Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _______________________________________________________________ FORM 10-K _______________________________________________________________ (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File N ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36569 LANTHEUS HOLDINGS, INC. (Exact name of registrant as specified in its charter) | Delaware | 35-2318913 ...

Financial Data and Key Metrics Changes - The company reported revenue of $321.7 million for Q2 2023, representing a 44% increase year-over-year [7][18] - Earnings per share (EPS) for the quarter were $1.54, an increase of 73.8% compared to the prior year [18][50] - Gross profit margin improved to 69.6%, up 359 basis points from Q2 2022 [20] Business Line Data and Key Metrics Changes - Precision Diagnostics revenue was $97.6 million, up 12% from the prior year [19] - Sales of DEFINITY reached $70.5 million, a 13.2% increase year-over-year [40] - Radiopharmaceutical oncology revenue was $211.3 million, up 61.1% year-over-year, with PYLARIFY contributing $210.5 million [46] Market Data and Key Metrics Changes - The company estimates a total addressable market (TAM) for PSMA radiopharmaceuticals of $3.5 billion, with approved PSMA radiotherapy expected to exceed $1 billion in sales this year [15] - The market for PYLARIFY is projected to be between $835 million to $860 million for the full year [53] Company Strategy and Development Direction - The company is focused on expanding its portfolio and pipeline, including PSMA-targeted radio therapeutics [41] - The company aims to maintain its leadership in the radiopharmaceutical market by investing in innovative diagnostics and therapeutics [27] - The company is advocating for the FIND Act to ensure continued access to innovative diagnostic radiopharmaceuticals [12][71] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth of PYLARIFY and the overall PSMA PET imaging market despite new competition [59][91] - The company noted a rebound in health system procedure volume as patient visits continue to recover post-pandemic [13] - Management is optimistic about the future impact on prostate cancer patients and the potential for continued growth in the radiopharmaceutical sector [40][55] Other Important Information - The company reduced its net contingent liability accrual by $7.6 million and recorded a fixed asset impairment of $6 million during the quarter [22] - Cash and cash equivalents stood at $414.1 million at the end of the quarter, with access to a $350 million undrawn bank revolver [24] Q&A Session Summary Question: What are the main drivers behind the guidance raise? - Management indicated that the guidance raise is primarily due to outperformance in Q2 and confidence in driving growth [58][80] Question: How does the company view competition from new PSMA agents? - Management believes that the introduction of new competitors will not significantly impact PYLARIFY's market position, as it remains clinically and commercially differentiated [79][91] Question: What are the expectations regarding reimbursement developments? - Management is optimistic about proposed changes from CMS that could enhance reimbursement for innovative radiopharmaceutical diagnostics [94][121] Question: How is the company addressing the adoption of PYLARIFY among physicians? - The company is focusing on increasing awareness and understanding among physicians regarding the benefits of PYLARIFY for patient management [104][127] Question: What is the company's strategy for the European market? - The company is confident in its partnership with Curium to expand PYLARIFY's presence in Europe, despite fewer PET facilities [124]

© 2023 Lantheus. All rights reserved. 22 Condensed Consolidated Statement of Operations – 2Q 2023 1. Internal analyses; 2. DRG Echo Monthly Monitor; 3. See slide 28 for reconciliations of GAAP to non-GAAP financials; certain amounts may be subject to rounding. (in thousands – unaudited) 13,092 354 © 2023 Lantheus. All rights reserved. Seasoned and Experienced with a Strong Track Record of Value Creation 1. CONDOR pivotal registrational study evaluated as a secondary endpoint change in intended patient manag ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Lantheus Holdings, Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, with accompanying notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $414,076 | $415,652 | | Total current assets | $752,219 | $677,616 | | Total assets | $1,337,720 | $1,321,258 | | **Liabilities & Equity** | | | | Total current liabilities | $154,043 | $247,701 | | Total liabilities | $785,075 | $874,111 | | Total stockholders' equity | $552,645 | $447,147 | - Total liabilities decreased significantly from **$874.1 million** at year-end 2022 to **$785.1 million**, primarily due to the settlement of a **$99.7 million** short-term contingent liability related to CVRs[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2023 | Q2 2022 | YTD 2023 | YTD 