1 T M Investor Presentation September 2021 w w w . l a n t h e u s . c o m | © 2 0 2 1 L a n t h e u s H o l d i n g s , I n c . A l l r i g h t s r e s e r v e d Safe Harbor Statements 2 Cautionary Statement Regarding Forward-Looking Statements This document 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 ...

Financial Data and Key Metrics Changes - Revenue for Q2 2021 was $101.1 million, an increase of 53.1% compared to the prior year quarter [43] - Gross profit margin for Q2 2021 was 52.6%, up from 41.7% in Q2 2020 [47] - Operating profit for the quarter was $10.4 million, an increase of 30.8% over the same period last year [49] - Reported net income for Q2 was a loss of $26.7 million, while adjusted net income was $7.8 million, an increase of 71.6% [53] - Operating cash flow totaled $25.9 million compared to a use of $2.2 million in Q2 2020 [54] Business Line Data and Key Metrics Changes - Precision diagnostics revenue was $90.4 million, a 43.6% increase from the prior year quarter [44] - DEFINITY sales were $59.8 million, up 61.2% compared to the prior year quarter [44] - TechneLite net revenue was $23.8 million, a 27.3% increase from the prior year quarter [44] - AZEDRA sales increased significantly, with a notable rise in patients completing the second dose of therapy [36][37] Market Data and Key Metrics Changes - DEFINITY maintained over 80% market share in the U.S. ultrasound enhancing agent market [10][102] - PYLARIFY has been used in various imaging centers, hospitals, and government facilities, indicating strong initial uptake [25][84] Company Strategy and Development Direction - The company is focused on expanding the availability of PYLARIFY across the U.S. and enhancing its commercial infrastructure [27][30] - A dedicated field sales team and market access team are being established to support PYLARIFY's launch [29][31] - The company aims to leverage PYLARIFY as a companion diagnostic in clinical development with leading pharmaceutical companies [21][99] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth momentum and ability to deliver shareholder value, particularly with the launch of PYLARIFY and strong performance of DEFINITY [61] - The company anticipates that 2022 will be a significant year for PYLARIFY as the launch gains traction [67] Other Important Information - The company has made a strategic decision to exit a TechneLite contract, impacting revenue by $5 million in the second half of the year [57] - The effective tax rate for the quarter was 9.9%, influenced by the divestiture of the Puerto Rico operation [52] Q&A Session Summary Question: What is the anticipated contribution of PYLARIFY for Q3? - Management indicated that while specific guidance on PYLARIFY is not provided, the launch is just beginning and the forecast includes some contribution from PYLARIFY [67] Question: What was the reason for exiting the TechneLite contract? - Management stated that the decision was based on the contract's unfavorable terms and that such contracts are negotiated annually [69] Question: How many PET manufacturing facilities will be operational in 2022? - There are currently 12 PMF sites activated, with plans to expand to over 30 by year-end [75] Question: What is the competitive landscape for DEFINITY? - DEFINITY maintains approximately 80% market share and continues to grow, with strong performance exceeding pre-pandemic levels [102] Question: How does the approval of Novartis' prostate cancer therapeutic impact the company? - Management noted that the approval highlights the role of isotopes in treatment and diagnostics, which aligns with the company's strategic focus [99]

Second Quarter 2021 Financial Results FIND July 28, 2021 w w w . l a n t h e u s . c o m | © 2 0 2 1 L a n t h e u s H o l d i n g s , I n c . A l l r i g h t s r e s e r v e d 1 Mary Anne Heino President and CEO Bob Marshall CFO and Treasurer Paul Blanchfield Chief Commercial Officer Mark Kinarney Sr. Director, Investor Relations | --- | --- | --- | |-------|--------------------------------------|-------| | | | | | | | | | | Q2 2021 Highlights & Business Update | | w w w . l a n t h e u s . c o m | © 2 0 2 ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for the three and six months ended June 30, 2021, including balance sheets, statements of operations, cash flows, and notes on key events [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2021, total assets slightly decreased to $857.8 million from $869.8 million at year-end 2020, reflecting a stable balance sheet Condensed Consolidated Balance Sheets (in thousands) | Balance Sheet Items (in thousands) | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Total Assets** | **$857,802** | **$869,821** | | Total Current Assets | $186,213 | $184,225 | | Intangibles, net | $365,259 | $376,012 | | Goodwill | $61,189 | $58,632 | | **Total Liabilities** | **$349,662** | **$355,616** | | Total Current Liabilities | $73,826 | $80,504 | | Long-term debt, net | $169,249 | $197,699 | | **Total Stockholders' Equity** | **$508,140** | **$514,205** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) In Q2 2021, revenues grew 53.1% to $101.1 million, but increased operating expenses