Act. The timing of our launch will consider the following factors: the timing of final FDA approval, the expiration of the 30-month Hatch-Waxman stay and disposition of the related legal proceedings, as well as manufacturing and commercial strategy to ensure launch success.
Strategic Program
On February 19, 2026, the Board approved a strategic program to simplify and streamline the Company’s operations so it can focus mainly on its radiodiagnostic business and pursue value-maximizing alternatives for its radiotherapeutic assets. As a result of the program, the Company has incurred $7.8 million of charges during the three months ended March 31, 2026 and expects to continue to incur costs for the remainder of 2026.
Sale of SPECT Business
On January 1, 2026 (the “Disposition Date”), as a result of the sale of our SPECT business pursuant to the Equity and Asset Purchase Agreement, by and among Lantheus Medical, Lantheus MI Canada, Inc., Lantheus EU Limited, and Illuminated, SHINE SPECT, LLC, SHINE SPECT Medical Products, Ltd., and SHINE SPECT Limited (collectively referred to as “SHINE SPECT”), dated as of May 1, 2025 (the “SHINE SPECT Agreement”), we completed the sale of our SPECT business to SHINE SPECT (the “Disposition”) and we received consideration consisting of cash, notes receivable, a portion of which have been and a portion of which may be settled in equity of Illuminated or in cash depending on their specific terms, a right to receive additional cash on the earlier of January 1, 2030 or upon the occurrence of certain specified events, and the right to certain contingent consideration. The fair value of total consideration that we received on the Disposition Date was approximately $130.5 million, including $31.4 million in cash. See Note 4, “Fair Value of Financial Instruments” in our condensed consolidated financial statements for more information on the sale of our SPECT business.
Leadership Transition Plan
Brian Markison retired from Lantheus as Chief Executive Officer (“CEO”) and resigned from our Board of Directors (“Board”), both effective December 31, 2025. Mary Anne Heino, the Chair of our Board, was appointed as our Executive Chair and principal executive officer effective November 7, 2025. Ms. Heino became our CEO on January 1, 2026 and will continue to serve in that role until such time as the Board completes the comprehensive search process that it initiated to identify and appoint the Company’s next CEO. Following his retirement, Mr. Markison served as a strategic advisor to the Company during the first quarter of 2026.
Acceptance of New Drug Application for MK-6240
In October 2025, we announced that the FDA had accepted our NDA for MK-6240, our registrational F-18 tau-targeted PET imaging agent for the detection of tau neurofibrillary tangle pathology in patients with cognitive impairment being evaluated for Alzheimer’s disease, and has set a PDUFA target action date of August 13, 2026. In 2025, we announced that MK-6240 successfully met its co-primary endpoints in
35
two pivotal studies assessing its sensitivity and specificity. The data from these two studies supported our NDA submission to the FDA. MK-6240 previously received Fast Track designation from the FDA for its potential to address an unmet medical need in Alzheimer’s disease diagnostics.
Exclusive License for Prostate Cancer Imaging Agent Piflufolastat F-18 in Japan
In September 2025, we announced an exclusive licensing agreement for GE HealthCare Limited (“GE HealthCare”) to develop, manufacture, and commercialize Lantheus’ piflufolastat F-18 PET imaging agent (marketed in the United States as PYLARIFY) in Japan for prostate cancer diagnostics and companion diagnostic use. Under the terms of the agreement, GE HealthCare paid us an upfront license fee and will pay us development milestones and tiered royalties based on product sales in Japan.
Share Repurchase Program
On July 31, 2025, our Board authorized a program to repurchase up to $400.0 million of shares of our common stock through December 31, 2027 (the “2025 Program”). The 2025 Program replaces the program authorized by the Board in November 2024 to repurchase up to $250 million of our common stock during the twelve months following the authorization (the “2024 Program”), including the remaining unused amounts under the 2024 Program, and authorizes us to purchase shares of our common stock from time to time via open market purchases at prevailing market prices, in privately negotiated transactions, block trades, or pursuant to trades intending to comply with Rule 10b5-1 under the Exchange Act or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations. The timing, manner, price and amount of any repurchase will be subject to the discretion of our Management. The 2025 Program does not obligate us to acquire any particular amount of its common stock, and we may suspend or discontinue the 2025 Program at any time. We did not repurchase any shares under the 2025 Program in the three months ended March 31, 2026. We repurchased 3.5 million shares for approximately $200.0 million under the 2025 Program, in 2025.
Acquisition of Lantheus Biosciences Ltd.
On July 21, 2025, we acquired Lantheus Biosciences, pursuant to the terms of the Sale and Purchase Agreement with Life Medical Group Limited (“Life Medical”) and Life Healthcare Group Holdings Limited (the “Sale and Purchase Agreement” and, such acquisition, the “LMI Acquisition”). Lantheus Biosciences, headquartered in Berlin, Germany, possesses an Alzheimer’s disease radiodiagnostic commercial infrastructure, research and development (“R&D”) capabilities, and an established international footprint. The LMI Acquisition includes Neuraceq, an Alzheimer’s disease radiodiagnostic. Neuraceq is commercially approved in the United States, Canada, the European Union, the United Kingdom, Switzerland, China, Japan, South Korea, and Taiwan.
As consideration for the LMI Acquisition, we remitted an upfront payment of $355.2 million in cash, and could be required to pay up to an additional $400.0 million in potential earn-out and milestone payments. In November 2025 and in accordance with the terms of the Sale and Purchase Agreement, we finalized the net working capital accounts with Life Medical and we received a $2.3 million payment from Life Medical. This $2.3 million payment was recorded as an adjustment to purchase consideration in the fourth quarter of 2025. Additionally, we assumed a contingent consideration liability owed to Piramal Holdings SA (“Piramal”), pursuant to a Securities Purchase Agreement between Piramal and Lantheus Biosciences.
Previously, on July 3, 2024,we acquired from Lantheus Biosciences the global rights to RM2, its clinical stage, gastrin-releasing peptide receptor (“GRPR”)-targeting agent, including the associated novel, clinical-stage radiodiagnostic and radiotherapeutic pair, previously referred to as 68Ga-DOTA-RM2 and 177Lu-DOTA-RM2 (and which we now refer to as LNTH-2401 and LNTH-2402, respectively), for an upfront payment of $35.0 million plus a $1.0 million payment made prior to the acquisition (the “RM2 Asset Purchase”), pursuant to the Sublicense, Development and Collaboration Agreement, by and between us and Lantheus Biosciences, dated as of June 27, 2024 (the “RM2 Sublicense Agreement”). In addition, and pursuant to the RM2 Sublicense Agreement, we incurred €10.0 million in regulatory milestones in 2025, and agreed to pay up to an additional €127.5 million (reduced as discussed below) in regulatory and development milestone payments upon achievement of clinical trial thresholds and approvals in different regions up to €280.0 million in net sale milestones if products are commercialized and meet certain sales thresholds, and royalties on net sales of RM2.
In connection with the LMI Acquisition, the RM2 Sublicense Agreement was amended to (i) reduce the contingent regulatory and development milestones by €45.0 million to €82.5 million; (ii) assign the right to future payments from Lantheus Biosciences to its former parent, Life Medical; and (iii) eliminate certain other non-substantive rights contained in the RM2 Sublicense Agreement (the “RM2 Amendment”).