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $321,700 | $223,723 | $622,484 | $432,603 | | Gross Profit | $202,647 | $138,029 | $279,723 | $267,099 | | Operating Income | $124,139 | $63,204 | $114,795 | $122,129 | | Net Income | $94,131 | $43,058 | $91,324 | $86,020 | | Diluted EPS | $1.33 | $0.61 | $1.31 | $1.22 | - Revenues for the three months ended June 30, 2023, increased by **43.8%** year-over-year, driven by strong product sales. Net income for the same period more than doubled to **$94.1 million** from **$43.1 million** in the prior year[12](index=12&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash provided by operating activities | $76,234 | $82,861 | | Net cash used in investing activities | ($65,210) | ($5,733) | | Net cash used in financing activities | ($12,720) | ($4,190) | - Cash from operating activities decreased slightly to **$76.2 million** for the first six months of 2023, impacted by a decrease in accruals from the CVR payment and an increase in accounts receivable[170](index=170&type=chunk) - Cash used in investing activities increased significantly to **$65.2 million**, primarily due to the **$45.3 million** acquisition of Cerveau and **$19.9 million** in capital expenditures[22](index=22&type=chunk)[172](index=172&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Revenue by Product Category (in thousands) | Product Category | Q2 2023 | Q2 2022 | YTD 2023 | YTD 2022 | | :--- | :--- | :--- | :--- | :--- | | PYLARIFY | $210,522 | $130,232 | $405,992 | $223,009 | | DEFINITY | $70,529 | $62,306 | $139,353 | $120,634 | | TechneLite | $21,594 | $19,440 | $42,580 | $42,045 | | Strategic partnerships & other | $12,783 | $5,454 | $21,763 | $34,032 | - In May 2023, the company paid **$99.6 million** in full satisfaction of the Contingent Value Rights (CVRs) obligation tied to PYLARIFY's 2022 sales performance[31](index=31&type=chunk)[41](index=41&type=chunk) - In February 2023, the company acquired Cerveau Technologies, Inc. for an upfront payment of approximately **$35.3 million**, with an additional **$10.0 million** paid in May 2023 and potential future milestone payments[95](index=95&type=chunk)[96](index=96&type=chunk) - The company recorded non-cash impairment charges in Q1 2023 totaling **$132.0 million** (**$116.4 million** in COGS and **$15.6 million** in R&D) related to the AZEDRA asset group after halting development activities for a future indication[61](index=61&type=chunk)[62](index=62&type=chunk) - On August 2, 2023, the company sold its right to RELISTOR net sales royalties for an initial payment of approximately **$98.0 million**[102](index=102&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes strong performance to PYLARIFY and DEFINITY growth, with total revenues up **43.9%** for H1 2023, maintaining strong liquidity with **$414.1 million** cash and a **$350 million** credit facility [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Revenue Change by Product Category - Six Months Ended June 30, 2023 vs 2022 (in thousands) | Product Category | Change $ | Change % | | :--- | :--- | :--- | | Total radiopharmaceutical oncology | $182,263 | 80.9% | | Total precision diagnostics | $19,887 | 11.5% | | Strategic partnerships and other revenue | ($12,269) | (36.1)% | - The increase in revenue for H1 2023 was primarily driven by an **82.1%** increase in PYLARIFY sales volume. The decrease in Strategic Partnerships revenue was due to a **$24.0 million** one-time licensing payment from Novartis recognized in the prior year[150](index=150&type=chunk)[151](index=151&type=chunk) - G&A expenses for H1 2023 decreased by **$20.8 million**, primarily due to a **$35.8 million** net reduction from fair value adjustments to contingent liabilities, partially offset by increased employee costs and technology investments[161](index=161&type=chunk) - R&D expenses for H1 2023 increased by **$19.5 million**, mainly due to a **$15.6 million** IPR&D asset impairment loss related to AZEDRA[163](index=163&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2023, the company had **$414.1 million** in cash and cash equivalents and access to a **$350.0 million** revolving credit facility, which was undrawn[184](index=184&type=chunk)[176](index=176&type=chunk) - Net cash from operating activities for H1 2023 was **$76.2 million**, a decrease from **$82.9 million** in H1 2022, mainly due to the CVR payment and increased accounts receivable[169](index=169&type=chunk)[170](index=170&type=chunk) - In December 2022, the company issued **$575.0 million** in 2.625% Convertible Senior Notes due 2027, with net proceeds of approximately **$557.8 million**[80](index=80&type=chunk)[179](index=179&type=chunk) - Management believes that current cash, cash generated from operations, and access to the revolving facility will be sufficient to meet capital requirements for the next twelve months and beyond[185](index=185&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reports no material changes to its market risk exposures since December 31, 2022, as