0000950170-25-103543.txt : 20250806 0000950170-25-103543.hdr.sgml : 20250806 20250806073952 ACCESSION NUMBER: 0000950170-25-103543 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20250806 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20250806 DATE AS OF CHANGE: 20250806 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Lantheus Holdings, Inc. CENTRAL INDEX KEY: 0001521036 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] ORGANIZATION NAME: 03 Life Sciences EIN: 352318913 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36569 FILM NUMBER: 251187482 BUSINESS ADDRESS: STREET 1: 331 TREBLE COVE ROAD CITY: NORTH BILLERICA STATE: MA ZIP: 01862 BUSINESS PHONE: 978 671-8001 MAIL ADDRESS: STREET 1: 331 TREBLE COVE ROAD CITY: NORTH BILLERICA STATE: MA ZIP: 01862 FORMER COMPANY: FORMER CONFORMED NAME: Lantheus MI Holdings, Inc. DATE OF NAME CHANGE: 20110517 8-K 1 lnth-20250806.htm 8-K 8-K
0001521036false00015210362025-08-062025-08-06

 

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): August 06, 2025

 

 

LANTHEUS HOLDINGS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-36569

35-2318913

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

201 Burlington Road

South Building

 

Bedford, Massachusetts

 

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:

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 class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common stock, par value $0.01 per share

 

LNTH

 

The 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 August 6, 2025, Lantheus Holdings, Inc. (the “Company”) announced via press release its financial results as of and for the three and six months ended June 30, 2025. 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 (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 7.01 Regulation FD Disclosure.

On August 6, 2025, the Company issued a press release announcing that the United States Food and Drug Administration has accepted a new drug application for a new formulation of its piflufolastat F-18 prostate-specific membrane antigen positron emission tomography imaging agent filed by its affiliate, Aphelion LLC. A copy of the press release is being furnished with this Current Report on Form 8-K as Exhibit 99.2 and is incorporated herein by reference.

The information in this Item 7.01, including Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of 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 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

On August 6, 2025, the Company announced that its board of directors has authorized a program to repurchase up to $400.0 million of shares of its common stock through December 31, 2027 (the “2025 Program”). The 2025 Program replaces the Company’s existing repurchase program, which was announced in November 2024. Repurchases under the 2025 Program may be made from time to time through open market transactions at prevailing market prices, in privately negotiated transactions and/or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations. The actual timing, number, and dollar amount of repurchase transactions will be determined by the Company’s management at its discretion and will depend on a number of factors including, but not limited to, the market price of the Company’s common stock. The Company may also establish 10b5-1 trading plans from time to time that will provide flexibility if and when it buys back its common stock. The announcement of the 2025 Program is included in the press release attached hereto as Exhibit 99.1.

Safe Harbor for Forward-Looking and Cautionary Statements

This report 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 and Section 21E of the Exchange Act. 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. These forward-looking statements include the Company’s capital allocation plans and are subject to risks and uncertainties the risk and uncertainties discussed in the Company’s filings with the Securities and Exchange Commission (including those described in the Risk Factors section in the Company’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q).
 

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1*

Press release of Lantheus Holdings, Inc. dated August 6, 2025, entitled “Lantheus Reports Second Quarter 2025 Financial Results and Provides Business Update”

99.2*

 

Press release of Lantheus Holdings, Inc. dated August 6, 2025, entitled “Lantheus Announces FDA Acceptance of NDA for New Formulation for Market-Leading PSMA PET Imaging Agent”


104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

* Exhibit 99.1 and 99.2 attached hereto are 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 or the Exchange Act, 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: August 6, 2025

 


EX-99.1 2 lnth-ex99_1.htm EX-99.1 EX-99.1

 

Exhibit 99.1

img66337839_0.jpg

 

 

Lantheus Reports Second Quarter 2025 Financial Results and Provides Business Update