GRPR is a member of the bombesin G protein-coupled receptor family, which has been found to be overexpressed in multiple cancers. First-in-human dosimetry showed a favorable safety and dosimetry profile and confirmed preclinical data demonstrating dose-dependent efficacy of LNTH-2402. We plan to initiate our registrational program for LNTH-2401 in patients with prostate cancer this year.
36
For more information on the acquisition of the global rights to RM2, see Note 17, “Acquisitions” in our condensed consolidated financial statements herein.
Acquisition of Evergreen Theragnostics, Inc.
On April 1, 2025, we acquired all the issued and outstanding shares of Evergreen by means of a statutory merger of our subsidiary with and into Evergreen, with Evergreen surviving as our wholly-owned subsidiary (the “Evergreen Merger”), pursuant to the terms of the Agreement and Plan of Merger (the “Evergreen Merger Agreement”) with Evergreen and Shareholder Representative Services LLC. Evergreen is a clinical-stage radiopharmaceutical company engaged in CDMO services as well as drug discovery and commercialization of proprietary products.
As consideration for the Evergreen Merger, we made an upfront payment of $276.4 million in cash. In the event of achievement of specified milestones, we would be required to pay up to an additional $727.5 million in cash, which may be adjusted pursuant to the terms of the Evergreen Merger Agreement.
For more information, see Note 17, “Acquisitions” in our condensed consolidated financial statements herein.
Radiopharm Theranostics Limited
On June 15, 2024, we entered into an agreement with Radiopharm to acquire all of Radiopharm’s rights to two licensed preclinical assets for an upfront payment of $2.0 million (the “Radiopharm Asset Purchase”). We acquired global, exclusive rights to both a leucine-rich repeat-containing protein 15 (“LRRC15”)-targeted monoclonal antibody, which we refer to as LNTH-2403, and a Trophoblast cell surface antigen 2 targeted nanobody, which we refer to as LNTH-2404, each of which is a preclinical therapeutic candidate. LNTH-2403 is our pre-clinical therapeutic targeting LRRC15, which is strongly expressed in multiple malignancies, including head and neck, breast, lung, and pancreatic cancers. In connection with this acquisition, we assumed the underlying license agreements related to the two preclinical assets, together with their respective milestone and royalty payment obligations.
During the third quarter of 2024, we purchased 149,625,180 shares of Radiopharm common stock (“Radiopharm Shares”) for an aggregate purchase price of approximately $5.0 million. During 2025, we purchased an additional 388,333,333 Radiopharm Shares for an aggregate purchase price of approximately $10.0 million.
For more information, see Note 17, “Acquisitions” and Note 4, “Fair Value of Financial Instruments” in our condensed consolidated financial statements herein.
Strategic Agreements with Perspective Therapeutics, Inc.
On January 8, 2024, we entered into multiple strategic agreements with Perspective Therapeutics, Inc. (“Perspective”), a radiopharmaceutical company that is pursuing advanced treatment applications for cancers throughout the body. Under the agreements, we obtained an option to exclusively license Perspective’s Pb212-VMT-α-NET, a clinical stage alpha therapy in development for the treatment of neuroendocrine tumors, and an option to co-develop certain early-stage therapeutic candidates targeting prostate cancer using Perspective’s innovative platform technology for an aggregate upfront payment of $28.0 million in cash.
During 2024, we also purchased an aggregate of 11,677,339 shares of Perspective’s common stock, after giving effect to a 1-for-10 reverse stock split.
For more information, see Note 17, “Acquisitions” and Note 4, “Fair Value of Financial Instruments” to our condensed consolidated financial statements herein.
Amendment of Credit Facility
In December 2024, we amended our five-year revolving credit facility (as amended, the “2022 Revolving Facility”). The amendment, among other things, extended the maturity date from December 2, 2027 to December 19, 2029, increased the 2022 Revolving Facility from $350.0 million to $750.0 million and increased the additional amount that we may request to add to the increased revolving commitment by $350.0 million. The amendment also, among other things, (i) reduces the ranges of margins based on our Total Net Leverage Ratio (as defined in the 2022 Revolving Facility) used to calculate interest for the revolving loans and (ii) reduces the maximum unused commitment fee from 0.35% per annum to 0.30% per annum.
Key Factors Affecting Our Results
Our business and financial performance have been, and continue to be, impacted by the following:
37
PYLARIFY and PSMA PET Revenue
PYLARIFY, an F-18-labeled PET imaging agent targeting PSMA, was approved by the FDA in May 2021 and commercially launched in the United States in June 2021. PYLARIFY is indicated for PET imaging of PSMA-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and in patients with suspected recurrence based on elevated prostate-specific antigen levels. PYLARIFY is available through a diverse, multi-partner network of PMFs, including both commercial and academic partners.
The continued substantial revenue contribution from PYLARIFY depends on our ability to maintain PYLARIFY as a widely utilized PSMA PET imaging agent in an increasingly competitive diagnostic imaging landscape. PYLARIFY’s competition includes three Ga-68-based PSMA imaging agents, an F-18-based PSMA imaging agent, and other non-PSMA-based imaging agents commonly referred to as conventional imaging. The potential for future generic entrants following the expiration of PYLARIFY’s new chemical entity exclusivity period in 2026 could further increase competition, along with the continued development of additional F-18 and Ga-68 tracers and PSMA-targeted agents using alternative isotopes, including Copper-64. We continue to make targeted investments to support PYLARIFY awareness, adoption, and appropriate clinical use.
Continued substantial revenue contribution from PYLARIFY will also depend on our ability to clinically differentiate PYLARIFY from competitive products so that customers continue to choose PSMA PET with PYLARIFY for appropriate patients because of its clinical differentiation and despite the loss of TPT Status and the related changes to Medicare fee-for-service (“FFS”) hospital outpatient payment. Our Healthcare Procedure Coding System code, which enables streamlined billing, went into effect as of January 1, 2022. In addition, from January 1, 2022 to December 31, 2024, PYLARIFY had TPT Status from CMS in the hospital outpatient setting, enabling traditional Medicare FFS to provide separate payment for PYLARIFY in addition to the payment for the PET/computed tomography procedure in that setting. In November 2024, CMS released the final rule for its calendar year 2025 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2025 OPPS Rule”), which recognized the value and need for broad access to diagnostic radiopharmaceuticals. The CMS 2025 OPPS Rule provided separate payment for those diagnostic radiopharmaceuticals with per day costs greater than $630 based on their mean unit cost (“MUC”) for patients with traditional Medicare FFS insurance coverage who are treated in the hospital outpatient setting. In November 2025, CMS released the final rule for its calendar year 2026 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2026 OPPS Rule”), which continues to provide for separate payment for diagnostic radiopharmaceuticals with per day costs greater than $655 based on their MUC. As a result, since January 1, 2025, CMS has maintained separate payment for PYLARIFY based on MUC in the hospital outpatient setting, which is lower than payments based on the average selling price that were made during TPT Status. Although PYLARIFY continues to be paid separately, other competitive PSMA PET imaging agents continue to have TPT Status after December 31, 2024, and hospital use of those products, for patients with traditional Medicare FFS in the hospital outpatient setting, generally will be paid separately based on ASP plus six percent rather than on MUC. In November 2025, in the preamble to the CMS 2026 OPPS Rule, CMS acknowledged that there could be value in the use of Average Sales Price (“ASP”) for determining separately paid diagnostic radiopharmaceutical payment amounts in the future. However, CMS will continue to use the arithmetic MUC to calculate payment for diagnostic radiopharmaceuticals in 2026, explaining that there must be more consistent, validated, and universal reporting of ASP data for diagnostic radiopharmaceuticals before ASP can be the basis for payment. CMS reiterated in the CMS 2026 OPPS Rule that, although ASP reporting for diagnostic radiopharmaceuticals remains voluntary at this time, it will continue to evaluate whether and how ASP could be used for future Medicare Outpatient Prospective Payment System (“OPPS”) payment once reporting is sufficiently consistent, validated, and universal. We report ASP and have repeatedly engaged CMS on methodology for reporting ASP, and we will continue to work with coalition partners and CMS to support using ASP rather than MUC to calculate payment for diagnostic radiopharmaceuticals in future years similar to the way OPPS currently pays for other drugs, biologics, and therapeutic radiopharmaceuticals.
