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lnth-20241106
FALSE000152103600015210362024-11-062024-11-06

 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 6, 2024
LANTHEUS HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
Delaware001-3656935-2318913
(State or other jurisdiction
of incorporation)		(Commission
File Number)		(IRS Employer
Identification No.)
201 Burlington Road, South Building, Bedford, MA
01730
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code: (978) 671-8001
Not Applicable
(Former name or former address, if changed since last report.)
    Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common stock, par value $0.01 per shareLNTHThe Nasdaq Global Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
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. ☐


Item 2.02.     Results of Operations and Financial Condition.
On November 6, 2024, Lantheus Holdings, Inc. (the “Company”) announced via press release its financial results as of and for the three and nine months ended September 30, 2024. A copy of that press release is being furnished as Exhibit 99.1 and is hereby incorporated by reference.
The information furnished pursuant to this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that Section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act.
Item 9.01.    Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.Description
99.1*
104Cover Page Interactive Data File (embedded within the Inline XBRL document)
*    Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, as amended, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
 


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 hereunto duly authorized.
 
LANTHEUS HOLDINGS, INC.
By:
/s/ Daniel M. Niedzwiecki
Name:
Daniel M. Niedzwiecki
Title:
Chief Administrative Officer and General Counsel
Date: November 6, 2024
 
Document

Exhibit 99.1
https://cdn.kscope.io/36116d08914aa9f8d0e0294dcc262ce3-newlantheuslogo.jpg
Lantheus Reports Third Quarter 2024 Financial Results
•Worldwide revenue of $378.7 million, an increase of 18.4% from third quarter 2023
•GAAP fully diluted earnings per share of $1.79, compared to $1.88 in the third quarter of 2023. Adjusted fully diluted earnings per share of $1.70 compared to $1.47 in the third quarter of 2023
•Company narrows full year 2024 revenue and fully diluted earnings per share guidance towards higher end of the previously issued guidance
•Company applauds CMS' CY25 rule to improve payment for specialized diagnostic radiopharmaceuticals, including PYLARIFY, advancing patient access and care
•Company announced that it expanded its Alzheimer's disease radiodiagnostics portfolio with NAV-4694, a novel, next generation late-stage beta-amyloid imaging agent
BEDFORD, Mass., November 6, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (Lantheus or the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today reported financial results for its third quarter ended September 30, 2024.
“PYLARIFY is on track to exceed $1 billion in sales in 2024 and maintain its market leadership and blockbuster status in 2025,” said Brian Markison, Chief Executive Officer of Lantheus. “The success of our flagship diagnostic agents enables us to invest, organically and inorganically in our pipeline to advance our radiopharmaceutical leadership. We are excited about our growing portfolio, especially oncology radiotherapeutics and Alzheimer's disease radiodiagnostics, and will continue to expand our portfolio of late-stage and high potential early-stage product candidates. We are driving growth and shareholder value through operational excellence, financial discipline and prudent capital deployment.”
Summary Financial Results
(in millions, except per share data – unaudited)Three Months Ended
September 30,
20242023% Change
Worldwide revenue$378.7 $319.9 18.4 %
GAAP net income$131.1 $132.0 (0.7)%
GAAP fully diluted earnings per share$1.79 $1.88 (4.8)%
Adj. net income (non-GAAP)$124.1 $103.1 20.4 %
Adj. fully diluted earnings per share (non-GAAP)$1.70 $1.47 15.6 %
Third Quarter 2024
•Worldwide revenue increased 18.4% to $378.7 million compared to the same period in 2023.
•Sales of PYLARIFY were $259.8 million, an increase of 20.6%. Growth was driven by increasing volumes at existing accounts with a slight net price offset as we secured strategic partnerships.
•Sales of DEFINITY were $77.0 million, an increase of 14.3%. Growth was driven by market growth and opportunistic sales due to competitor supply challenges.