Recorded second quarter 2025 worldwide revenue of $378.0 million, GAAP fully diluted earnings per share of $1.12, adjusted fully diluted earnings per share of $1.57 and free cash flow of $79.1 million
Announced FDA acceptance of NDA for new formulation for piflufolastat F 18 PSMA PET imaging agent with a PDUFA date of March 6, 2026
Closed acquisition of Life Molecular Imaging in July, immediately expanding near- and long-term growth profile and commercial portfolio with Neuraceq® (florbetaben F 18 injection), a globally approved beta-amyloid targeted radiodiagnostic for Alzheimer's disease; FDA label expansion for Neuraceq in June
Board of Directors authorized a program to repurchase up to $400 million of Lantheus common stock, replacing the 12-month program announced in November 2024
Provided updated corporate guidance for full year 2025 revenue and adjusted fully diluted earnings per share, reflecting the Life Molecular Imaging acquisition and current business outlook

BEDFORD, Mass., August 6, 2025 (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 second quarter ended June 30, 2025.

“In the second quarter and the month thereafter, we completed the acquisitions of both Evergreen Theragnostics and Life Molecular Imaging – key steps in executing our strategy to expand capabilities across the radiopharmaceutical value chain, diversify revenue, including with Neuraceq, and drive future growth. At the same time, we navigated increased competition in the PSMA PET landscape, which impacted PYLARIFY performance. We are taking actions to reinforce PYLARIFY’s clinical differentiation and support the value of our PSMA PET franchise,” said Brian Markison, CEO. “Today, we announced the FDA has accepted our NDA for a new PSMA PET formulation and the Board authorized a new $400 million stock repurchase program, which reflects our confidence in our long-term strategy to deliver value for our business, patients, and shareholders.”

Summary Financial Results

 

 

Three Months Ended
June 30,

 

(in millions, except per share data - unaudited)

 

2025

 

 

2024

 

 

% Change

 

Worldwide revenue

 

$

378.0

 

 

$

394.1

 

 

 

(4.1

%)

GAAP net income

 

$

78.8

 

 

$

62.1

 

 

 

26.9

%

GAAP fully diluted earnings per share

 

$

1.12

 

 

$

0.88

 

 

 

27.3

%

Adjusted net income (non-GAAP)

 

$

110.6

 

 

$

126.8

 

 

 

(12.8

%)

Adjusted fully diluted earnings per share (non-GAAP)

 

$

1.57

 

 

$

1.80

 

 

 

(12.8

%)

Second Quarter 2025

Sales of PYLARIFY were $250.6 million, a decrease of 8.3%.
Sales of DEFINITY were $83.9 million, an increase of 7.5%.
Operating income decreased 14.4% to $88.0 million. Adjusted operating income (non-GAAP) decreased 10.8% to $152.6 million.
Fully diluted earnings per share increased 27.3% to $1.12, compared to $0.88 in the prior year period. Adjusted fully diluted earnings per share (non-GAAP) decreased 12.8% to $1.57, compared to $1.80 in the prior year period.

Page 1 of 11


 

Net cash provided by operating activities and free cash flow were $87.1 million and $79.1 million, respectively.

Balance Sheet

At June 30, 2025, the Company's cash and cash equivalents were $695.6 million, after payment of $276.4 million for the Evergreen Theragnostics, Inc. (“Evergreen”) acquisition, which closed early in the second quarter of 2025, compared to $912.8 million at December 31, 2024.
The Company currently has access to up to $750.0 million from a revolving line of credit.