Our strategy to support the continued growth of our PSMA PET franchise includes the approval and planned commercialization of a new formulation of our F-18 PSMA PET imaging agent, including obtaining TPT Status for this formulation. On March 6, 2026, the FDA approved this new formulation, PYLARIFY TruVu, which is designed to enhance product stability at higher radioactive concentrations and support more efficient manufacturing and distribution. PYLARIFY TruVu is expected to become commercially available beginning in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, with the intent to transition customers from PYLARIFY to PYLARIFY TruVu.
In addition to the planned launch of PYLARIFY TruVu, our PSMA PET strategy includes conveying the clinical and operational value of PSMA PET imaging, negotiating and executing strategic customer contracts in the United States, expanding PSMA PET use in appropriate patient populations, and pursuing strategic partnerships and collaborations, including outside the United States.
Internationally, we have licensed exclusive rights to Curium Pharma (“Curium”) to develop and commercialize piflufolastat F-18 in Europe, where it is marketed in the European Union under the brand name PYLCLARI. In September 2025, we entered into an exclusive licensing agreement with GE Healthcare to develop, manufacture, and commercialize piflufolastat F-18 in Japan for prostate cancer diagnostics and companion diagnostic use. We have also entered into strategic collaborations with pharmaceutical companies for the use of PYLARIFY in
38
connection with the development of PSMA-targeted therapeutics. Additional information on these collaborations are described further under Part I, Item 1. “Business - Strategic Partnerships and Other Revenue – Oncology” of our Form 10-K for the year ended December 31, 2025.
Neuraceq Revenue
Neuraceq is an F-18-labeled PET imaging agent that binds selectively to beta-amyloid plaques in the brain and was approved by the FDA in 2014. Neuraceq is indicated for PET imaging of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. In 2025, additional labeling updates were approved to support patient selection for amyloid-targeting therapies, where indicated in the prescribing information of the therapeutics products, as well as quantitative PET analysis.
We believe future growth in Neuraceq revenue will depend on several factors, including: (i) expansion of awareness and adoption of Neuraceq among existing and new customers, including leveraging our established commercial relationships; (ii) continued expansion of manufacturing capacity and geographic access through additional PET manufacturing sites; (iii) increased utilization of beta‑amyloid PET imaging driven by evolving clinical practice and the growing availability of amyloid‑targeting therapies; (iv) customer education regarding the approved uses of Neuraceq, including its role in patient selection and quantitative assessment of amyloid burden; and (v) our ability to differentiate Neuraceq based on its clinical profile and operational reliability in an increasingly competitive diagnostic imaging market.
In addition, Neuraceq utilization may be influenced by reimbursement dynamics, including differences in Medicare hospital outpatient payment methodologies resulting in a lower reimbursement for Neuraceq relative to other products, which could affect customer purchasing decisions despite clinical considerations.
DEFINITY Revenue
We believe we will be able to increase use of DEFINITY through continued education of physicians and HCPs about the benefits of ultrasound enhancing agents in suboptimal echocardiograms. The U.S. market currently has three echocardiography ultrasound enhancing agents approved by the FDA; we estimate that DEFINITY will continue to hold at least an 80% share of the U.S. segment for ultrasound enhancing agents in echocardiography procedures.
As we continue to grow our Microbubble Platform, we continue to prosecute and maintain patents and patent applications in connection with DEFINITY, both in the United States and internationally. In the United States for DEFINITY, we have method-of-use patents listed in the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”), as well as additional manufacturing patents that are not Orange Book-listed.
Expansion of Strategic Partnerships and Other Revenue
We continue to seek ways to increase the overall value of our portfolio of products and product candidates. We are evaluating a number of different opportunities to collaborate, in-license or acquire additional products, product candidates, businesses and technologies to drive our future growth. In particular, with respect to our Strategic Partnerships and Other Revenue category, we are focused on radiopharmaceutical diagnostic and therapeutic product opportunities in oncology, neurology, and other strategic areas that will complement our existing portfolio.
Our Strategic Partnerships and Other Revenue category includes our Strategic Partnerships, Digital Solutions, PharmaSolutions and CDMO services and is focused on enabling precision medicine with biomarkers, digital solutions and CDMO services.
39
Inventory Supply & Third-Party Suppliers
We obtain a substantial portion of our imaging agents from third-party suppliers. Jubilant HollisterStier (“JHS”) is currently a significant supplier of DEFINITY. Our manufacturing and supply agreement with JHS (the “JHS MSA”) runs through December 31, 2027 and can be further extended by mutual agreement of the parties. The JHS MSA requires us to purchase from JHS specified percentages of our total requirements for DEFINITY each year during the contract term. Either party can terminate the JHS MSA upon the occurrence of certain events, including the material breach or bankruptcy of the other party.
Radiopharmaceuticals are decaying radioisotopes with half-lives ranging from a few hours to several days. Radiopharmaceutical finished goods, such as doses of PYLARIFY and Neuraceq, cannot be kept in inventory because of their limited shelf lives and are subject to just-in-time manufacturing, processing, and distribution, which takes place at multiple PMF manufacturing partner sites that produce and deliver doses for us across the United States.
Research and Development Expenses
To ensure we remain the leading radiopharmaceutical-focused company, we have historically made and will continue to make substantial investments in new product development and lifecycle management for existing products, including:
40
See Note 17, “Acquisitions” in our condensed consolidated financial statements herein for additional information on potential milestone and royalty payments related to the product candidates listed above.
PNT2002
Under the terms of the PNT2002 License Agreement, we paid POINT Biopharma Global Inc. (“POINT”) an upfront cash payment of $250.0 million. The Phase 3 registrational clinical trial for PNT2002, known as the “SPLASH” study, reached 100% of pre-specified overall survival events. The results of the readout were comparable to the previously reported 46% and 75% readouts and remain confounded by the overwhelming number of patients who crossed over within the study to receive PNT2002. While we continue to review the available PNT2002 data, we do not currently plan to pursue an NDA or further invest in this asset.