detailed in its Annual Report on Form 10-K - The company's exposures to market risk have not changed materially since December 31, 2022[190](index=190&type=chunk) [Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period[191](index=191&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended June 30, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[192](index=192&type=chunk) [PART II. OTHER INFORMATION](index=45&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) As of June 30, 2023, the company reported no material ongoing litigation to which it was a party - As of June 30, 2023, the Company did not have any material ongoing litigation to which it was a party[93](index=93&type=chunk)[195](index=195&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) The company reports no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2022 - There have been no material changes to the risk factors set forth in the company's Annual Report on Form 10-K for the year ended December 31, 2022[197](index=197&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details share repurchases for tax obligations, noting **$75 million** remaining under the **$150 million** repurchase program, and the company's policy to retain earnings for growth Share Repurchases (Withheld for Taxes) - Q2 2023 | Period | Total Number of Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | April 2023 | 11,215 | $89.16 | | May 2023 | 3,997 | $98.11 | | June 2023 | 1,272 | $89.81 | | **Total** | **16,484** | | - As of June 30, 2023, approximately **$75.0 million** remained available for repurchase under the publicly announced program authorized in December 2022[198](index=198&type=chunk)[199](index=199&type=chunk) - The company did not declare or pay any dividends and does not intend to in the foreseeable future, retaining earnings for business growth and debt repayment[200](index=200&type=chunk) [Other Information](index=47&type=section&id=Item%205.%20Other%20Information) This section discloses that Board members and the President entered into Rule 10b5-1 trading plans for potential future sales of common stock during Q2 2023 - During May and June 2023, multiple members of the Board of Directors and the company's President entered into Rule 10b5-1 trading plans for the potential sale of common stock[203](index=203&type=chunk)[204](index=204&type=chunk)[208](index=208&type=chunk) [Exhibits](index=49&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the 10-Q report, including an amended office lease, the 2023 Employee Stock Purchase Plan, and CEO/CFO certifications - Filed exhibits include an amended office lease, the Lantheus Holdings, Inc. 2023 Employee Stock Purchase Plan, and CEO/CFO certifications[210](index=210&type=chunk)

Financial Data and Key Metrics Changes - In Q1 2023, the company reported record revenues of $300 million, an increase of $91.9 million or 44% year-over-year [39] - Adjusted earnings per share (EPS) for the quarter were $1.47, reflecting an increase of $0.50 or 51.3% compared to the prior year [39] - Gross profit margin improved to 68.6%, up 165 basis points from Q1 2022, driven by favorable volume and product mix [32] Business Line Data and Key Metrics Changes - The radiopharmaceutical oncology category generated $196.2 million in sales, significantly up year-over-year, primarily due to the growth of PYLARIFY [30] - Sales of PYLARIFY reached $195.5 million, representing a 110% increase year-over-year and 22% sequential growth [33] - DEFINITY sales were $68.8 million, an 18% increase from the prior year, benefiting from increased patient office visits [36] Market Data and Key Metrics Changes - The global radiopharmaceutical market is projected to grow from $6 billion in 2021 to over $35 billion by 2031, driven by new approvals and increasing patient diagnoses [24] - The company holds approximately 75% market share in the PSMA PET imaging market, indicating strong competitive positioning [115] Company Strategy and Development Direction - The company is focused on expanding its commercial portfolio and pipeline, including the recent acquisition of Cerveau Technologies for MK-6240, aimed at Alzheimer's diagnostics [8][19] - The partnership with POINT Biopharma is expected to lead to the launch of two additional oncology radiotherapeutics in the coming years [25] - The company aims to leverage its manufacturing and supply chain capabilities to drive growth in both therapeutics and diagnostics within the radiopharmaceutical sector [118] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future of the radiopharmaceutical industry, highlighting the company's unique position to lead and innovate [12] - The FDA's Fast Track designation for PNT2002 is expected to facilitate quicker development and review processes, enhancing the company's growth prospects in treating metastatic prostate cancer [6][20] - The anticipated top-line data readout for the PNT2002 SPLASH trial in the second half of 2023 is viewed as a significant milestone [21] Other Important Information - The company has a strong liquidity position with cash and cash equivalents of $470.9 million and access to a $350 million undrawn bank revolver [46] - The full-year revenue guidance has been updated to a range of $1.23 billion to $1.27 billion, reflecting strong performance in Q1 [72] Q&A Session All Questions and Answers Question: How large are the PMFs and how impactful to volumes can those sites be? - The company continues to expand its PMF network to enhance flexibility and customer experience, although specific numbers of hospitals in the network were not disclosed [52][54] Question: Is DEFINITY expected to sustain double-digit growth? - Management indicated that DEFINITY's growth is supported by returning patient volumes and improved hospital efficiencies, with expectations for continued growth [86][107] Question: What is the value proposition of PYLARIFY versus competitors? - PYLARIFY holds a significant market share due to its superior imaging capabilities and is preferred by healthcare professionals for its effectiveness in prostate cancer imaging [115] Question: What are the plans for PNT2003 and its market opportunity? - PNT2003 is on track for development, with an estimated market opportunity of approximately $800 million [156] Question: What is the impact of the Fast Track designation for PNT2002? - The Fast Track designation allows for more frequent interactions with the FDA, facilitating a more efficient submission process for the NDA [135][161]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Lantheus reported strong revenue growth driven by PYLARIFY, but a net loss due to a significant AZEDRA impairment, alongside robust operating cash flow [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets slightly increased to **$1.35 billion** driven by higher cash, while liabilities rose and equity saw a minor decrease Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $470,863 | $415,652 | | Intangibles, net | $219,863 | $315,285 | | Total assets | $1,349,284 | $1,321,258 | | **Liabilities & Equity** | | | | Total current liabilities | $276,388 | $247,701 | | Long-term debt, net | $558,536 | $557,712 | | Total liabilities | $903,768 | $874,111 | | Total stockholders' equity | $445,516 | $447,147 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Revenues increased significantly, but a substantial rise in cost of goods sold, including an impairment charge, led to an operating and net loss Q1 2023 vs Q1 2022 Statement of Operations (in thousands, except per share data) | Metric | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Revenues | $300,784 | $208,880 | | Gross Profit | $77,076 | $129,070 | | Operating (Loss) Income | $(9,344) | $58,925 | | Net (Loss) Income | $(2,807) | $42,962 | | Diluted EPS | $(0.04) | $0.61 | - The significant increase in Cost of Goods Sold to **$223.7 million** in Q1 2023 from **$79.8 million** in Q1 2022 was a primary driver of the net loss[11](index=11&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating cash flow significantly increased due to non-cash adjustments, while investing activities included the Cerveau acquisition, ending with strong cash reserves Q1 2023 vs Q1 2022 Cash Flow Summary (in thousands) | Activity | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Net cash provided by operating activities | $108,500 | $10,264 | | Net cash used in investing activities | $(44,513) | $(1,390) | | Net cash used in financing activities | $(8,669) | $(2,179) | | Net increase in cash | $55,220 | $6,846 | - A major non-cash adjustment reconciling net loss to operating cash flow was a **$132.1 million** impairment of long-lived assets[22](index=22&type=chunk) - Investing activities included **$35.3 million** for the acquisition of assets, identified as the Cerveau acquisition[22](index=22&type=chunk)[94](index=94&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes highlight PYLARIFY-driven revenue growth, a significant AZEDRA impairment, the Cerveau acquisition, upcoming CVR payments, and recent debt refinancing Revenue by Product Category (in thousands) | Product Category | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Total radiopharmaceutical oncology | $196,187 | $94,104 | | - PYLARIFY | $195,470 | $92,777 | | Total precision diagnostics | $95,617 | $86,198 | | - DEFINITY | $68,824 | $58,328 | | Strategic partnerships and other | $8,980 | $28,578 | - In March 2023, the company stopped development for a future indication of AZEDRA, leading to a non-cash impairment charge of **$15.6 million** in R&D and **$116.4 million** in cost of goods sold[64](index=64&type=chunk) - On February 6, 2023, the company acquired Cerveau and its PET imaging agent MK-6240 for an upfront payment of approximately **$35.3 million**, with potential for future milestone and royalty payments[94](index=94&type=chunk)[95](index=95&type=chunk) - The company expects to pay **$99.7 million** in Q2 2023 to satisfy its Contingent Value Rights (CVR) obligation related to PYLARIFY's 2022 sales