•Operating income increased 19.0% to $133.7 million. Adjusted operating income (non-GAAP) increased 18.3% to $165.1 million.
•Fully diluted earnings per share decreased to $1.79, compared to $1.88 in the prior year period. Adjusted fully diluted earnings per share (non-GAAP) increased 15.6% to $1.70, compared to $1.47 in the prior year period.
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•Net cash provided by operating activities and free cash flow were $175.1 million and $159.3 million, respectively.
Balance Sheet
•At September 30, 2024, the Company's cash and cash equivalents grew to $866.4 million, compared to $713.7 million at December 31, 2023, even after accounting for the $35.0 million net investment related to the acquisition of RM2 from Life Molecular, a $5 million equity investment in Radiopharm Theranostics as well as a $10 million milestone payment related to the NAV-4694 asset in the third quarter 2024.
•The Company currently has access to up to $350.0 million from a revolving line of credit.
Recent Business Highlights
Radiopharmaceutical Pipeline Progress   
•The Company announced an expansion of its Alzheimer’s disease portfolio in the third quarter, acquiring NAV-4694, a novel, next generation beta-amyloid imaging agent in Phase 3 clinical development. NAV-4694 complements MK-6240, Lantheus’ novel, next-generation, tau radiodiagnostic. The Company plans to submit New Drug Applications for MK-6240 in 2025 and NAV-4694 in 2026.
•With respect to the SPLASH Phase 3 registrational study of PNT2002, the second interim analysis performed at 75% of protocol specified events demonstrated results for radiographic progression free survival (rPFS) and overall survival (OS) that did not materially change from the initial interim analysis conducted at 46% of specified events. PNT2002 is an investigational PSMA-targeted radiotherapeutic for the treatment of patients with metastatic castration-resistant prostate cancer. The SPLASH study met its primary endpoint of rPFS, which was a meaningful and statistically significant improvement for the PNT2002 arm vs. the alternate androgen receptor pathway inhibitor (ARPI) or hormone therapy. The OS results and hazard ratio in the intention-to-treat (ITT) population remain confounded by the overwhelming number of patients who crossed over to receive PNT2002. Crossover adjusted analyses are post-hoc, and the Company will continue to review the data and perform additional sub-set analyses with our partner, Eli Lilly, that may be compelling to the FDA in preparation for an interaction on our path forward.
Other Key Updates
•The Centers for Medicare & Medicaid Services (CMS) released its final Medicare Hospital Outpatient Prospective Payment System (OPPS) rule for calendar year 2025 which included improved payment for specialized diagnostic radiopharmaceuticals to support patient access for Medicare fee-for-service (FFS) beneficiaries. In the rule, innovative diagnostic radiopharmaceuticals, including PYLARIFY, will be paid separately by CMS for traditional Medicare FFS patients in the hospital outpatient setting following the expiry of transitional pass-through payment status. The final rule will take effect January 1, 2025.
Full Year 2024 Financial Guidance
Guidance Issued November 6, 2024
Guidance Issued July 31, 2024
FY 2024 Revenue
$1.51 billion - $1.52 billion
$1.50 billion - $1.52 billion
FY 2024 Adjusted Fully Diluted EPS
$6.65 - $6.70
$6.60 - $6.70
On a forward-looking basis, the Company does not provide GAAP income per common share guidance or a reconciliation of GAAP income per common share to adjusted fully diluted EPS because the Company is unable to predict with reasonable certainty business development and acquisition related expenses, purchase accounting fair value adjustments, and any one-time, non-recurring charges. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. As a result, it is the Company’s view that a quantitative reconciliation of adjusted fully diluted EPS on a forward-looking basis is not available without unreasonable effort.  
Conference Call and Webcast
As previously announced, the Company will host a conference call and webcast on Wednesday, November 6, 2024, at 8:00 a.m. ET. To access the conference call or webcast, participants should register online at https://investor.lantheus.com/news-events/calendar-of-events.