led to a net loss of $26.7 million, compared to a $7.0 million net loss in Q2 2020 Condensed Consolidated Statements of Operations (in thousands) | (in thousands) | Q2 2021 | Q2 2020 | Six Months 2021 | Six Months 2020 | | :--- | :--- | :--- | :--- | :--- | | **Revenues** | **$101,064** | **$66,010** | **$193,573** | **$156,714** | | Gross Profit | $46,088 | $25,848 | $87,118 | $63,850 | | Total Operating Expenses | $72,869 | $31,393 | $113,540 | $62,270 | | Operating (Loss) Income | $(26,781) | $(5,545) | $(11,159) | $1,580 | | **Net Loss** | **$(26,657)** | **$(7,012)** | **$(17,649)** | **$(3,675)** | | Diluted Net Loss per Share | $(0.39) | $(0.16) | $(0.26) | $(0.09) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash from operating activities significantly increased to $35.7 million for the six months ended June 30, 2021, while financing activities used $35.5 million mainly for debt repayments Cash Flow Summary (in thousands) | (in thousands) | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash provided by operating activities | $35,687 | $7,252 | | Net cash provided by investing activities | $10,647 | $2,609 | | Net cash used in financing activities | $(35,506) | $(10,218) | | **Net increase (decrease) in cash** | **$10,948** | **$(469)** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail key accounting events, including the Progenics acquisition and PYLARIFY FDA approval, revenue drivers, contingent liability changes, the sale of the Puerto Rico subsidiary, and segment restructuring - The company completed its acquisition of Progenics on June 19, 2020. **PYLARIFY**, a key product from this acquisition, was approved by the FDA on **May 26, 2021**, and its commercial launch has begun[30](index=30&type=chunk)[31](index=31&type=chunk) Revenue by Product Category (in thousands) | Revenue by Product Category (in thousands) | Q2 2021 | Q2 2020 | Six Months 2021 | Six Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Precision diagnostics | $90,356 | $62,933 | $176,111 | $151,274 | | Radiopharmaceutical oncology | $2,812 | $2,183 | $4,312 | $4,151 | | Strategic partnerships and other | $7,896 | $894 | $13,150 | $1,289 | | **Total revenues** | **$101,064** | **$66,010** | **$193,573** | **$156,714** | - The fair value of contingent consideration liabilities, primarily related to PYLARIFY CVRs, increased from **$15.8 million** at year-end 2020 to **$43.8 million** at June 30, 2021. This change resulted in a non-cash expense of **$25.9 million** for the six-month period[47](index=47&type=chunk)[53](index=53&type=chunk) - On **January 29, 2021**, the company sold its Puerto Rico radiopharmacy subsidiary for **$18.0 million** in cash, resulting in a pre-tax gain of **$15.3 million**[77](index=77&type=chunk)[78](index=78&type=chunk)[82](index=82&type=chunk) - In the **first quarter of 2021**, the company changed its operating and reporting structure to a **single business segment**, reflecting a consolidated worldwide management approach[108](index=108&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, highlighting 53.1% Q2 2021 revenue growth driven by DEFINITY and Progenics, key factors like PYLARIFY launch and Mo-99 supply, and strong liquidity with $35.7 million operating cash flow [Key Factors Affecting Our Results](index=29&type=section&id=Key%20Factors%20Affecting%20Our%20Results) Key factors influencing performance include ongoing COVID-19 impacts, the PYLARIFY launch requiring significant investment, anticipated growth for DEFINITY, and challenges with Mo-99 supply chain and third-party manufacturing reliance - On **May 27, 2021**, the FDA approved **PYLARIFY**, a PET imaging agent for prostate cancer. The commercial launch is underway, with availability expanding across the U.S. throughout **2021**[121](index=121&type=chunk)[122](index=122&type=chunk) - The company anticipates continued sales growth for **DEFINITY**, its fastest-growing and highest-margin product, which held an estimated **80% U.S. market share** as of **December 31, 2020**[133](index=133&type=chunk) - The company faces logistical and supplier challenges in its **Mo-99 supply chain**, which is critical for its TechneLite generators. A prolonged disruption from one of its **three main suppliers** could have a substantial negative effect on business[140](index=140&type=chunk) - The integration of the **Progenics acquisition** has increased the complexity of the business and added substantial clinical development expenses for pipeline products like **1095** and **AZEDRA**[145](index=145&type=chunk)[148](index=148&type=chunk)[150](index=150&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20Operations) Q2 2021 revenues increased 53.1% to $101.1 million driven by DEFINITY sales, but operating expenses more than doubled to $72.9 million due to contingent liability adjustments and PYLARIFY launch costs, resulting in a $26.7 million net loss Results of Operations Summary (in thousands) | (in thousands) | Q2 2021 | Q2 2020 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | **Revenues** | **$101,064** | **$66,010** | **$35,054** | **53.1%** | | Gross Profit | $46,088 | $25,848 | $20,240 | 78.3% | | Total Operating Expenses | $72,869 | $31,393 | $41,476 | 132.1% | | **Net Loss** | **$(26,657)** | **$(7,012)** | **$(19,645)** | **280.2%** | - The increase in General and Administrative expenses of **$22.5 million** in Q2 2021 was primarily driven by a **$25.6 million** fair value adjustment to contingent assets and liabilities, mainly related to the **PYLARIFY CVRs**[168](index=168&type=chunk) - Sales and Marketing expenses increased by **$11.3 million** in Q2 2021 due to the integration of the **Progenics organization** and preparation activities for the **PYLARIFY launch**[166](index=166&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintained solid liquidity with $91.5 million cash and $35.7 million operating cash flow for H1 2021, making $38.1 million debt payments including the $30.9 million Progenics loan, and has access to a $200.0 million revolving credit facility Cash Flow Summary (in thousands) | Cash Flow Summary (in thousands) | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash provided by operating activities | $35,687 | $7,252 | | Net cash provided by investing activities | $10,647 | $2,609 | | Net cash used in financing activities | $(35,506) | $(10,218) | - On **March 31, 2021**, the company voluntarily repaid in full the entire outstanding principal of **$30.9 million** on the **Royalty-Backed Loan** assumed in the **Progenics acquisition**[197](index=197&type=chunk) - As of **June 30, 2021**, the company had **$91.5 million** of cash and cash equivalents and access to a **$200.0 million** revolving credit facility[202](index=202&type=chunk)[190](index=190&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in several ongoing legal matters inherited from the Progenics acquisition, including European patent opposition proceedings, litigation in Germany over PSMA-617 inventions, and a U.S. patent post-grant review petition - The company is appealing a German court's decision that dismissed its claims of co-ownership of inventions related to **PSMA-617**, which were filed by the **University of Heidelberg**[102](index=102&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk) - A competitor, **Advanced Accelerator Applications USA, Inc.**, has filed a petition for post-grant review challenging the validity of claims in one of the company's U.S. patents (**No. 10,640,461**)[107](index=107&type=chunk) [Item 1A. Risk Factors](index=49&type=section&id=Item%201A.%20Risk%20Factors) This section updates key risks, including potential side effects of DEFINITY leading to a new label contraindication, heavy dependence on a few large radiopharmacy customers, and financial risks from Contingent Value Rights (CVRs) related to PYLARIFY sales - In **April 2021**, the FDA and the company agreed to add a contraindication to the **DEFINITY** label for patients with a prior history of allergic reactions to **polyethylene glycol (PEG)**, an inactive ingredient[214](index=214&type=chunk) - The company is heavily dependent on a few large radiopharmacy customers, such as **Cardinal** and **RLS**, for the distribution of its nuclear imaging products in the U.S., creating **customer concentration risk**[215](index=215&type=chunk) - The **CVRs** issued in the **Progenics acquisition** could result in substantial future cash payments based on **PYLARIFY sales** and require recurring fair value estimates, which can impact financial statements and are based on significant management assumptions[218](index=218&type=chunk)[219](index=219&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=51&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q2 2021, the company withheld 9,465 shares for employee tax obligations, had no share repurchase program, and reiterated its policy of not paying dividends to retain earnings for growth and debt repayment - The company withheld **9,465 shares** to cover employee taxes on vested equity awards during **Q2 2021**. No formal share repurchase program is in effect[222](index=222&type=chunk)[223](index=223&type=chunk) - The company does not currently intend to pay dividends and expects to retain future earnings to finance **business growth** and **repay debt**[224](index=224&type=chunk) [Other Items (Items 3, 4, 5, 6)](index=51&type=section&id=Other%20Items) This section confirms standard corporate disclosures, reporting no defaults on senior securities, no mine safety disclosures, no other material information, and lists the exhibits filed with the Form 10-Q - The company reported **no defaults on senior securities** (Item 3), **no mine safety disclosures** (Item 4), and **no other information** (Item 5) for the reporting period[225](index=225&type=chunk)[226](index=226&type=chunk)[227](index=227&type=chunk)

Lantheus Holdings, Inc. (NASDAQ:LNTH) Q1 2021 Results Earnings Conference Call May 4, 2021 8:00 AM ET Company Participants Mark Kinarney - Senior Director of Investor Relations Mary Anne Heino - President and Chief Executive Officer Robert Marshall - Chief Financial Officer and Treasurer Conference Call Participants Richard Newitter - SVB Leerink Anthony Petrone - Jefferies Larry Solow - CJS Securities Operator Good morning, ladies and gentlemen. Welcome to the Lantheus Holdings First Quarter 2021 Earnings ...