performance[32](index=32&type=chunk)[43](index=43&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses strong revenue growth driven by PYLARIFY, the net loss from AZEDRA impairment, strategic acquisitions, and debt refinancing, affirming sufficient liquidity [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Revenue growth was driven by PYLARIFY and DEFINITY, but gross profit declined due to a significant AZEDRA impairment charge in COGS and R&D Revenue Change by Category (in thousands) | Category | Q1 2023 | Q1 2022 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Total radiopharmaceutical oncology | $196,187 | $94,104 | $102,083 | 108.5% | | Total precision diagnostics | $95,617 | $86,198 | $9,419 | 10.9% | | Strategic partnerships and other | $8,980 | $28,578 | $(19,598) | (68.6)% | | **Total revenues** | **$300,784** | **$208,880** | **$91,904** | **44.0%** | - The decrease in gross profit was primarily due to the impairment of the AZEDRA currently marketed intangible asset[156](index=156&type=chunk) - Sales and marketing expenses increased by **$12.3 million** due to continued promotional activities for PYLARIFY[158](index=158&type=chunk) - Research and development expenses increased by **$18.3 million**, driven by the AZEDRA IPR&D asset impairment loss of **$15.6 million**[162](index=162&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) Strong liquidity is supported by cash reserves and operating cash flow, with recent debt refinancing and an upcoming CVR payment, ensuring sufficient funding for future operations Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2023 | | :--- | :--- | | Net cash provided by operating activities | $108,500 | | Net cash used in investing activities | $(44,513) | | Net cash used in financing activities | $(8,669) | - In December 2022, the company issued **$575.0 million** in 2.625% Convertible Senior Notes due 2027, with net proceeds of approximately **$557.8 million**[122](index=122&type=chunk)[178](index=178&type=chunk) - The company also replaced its prior credit facility with a new **$350.0 million** five-year revolving credit facility, which was undrawn as of March 31, 2023[120](index=120&type=chunk)[175](index=175&type=chunk) - The company expects to make a **$99.7 million** payment in the second quarter of 2023 to fully satisfy its CVR obligations from the Progenics acquisition[130](index=130&type=chunk)[184](index=184&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reports no material changes to its market risk exposures since December 31, 2022 - There have been no material changes in the company's market risk exposures since December 31, 2022[190](index=190&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2023[191](index=191&type=chunk) - No changes occurred in the company's internal control over financial reporting during Q1 2023 that have materially affected, or are reasonably likely to materially affect, these controls[192](index=192&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no material ongoing litigation as of March 31, 2023 - The company did not have any material ongoing litigation as of March 31, 2023[93](index=93&type=chunk)[195](index=195&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) No material changes to previously disclosed risk factors were reported - There have been no material changes to the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022[197](index=197&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company repurchased shares for employee tax obligations, has remaining repurchase authorization, and does not intend to pay dividends - A total of **154,146** shares were purchased during the quarter, reflecting shares withheld to satisfy employee tax obligations on vested equity awards[199](index=199&type=chunk) - The company has a remaining authorization to repurchase up to **$75.0 million** of its common stock[198](index=198&type=chunk)[199](index=199&type=chunk) - The company did not pay dividends and does not intend to in the foreseeable future, expecting to retain earnings for growth and debt repayment[200](index=200&type=chunk) [Item 3. Defaults Upon Senior Securities](index=44&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported - The company reports no defaults upon senior securities[201](index=201&type=chunk) [Item 5. Other Information](index=44&type=section&id=Item%205.%20Other%20Information) No other information was reported under this item - The company reports no other information under this item[203](index=203&type=chunk)

Lantheus Holdings, Inc. (NASDAQ:LNTH) Q4 2022 Earnings Conference Call February 23, 2023 8:00 AM ET Company Participants Mark Kinarney - Vice President of Investor Relations Mary Anne Heino - President & Chief Executive Officer Paul Blanchfield - Chief Operating Officer Bob Marshall - Chief Financial Officer Conference Call Participants Richard Newitter - Truist Anthony Petrone - Mizuho Group Roanna Ruiz - SVB Securities Matt Taylor - Jefferies Larry Solow - CJS Securities Yuan Zhi - B. Riley Justin Walsh - ...