PNT2003
Under the terms of the PNT2003 License Agreement, we paid POINT an upfront payment of $10.0 million, and could pay up to an additional $34.5 million in milestone payments upon the achievement of specified U.S. and ex-U.S. regulatory milestones. POINT is also eligible to receive up to $275.0 million in sales milestone payments upon the achievement of specified annual sales thresholds of PNT2003. In addition, POINT is eligible to receive royalty payments of 15% of net sales of PNT2003.
Our investments in these additional clinical activities and lifecycle management opportunities will increase our operating expenses and impact our results of operations and cash flow, and we can give no assurances as to whether any of these clinical development candidates or lifecycle management opportunities will be successful.
41
Results of Operations
The following is a summary of our consolidated results of operations:
|
|
Three Months Ended March 31, |
|
|||||||||||||
(in thousands, except percent data) |
|
2026 |
|
|
2025 |
|
|
Change $ |
|
|
Change % |
|
||||
Revenues |
|
$ |
377,333 |
|
|
$ |
372,764 |
|
|
$ |
4,569 |
|
|
|
1.2 |
% |
Cost of goods sold |
|
|
146,411 |
|
|
|
135,064 |
|
|
|
11,347 |
|
|
|
8.4 |
% |
Gross profit |
|
|
230,922 |
|
|
|
237,700 |
|
|
|
(6,778 |
) |
|
|
(2.9 |
%) |
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Sales and marketing |
|
|
52,684 |
|
|
|
42,503 |
|
|
|
10,181 |
|
|
|
24.0 |
% |
General and administrative |
|
|
57,533 |
|
|
|
56,816 |
|
|
|
717 |
|
|
|
1.3 |
% |
Research and development |
|
|
39,379 |
|
|
|
36,314 |
|
|
|
3,065 |
|
|
|
8.4 |
% |
Total operating expenses |
|
|
149,596 |
|
|
|
135,633 |
|
|
|
13,963 |
|
|
|
10.3 |
% |
Operating income |
|
|
81,326 |
|
|
|
102,067 |
|
|
|
(20,741 |
) |
|
|
(20.3 |
%) |
Interest expense |
|
|
4,864 |
|
|
|
4,804 |
|
|
|
60 |
|
|
|
1.2 |
% |
Investment in equity securities - unrealized (gain) loss |
|
|
(14,905 |
) |
|
|
14,862 |
|
|
|
(29,767 |
) |
|
|
(200.3 |
%) |
Gain on sale of business, net of transaction costs |
|
|
(59,328 |
) |
|
|
— |
|
|
|
(59,328 |
) |
|
|
100.0 |
% |
Other income, net |
|
|
(5,710 |
) |
|
|
(14,128 |
) |
|
|
8,418 |
|
|
|
(59.6 |
%) |
Income before income taxes |
|
|
156,405 |
|
|
|
96,529 |
|
|
|
59,876 |
|
|
|
62.0 |
% |
Income tax expense |
|
|
37,988 |
|
|
|
23,584 |
|
|
|
14,404 |
|
|
|
61.1 |
% |
Net income |
|
$ |
118,417 |
|
|
$ |
72,945 |
|
|
$ |
45,472 |
|
|
|
62.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Comparison of the Periods Ended March 31, 2026 and 2025
Revenues
Prior to January 1, 2026, we classified our revenues into three product categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Other Revenue. As of January 1, 2026, we classify our revenues into four product categories: Oncology, Neurology, Cardiology, and Strategic Partnerships and Other Revenue. We have presented the prior year numbers for revenues to conform with our current year presentation, including the disaggregation of revenue related to the sale of our SPECT business to SHINE on January 1, 2026.
Revenues are summarized by product category on a net basis as follows:
|
|
|
|
|||||||||||||
|
|
Three Months Ended March 31, |
|
|||||||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
Change $ |
|
|
Change % |
|
||||
PYLARIFY |
|
$ |
240,924 |
|
|
$ |
257,654 |
|
|
$ |
(16,730 |
) |
|
|
(6.5 |
)% |
Total oncology |
|
|
240,924 |
|
|
|
257,654 |
|
|
|
(16,730 |
) |
|
|
(6.5 |
)% |
Neuraceq |
|
|
35,439 |
|
|
|
— |
|
|
|
35,439 |
|
|
|
100.0 |
% |
Total neurology |
|
|
35,439 |
|
|
|
— |
|
|
|
35,439 |
|
|
|
100.0 |
% |
DEFINITY |
|
|
84,627 |
|
|
|
79,211 |
|
|
|
5,416 |
|
|
|
6.8 |
% |
Total cardiology |
|
|
84,627 |
|
|
|
79,211 |
|
|
|
5,416 |
|
|
|
6.8 |
% |
Strategic partnerships and other |
|
|
16,343 |
|
|
|
10,747 |
|
|
|
5,596 |
|
|
|
52.1 |
% |
SPECT |
|
|
— |
|
|
|
25,152 |
|
|
|
(25,152 |
) |
|
|
(100.0 |
)% |
Total revenues |
|
$ |
377,333 |
|
|
$ |
372,764 |
|
|
$ |
4,569 |
|
|
|
1.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
The increase in revenues for the three months ended March 31, 2026, as compared to the same period of 2025, was primarily driven by revenues generated from sales of Neuraceq subsequent to our acquisition of Lantheus Biosciences in July 2025 and revenue from CDMO services generated subsequent to our acquisition of Evergreen in April 2025, in both cases for which there were no comparable amounts in the same period of 2025, as well as an increase in PYLARIFY and DEFINITY sales volume and revenue generated from sales of MK-6240 for investigational use. These increases were partially offset by a decrease in revenue resulting from a decrease in net sales price of PYLARIFY in 2026 and by revenue related to the SPECT business recognized during the three months ended March 31,2025 for which there is no comparable amount in the same period of 2026.
Rebates
Estimates for rebates represent our estimated obligations under contractual arrangements with third parties. Rebate accruals are recorded in the same period the related revenue is recognized, resulting in a reduction of revenue and the establishment of a liability which is included
42
in accrued expenses and other current liabilities in our condensed consolidated balance sheets. These rebates result from performance-based offers that are primarily based on attaining contractually specified sales volumes and growth, Medicaid rebate programs for our products, administrative fees of group purchasing organizations and certain distributor-related commissions. The calculation of the accrual for these rebates is based on an estimate of the third-party’s expected purchases and the resulting applicable contractual rebate to be earned over a contractual period.