Financial Performance - The company reported revenues of $92.5 million in Q1 2021, a 2% increase year-over-year[39] - Free cash flow was $7.3 million in Q1 2021, compared to $6.7 million in Q1 2020[39] - Adjusted net income was $3.3 million, or $0.05 per share, compared to $14.3 million, or $0.36 per share in Q1 2020[39] - The company had $68.9 million in unrestricted cash and cash equivalents as of March 31, 2021[39] Product Performance - DEFINITY sales increased, driven by sequentially higher volumes, but with regional differences[44] - TechneLite volumes are returning to pre-COVID-19 levels[44] - Other precision diagnostics revenue decreased by 46.5% due to the sale of Puerto Rico operations[44] - Strategic partnerships and other revenue increased by 1,230.1%, driven by newly acquired assets[44] Strategic Initiatives - The company is preparing for the potential FDA approval and commercial launch of PyL[57] - The company acquired exclusive worldwide rights to NTI-1309, an innovative PET oncology imaging agent[34] - The company voluntarily repaid in full the entire outstanding principal on the RELISTOR Royalty-Backed Loan[51] Financial Guidance - The company issued revenue guidance for Q2 2021 of $93 million - $97 million[55] - The company issued adjusted fully diluted EPS guidance for Q2 2021 of $0.03 - $0.06[55] - The company updated FY 2021 revenue guidance to $390 million - $400 million[55] - The company updated FY 2021 adjusted fully diluted EPS guidance to $0.36 - $0.41[55]

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 March 31, 2021 ☐ 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 | | ...

Lantheus Holdings, Inc. (NASDAQ:LNTH) Q4 2020 Earnings Conference Call February 25, 2021 4:30 PM ET Company Participants Mark Kinarney - Senior Director of Investor Relations Mary Anne Heino - President and CEO Bob Marshall - Chief Financial Officer Conference Call Participants Anthony Petrone - Jefferies Erin Wright - Credit Suisse Lee Jagoda - CJS Securities Erin Fahey - SVB Leerink Operator Good afternoon, ladies and gentlemen. Welcome to Lantheus Holdings Fourth Quarter and Full Year 2020 Financial Resu ...

1 Fourth Quarter and Full Year 2020 Financial Results FIND ) February 25, 2021 w w w . l a n t h e u s . c o m | © 2 0 2 1 L a n t h e u s H o l d i n g s , I n c . A l l r i g h t s r e s e r v e d Mary Anne Heino President and CEO Bob Marshall CFO and Treasurer Mark Kinarney Sr. Director, Investor Relations | --- | --- | --- | --- | |-------|---------------------|---------------------------------|-------| | | | Q4 Highlights & Business Update | | | | Q4 Financial Update | | | w w w . l a n t h e u s . c o ...