Vice President, Investor Relations 65 years of radiopharmaceutical expertise, including development, manufacturing, and commercialization Mary Anne Heino President and CEO Closing Remarks Lantheus – A Growth Company February 23, 2023 Bob Marshall Paul Blanchfield Chief Operating Officer Highlights & Business Update Financial Update Q&A 2 Safe Harbor Statements 3 This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are ...

Market Position and Competition - TechneLite had approximately one third of the U.S. generator market as of December 31, 2022, competing primarily with Curium and NorthStar Medical Radioisotopes[43] - The company faces competition from large global companies with substantial resources, including Telix Pharmaceuticals Limited and Novartis AG for PYLARIFY, and GE Healthcare for DEFINITY[78] - The company has substantial capital investments in its TechneLite production line, creating significant competitive advantages in generator manufacturing and distribution[45] Product Development and Innovation - The company is focused on late-stage diagnostic and therapeutic product opportunities in oncology and other strategic areas to drive future growth[57] - PYLARIFY AI, launched in November 2021, is designed for standardized quantitative assessment of PSMA PET/CT images, enhancing consistency and accuracy in prostate cancer diagnostics[63] - The Phase 2 clinical trial of NM-01, a novel imaging agent for assessing PD-L1 expression, is expected to complete enrollment in 2023[59] - The company is eligible for up to $60.0 million in regulatory and sales milestone payments from GE Healthcare for the flurpiridaz project, which is expected to begin commercialization in 2024[65] Financial Performance - Revenues for the year ended December 31, 2022, were $935,061 thousand, a significant increase of 120% compared to $425,208 thousand in 2021[502] - Gross profit for 2022 was $581,703 thousand, up from $187,695 thousand in 2021, indicating a gross margin improvement[502] - Operating income for 2022 was $36,195 thousand, a turnaround from an operating loss of $60,825 thousand in 2021[502] - Net income for 2022 was $28,067 thousand, compared to a net loss of $71,279 thousand in 2021, marking a substantial recovery[502] Research and Development - The company invested $311.7 million in research and development (R&D) for the year ended December 31, 2022, a significant increase from $45.0 million in 2021[67] - Research and development expenses surged to $311,681 thousand in 2022, up from $44,966 thousand in 2021, reflecting increased investment in innovation[502] Regulatory and Compliance - The company is subject to ongoing regulatory compliance, including record-keeping and reporting of adverse experiences with approved products[129] - The FDA may require Phase 4 testing for drugs post-approval, which could lead to additional costs and delays[126] - The company is subject to various federal and state laws targeting fraud and abuse, with potential penalties including fines and exclusion from federal health care programs[151] Intellectual Property - The company has four Orange Book-listed patents for PYLARIFY in the U.S., with the last expiring in 2037, and is pursuing additional patents internationally[55] - The company relies on various intellectual property protections, including patents and trade secrets, to maintain its competitive position[97] - DEFINITY has six Orange Book-listed method of use patents in the U.S., with expiration dates ranging from 2035 to 2037, and additional manufacturing patents expiring in 2023 and 2037[102] Customer Base and Sales - No single customer accounted for more than 10% of revenues for the year ended December 31, 2022, indicating a diversified customer base[72] - The company’s products are primarily sold to hospitals and independent diagnostic testing facilities, with a significant portion of sales generated through direct sales teams[520] Strategic Collaborations - A strategic collaboration with Novartis was announced in March 2022 to include PYLARIFY in prostate cancer trials with PLUVICTO[49] - The company has established multiple collaborations for prostate cancer therapies, including agreements with Curium and Novartis to integrate PYLARIFY into clinical trials[59] Financial Liabilities and Assets - The company had a liability of approximately $22.5 million and $20.8 million for asset retirement obligations as of December 31, 2022 and 2021, respectively[170] - Total assets increased to $1,321,258 thousand in 2022 from $863,784 thousand in 2021, representing a growth of approximately 53%[500] Corporate Social Responsibility - The company has a female CEO and approximately 50% of its employees are women, reflecting its commitment to diversity and inclusion[177] - The company has developed a mechanism to track and monitor energy use, water use, and waste generation across its facilities[172]