A roll forward of the amount of, and change in, accruals for rebate liabilities is summarized as follows:
(in thousands) |
|
Rebates |
|
|
Balance at January 1, 2026 |
|
$ |
66,448 |
|
Provision related to current period revenues |
|
|
49,848 |
|
Payments or credits made during the period |
|
|
(46,419 |
) |
Balance at March 31, 2026 |
|
$ |
69,877 |
|
Gross Profit
The decrease in gross profit for the three months ended March 31, 2026, as compared to the prior year period, is primarily due to the decrease in PYLARIFY net sales price, an increase in amortization of intangible assets resulting from the 2025 acquisition of Lantheus Biosciences, for which there was no comparable amount for the three months ended March 31, 2025, and the sale of our SPECT business. The decrease was partially offset by an increase in gross profit resulting from sales of Neuraceq subsequent to our acquisition of Lantheus Biosciences in July 2025, an increase in PYLARIFY sales volume, an increase in revenue from MK-6240 for investigational use and an increase in DEFINITY sales volume.
Sales and Marketing
Sales and marketing expenses consist primarily of salaries and other related costs for personnel in field sales, marketing, and customer service functions. Other costs in sales and marketing expenses include the development of advertising and promotional material, professional services, market research, and sales meetings.
Sales and marketing expenses increased $10.2 million for the three months ended March 31, 2026, as compared to the prior year period. This was primarily due to increased employee-related costs in connection with sales of Neuraceq subsequent to the acquisition of Lantheus Biosciences. In addition, there was an increase in marketing expenditures related to the launch preparations, primarily for PYLARIFY TruVu.
General and Administrative
General and administrative expenses consist of salaries and other related costs for personnel in executive, finance, legal, information technology, and human resource functions. Other costs included in general and administrative expenses are professional fees for information technology services, external legal fees, consulting and accounting services as well as bad debt expense, certain facility and insurance costs, including director and officer liability insurance, and fair value adjustments related to contingent consideration from acquisitions.
General and administrative expenses increased $0.7 million for the three months ended March 31, 2026, as compared to prior year period. This was primarily driven by the impact of the acquisitions of Evergreen in April 2025 and Lantheus Biosciences in July 2025, including increased professional fees and employee-related costs, such as stock-based compensation expense. This increase was partially offset by a decrease in litigation costs incurred during the three months ended March 31, 2025 for which there are no comparable costs in 2026 and a legal settlement received during the first quarter of 2026.
Research and Development
R&D expenses relate primarily to salaries and costs related to the development of product candidates to add to our portfolio and costs related to our medical affairs, medical information and regulatory functions.
R&D expenses increased $3.1 million for the three months ended March 31, 2026, as compared to the same prior year period. This was primarily driven by the impact of the acquisitions of Lantheus Biosciences in July 2025 and Evergreen in April 2025 and increase in project costs related to LNTH-2403. This increases was partially offset by a non-recurring payment made in 2025 of $5.4 million to Lantheus Biosciences related to regulatory activities for LNTH-2401 for which there was no comparable payment in 2026.
43
Gain on Sale of Assets
As a result of the sale of our SPECT business on January 1, 2026, we recognized a gain on sale of assets of $59.3 million for the three months ended March 31, 2026.
Investment in Equity Securities - Unrealized (Gain) Loss
Each quarter, our investments in equity securities of Radiopharm and Perspective are revalued to market price. Investment in equity securities - unrealized (gain) loss decreased $29.8 million from a loss to a gain for the three months ended March 31, 2026, as compared to the same period of 2025. We recorded an unrealized loss on the investment in Radiopharm of $1.6 million and an unrealized gain on the investment in Perspective of $16.6 million during the three months ended March 31, 2026, compared to an unrealized losses on the investment in Radiopharm and Perspective of $2.5 million and $12.4 million, respectively, for the three months ended March 31, 2025.
Other Income, net
Other income, net decreased $8.4 million for the three months ended March 31, 2026, as compared to the prior year period, primarily due to a decrease in interest income on lower average cash balances after the acquisitions of Evergreen in April 2025 and Lantheus Biosciences in July 2025 as well as a $4.7 million adjustment recorded in the first quarter of 2025 to reduce the previous estimate of remediation costs related to the potential decommissioning of our previously owned facilities for our SPECT business of their radioactive-related operations.
Income Tax Expense
Our effective tax rate for each reporting period is presented as follows:
|
|
Three Months Ended |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Effective tax rate |
|
|
24.3 |
% |
|
|
24.4 |
% |
Our effective tax rate for the three months ended March 31, 2026 differs from the U.S. statutory rate of 21% primarily due to state income taxes, partially offset by the change in valuation allowance related to the fluctuation in value of our investment in equity securities balance.
The decrease in the effective income tax rate for the three months ended March 31, 2026 is primarily due to the change in valuation allowance related to the fluctuation in value of our investment in equity securities balance, partially offset by the decrease in excess tax benefits associated with our payment of stock-based compensation.
Liquidity and Capital Resources
Cash Flows
The following table provides information regarding our cash flows:
|
|
Three Months Ended |
|
|||||
(in thousands) |
|
2026 |
|
|
2025 |
|
||
Net cash provided by operating activities |
|
$ |
125,127 |
|
|
$ |
107,563 |
|
Net cash provided by (used in) investing activities |
|
$ |
25,986 |
|
|
$ |
(63,718 |
) |
Net cash used in financing activities |
|
$ |
(11,623 |
) |
|
$ |
(18,219 |
) |
Net Cash Provided by Operating Activities
Net cash provided by operating activities of $125.1 million in the three months ended March 31, 2026 was primarily comprised of net income adjusted for the net effect of non-cash items such as unrealized gain on investment in equity securities, adjustments to the fair value of asset retirement obligation and contingent assets and liabilities, depreciation, amortization and accretion expense, gain on sale of business, deferred taxes and stock-based compensation expense. The primary working capital sources of cash include an increase in accounts payable which was attributable to the timing of payments to large vendors, a decrease in accounts receivable associated with the timing of billings and collections, a decrease in inventory, a decrease in income taxes receivable and increase in income taxes payable due to the timing of income tax payments.
Net cash provided by operating activities of $107.6 million in the three months ended March 31, 2025 was primarily comprised of net income adjusted for the net effect of non-cash items such as unrealized loss on investment in equity securities, charges incurred in connection
44
with the RM2 license, adjustments to the fair value of asset retirement obligation, depreciation, amortization and accretion expense and stock-based compensation expense. The primary working capital sources of cash include an increase in accounts payable and accrued expenses which was attributable to the timing of payments to large vendors and an increase in income taxes payable. The primary working capital uses of cash were an increase in trade receivables associated primarily with the timing of billings and collections.
Net Cash Provided by (Used in) Investing Activities
Net cash provided by investing activities during the three months ended March 31, 2026 was driven by $24.2 million of net proceeds that we received from the sale of our SPECT business to SHINE on January 1, 2026 and $5.0 million of proceeds from the achievement of a sales-based milestone related to RELISTOR, partially offset by $3.2 million of capital expenditures.
Net cash used in investing activities during the three months ended March 31, 2025 was driven by a deposit of $50.0 million paid to the paying agent on March 31, 2025 in connection with the acquisition of Evergreen, $5.0 million used to purchase equity securities and $8.7 million of capital expenditures.
Net Cash Used in Financing Activities
Net cash used in financing activities during the three months ended March 31, 2026 is primarily attributable to the payments for minimum statutory tax withholding related to net share settlement of equity awards of $15.7 million and payments for finance leases of $0.2 million, offset by proceeds of $4.3 million from stock option exercises and issuance of common stock.
