LNTH Lantheus Holdings Inc

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 second quarter ended June 30, 2024.

“We delivered another strong quarter as we continued to maximize the value of our commercial portfolio,” said Brian Markison, Chief Executive Officer of Lantheus. “With the strength of our balance sheet and radiopharmaceutical expertise, we also announced three strategic transactions that underscore our ongoing commitment to expand our pipeline of radiodiagnostics and radiotherapeutics to address unmet medical needs for significant patient populations. Looking ahead, we will continue to sustain an attractive financial profile by driving strong performance from our commercial products, advancing our R&D pipeline and executing strategically impactful business development.”

Summary Financial Results

(in millions, except per share data – unaudited)		Three Months Ended June 30,
			2024			2023		% Change
Worldwide revenue		$	394.1		$	321.7		22.5	%
GAAP net income		$	62.1		$	94.1		(34.1	)%
GAAP fully diluted earnings per share		$	0.88		$	1.33		(33.7	)%
Adj. net income (non-GAAP)		$	126.8		$	109.6		15.7	%
Adj. fully diluted earnings per share (non-GAAP)		$	1.80		$	1.54		16.4	%

Second Quarter 2024

• Worldwide revenue increased 22.5% to $394.1 million compared to the same period in 2023. Growth was primarily driven by PYLARIFY and DEFINITY.
• Sales of PYLARIFY were $273.3 million, an increase of 29.8% over $210.5 million in the prior year period. Growth was driven by increasing utilization of PSMA PET with PYLARIFY at existing customers and expansion of the PSMA PET imaging market.
• Sales of DEFINITY were $78.1 million, an increase of 10.7% over $70.5 million in the prior year period.
• Operating income decreased to $102.7 million, compared to $124.1 million in the prior year period. Adjusted operating income (non-GAAP) increased 14.0% to $171.1 million, compared to $150.1 million in the prior year period.
• Fully diluted earnings per share decreased to $0.88, compared to $1.33 in the prior year period. Adjusted fully diluted earnings per share (non-GAAP) increased 16.4% to $1.80, compared to $1.54 in the prior year period.
• Net cash provided by operating activities and free cash flow were $84.7 million and $73.5 million, respectively.

Balance Sheet

• At June 30, 2024, the Company's cash and cash equivalents grew to $757.0 million, compared to $713.7 million at December 31, 2023, taking into account the $98.3 million net investment related to the Perspective partnership in the first quarter 2024 and the $32.9 million net payment related to the acquisition of NAV-4694 in the second 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 

• In July 2024, the Company announced its acquisition of NAV-4694, expanding its position in the Alzheimer’s disease market. NAV-4694 is currently in Phase 3 clinical trials and is also being used in academic and industry trials evaluating investigational therapeutics. NAV-4694 complements Lantheus’ F18-labeled PET imaging agent candidate, MK-6240, which targets Tau tangles in Alzheimer’s disease; adding amyloid imaging as a potential product in addition to a tau-based imaging agent could further inform diagnosis and staging of Alzheimer’s disease.
• In June 2024, the Company acquired global rights to RM2, which targets the gastrin-releasing peptide receptor (GRPR), including the associated novel, clinical-stage radiodiagnostic and radiotherapeutic pair, referred to as 68Ga-RM2 (now LNTH-2401), and 177Lu-RM2 (now LNTH-2402). This acquisition strengthens Lantheus’ presence in prostate cancer and expands its pipeline to include breast and other cancers. With this radiotheranostic pair, Lantheus can now potentially reach more prostate cancer patients including those for whom PSMA-targeted therapy may not be appropriate. Lantheus plans to work with Life Molecular to initiate a Phase 1/2a study with LNTH-2402 in prostate cancer in 2025 with LNTH-2401 to be used as a companion diagnostic.
• In June 2024, the Company agreed to invest in Radiopharm Theranostics (RAD). Additionally, the Company acquired the rights to two of RAD's licensed pre-clinical assets, an LRRC15 targeting mAb (now LNTH-2403) and a TROP2 targeting nanobody (now LNTH-2404), bolstering the Company’s early oncology portfolio. LNTH-2403 is a potential first-in-class highly specific monoclonal antibody radiotherapeutic with both Orphan Drug and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. The product candidate is designed to target the surrounding tumor micro-environment cells expressing the protein LRRC15 and has the potential to treat a broad range of cancers. LNTH-2404, the TROP2-targeted nanobody radiotherapeutic, is advancing in preclinical development for TROP-2-expressing cancers.

Other Key Updates

• The Centers for Medicare & Medicaid Services (CMS) released its Proposed Medicare Hospital Outpatient Prospective Payment System (OPPS) rule for calendar year 2025 for improved payment for specialized diagnostic radiopharmaceuticals to support patient access for Medicare beneficiaries. In the proposed rule, innovative diagnostic radiopharmaceuticals, including PYLARIFY, would continue to be paid separately by CMS for traditional Medicare Fee for Service patients in the hospital outpatient setting following the expiry of traditional pass-through payment status. The final rule will be issued in early November and take effect January 1, 2025.
• The Company recently appointed Jeffrey Humphrey, M.D., to the position of Chief Medical Officer, along with Jamie Spaeth to the position of Chief People Officer and Kimberly Brown to the position of Chief Accounting Officer.