Recent Business Highlights

Business Development Updates

In July, the Company announced the completion of the acquisition of Life Molecular Imaging, a global radiopharmaceutical company dedicated to developing and offering novel cutting-edge radiopharmaceuticals that improve early detection and characterization of chronic and life-threatening diseases. Through the transaction, Lantheus acquired Neuraceq, a globally approved beta-amyloid targeted radiodiagnostic for Alzheimer’s disease, as well as an international commercial footprint and infrastructure.
In June, the FDA approved an updated label for Neuraceq, expanding the clinical indication to include the use in both diagnostic assessment and identification of appropriate candidates for FDA-approved amyloid-targeting therapies. The expanded label also includes the utilization of quantitative amyloid plaque metrics in conjunction with visual image interpretation and broader use for monitoring of therapy and following progression to Alzheimer's disease.
In May, the Company announced an agreement to sell its SPECT business to Illuminated Holdings, Inc., the parent company of SHINE Technologies, LLC (“SHINE”). The transaction allows Lantheus to focus on growing its commercial portfolio of innovative PET radiodiagnostics and microbubbles, while advancing its pipeline of radiopharmaceuticals. The transaction is expected to close by the end of the year, subject to customary closing conditions.
In April, the Company announced the completion of the acquisition of Evergreen, a clinical-stage radiopharmaceutical company based in New Jersey. Through the transaction, Lantheus acquired OCTEVY™, a registrational-stage PET imaging agent targeting neuroendocrine tumors, which complements Lantheus’ therapeutic candidate PNT2003, and also acquired a portfolio of clinical and pre-clinical theranostic pairs. The acquisition also advances Lantheus’ capabilities with the addition of Evergreen’s radioligand therapy manufacturing infrastructure, including a revenue-generating CDMO business.

Radiopharmaceutical Pipeline Updates

This morning, the Company announced FDA acceptance of a new drug application (“NDA”) for a new formulation of piflufolastat F 18 PSMA PET imaging agent. The new formulation will increase batch size by ~50%, which would allow Lantheus to serve significantly more patients while maintaining the same high standards that have made PYLARIFY the trusted choice for providers.
In April, the Company announced that MK-6240, its next-generation tau imaging agent, met its primary endpoints in two pivotal clinical studies assessing the investigational asset’s sensitivity and specificity. The Company plans to submit an NDA to the FDA in the third quarter of 2025.

Other Key Updates

Full Year 2025 Updated Corporate Financial Guidance

 

 

Guidance Issued August 6, 2025

 

Guidance Issued May 7, 2025

FY 2025 Revenue

 

$1.475 billion - $1.51 billion

 

$1.550 billion - $1.585 billion

FY 2025 Adjusted fully diluted EPS

 

$5.50 - $5.70

 

$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,

Page 2 of 11


 

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, August 6, 2025, 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

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 New Jersey, Canada, Germany, Sweden and Switzerland, Lantheus has been providing radiopharmaceutical solutions for nearly 70 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 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.

Page 3 of 11


 

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. These forward-looking statements may be identified by their use of terms such as “advance,” “believe,” “continue,” “could,” “driving,” “expect,” “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 2025 and our plans to expand our portfolio of late-stage assets and high potential early-stage candidates, our acquisitions of Evergreen and Life Molecular and our plans to divest our SPECT business to SHINE, 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 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, in amounts and at the times needed; (iii) the availability of raw materials, key components, and equipment, either used in the production of our products and product candidates, or in the use by healthcare professionals (“HCPs”) of our products and product candidates, including, but not limited to positron emission tomography (“PET”) scanners for PYLARIFY, MK-6240 and NAV-4694; (iv) 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, including the timing for any potential regulatory submissions for these investigational assets; (v) our ability to successfully integrate acquisitions, including of Life Molecular and Evergreen, including the potential for unforeseen expenses related to integration activities, the accuracy of our financial models, 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; (vi) our ability to obtain U.S. Food and Drug Administration (“FDA”) approval for our new F 18 PSMA PET product candidate, to complete the technology transfer across our PET manufacturing facilities network for such new product candidate, and to obtain adequate coding, coverage and payment, including transitional pass-through payment status, for such new product candidate; (vii) our ability to complete the sale of our single-photon emission computerized tomography (“SPECT”) business to SHINE on the proposed terms or on the anticipated timeline, or at all, including risks and uncertainties related to securing the necessary regulatory approvals and satisfaction of other closing conditions to consummate the transaction, unforeseen expenses related to the divestiture, and failure to realize the expected benefits of the transaction; (viii) our ability to obtain FDA approval for LNTH-2501, our investigational kit for the preparation of Gallium-68 DOTATOC, which may be used in conjunction with a PET scan to stage and localize gastroenteropancreatic neuroendocrine tumors in adults and children, and approval for PNT2003, and to be successful in the patent litigation associated with PNT2003; (ix) the cost, 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; (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 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 -

Page 4 of 11


 

Lantheus Holdings, Inc.