Net cash used in financing activities during the three months ended March 31, 2025 is primarily attributable to the payments for minimum statutory tax withholding related to net share settlement of equity awards of $23.7 million, offset by proceeds of $5.9 million from stock option exercises and issuance of common stock.
External Sources of Liquidity
In December 2024, we entered into an amendment to the 2022 Revolving Facility that, among other things, extended the maturity date from December 2, 2027 to December 19, 2029, increased the 2022 Revolving Facility from $350.0 million to $750.0 million and increased the additional amount that Lantheus Medical may request to add to the increased revolving commitment by $350.0 million. The amendment also, among other things, (i) reduces the ranges of margins based on our Total Net Leverage Ratio (as defined in the 2022 Revolving Facility) used to calculate interest for the revolving loans and (ii) reduces the maximum unused commitment fee from 0.35% per annum to 0.30% per annum. The full terms of the 2022 Revolving Facility are set forth in the Credit Agreement, dated as of December 2, 2022, by and among us, the lenders from time to time party thereto and Citizens Bank, N.A., as administrative agent and collateral agent, as amended. We have the right to request an increase to the 2022 Revolving Facility or request the establishment of one or more new incremental term loan facilities, in an aggregate principal amount of up to the greater of $685.0 million (so that the total amount available is $1.44 billion) or 100% of consolidated earnings before interest, taxes, depreciation and amortization for the four consecutive fiscal quarters most recently ended, plus additional amounts, in certain circumstances.
Under the terms of the 2022 Revolving Facility, the lenders thereunder agreed to extend credit to us from time to time until December 19, 2029 consisting of revolving loans in an aggregate principal amount not to exceed $750.0 million at any time. The 2022 Revolving Facility includes a $40.0 million sub-facility for the issuance of letters of credit (the “Letters of Credit”). The 2022 Revolving Facility includes a $20.0 million sub-facility for swingline loans (the “Swingline Loans”). The Letters of Credit, Swingline Loans and the borrowings under the 2022 Revolving Facility are expected to be used for working capital and other general corporate purposes.
For more information on the 2022 Revolving Facility, see Note 11. “Long-Term Debt, Net, and Other Borrowings, Net of Current Portion” to our condensed consolidated financial statements of this Form 10-Q.
As of March 31, 2026, we were in compliance with all financial and other covenants under the 2022 Credit Agreement.
On December 8, 2022, we issued $575.0 million in aggregate principal amount of 2.625% Convertible Senior Notes due 2027 (the “Notes”), which includes $75.0 million in aggregate principal amount of Notes sold pursuant to the full exercise of the initial purchasers’ option to purchase additional Notes. The Notes were issued under the Indenture. The net proceeds from the issuance of the Notes were approximately $557.8 million, after deducting the initial purchasers’ discounts and offering expenses payable by us.
On July 31, 2025, our Board authorized the 2025 Program. The 2025 Program replaces the 2024 Program, including the remaining unused amounts under the 2024 Program. We repurchased 1.3 million shares for approximately $100.0 million under the 2024 Program in 2025. The 2025 Program authorizes us to purchase shares of our common stock from time to time via open market purchases at prevailing market prices, in privately negotiated transactions, block trades, or pursuant to trades intending to comply with Rule 10b5-1 under the Exchange Act or through other legally permissible means, depending on market conditions and in accordance with applicable rules and
45
regulations. The timing, manner, price and amount of any repurchase will be subject to the discretion of our Management. The 2025 Program does not obligate us to acquire any particular amount of our common stock, and we may suspend or discontinue the 2025 Program at any time. We did not repurchase any shares under the 2025 Program during the three months ended March 31, 2026. We repurchased 3.5 million shares for approximately $200.0 million under the 2025 Program in 2025, with approximately $200.0 million remaining available for repurchase as of March 31, 2026.
On January 1, 2026 as a result of the sale of our SPECT business to SHINE SPECT, we received consideration consisting of cash, notes receivable that may be settled in equity of Illuminated or in cash depending on their specific terms, a right to receive additional cash on the earlier of January 1, 2030 or upon the occurrence of certain specified events, and the right to certain contingent consideration. The fair value of total consideration that we received on the Disposition Date was approximately $130.5 million, including $31.4 million in cash. See Note 4, “Fair Value of Financial Instruments” for more information on the sale of our SPECT business.
Our ability to fund our future capital needs will be affected by our ability to continue to generate cash from operations and may be affected by our ability to access the capital markets, money markets or other sources of funding, as well as the capacity and terms of our financing arrangements.
We may from time to time repurchase or otherwise retire our debt and take other steps to reduce our debt or otherwise improve our balance sheet. These actions may include prepayments of our term loans or other retirements or refinancing of outstanding debt, privately negotiated transactions or otherwise. The amount of debt that may be retired, if any, could be material and would be decided at the sole discretion of our Board and will depend on market conditions, our cash position and other considerations.
Funding Requirements
Our future capital requirements will depend on many factors, including:
46
Disruption in our financial performance could occur if we experience significant adverse changes in product or customer mix, significant changes in our competitive or regulatory environment, broad economic downturns, sustained inflation, adverse industry or company conditions or catastrophic external events, including pandemics, natural disasters and political or military conflict. If we experience one or more of these events in the future, we may be required to implement expense reductions, such as a delay or elimination of discretionary spending in all functional areas, as well as scaling back select operating and strategic initiatives.
If our capital resources become insufficient to meet our future capital requirements, we would need to finance our cash needs through public or private equity offerings, debt financings, assets securitizations, sale-leasebacks or other financing or strategic alternatives, to the extent such transactions are permissible under the covenants of our 2022 Credit Agreement. Additional equity or debt financing, or other transactions, may not be available on acceptable terms, if at all. If any of these transactions require an amendment or waiver under the covenants in our 2022 Credit Agreement, which could result in additional expenses associated with obtaining the amendment or waiver, we will seek to obtain such an amendment or waiver to remain in compliance with those covenants. However, we cannot provide assurance that such an amendment or waiver would be granted, or that additional capital will be available on acceptable terms, if at all.
At March 31, 2026, our only current committed external source of funds is our borrowing availability under our 2022 Revolving Facility. We had $498.6 million of cash and cash equivalents as of March 31, 2026. Our 2022 Revolving Facility contains a number of affirmative, negative, reporting and financial covenants, in each case subject to certain exceptions and materiality thresholds. Incremental borrowings under the 2022 Revolving Facility may affect our ability to comply with the covenants including the financial covenants restricting consolidated net leverage and interest coverage. Accordingly, we may be limited in utilizing the full amount of our 2022 Revolving Facility as a source of liquidity.
Based on our current operating plans, we believe our balance of cash and cash equivalents, along with cash generated by ongoing operations and continued access to our 2022 Revolving Facility, will be sufficient to satisfy our cash requirements over the next twelve months and beyond.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect our reported assets and liabilities, revenues and expenses, and other financial information. Actual results may differ materially from these estimates under different assumptions and conditions. In addition, our reported financial condition and results of operations could vary due to a change in the application of a particular accounting standard.