A replay will be available approximately two hours after completion of the webcast and will be archived on the same web page for at least 30 days.
The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.
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The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.
About Lantheus Holdings, Inc.
Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for more than 65 years. For more information, visit www.lantheus.com. 
Internet Posting of Information
The Company routinely posts information that may be important to investors in the “Investors” section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company. 
Non-GAAP Financial Measures
The Company uses non-GAAP financial measures, such as adjusted net income and its line components; adjusted net income per share - fully diluted; adjusted operating income and free cash flow. The Company’s management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the Company’s operations, period over period. However, these measures may exclude items that may be highly variable, difficult to predict and of a size that could have a substantial impact on the Company’s reported results of operations for a particular period. Management uses these and other non-GAAP measures internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.  
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “advance,” “believe,” “continue,” “could,” “driving,” “guidance,” “maintain,” “may,” “on track,” “plan,” “potential,” “predict,” “progress,” “should,” “target,” “will,” “would” and other similar terms. Such forward-looking statements include our guidance for the fiscal year 2024 and our plans to expand our portfolio of late-stage assets and high potential early-stage candidates and are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes 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. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include: (i) continued market expansion and penetration for our established commercial products, particularly PYLARIFY and DEFINITY, in a competitive environment in which other imaging agents have been approved and are being commercialized, and our ability to clinically and commercially differentiate our products; (ii) our ability to have third parties manufacture our products and our ability to manufacture DEFINITY in our in-house manufacturing facility; (iii) the global availability of Molybdenum-99 (“Mo-99”) and other raw material and key components; (iv) our strategies, future prospects, and our projected growth, including revenue related to our collaboration agreements with POINT Biopharma Global Inc., including our ability to obtain FDA approval for PNT2002 and PNT2003; (v) our ability to satisfy our obligations under our existing clinical development partnerships using MK-6240 or NAV-4694 as a research tool and under the license agreements through which we have rights to MK-6240 and NAV-4694, and to further develop and commercialize MK-6240 and NAV-4694 as approved products; (vi) our ability to successfully execute on our agreements with Perspective Therapeutics, Inc. ("Perspective"), including finalizing the license agreements in the event we exercise our options to do so, the value of our current and any future equity interest in Perspective, and Perspective’s ability to successfully develop its alpha-particle therapy and innovative platform technology; (vii) our ability to successfully identify strategic transaction opportunities, such as our investment in Radiopharm Theranostics Limited ("Radiopharm") common stock, and the value of such current and any future equity interests; (viii) the efforts and timing for clinical development, regulatory approval, adequate coding, coverage and payment and successful commercialization of our product candidates and new clinical applications and territories for our products, in each case, that we or our strategic partners may undertake; (ix) our ability to identify and acquire or in-license additional diagnostic and therapeutic product opportunities in oncology, Alzheimer's disease and other strategic areas and continue to grow and advance our pipeline of products; and (x) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).
- Tables Follow -
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Lantheus Holdings, Inc.
Consolidated Statements of Operations
(in thousands, except per share data – unaudited)
Three Months Ended
September 30,		Nine Months Ended
September 30,
2024202320242023
Revenues$378,734 $319,946 $1,142,800 $942,430 
Cost of goods sold136,608 119,995 403,054 462,756 
Gross profit242,126 199,951 739,746 479,674 
Operating expenses
Sales and marketing43,719 37,399 134,300 106,472 
General and administrative40,516 35,741 135,820 85,163 
Research and development24,148 14,450 132,773 60,883 
Total operating expenses108,383 87,590 402,893 252,518 
Gain on sale of assets— — 6,254 — 
Operating income133,743 112,361 343,107 227,156 
Interest expense4,903 5,054 14,624 14,978 
Investment in equity securities - unrealized gain(37,325)— (75,492)— 
Other income(9,953)(52,649)(27,785)(60,362)
 Income before income taxes176,118 159,956 431,760 272,540 
Income tax expense45,025 27,999 107,528 49,259 
Net income$131,093 $131,957 $324,232 $223,281 
Net income per common share:
Basic$1.89 $1.93 $4.69 $3.27 
Diluted$1.79 $1.88 $4.55 $3.18 
Weighted-average common shares outstanding:
Basic69,464 68,436 69,193 68,188 
Diluted73,065 70,046 71,331 70,268 
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Lantheus Holdings, Inc.