[PART I](index=5&type=section&id=PART%20I) [Item 1. Business](index=5&type=section&id=Item%201.%20Business) Lantheus provides imaging diagnostics, targeted therapeutics, and AI solutions, expanding its oncology portfolio through the Progenics acquisition [Overview and Progenics Acquisition](index=6&type=section&id=Overview%20and%20Progenics%20Acquisition) Lantheus, a provider of innovative imaging diagnostics, targeted therapeutics, and AI solutions, expanded its portfolio with the June 19, 2020 acquisition of oncology-focused Progenics - Lantheus operates in two reportable segments: U.S. and International, utilizing direct sales in the U.S., Canada, and Puerto Rico, and third-party distributors elsewhere[22](index=22&type=chunk) - The June 19, 2020 acquisition of Progenics added therapeutic agents (AZEDRA, 1095), diagnostic agents (PyL, 1404), RELISTOR royalties, and AI imaging technologies to Lantheus' portfolio[20](index=20&type=chunk) Key Products/Candidates from Progenics Acquisition | Product/Candidate | Description | Status | Market Rights | | :--- | :--- | :--- | :--- | | **AZEDRA** | Ultra-Orphan Therapeutic for pheochromocytoma | Approved | Progenics (U.S.) | | **PyL (18F-DCFPyL)** | PSMA-targeted PET/CT imaging for prostate cancer | NDA accepted; PDUFA May 28, 2021 | Progenics (Worldwide ex. EU, AU, NZ) | | **1095 (I 131 1095)** | PSMA-targeted therapeutic for metastatic prostate cancer | Phase 2 | Progenics (Worldwide) | | **RELISTOR** | Treatment for Opioid-Induced Constipation (OIC) | Approved | Bausch (Worldwide) | [Commercial Product Portfolio](index=8&type=section&id=Commercial%20Product%20Portfolio) The company's commercial portfolio is anchored by DEFINITY, a leading ultrasound enhancing agent, and TechneLite, a critical Technetium-99m generator, alongside radiotherapeutics and AI-driven tools - **DEFINITY** is the leading ultrasound enhancing agent in the U.S., used in echocardiography exams for patients with suboptimal images, with an estimated **6.3 million** suboptimal echocardiograms in the U.S. in 2020[27](index=27&type=chunk)[29](index=29&type=chunk) - **TechneLite** is a Technetium-99m (Tc-99m) generator, providing essential nuclear material for diagnostic procedures and holding approximately **one-third** of the U.S. generator market[25](index=25&type=chunk)[37](index=37&type=chunk) - **AZEDRA** is the first and only FDA-approved therapy for adult and pediatric patients (12+) with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma[25](index=25&type=chunk) - The company receives royalties from Bausch on sales of **RELISTOR**, a treatment for opioid-induced constipation (OIC)[25](index=25&type=chunk) [Clinical Development and Strategic Partnerships](index=13&type=section&id=Clinical%20Development%20and%20Strategic%20Partnerships) Lantheus invested **$32.8 million** in R&D in 2020, focusing on key clinical candidates like PyL and flurpiridaz F 18, supported by multiple strategic partnerships - The company's lead product candidate, **PyL**, a PSMA-targeted PET imaging agent for prostate cancer, received priority review with a PDUFA date of May 28, 2021, following its NDA filing in September 2020[41](index=41&type=chunk)[43](index=43&type=chunk) - Lantheus has an exclusive collaboration with GE Healthcare for the Phase 3 development and worldwide commercialization of **flurpiridaz F 18**, a PET MPI agent, with GE Healthcare expecting to complete enrollment in H2 2021 and begin commercialization in early 2023[44](index=44&type=chunk) R&D Investment (2018-2020) | Year | R&D Investment (in millions) | | :--- | :--- | | 2020 | $32.8 | | 2019 | $20.0 | | 2018 | $17.1 | - The company is eligible for significant milestone payments and tiered royalties ranging from **15% to 19%** on worldwide net sales from its partnership with Bausch for **RELISTOR**[46](index=46&type=chunk) [Operations and Market Strategy](index=18&type=section&id=Operations%20and%20Market%20Strategy) Lantheus employs a specialized sales force in the U.S. and Canada, relies on third-party distributors internationally, and faces critical supply chain dependencies for Molybdenum-99 - In the U.S., the majority of radiopharmaceutical products are sold to five key radiopharmacy groups: Cardinal, RLS, UPPI, Jubilant Radiopharma, and PharmaLogic, under multi-year supply agreements[52](index=52&type=chunk)[53](index=53&type=chunk) - The company relies on a limited number of international suppliers (IRE, NTP, ANSTO) for Molybdenum-99 (Mo-99), a critical raw material for TechneLite, which has experienced periodic outages creating supply chain challenges[63](index=63&type=chunk)[64](index=64&type=chunk)[67](index=67&type=chunk) - A substantial portion of products are manufactured by third-party CMOs, with JHS being the sole source for DEFINITY, NEUROLITE, and Cardiolite, and SBL for DEFINITY RT[73](index=73&type=chunk)[76](index=76&type=chunk) - The company is expanding its strategic focus into oncology and pharma services, including collaborations for a PD-L1 imaging biomarker and clinical supply agreements for PyL with pharmaceutical companies developing PSMA-targeted therapies[78](index=78&type=chunk) [Intellectual Property and Regulatory