Consolidated Statements of Operations

(in thousands, except per share data – unaudited)

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Revenues

 

$

378,045

 

 

$

394,091

 

 

$

750,809

 

 

$

764,066

 

Cost of goods sold

 

 

137,034

 

 

 

138,317

 

 

 

272,098

 

 

 

266,446

 

Gross profit

 

 

241,011

 

 

 

255,774

 

 

 

478,711

 

 

 

497,620

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing

 

 

41,041

 

 

 

45,035

 

 

 

83,544

 

 

 

90,581

 

General and administrative

 

 

66,515

 

 

 

47,409

 

 

 

123,331

 

 

 

95,304

 

Research and development

 

 

45,489

 

 

 

60,601

 

 

 

81,803

 

 

 

108,625

 

Total operating expenses

 

 

153,045

 

 

 

153,045

 

 

 

288,678

 

 

 

294,510

 

Gain on sale of assets

 

 

 

 

 

 

 

 

 

 

 

6,254

 

Operating income

 

 

87,966

 

 

 

102,729

 

 

 

190,033

 

 

 

209,364

 

Interest expense

 

 

4,917

 

 

 

4,862

 

 

 

9,721

 

 

 

9,721

 

Investment in equity securities - unrealized (gain) loss

 

 

(14,573

)

 

 

22,537

 

 

 

289

 

 

 

(38,167

)

Other income

 

 

(6,895

)

 

 

(9,044

)

 

 

(21,023

)

 

 

(17,832

)

Income before income taxes

 

 

104,517

 

 

 

84,374

 

 

 

201,046

 

 

 

255,642

 

Income tax expense

 

 

25,762

 

 

 

22,301

 

 

 

49,346

 

 

 

62,503

 

Net income

 

$

78,755

 

 

$

62,073

 

 

$

151,700

 

 

$

193,139

 

Net income per common share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

1.15

 

 

$

0.89

 

 

$

2.21

 

 

$

2.80

 

Diluted

 

$

1.12

 

 

$

0.88

 

 

$

2.14

 

 

$

2.74

 

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

68,516

 

 

 

69,356

 

 

 

68,591

 

 

 

69,056

 

Diluted

 

 

70,312

 

 

 

70,601

 

 

 

70,896

 

 

 

70,364

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Page 5 of 11


 

Lantheus Holdings, Inc.

Consolidated Revenues Analysis

(in thousands, except percent data – unaudited)

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2025

 

 

2024

 

 

Change $

 

 

Change %

 

 

 

2025

 

 

 

2024

 

 

Change $

Change %

 

PYLARIFY

 

$

250,642

 

 

$

273,255

 

 

$

(22,613

)

 

 

(8.3

)%

 

$

508,296

 

 

$

532,125

 

 

$

(23,829

)

 

 

(4.5

)%

Other radiopharmaceutical oncology

 

 

 

 

 

 

 

 

 

%

 

 

 

 

 

384

 

 

 

(384

)

 

 

(100.0

)%

Total radiopharmaceutical oncology

 

 

250,642

 

 

 

273,255

 

 

 

(22,613

)

 

 

(8.3

)%

 

 

508,296

 

 

 

532,509

 

 

 

(24,213

)

 

 

(4.5

)%

DEFINITY

 

 

83,939

 

 

 

78,100

 

 

 

5,839

 

 

 

7.5

%

 

 

163,150

 

 

 

154,664

 

 

 

8,486

 

 

 

5.5

%

TechneLite

 

 

24,982

 

 

 

28,186

 

 

 

(3,204

)

 

 

(11.4

)%

 

 