Consolidated Revenues Analysis
(in thousands – unaudited)
Three Months Ended
September 30,		Nine Months Ended
September 30,
20242023% Change20242023% Change
   PYLARIFY$259,756 $215,428 20.6 %$791,881 $621,419 27.4 %
   Other radiopharmaceutical oncology— 848 (100.0)%384 2,383 (83.9)%
Total radiopharmaceutical oncology259,756 216,276 20.1 %792,265 623,802 27.0 %
   DEFINITY76,965 67,336 14.3 %231,629 206,688 12.1 %
   TechneLite20,480 23,272 (12.0)%70,380 65,853 6.9 %
   Other precision diagnostics6,282 5,740 9.4 %18,039 17,002 6.1 %
Total precision diagnostics103,727 96,348 7.7 %320,048 289,543 10.5 %
Strategic partnerships and other revenue15,251 7,322 108.3 %30,487 29,085 4.8 %
Total revenues$378,734 $319,946 18.4 %$1,142,800 $942,430 21.3 %
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Lantheus Holdings, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(in thousands, except per share data – unaudited)
Three Months Ended
September 30,		Nine Months Ended
September 30,
2024202320242023
Net income$131,093 $131,957 $324,232 $223,281 
Stock and incentive plan compensation20,366 13,976 54,229 36,335 
Amortization of acquired intangible assets11,908 11,659 31,961 35,132 
Campus consolidation costs23 45 37 3,185 
Contingent consideration fair value adjustments(1,505)(500)(1,405)(9,475)
Non-recurring refinancing related fees— 3 — 216 
Non-recurring fees— (51,789)— (54,523)
Gain on sale of assets— — (6,254)— 
Strategic collaboration and license costs30 — 66,221 — 
Investment in equity securities - unrealized gain(37,325)— (75,492)— 
Acquisition-related costs(263)169 1,346 507 
Impairment of long-lived assets— — — 138,050 
ARO Acceleration and other related costs— 320 — 1,045 
Other805 1,510 2,273 2,194 
Income tax effect of non-GAAP adjustments(a)
(1,048)(4,256)(27,907)(61,093)
Adjusted net income$124,084 $103,094 $369,241 $314,854 
Adjusted net income, as a percentage of revenues32.8 %32.2 %32.3 %33.4 %
Three Months Ended
September 30,		Nine Months Ended
September 30,
2024202320242023
Net income per share - diluted$1.79 $1.88 $4.55 $3.18 
Stock and incentive plan compensation0.28 0.20 0.76 0.52 
Amortization of acquired intangible assets0.16 0.17 0.45 0.50 
Campus consolidation costs— — — 0.05 
Contingent consideration fair value adjustments(0.02)(0.01)(0.02)(0.13)
Non-recurring refinancing related fees— — — — 
Non-recurring fees— (0.74)— (0.78)
Gain on sale of assets— — (0.09)— 
Strategic collaboration and license costs— — 0.93 — 
Investment in equity securities - unrealized gain(0.51)— (1.06)— 
Acquisition-related costs— — 0.02 0.01 
Impairment of long-lived assets— — — 1.96 
ARO Acceleration and other related costs— 0.01 — 0.01 
Other0.01 0.02 0.03 0.03 
Income tax effect of non-GAAP adjustments(a)
(0.01)(0.06)(0.39)(0.87)
Adjusted net income per share - diluted$1.70 $1.47 $5.18 $4.48 
Weighted-average common shares outstanding - diluted73,065 70,046 71,331 70,268 
(a)The income tax effect of the adjustments between GAAP net income and adjusted net income (non-GAAP) takes into account the tax treatment and related tax rate that apply to each adjustment in the applicable tax jurisdiction.