Environment](index=27&type=section&id=Intellectual%20Property%20and%20Regulatory%20Environment) Lantheus maintains a robust intellectual property portfolio with patents extending into the 2030s for key products, operating within a highly regulated environment subject to extensive oversight from health and safety agencies - As of December 31, 2020, the company's patent portfolio included **107** issued U.S. patents and **804** issued foreign patents[83](index=83&type=chunk) Key Product Patent Expirations (U.S.) | Product | Key Patent Expiration(s) | | :--- | :--- | | **DEFINITY** | Method of use patents expire in 2035 and 2037 | | **DEFINITY RT** | Composition of matter patent expires in 2035 | | **TechneLite** | Component technology patents expire in 2029 | | **PyL** | Composition of matter patents expire in 2029 and 2030 | | **flurpiridaz F 18** | Composition of matter patent expires in 2026; formulation patent expires in 2032 | - The company is subject to comprehensive regulation by the FDA, NRC, and other domestic and foreign agencies, covering drug development, manufacturing (cGMP), marketing, and post-market surveillance[103](index=103&type=chunk)[104](index=104&type=chunk) - The business is affected by healthcare reform, including the Affordable Care Act, which influences reimbursement rates, and is subject to fraud and abuse laws like the Anti-Kickback Statute and the False Claims Act[125](index=125&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including dependence on DEFINITY's growth, unstable Mo-99 supply, pipeline approval challenges, Progenics integration issues, reimbursement policy impacts, and substantial indebtedness - Key risks include dependence on **DEFINITY's** continued growth, instability of the global **Mo-99** supply, reliance on third-party manufacturers, and challenges in obtaining regulatory approval and successful commercialization for pipeline products like **PyL**[169](index=169&type=chunk) - The integration of the Progenics acquisition involves risks such as unexpected costs, retention of key personnel, and the potential for CVRs to result in substantial future payments[172](index=172&type=chunk)[235](index=235&type=chunk) - The COVID-19 pandemic poses a significant risk, potentially causing declines in procedure volumes, disruptions to supply chains and clinical trials, and adverse effects on global economies[174](index=174&type=chunk)[260](index=260&type=chunk) - The company has substantial indebtedness (**$185.0 million** term loan as of December 31, 2020), which includes restrictive covenants that may limit financial and operating flexibility[308](index=308&type=chunk)[312](index=312&type=chunk) [Item 2. Properties](index=84&type=section&id=Item%202.%20Properties) The company's primary property is its owned **431,000 square foot** corporate headquarters and manufacturing facility in North Billerica, Massachusetts, alongside leased spaces and a recently sold Puerto Rico facility - The company owns its main **431,000 sq. ft.** facility in North Billerica, MA, which serves as its corporate headquarters and a manufacturing site[320](index=320&type=chunk) - Key leased properties include office space in New York, NY (**26,000 sq. ft.**) and a manufacturing facility in Somerset, NJ (**11,400 sq. ft.**)[320](index=320&type=chunk) - The company sold its Puerto Rico radiopharmacy and PET manufacturing facility to PharmaLogic in a transaction that closed on January 29, 2021[321](index=321&type=chunk) [Item 3. Legal Proceedings](index=84&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in various legal proceedings, with specific details incorporated by reference from Note 19 of the consolidated financial statements - Information regarding legal proceedings is located in Note 19, "Commitments and Contingencies," of the financial statements[322](index=322&type=chunk) [PART II](index=85&type=section&id=PART%20II) [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=85&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Lantheus' common stock trades on the NASDAQ Global Market under "LNTH," with **43** stockholders of record as of February 19, 2021, and the company does not currently pay dividends - The company's common stock (LNTH) trades on the NASDAQ Global Market, with **43** stockholders of record as of February 19, 2021[325](index=325&type=chunk)[326](index=326&type=chunk) - The company does not pay dividends and does not intend to in the foreseeable future, retaining earnings for growth and debt repayment[332](index=332&type=chunk) Issuer Purchases of Equity Securities (Q4 2020) | Period | Total Number of Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | October 2020 | 1,957 | $13.23 | | November 2020 | 1,465 | $12.46 | | December 2020 | 243 | $14.26 | | **Total** | **3,665** | | [Item 6. Selected Financial Data](index=87&type=section&id=Item%206.