Full Year 2024 Financial Guidance

		Guidance Issued July 31, 2024	Guidance Issued May 2, 2024
FY 2024 Revenue		$1.50 billion - $1.52 billion	$1.50 billion - $1.52 billion
FY 2024 Adjusted Fully Diluted EPS		$6.60 - $6.70	$7.00 - $7.20

On a forward-looking basis, the Company does not provide GAAP income per common share guidance or a reconciliation of adjusted fully diluted EPS to GAAP income per common share 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.

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. 

Conference Call and Webcast

As previously announced, the Company will host a conference call and webcast on Wednesday, July 31, 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.

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. 

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 “believe,” “continue,” “could,” “guidance,” “may,” “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 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) 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; (viii) 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 (ix) 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).

Lantheus Holdings, Inc.Consolidated Statements of Operations(in thousands, except per share data – unaudited)
		Three Months Ended June 30,								Six Months Ended June 30,
			2024				2023				2024				2023
Revenues		$	394,091			$	321,700			$	764,066			$	622,484
Cost of goods sold			138,317				119,053				266,446				342,761
Gross profit			255,774				202,647				497,620				279,723
Operating expenses
Sales and marketing			45,035				36,456				90,581				69,073
General and administrative			47,409				26,151				95,304				49,422
Research and development			60,601				15,901				108,625				46,433
Total operating expenses			153,045				78,508				294,510				164,928
Gain on sale of assets			—				—				6,254				—
Operating income			102,729				124,139				209,364				114,795
Interest expense			4,862				4,933				9,721				9,924
Investment in equity securities - unrealized loss (gain)			22,537				—				(38,167	)			—
Other income			(9,044	)			(4,482	)			(17,832	)			(7,713	)
Income before income taxes			84,374				123,688				255,642				112,584
Income tax expense			22,301				29,557				62,503				21,260
Net income		$	62,073			$	94,131			$	193,139			$	91,324
Net income per common share:
Basic		$	0.89			$	1.38			$	2.80			$	1.34
Diluted		$	0.88			$	1.33			$	2.74			$	1.31
Weighted-average common shares outstanding:
Basic			69,356				68,371				69,056				68,062
Diluted			70,601				71,014				70,364				69,957

Lantheus Holdings, Inc.Consolidated Revenues Analysis(in thousands – unaudited)
		Three Months Ended June 30,									Six Months Ended June 30,
		2024			2023			% Change			2024			2023			% Change
PYLARIFY		$	273,255		$	210,522		29.8	%		$	532,125		$	405,992		31.1	%
Other radiopharmaceutical oncology			—			818		(100.0	)%			384			1,535		(75.0	)%
Total radiopharmaceutical oncology			273,255			211,340		29.3	%			532,509			407,527		30.7	%
DEFINITY			78,100			70,529		10.7	%			154,664			139,353		11.0	%
TechneLite			28,186			21,594		30.5	%			49,900			42,580		17.2	%
Other precision diagnostics			5,825			5,454		6.8	%			11,757			11,261		4.4	%
Total precision diagnostics			112,111			97,577		14.9	%			216,321			193,194		12.0	%
Strategic partnerships and other revenue			8,725			12,783		(31.7	)%			15,236			21,763		(30.0	)%
Total revenues		$	394,091		$	321,700		22.5	%		$	764,066		$	622,484		22.7	%

Lantheus Holdings, Inc.Reconciliation of GAAP to Non-GAAP Financial Measures(in thousands, except per share data – unaudited)
		Three Months Ended June 30,								Six Months Ended June 30,
			2024				2023				2024				2023
Net income		$	62,073			$	94,131			$	193,139			$	91,324
Stock and incentive plan compensation			18,479				12,692				33,863				22,359
Amortization of acquired intangible assets			10,122				12,374				20,053				23,473
Campus consolidation costs			(5	)			1,681				14				3,140
Contingent consideration fair value adjustments			100				(7,575	)			100				(8,975	)
Non-recurring refinancing related fees			—				(48	)			—				213
Non-recurring fees			—				—				—				(2,734	)
Gain on sale of assets			—				—				(6,254	)			—
Strategic collaboration and license costs			38,191				—				66,191				—
Investment in equity securities - unrealized loss (gain)			22,537				—				(38,167	)			—
Acquisition-related costs			821				169				1,609				338
Impairment of long-lived assets			—				5,998				—				138,050
ARO Acceleration and other related costs			—				577				—				725
Other			679				59				1,468				684
Income tax effect of non-GAAP adjustments(a)			(26,158	)			(10,461	)			(26,859	)			(56,837	)
Adjusted net income		$	126,839			$	109,597			$	245,157			$	211,760
Adjusted net income, as a percentage of revenues			32.2	%			34.1	%			32.1	%			34.0	%