There have been no significant changes to our critical accounting policies or in the underlying accounting assumptions and estimates used in such policies in the three months ended March 31, 2026. For further information, refer to our summary of significant accounting policies and estimates in our Form 10-K for the year ended December 31, 2025.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements as of March 31, 2026, including structured finance, special purpose entities or variable interest entities.
47
Item 3. Quantitative and Qualitative Disclosures About Market Risk
For quantitative and qualitative disclosures about market risk, see Part II, Item 7A. “Quantitative and Qualitative Disclosures About Market Risk,” of our Form 10-K for the year ended December 31, 2025. Our exposures to market risk have not changed materially since December 31, 2025.
Equity Investment Risk
As of March 31, 2026, our recorded carrying value of investments in equity securities was $56.4 million, comprised of our equity investments in Perspective and Radiopharm, and is recorded at fair value, subject to market price volatility. We record our equity investments in public companies at fair value and adjust our equity investments in public companies for observable price changes or impairments. Valuations of public companies are variable and subject to change in share price at the applicable measurement period.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
The Company’s management, with the participation of the Company’s Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), its principal executive officer and principal financial officer, respectively, has evaluated the effectiveness of the Company’s disclosure controls and procedures as defined in Rule 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on that evaluation, the Company’s CEO and CFO concluded that the Company’s disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) were effective as of the period covered by this report.
Changes in Internal Controls Over Financial Reporting
There were no changes in our internal control over financial reporting during the three months ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Information with respect to certain legal proceedings is included in Note 15, “Commitments and Contingencies”, to the condensed consolidated financial statements contained in Part I, Item 1. Financial Statements of this Quarterly report on Form 10-Q and is incorporated herein by reference.
Item 1A. Risk Factors
There have been no material changes to the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2025 (our “Form 10-K”), except as set forth below:
Risks Related to Our and our Strategic Partners’ Portfolios of Clinical Development Candidates
We may not, or may take longer to, realize the expected benefits and opportunities related to PYLARIFY TruVu, our recently-approved new formulation of our prostate-specific membrane antigen (“PSMA”) positron emission tomography (“PET”) Imaging Agent.
On March 6, 2026, the U.S. Food and Drug Administration (the “FDA”) approved PYLARIFY TruVu (piflufolastat F18), a new formulation of our F-18 PSMA PET imaging agent. PYLARIFY TruVu is designed to enhance product stability at higher radioactive concentrations, supporting more efficient manufacturing and distribution, including the potential to increase batch sizes and enable certain manufacturing sites to reach more patients and serve broader geographic markets. PYLARIFY TruVu is expected to become commercially available beginning in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, with the intent transition customers from PYLARIFY to PYLARIFY TruVu. It is anticipated that once a PMF site begins to supply PYLARIFY TruVu commercially, it will no longer supply PYLARIFY. We plan to work closely with clinicians and PET manufacturing facility (“PMF”) sites to support a smooth transition, including providing guidance on ordering, handling, and clinical use to support continuity of care. We also plan to pursue reimbursement for the new formulation from the Centers for Medicare and Medicaid Services (“CMS”), including seeking three years of transitional pass-through payment status (“TPT Status”). However, we can provide no assurance that we will be able to complete the technology transfer across our PMF network for PYLARIFY TruVu or obtain FDA approval for each PMF site to manufacture PYLARIFY TruVu on our expected timeline or at all. Additionally, we may be unable to obtain adequate coding, coverage and payment, including TPT Status, for PYLARIFY TruVu. Furthermore, there is no assurance that any customer transition will occur on our expected timeline or that our customers will adopt PYLARIFY TruVu at all. If customers do not adopt PYLARIFY TruVu we may not be able to reintroduce PYLARIFY and we would then lose customers to competitors which would have an adverse effect on our business, results or operations, financial condition and cash flows. All of the risks as described in Part I, Item 1A, “Risk Factors” in our Form 10-K with respect to our ability to continue to generate substantial revenue from PYLARIFY, as well as the risks associated with launching a product, also apply to PYLARIFY TruVu, and we can provide no assurances that the anticipated increase in batch size or other expected improvements associated with the design of the new formulation will be realized or be viewed in the market as differentiating factors.
We may not, or may take longer to, realize the expected benefits and opportunities related to our acquisition of the rights to LNTH-2501.
In April 2025, we acquired Evergreen, including the rights to LNTH-2501. On October 30, 2025, we announced that the FDA had accepted our New Drug Application (“NDA”) for LNTH-2501 and set a PDUFA target action date of March 29, 2026. On March 17, 2026, the FDA extended its review of the NDA, moving the PDUFA target action date to June 29, 2026, which will allow the FDA additional time to review and consider further manufacturing-related information. We can provide no assurance that LNTH-2501 will be approved by the FDA in the expected timeline or at all. If LNTH-2501 is approved, there is no guarantee that we will be successful in gaining post-approval market acceptance and adequate coding, coverage, and payment for LNTH-2501 or that our manufacturer will be able to successfully develop and scale the manufacturing capabilities to support the launch of LNTH-2501. Even if we do receive NDA approval, all of the risks as described in Part I, Item 1A, “Risk Factors” in our Form 10-K with respect to launching a product would apply to LNTH-2501. Additionally, LNTH-2501 is a kit product with a supply chain that differs from that of our other commercial products, which may introduce additional operational complexity, coordination requirements, and sourcing and supply risks, and we can provide no assurance that we will be able to successfully or timely launch LNTH-2501, achieve anticipated adoption, or realize expected commercial results.
We may not, or may take longer to, realize the expected benefits and opportunities related to, the POINT Biopharma Global Inc. (“POINT”) License Agreements, including PNT2003.
49
On December 20, 2022, we announced the closing of a set of strategic collaborations with an affiliate of POINT, in which we were granted a license to exclusive worldwide rights (excluding Japan, South Korea, China (including Hong Kong, Macau and Taiwan), Singapore and Indonesia) to co-develop and commercialize POINT’s PNT2003 and PNT2002 product candidates (the “POINT License Agreements”). The expected benefits and opportunities related to the POINT License Agreements and related agreements for the supply of PNT2003 by POINT may not be realized or may take longer to realize than expected due to, for example, challenges and uncertainties inherent in product research, development, manufacturing, regulatory approval, marketing and competition. In particular, activities under the POINT License Agreements may not result in viable products suitable for commercialization in a timely manner or at all, due to a variety of reasons, including any inability of the relevant parties to perform their commitments and obligations under the POINT License Agreements. The POINT License Agreements impose various development, regulatory filing, commercialization and other obligations on us, and require us to meet development timelines or to exercise commercially reasonable efforts to develop and commercialize licensed products.
With respect to PNT2003, in March 2026, we received tentative approval of our Abbreviated New Drug Application (“ANDA”) for PNT2003, which indicates that the FDA has completed its review of the ANDA and determined that it meets the requirements for approval. The timing of our launch will consider the following factors: the timing of final FDA approval, the expiration of the 30-month Hatch-Waxman stay and disposition of the related legal proceedings, as well as manufacturing and commercial strategy to ensure launch success, however, even if we do receive ANDA approval, all of the risks as described in Part I, Item 1A, “Risk Factors” in our Form 10-K with respect to launching and successfully commercializing a radiopharmaceutical product as well as those related to our dependence on third parties for the manufacturing of products would apply to PNT2003.