%20Selected%20Financial%20Data) The company's selected financial data for the five years ended December 31, 2020, shows relatively stable revenues, a net loss of **$13.5 million** in 2020, and significant asset growth due to the Progenics acquisition Selected Financial Data (2018-2020) | (in millions, except per share data) | 2020 | 2019 | 2018 | | :--- | :--- | :--- | :--- | | **Revenues** | $339.4 | $347.3 | $343.4 | | **Operating (loss) income** | $(4.2) | $51.7 | $64.5 | | **Net (loss) income** | $(13.5) | $31.7 | $40.5 | | **Diluted (loss) income per share** | $(0.25) | $0.79 | $1.03 | | **Total assets** | $869.8 | $405.9 | $439.8 | | **Long-term debt, net** | $197.7 | $183.9 | $263.7 | | **Total stockholders' equity** | $514.2 | $114.6 | $71.0 | [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=89&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion highlights the impact of the Progenics acquisition and COVID-19 on 2020 results, showing a **2.3%** revenue decrease, a **20.6%** gross profit decline, and an operating loss of **$4.2 million**, while maintaining sufficient liquidity [Results of Operations](index=96&type=section&id=Results%20of%20Operations) For the year ended December 31, 2020, total revenues decreased **2.3%** to **$339.4 million**, gross profit fell **20.6%** to **$138.8 million**, and operating expenses rose, resulting in an operating loss of **$4.2 million** and a net loss of **$13.5 million** Consolidated Results of Operations (2018-2020) | (in millions) | 2020 | 2019 | 2018 | | :--- | :--- | :--- | :--- | | **Revenues** | $339.4 | $347.3 | $343.4 | | **Gross Profit** | $138.8 | $174.8 | $174.9 | | **Operating (loss) income** | $(4.2) | $51.7 | $64.5 | | **Net (loss) income** | $(13.5) | $31.7 | $40.5 | - U.S. revenues decreased by **3.0%** in 2020, primarily due to COVID-19 related business losses, including a **$4.5 million** decrease in DEFINITY revenue and a **$2.8 million** decrease in TechneLite revenue[375](index=375&type=chunk) - Gross profit in the U.S. segment decreased by **22.1%** in 2020 due to lower volumes from COVID-19, amortization of assets from the Progenics acquisition, and a **$7.3 million** asset impairment loss on other nuclear products[381](index=381&type=chunk) - General and administrative expenses increased by **13.1%** in 2020, driven by acquisition-related costs for the Progenics deal, with the Progenics business contributing approximately **$5.9 million** to G&A expenses post-acquisition[387](index=387&type=chunk)[388](index=388&type=chunk)[389](index=389&type=chunk) - Research and development expenses increased by **63.8%** to **$32.8 million** in 2020, primarily due to the addition of the Progenics business, which contributed **$18.5 million** of R&D expense, including the PyL NDA filing fee and a **$2.7 million** IPR&D asset impairment loss[391](index=391&type=chunk)[392](index=392&type=chunk)[393](index=393&type=chunk) [Liquidity and Capital Resources](index=102&type=section&id=Liquidity%20and%20Capital%20Resources) Net cash from operating activities decreased significantly to **$16.4 million** in 2020, with **$79.6 million** in cash and cash equivalents and total principal indebtedness of **$217.6 million**, supported by an undrawn **$200.0 million** revolving credit facility Cash Flow Summary (2018-2020) | (in millions) | 2020 | 2019 | 2018 | | :--- | :--- | :--- | :--- | | Net cash provided by operating activities | $16.4 | $80.4 | $61.2 | | Net cash used in investing activities | $(4.9) | $(22.1) | $(19.1) | | Net cash used in financing activities | $(21.9) | $(78.9) | $(4.7) | - As of December 31, 2020, the company had **$185.0 million** outstanding under its 2019 Term Facility and **$32.6 million** on a royalty-backed loan assumed from Progenics, with full availability of its **$200.0 million** revolving credit facility[308](index=308&type=chunk)[427](index=427&type=chunk) - In June 2020, the company amended its credit agreement to waive the Total Net Leverage Ratio covenant through December 31, 2020, and introduced a new minimum Consolidated Liquidity covenant of **$150.0 million** through March 31, 2021[415](index=415&type=chunk)[416](index=416&type=chunk)[417](index=417&type=chunk) Contractual Obligations as of December 31, 2020 | (in millions) | Total | Less than 1 Year | 1 - 3 Years | 3 - 5 Years | More than 5 Years | | :--- | :--- | :--- | :--- | :--- | :--- | | Debt obligations (principal) | $217.6 | $20.5 | $48.4 | $148.8 | $— | | Interest on debt obligations | $26.5 | $9.7 | $14.5 | $2.4 | $— | | Operating lease obligations | $23.2 | $2.0 | $4.5 | $4.6 | $12.2 | | **Total** | **$274.8** | **$36.6** | **$70.0** | **$156.0** | **$12.2** | [Critical Accounting Policies and Estimates](index=109&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) The company's critical accounting policies involve significant management judgment and estimates, particularly in revenue recognition, business combinations, and the valuation and impairment testing of intangible and long-lived assets - Revenue recognition requires judgment in estimating variable consideration, such as discounts, returns, and rebates, based on historical experience, contractual requirements, and market trends[442](index=442&type=chunk) - For business combinations, the company uses the acquisition method, allocating the purchase price to assets and liabilities based on their fair values, which involves significant estimates, especially for intangible assets like IPR&D[444](index=444&type=chunk) - Intangible assets, including goodwill and IPR&D, are tested for impairment at least annually, with IPR&D treated