44,693

 

 

 

49,900

 

 

 

(5,207

)

 

 

(10.4

)%

Other precision diagnostics

 

 

6,892

 

 

 

5,825

 

 

 

1,067

 

 

 

18.3

%

 

 

12,333

 

 

 

11,757

 

 

 

576

 

 

 

4.9

%

Total precision diagnostics

 

 

115,813

 

 

 

112,111

 

 

 

3,702

 

 

 

3.3

%

 

 

220,176

 

 

 

216,321

 

 

 

3,855

 

 

 

1.8

%

Strategic partnerships and other revenue

 

 

11,590

 

 

 

8,725

 

 

 

2,865

 

 

 

32.8

%

 

 

22,337

 

 

 

15,236

 

 

 

7,101

 

 

 

46.6

%

Total revenues

 

$

378,045

 

 

$

394,091

 

 

$

(16,046

)

 

 

(4.1

)%

 

$

750,809

 

 

$

764,066

 

 

$

(13,257

)

 

 

(1.7

)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Page 6 of 11


 

Lantheus Holdings, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(in thousands, except per share and percent data – unaudited)

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Net income

 

$

78,755

 

 

$

62,073

 

 

$

151,700

 

 

$

193,139

 

Stock and incentive plan compensation

 

 

22,321

 

 

 

18,479

 

 

 

43,519

 

 

 

33,863

 

Amortization of acquired intangible assets

 

 

7,971

 

 

 

10,122

 

 

 

15,987

 

 

 

20,053

 

Campus consolidation costs

 

 

7

 

 

 

(5

)

 

 

67

 

 

 

14

 

Contingent consideration fair value adjustments

 

 

 

 

 

100

 

 

 

 

 

 

100

 

Non-recurring fees

 

 

155

 

 

 

 

 

 

2,633

 

 

 

 

Gain on sale of assets

 

 

 

 

 

 

 

 

 

 

 

(6,254

)

Strategic collaboration and license costs

 

 

10,000

 

 

 

38,191

 

 

 

15,413

 

 

 

66,191

 

Investment in equity securities - unrealized (gain) loss(a)

 

 

(14,531

)

 

 

22,537

 

 

 

331

 

 

 

(38,167

)

Acquisition, integration and divestiture-related costs

 

 

22,921

 

 

 

821

 

 

 

27,672

 

 

 

1,609

 

Other

 

 

1,231

 

 

 

679

 

 

 

(3,221

)

 

 

1,468

 

Income tax effect of non-GAAP adjustments(b)

 

 

(18,206

)

 

 

(26,158

)

 

 

(34,002

)

 

 

(26,859

)

Adjusted net income

 

$

110,624

 

 

$

126,839

 

 

$

220,099

 

 

$

245,157

 

Adjusted net income, as a percentage of revenues

 

 

29.3

%

 

 

32.2

%

 

 

29.3

%

 

 

32.1

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Net income per share - diluted

 

$

1.12

 

 

$

0.88

 

 

$

2.14

 

 

$

2.74

 

Stock and incentive plan compensation

 

 

0.32

 

 

 

0.26

 

 

 

0.61

 

 

 

0.48

 

Amortization of acquired intangible assets

 

 

0.11

 

 

 

0.14

 

 

 

0.23

 

 

 

0.28

 

Campus consolidation costs

 

 

0.00

 

 

 

(0.00

)

 

 

0.00

 

 

 

0.00

 

Contingent consideration fair value adjustments

 

 

 

 

 

0.00

 

 

 

 

 

 

0.00

 

Non-recurring fees

 

 

0.00

 

 

 

 

 

 

0.04

 

 

 

 

Gain on sale of assets

 

 

 

 

 

 

 

 

 

 

 

(0.09

)

Strategic collaboration and license costs

 

 

0.14

 

 

 

0.54

 

 

 

0.22

 

 

 

0.94

 

Investment in equity securities - unrealized (gain) loss(a)

 

 

(0.21

)

 

 

0.32

 

 

