Lantheus Reports Third Quarter 2024 Financial Results

Source: GlobeNewswire
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., Nov. 06, 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,
  2024   2023  % 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.
  • 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, 2024Guidance 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.

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 -

Lantheus Holdings, Inc.

Consolidated Statements of Operations

(in thousands, except per share data – unaudited)
 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
  2024   2023   2024   2023 
Revenues$378,734  $319,946  $1,142,800  $942,430 
Cost of goods sold 136,608   119,995   403,054   462,756 
Gross profit 242,126   199,951   739,746   479,674 
Operating expenses       
Sales and marketing 43,719   37,399   134,300   106,472 
General and administrative 40,516   35,741   135,820   85,163 
Research and development 24,148   14,450   132,773   60,883 
Total operating expenses 108,383   87,590   402,893   252,518 
Gain on sale of assets       6,254    
Operating income 133,743   112,361   343,107   227,156 
Interest expense 4,903   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 taxes 176,118   159,956   431,760   272,540 
Income tax expense 45,025   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:       
Basic 69,464   68,436   69,193   68,188 
Diluted 73,065   70,046   71,331   70,268 
                


Lantheus Holdings, Inc.

Consolidated Revenues Analysis

(in thousands – unaudited)
 
  Three Months Ended
September 30,
 Nine Months Ended
September 30,
   2024   2023  % Change  2024   2023  % 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 oncology  259,756   216,276   20.1%  792,265   623,802   27.0%
DEFINITY  76,965   67,336   14.3%  231,629   206,688   12.1%
TechneLite  20,480   23,272   (12.0)%  70,380   65,853   6.9%
Other precision diagnostics  6,282   5,740   9.4%  18,039   17,002   6.1%
Total precision diagnostics  103,727   96,348   7.7%  320,048   289,543   10.5%
Strategic partnerships and other revenue  15,251   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%
                         


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,
  2024   2023   2024   2023 
Net income$131,093  $131,957  $324,232  $223,281 
Stock and incentive plan compensation 20,366   13,976   54,229   36,335 
Amortization of acquired intangible assets 11,908   11,659   31,961   35,132 
Campus consolidation costs 23   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 costs 30      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 
Other 805   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 revenues 32.8%  32.2%  32.3%  33.4%
                


 Three Months Ended
September 30,
 Nine Months Ended
September 30,
  2024   2023   2024   2023 
Net income per share - diluted$1.79  $1.88  $4.55  $3.18 
Stock and incentive plan compensation 0.28   0.20   0.76   0.52 
Amortization of acquired intangible assets 0.16   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 
Other 0.01   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 - diluted 73,065   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.

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,
  2024   2023   2024   2023 
Operating income$133,743  $112,361  $343,107  $227,156 
Stock and incentive plan compensation 20,366   13,976   54,229   36,335 
Amortization of acquired intangible assets 11,908   11,659   31,961   35,132 
Campus consolidation costs 23   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 costs 30      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 
Other 805   1,510   2,273   2,194 
Adjusted operating income$165,107  $139,543  $491,515  $431,611 
Adjusted operating income, as a percentage of revenues 43.6%  43.6%  43.0%  45.8%
                


Lantheus Holdings, Inc.

Reconciliation of Free Cash Flow

(in thousands – unaudited)
 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
  2024   2023   2024   2023 
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)
                


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, net 329,336   284,292 
Inventory 70,835   64,029 
Other current assets 21,998   16,683 
Assets held for sale 7,159   7,159 
Total current assets 1,295,714   1,085,819 
Investment in equity securities 158,791    
Property, plant and equipment, net 169,512   146,697 
Intangibles, net 173,606   151,985 
Goodwill 61,189   61,189 
Deferred tax assets, net 144,641   150,198 
Other long-term assets 46,177   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 payable 44,914   41,189 
Accrued expenses and other liabilities 174,452   145,338 
Total current liabilities 784,079   187,350 
Asset retirement obligations 23,237   22,916 
Long-term debt, net and other borrowings 613   561,670 
Other long-term liabilities 61,993   63,321 
Total liabilities 869,922   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 capital 797,430   757,727 
Treasury Stock at cost - 1,339 shares as of September 30, 2024 and December 31, 2023 (75,000)  (75,000)
Retained earnings 457,735   133,503 
Accumulated other comprehensive loss (1,166)  (1,037)
Total stockholders’ equity 1,179,708   815,892 
Total liabilities and stockholders’ equity$2,049,630  $1,651,149 
        

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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