In addition, we are also currently dependent on POINT to develop commercial product capacity and manufacture for both PNT2003 and PNT2002. Disagreements with POINT in the POINT License Agreements over proprietary rights, contract interpretation or the preferred course of product research, development, regulatory strategy or marketing, might cause delays in performance of the POINT License Agreements or termination of the POINT License Agreements, or might result in litigation or arbitration, which could be time-consuming and expensive.
Additionally, if we fail to comply with our obligations under the POINT License Agreements, then POINT may conclude that we have materially breached and may terminate one or both of the POINT License Agreements, in which event we may lose our rights to develop and market PNT2003 and PNT2002 or incur liability for damages.
The Phase 3 registrational clinical trial for PNT2002, known as the “SPLASH” study, reached 100% of prespecified overall survival events. The results of the readout were comparable to the previously reported 46% and 75% readouts and remain confounded by the overwhelming number of patients who crossed over within the study to receive PNT2002. While we continue to review the available PNT2002 data, we do not currently plan to pursue an NDA or further invest in this asset. As a result, we may never realize any future benefits from the related POINT License Agreement.
Any of the foregoing risks could have a material adverse effect on our business, results of operations, financial condition and cash flows.
Risks Related to Our Business Operations and Financial Results
We may not receive the expected financial benefits from our sale of our single-photon emission computerized tomography (“SPECT”) business, and a failure to receive future and contingent payments could adversely affect our liquidity and financial condition.
On January 1, 2026, as a result of the sale of the Company’s SPECT business pursuant to the Equity and Asset Purchase Agreement, by and among Lantheus Medical, Lantheus MI Canada, Inc., Lantheus EU Limited, and Illuminated Holdings, Inc. (“Illuminated”), SHINE SPECT, LLC, SHINE SPECT Medical Products, Ltd., and SHINE SPECT Limited (collectively referred to as “SHINE SPECT”), dated as of May 1, 2025 (the “SHINE SPECT Agreement”), we are entitled to receive future and contingent consideration, including (i) a seller note with a principal amount of $20.0 million (the “Seller Note”), which bears interest at 8.0% per year payable semi-annually (with up to half payable in-kind) and matures on the earlier of January 1, 2029 or completion of an initial public offering by Illuminated (a “SHINE IPO”), and which may be repaid earlier in certain circumstances, including in connection with a change in control or a material financing, as defined in the governing note agreement, and (ii) $20.0 million in cash on the earlier of January 1, 2029 or a SHINE IPO (the “Deferred Cash Purchase Price”), with an additional $5.0 million payable if the Deferred Cash Purchase Price is not paid by January 1, 2029, for a total of $25.0 million in cash to be paid no later than January 1, 2030. In addition, we may earn up to $30.0 million in a combination of cash and capital stock of Illuminated upon exceeding specified annual and cumulative revenue milestones of the SPECT business for each calendar year through December 31, 2027.
There can be no assurance that SHINE SPECT will have sufficient financial resources to make payments on the Seller Note or the Deferred Cash Purchase Price as they come due, or at all. The Seller Note is an unsecured obligation, and we do not have collateral protection in the event of non-payment, insolvency or other financial distress of the obligor. Further, the contingent consideration depends on the achievement of specified revenue milestones that may not be achieved in whole or in part, may take longer than we expect to be achieved, or may never be achieved, and the form of any contingent consideration may include equity rather than cash. If we do not receive some or all of
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these future and contingent payments, or if receipt of these amounts is delayed, disputed or otherwise not realized on the expected terms or timing, our liquidity, financial condition and results of operations could be materially adversely affected.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
On July 31, 2025, the Board authorized a program to repurchase up to $400.0 million of shares of the Company’s common stock through December 31, 2027 (the “2025 Program”). The 2025 Program replaced the program authorized in November 2024 to repurchase up to $250.0 million of shares of the Company’s common stock (the “2024 Program”), including the remaining unused amounts under the 2024 Program, so there could be no additional repurchases under the 2024 Program subsequent to July 31, 2025. During 2025, the Company repurchased 1.3 million shares for approximately $100.0 million under the 2024 Program for an average stock price of $79.37. The Company did not repurchase any of its common stock available under the 2025 Program during the three months ended March 31, 2026. During 2025, the Company repurchased a total of 3.5 million shares for an aggregate purchase price of approximately $200.0 million under the 2025 Program for an average stock price of $56.72. A total of approximately $200.0 million of shares of the Company’s common stock remain available for repurchase under the 2025 Program.
The following table presents information with respect to purchases of common stock we made during the first quarter of 2026:
Period |
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Total Number of |
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Average Price |
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Total Number of |
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Approximate Dollar |
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January 2026 |
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2,295 |
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$ |
64.86 |
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— |
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$200.0 million |
February 2026 |
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2,966 |
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$ |
72.08 |
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— |
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$200.0 million |
March 2026 |
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200,636 |
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$ |
76.36 |
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— |
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$200.0 million |
Total |
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205,897 |
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— |
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$200.0 million |
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Dividend Policy
We did not declare or pay any dividends, and we do not currently intend to pay dividends in the foreseeable future. We currently expect to retain future earnings, if any, for the foreseeable future, to finance the growth and development of our business and to repay indebtedness. Our ability to pay dividends is restricted by our financing arrangements. See Part I, Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations-Liquidity and Capital Resources-External Sources of Liquidity” of this Form 10-Q for further information.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Rule 10b5-1 Trading Plans
On
On
On
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On
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Item 6. Exhibits
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INCORPORATED BY REFERENCE |
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EXHIBIT NUMBER |
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DESCRIPTION OF EXHIBITS |
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FORM |
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FILING DATE |
10.1*+ |
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10.2*+
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Letter Agreement, dated July 30, 2025, by and between Life Molecular GmbH and Ludger Dinkelborg. |
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10.3*+#
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10.4*+
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31.1* |
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Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a). |
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31.2* |
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Certification of Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a). |
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32.1** |
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101.INS* |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
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101.SCH* |
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Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
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104* |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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* Filed herewith.
** Furnished herewith.
+ Indicates management contract or compensatory plan or arrangement.
# Pursuant to Item 601(b)(10)(iv) of Regulation S-K promulgated by the SEC, certain portions of this exhibit have been redacted because the Company customarily and actually treats such omitted information as private or confidential and because such omitted information is not material.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
LANTHEUS HOLDINGS, INC. |
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By: |
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/s/ MARY ANNE HEINO |
Name: |
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Mary Anne Heino |
Title: |
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Chief Executive Officer and Chairperson of the Board |
Date: |
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May 7, 2026 |
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LANTHEUS HOLDINGS, INC. |
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By: |
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/s/ ROBERT J. MARSHALL, JR. |
Name: |
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Robert J. Marshall, Jr. |
Title: |
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Chief Financial Officer and Treasurer |
Date: |
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May 7, 2026 |
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ATTACHMENTS / EXHIBITS
XBRL TAXONOMY EXTENSION SCHEMA WITH EMBEDDED LINKBASES DOCUMENT