 

0.00

 

 

 

(0.54

)

Acquisition, integration and divestiture-related costs

 

 

0.33

 

 

 

0.01

 

 

 

0.39

 

 

 

0.02

 

Other

 

 

0.02

 

 

 

0.01

 

 

 

(0.05

)

 

 

0.02

 

Income tax effect of non-GAAP adjustments(b)

 

 

(0.26

)

 

 

(0.36

)

 

 

(0.48

)

 

 

(0.37

)

Adjusted net income per share - diluted(c)

 

$

1.57

 

 

$

1.80

 

 

$

3.10

 

 

$

3.48

 

Weighted-average common shares outstanding - diluted

 

 

70,312

 

 

 

70,601

 

 

 

70,896

 

 

 

70,364

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(a)
Non-GAAP amount excludes a gain of $42 from the change in value of other assets for the three and six months ended June 30, 2025.
(b)
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.
(c)
Amounts may not add due to rounding.

Page 7 of 11


 

Lantheus Holdings, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures (Continued)

(in thousands, except per share and percent data – unaudited)

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Operating income

 

$

87,966

 

 

$

102,729

 

 

$

190,033

 

 

$

209,364

 

Stock and incentive plan compensation

 

 

22,321

 

 

 

18,479

 

 

 

43,519

 

 

 

33,863

 

Amortization of acquired intangible assets

 

 

7,971

 

 

 

10,122

 

 

 

15,987

 

 

 

20,053

 

Campus consolidation costs

 

 

7

 

 

 

(5

)

 

 

67

 

 

 

14

 

Contingent consideration fair value adjustments

 

 

 

 

 

100

 

 

 

 

 

 

100

 

Non-recurring fees

 

 

155

 

 

 

 

 

 

2,633

 

 

 

 

Gain on sale of assets

 

 

 

 

 

 

 

 

 

 

 

(6,254

)

Strategic collaboration and license costs

 

 

10,000

 

 

 

38,191

 

 

 

15,413

 

 

 

66,191

 

Acquisition, integration and divestiture-related costs

 

 

22,921

 

 

 

821

 

 

 

27,672

 

 

 

1,609

 

Other

 

 

1,231

 

 

 

679

 

 

 

1,506

 

 

 

1,468

 

Adjusted operating income

 

$

152,572

 

 

$

171,116

 

 

$

296,830

 

 

$

326,408

 

Adjusted operating income, as a percentage of revenues

 

 

40.4

%

 

 

43.4

%

 

 

39.5

%

 

 

42.7

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Page 8 of 11


 

Lantheus Holdings, Inc.

Reconciliation of Free Cash Flow

(in thousands – unaudited)

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Net cash provided by operating activities

 

$

87,106

 

 

$

84,720

 

 

$

194,669

 

 

$

211,958

 

Capital expenditures

 

 

(7,961

)

 

 

(11,175

)

 

 

(16,679

)

 

 

(19,448

)

Free cash flow

 

$

79,145

 

 

$

73,545

 

 

$

177,990

 

 

$

192,510

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net cash used in investing activities

 

$

(232,472

)

 

$

(45,086

)

 

$

(296,190

)

 

$

(151,615

)

Net cash (used in) provided by financing activities

 

$

(98,413

)

 

$

99

 

 

$

(116,632

)

 

$

(16,746

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Page 9 of 11


 

Lantheus Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands – unaudited)

 

 

June 30,

 

 

December 31,

 

 

 

2025

 

 

2024

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

695,572

 

 

$

912,814

 

Accounts receivable, net

 

 

336,579

 

 

 

321,258

 

Inventory

 

 

62,157

 

 

 

68,025

 

Other current assets

 

 

34,093

 

 

 

24,536

 

Assets held for sale

 

 

73,415

 

 

 

 

Total current assets

 

 

1,201,816

 

 

 

1,326,633

 

Investment in equity securities

 

 

45,068

 

 

 

39,489

 

Property, plant and equipment, net

 

 

157,726

 

