Lantheus Reports Third Quarter 2024 Financial Results
LNTH 11.06.2024
Drug:PYLARIFY-001 PYLARIFY
Drug:DEFINITY-001 DEFINITY
Drug:NAV-4694-001 NAV-4694
Diseases:Alzheimer's Disease
About Gravity Analytica
Recent News
- 01.13.2025 - Lantheus' Acquisition of Life Molecular Imaging Conference Call
- 01.13.2025 - Lantheus to Acquire Life Molecular Imaging for an Upfront Payment of $350 Million to Accelerate Innovation for Patients in the Growing Alzheimer’s Disease Radiodiagnostic Market
- 12.18.2024 - Paul K. Choi
Recent Filings
- 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
“PYLARIFY is on track to exceed
Summary Financial Results
| (in millions, except per share data – unaudited) | Three Months Ended | |||||||||||
| 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 atDecember 31, 2023 , even after accounting for the$35.0 million net investment related to the acquisition ofRM2 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 effectJanuary 1, 2025 .
Full Year 2024 Financial Guidance
| Guidance Issued | Guidance Issued | |
| FY 2024 Revenue | ||
| FY 2024 Adjusted Fully Diluted EPS | ||
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
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
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
Internet Posting of Information
The Company routinely posts information that may be important to investors in the “Investors” section of its website atwww.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 year2024and 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
- Tables Follow -
| Three Months Ended | Nine Months Ended | ||||||||||||||
| 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 | |||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||
| 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 | % | ||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| 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 | Nine Months Ended | ||||||||||||||
| 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.
| Three Months Ended | Nine Months Ended | ||||||||||||||
| 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 | % | |||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| 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 | ) | |||||
| 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 | |||||
| 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 ( | — | — | |||||
| Common stock ( | 709 | 699 | |||||
| Additional paid-in capital | 797,430 | 757,727 | |||||
| Treasury Stock at cost - 1,339 shares as of | (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 | |||
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Source: Lantheus Holdings, Inc.