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Lantheus Holdings, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures (Continued)
(in thousands, except per share data – unaudited)
Three Months Ended
September 30,		Nine Months Ended
September 30,
2024202320242023
Operating income$133,743 $112,361 $343,107 $227,156 
Stock and incentive plan compensation20,366 13,976 54,229 36,335 
Amortization of acquired intangible assets11,908 11,659 31,961 35,132 
Campus consolidation costs23 45 37 3,185 
Contingent consideration fair value adjustments(1,505)(500)(1,405)(9,475)
Non-recurring refinancing related fees— 3 — 216 
Non-recurring fees— — — (2,734)
Gain on sale of assets— — (6,254)— 
Strategic collaboration and license costs30 — 66,221 — 
Acquisition-related costs(263)169 1,346 507 
Impairment of long-lived assets— — — 138,050 
ARO Acceleration and other related costs— 320 — 1,045 
Other805 1,510 2,273 2,194 
Adjusted operating income$165,107 $139,543 $491,515 $431,611 
Adjusted operating income, as a percentage of revenues43.6 %43.6 %43.0 %45.8 %
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Lantheus Holdings, Inc.
Reconciliation of Free Cash Flow
(in thousands – unaudited)
Three Months Ended
September 30,		Nine Months Ended
September 30,
2024202320242023
Net cash provided by operating activities$175,062 $116,739 $387,020 $192,973 
Capital expenditures(15,808)(14,621)(35,256)(34,486)
Free cash flow$159,254 $102,118 $351,764 $158,487 
Net cash (used in) provided by investing activities$(67,798)$83,218 $(219,413)$18,008 
Net cash provided by (used in) financing activities$1,869 $108 $(14,877)$(12,612)
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Lantheus Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands – unaudited)
September 30,
2024		December 31,
2023
Assets
Current assets
Cash and cash equivalents$866,386 $713,656 
Accounts receivable, net329,336 284,292 
Inventory70,835 64,029 
Other current assets21,998 16,683 
Assets held for sale7,159 7,159 
Total current assets1,295,714 1,085,819 
Investment in equity securities158,791 — 
Property, plant and equipment, net169,512 146,697 
Intangibles, net173,606 151,985 
Goodwill61,189 61,189 
Deferred tax assets, net144,641 150,198 
Other long-term assets46,177 55,261 
Total assets$2,049,630 $1,651,149 
Liabilities and stockholders’ equity
Current liabilities
Current portion of long-term debt and other borrowings$564,713 $823 
Accounts payable44,914 41,189 
Accrued expenses and other liabilities174,452 145,338 
Total current liabilities784,079 187,350 
Asset retirement obligations23,237 22,916 
Long-term debt, net and other borrowings613 561,670 
Other long-term liabilities61,993 63,321 
Total liabilities869,922 835,257 
Commitments and contingencies (See Note 18)
Stockholders’ equity
Preferred stock ($0.01 par value, 25,000 shares authorized; no shares issued and outstanding)— — 
Common stock ($0.01 par value, 250,000 shares authorized; 70,854 and 69,863 shares issued as of September 30, 2024 and December 31, 2023, respectively)709 699 
Additional paid-in capital797,430 757,727 
Treasury Stock at cost - 1,339 shares as of September 30, 2024 and December 31, 2023(75,000)(75,000)
Retained earnings457,735 133,503 
Accumulated other comprehensive loss(1,166)(1,037)
Total stockholders’ equity1,179,708 815,892 
Total liabilities and stockholders’ equity$2,049,630 $1,651,149 
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###
Contacts:
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com

Melissa Downs
Senior Director, External Communications
646-975-2533
media@lantheus.com
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