 

 

176,798

 

Intangibles, net

 

 

359,946

 

 

 

161,761

 

Goodwill

 

 

176,869

 

 

 

61,189

 

Deferred tax assets, net

 

 

138,262

 

 

 

170,233

 

Other long-term assets

 

 

36,390

 

 

 

44,237

 

Total assets

 

$

2,116,077

 

 

$

1,980,340

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Current portion of long-term debt and other borrowings

 

$

796

 

 

$

974

 

Accounts payable

 

 

40,891

 

 

 

34,560

 

Accrued expenses and other liabilities

 

 

208,600

 

 

 

204,992

 

Liabilities held for sale

 

 

29,845

 

 

 

 

Total current liabilities

 

 

280,132

 

 

 

240,526

 

Asset retirement obligations

 

 

136

 

 

 

23,344

 

Long-term debt and other borrowings, net of current portion

 

 

566,847

 

 

 

565,279

 

Other long-term liabilities

 

 

102,179

 

 

 

63,180

 

Total liabilities

 

 

949,294

 

 

 

892,329

 

Total stockholders’ equity

 

 

1,166,783

 

 

 

1,088,011

 

Total liabilities and stockholders’ equity

 

$

2,116,077

 

 

$

1,980,340

 

 

 

 

 

 

 

 

 

Page 10 of 11


 

###

Contacts:

Mark Kinarney

Vice President, Investor Relations

978-671-8842

ir@lantheus.com

 

Melissa Downs

Executive Director, External Communications

646-975-2533

media@lantheus.com

Page 11 of 11


EX-99.2 3 lnth-ex99_2.htm EX-99.2 EX-99.2

 

Exhibit 99.2

 

img67261360_0.jpg

 

Lantheus Announces FDA Acceptance of NDA for New Formulation for Market-Leading PSMA PET Imaging Agent

Designed to expand PSMA PET imaging access for patients by increasing batch size by ~50% and enhancing supply resilience

PDUFA date set for March 6, 2026

BEDFORD, Mass., August 6, 2025 – Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that the Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for a new formulation of its F 18 PSMA imaging agent filed by its affiliate, Aphelion. The FDA has set an action date goal of March 6, 2026 under the Prescription Drug User Fee Act (PDUFA).

This NDA acceptance builds on the success of Lantheus’ market-leading PSMA PET imaging agent, PYLARIFY, which has demonstrated high diagnostic performance and meaningful impact on clinical decision making. If approved, we expect that this new formulation will offer an efficacy consistent with the market-leading PSMA PET agent, PYLARIFY, which has demonstrated an 86% median true-positive rate based on three independent readers in a study of patients with recurrent prostate cancer based on rising PSA after therapy. 1

“We are pleased the FDA accepted Aphelion’s NDA for the new piflufolastat F 18 formulation, which we expect will improve patient access due to a significant increase in the number of doses per batch,” said Brian Markison, CEO, Lantheus. “This formulation is a natural next step in our commitment to advancing PSMA imaging. There is a growing burden of prostate cancer in the U.S. and a clear need for accurate and early detection. Building on PYLARIFY’s proven performance and accuracy, Lantheus is well-positioned for continued leadership in prostate cancer imaging.”

This new formulation optimizes the manufacturing process and is expected to increase batch size by ~50%, allowing Lantheus to serve significantly more patients while maintaining the same high standards that has made PYLARIFY the trusted choice for providers. The new formulation increases the radioactive concentration of the agent and has the potential to expand patient access in new geographic locations.

“We have reached a key milestone and delivered on our commitment to advance prostate cancer imaging through sustainable innovation,” said Paul Blanchfield, President, Lantheus. “By enhancing the efficiency of production, we expect to improve patient access, streamline operations, and support the broader healthcare system’s ability to deliver timely diagnostic imaging.”