		Three Months Ended June 30,								Six Months Ended June 30,
			2024				2023				2024				2023
Net income per share - diluted		$	0.88			$	1.33			$	2.74			$	1.31
Stock and incentive plan compensation			0.26				0.18				0.48				0.32
Amortization of acquired intangible assets			0.14				0.17				0.28				0.34
Campus consolidation costs			—				0.02				—				0.04
Contingent consideration fair value adjustments			—				(0.11	)			—				(0.13	)
Non-recurring refinancing related fees			—				—				—				—
Non-recurring fees			—				—				—				(0.04	)
Gain on sale of assets			—				—				(0.09	)			—
Strategic collaboration and license costs			0.54				—				0.94				—
Investment in equity securities - unrealized loss (gain)			0.32				—				(0.54	)			—
Acquisition-related costs			0.01				—				0.02				—
Impairment of long-lived assets			—				0.08				—				1.97
ARO Acceleration and other related costs			—				0.02				—				0.02
Other			0.01				—				0.02				0.01
Income tax effect of non-GAAP adjustments(a)			(0.36	)			(0.15	)			(0.37	)			(0.81	)
Adjusted net income per share - diluted		$	1.80			$	1.54			$	3.48			$	3.03
Weighted-average common shares outstanding - diluted			70,601				71,014				70,364				69,957

(a)	The income tax effect of the adjustments between GAAP net loss and non-GAAP adjusted net income takes into account the tax treatment and related tax rate that apply to each adjustment in the applicable tax jurisdiction.

Lantheus Holdings, Inc.Reconciliation of GAAP to Non-GAAP Financial Measures (Continued)(in thousands, except per share data – unaudited)
		Three Months Ended June 30,								Six Months Ended June 30,
			2024				2023				2024				2023
Operating income		$	102,729			$	124,139			$	209,364			$	114,795
Stock and incentive plan compensation			18,479				12,692				33,863				22,359
Amortization of acquired intangible assets			10,122				12,374				20,053				23,473
Campus consolidation costs			(5	)			1,681				14				3,140
Contingent consideration fair value adjustments			100				(7,575	)			100				(8,975	)
Non-recurring refinancing related fees			—				(48	)			—				213
Non-recurring fees			—				—				—				(2,734	)
Gain on sale of assets			—				—				(6,254	)			—
Strategic collaboration and license costs			38,191				—				66,191				—
Acquisition-related costs			821				169				1,609				338
Impairment of long-lived assets			—				5,998				—				138,050
ARO Acceleration and other related costs			—				577				—				725
Other			679				59				1,468				684
Adjusted operating income		$	171,116			$	150,066			$	326,408			$	292,068
Adjusted operating income, as a percentage of revenues			43.4	%			46.6	%			42.7	%			46.9	%

Lantheus Holdings, Inc.Reconciliation of Free Cash Flow(in thousands – unaudited)
	Three Months Ended June 30,								Six Months Ended June 30,
		2024				2023				2024				2023
Net cash provided by (used in) operating activities	$	84,720			$	(32,266	)		$	211,958			$	76,234
Capital expenditures		(11,175	)			(10,697	)			(19,448	)			(19,865	)
Free cash flow	$	73,545			$	(42,963	)		$	192,510			$	56,369
Net cash used in investing activities	$	(45,086	)		$	(20,697	)		$	(151,615	)		$	(65,210	)
Net cash provided by (used in) financing activities	$	99			$	(4,051	)		$	(16,746	)		$	(12,720	)

Lantheus Holdings, Inc.Condensed Consolidated Balance Sheets(in thousands – unaudited)
	June 30,2024			December 31,2023
Assets
Current assets
Cash and cash equivalents	$	757,018		$	713,656
Accounts receivable, net		372,288			284,292
Inventory		70,516			64,029
Other current assets		24,165			16,683
Assets held for sale		7,159			7,159
Total current assets		1,231,146			1,085,819
Investment in equity securities		116,423			—
Property, plant and equipment, net		158,158			146,697
Intangibles, net		172,239			151,985
Goodwill		61,189			61,189
Deferred tax assets, net		151,185			150,198
Other long-term assets		49,491			55,261
Total assets	$	1,939,831		$	1,651,149
Liabilities and stockholders’ equity
Current liabilities
Current portion of long-term debt and other borrowings	$	868		$	823
Accounts payable		49,774			41,189
Accrued expenses and other liabilities		212,643			145,338
Total current liabilities		263,285			187,350
Asset retirement obligations		23,130			22,916
Long-term debt, net and other borrowings		563,188			561,670
Other long-term liabilities		63,543			63,321
Total liabilities		913,146			835,257
Total stockholders’ equity		1,026,685			815,892
Total liabilities and stockholders’ equity	$	1,939,831		$	1,651,149

Contacts: Mark Kinarney Vice President, Investor Relations978-671-8842ir@lantheus.com

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