About Prostate Cancer

In the U.S., prostate cancer is the second most frequently diagnosed cancer and fifth-leading cause of cancer-related deaths among men globally. For 2025, estimates suggest nearly 315,000 new cases and


 

more than 35,000 deaths.2 Projections indicate a significant increase in prostate cancer incidence, with annual cases expected to nearly double to 2.9 million by 2040.3 This is largely attributed to aging populations and increased life expectancy, particularly in low- and middle-income countries where healthcare access and early detection may be limited.

About PYLARIFY® (piflufolastat F 18) Injection

PYLARIFY® (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.3-9

PYLARIFY has made a profound impact on the lives of patients battling prostate cancer. It is the number one ordered PSMA PET imaging agent in the U.S., and is a proven diagnostic backed by real-world experience, including in over 500,000 scans across 48 states, Puerto Rico and Washington, D.C.

PYLARIFY® (piflufolastat F 18) Injection

Indication

PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Important Safety Information

Contraindications

None.

Warnings and Precautions

Risk of Image Misinterpretation

Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.


 

Hypersensitivity Reactions

Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks

Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions

The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please read the accompanying full Prescribing Information also available at PYLARIFY.com.

Safe Harbor for Forward-Looking and Cautionary Statements

This press release contains “forward-looking statements” that are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements relating to the potential FDA approval of the NDA for a new formulation of piflufolastat F18, the Company’s F-18 based PET imaging agent and statements regarding Lantheus’ expectations, hopes, beliefs, intentions or strategies regarding the future. Forward-looking statements may be identified by their use of terms such as “aim,” “designed,” “expect,” “expected,” “will” and other similar terms. Such forward-looking statements 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, including our ability to obtain FDA approval for our new formulation of PYLARIFY, to complete the technology transfer across our PET manufacturing facilities network for such new formulation, and to obtain adequate coding, coverage and payment, as well as 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).


 

About Lantheus

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 New Jersey, Canada, Germany, Sweden and Switzerland, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. For more information, visit www.lantheus.com.

1Morris MJ, et al; CONDOR Study Group. Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study. Clin Cancer Res. 2021 Jul 1;27(13):3674-3682. doi: 10.1158/1078-0432.CCR-20-4573. Epub 2021 Feb 23. PMID: 33622706; PMCID: PMC8382991.

2American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025. Available at https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2025-cancer-facts-figures.html

3Harris E. Prostate Cancer Cases Might Rise to 3 Million Globally by 2040. JAMA. 2024;331(20):1698. doi:10.1001/jama.2024.6729

4PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.

5Data on file. Bedford, MA: Progenics Pharmaceuticals, Inc.; 2024.

6Mena E, Lindenberg ML, Turkbey IB, et al. 18F-DCFPyL PET/CT imaging in patients with biochemically recurrent prostate cancer after primary local therapy. J Nucl Med. 2020;61(6):881-889.

7Werner RA, Derlin T, Lapa C, et al. 18F-labeled, PSMA-targeted radiotracers: leveraging the advantages of radiofluorination for prostate cancer molecular imaging. Theranostics. 2020;10(1):1-16.

8Alipour R, Azad A, Hofman MS. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? TherAdv Med Oncol. 2019;11:1-14.

9Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):10.

Contacts:

Lantheus

Mark Kinarney

Vice President, Investor Relations

978-671-8842

ir@lantheus.com

Melissa Downs

Executive Director, External Communications

646-975-2533

media@lantheus.com


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Document And Entity Information
Aug. 06, 2025
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Aug. 06, 2025
Entity Registrant Name LANTHEUS HOLDINGS, INC.
Entity Central Index Key 0001521036
Entity Emerging Growth Company false
Entity File Number 001-36569
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 35-2318913
Entity Address, Address Line One 201 Burlington Road
Entity Address, Address Line Two South Building
Entity Address, City or Town Bedford
Entity Address, State or Province MA
Entity Address, Postal Zip Code 01730
City Area Code (978)
Local Phone Number 671-8001
Entity Information, Former Legal or Registered Name Not Applicable
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common stock, par value $0.01 per share
Trading Symbol LNTH
Security Exchange Name NASDAQ

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