as an indefinite-lived asset until the project is completed or abandoned[449](index=449&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=110&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks from changes in interest rates and foreign currency exchange rates, mitigating interest rate risk with swaps on **$100.0 million** notional debt, while foreign currency risk is primarily from the Canadian dollar - The company has substantial variable rate debt under its 2019 Term Facility (**$185.0 million** outstanding at year-end 2020), exposing it to interest rate risk[451](index=451&type=chunk) - To hedge interest rate risk, the company entered into interest rate swaps to fix the LIBOR rate on a notional amount of **$100.0 million** through May 2024 at an average fixed rate of approximately **0.82%**[455](index=455&type=chunk) - A hypothetical **100 basis point** adverse change in market interest rates would increase annual interest expense by approximately **$1.9 million**, excluding the impact of the interest rate swaps[456](index=456&type=chunk) - The primary foreign currency risk is from the Canadian dollar, with the net impact of foreign currency changes on transactions in 2020 resulting in a loss of **$0.3 million**[458](index=458&type=chunk)[459](index=459&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=113&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements for the fiscal year ended December 31, 2020, along with the independent auditor's report, highlighting the valuation of intangible assets from the Progenics acquisition as a critical audit matter [Consolidated Financial Statements](index=117&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements present the company's financial position as of December 31, 2020, with total assets of **$869.8 million** and a net loss of **$13.5 million**, reflecting significant changes due to the Progenics acquisition Consolidated Balance Sheet Highlights (as of Dec 31, 2020) | (in millions) | Amount | | :--- | :--- | | **Total Assets** | **$869.8** | | Cash and cash equivalents | $79.6 | | Intangibles, net | $376.0 | | Goodwill | $58.6 | | **Total Liabilities** | **$355.6** | | Long-term debt, net | $197.7 | | **Total Stockholders' Equity** | **$514.2** | Consolidated Statement of Operations Highlights (Year Ended Dec 31, 2020) | (in millions) | Amount | | :--- | :--- | | **Revenues** | **$339.4** | | Gross Profit | $138.8 | | Operating (loss) income | $(4.2) | | **Net (loss) income** | **$(13.5)** | [Notes to Consolidated Financial Statements](index=123&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes provide detailed information on the Progenics acquisition, including its **$419.0 million** purchase price allocation, revenue recognition policies, intangible assets, long-term debt, leases, and legal contingencies, such as RELISTOR patent litigation - The Progenics acquisition was completed on June 19, 2020, for a total consideration of **$419.0 million**, including common stock, replacement stock options, and contingent value rights (CVRs)[495](index=495&type=chunk)[604](index=604&type=chunk) - As part of the Progenics acquisition, significant intangible assets were recognized, including IPR&D (**$151.1 million**), a currently marketed product (**$142.9 million**), and licenses (**$85.8 million**), along with goodwill of **$42.9 million**[607](index=607&type=chunk)[609](index=609&type=chunk) - The company is involved in ongoing patent litigation concerning its RELISTOR products, with settlements reached with Mylan in December 2020 and Actavis in February 2021[681](index=681&type=chunk)[684](index=684&type=chunk)[688](index=688&type=chunk) - As of December 31, 2020, the company had **$492.5 million** in U.S. federal net operating loss carryforwards and **$18.0 million** in state net operating loss carryforwards (tax-effected)[591](index=591&type=chunk) [Item 9A. Controls and Procedures](index=165&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2020, a conclusion affirmed by the independent auditor, Deloitte & Touche LLP - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[709](index=709&type=chunk) - Based on the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2020[711](index=711&type=chunk) - The independent auditor, Deloitte & Touche LLP, issued an unqualified opinion on the effectiveness of the company's internal control over financial reporting as of December 31, 2020[713](index=713&type=chunk) [PART III](index=168&type=section&id=PART%20III) [Item 10. Directors, Executive Officers and Corporate Governance](index=168&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance, including the company's Code of Conduct, is incorporated by reference from the company's Definitive Proxy Statement for its 2021 Annual Meeting of Stockholders - The required information for this item will be incorporated by reference from the company's 2021 Proxy Statement[725](index=725&type=chunk) [Item 11. Executive Compensation](index=168&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's Definitive Proxy Statement for its 2021 Annual Meeting of Stockholders - The required information for this item will be incorporated by reference from the company's 2021 Proxy Statement[726](index=726&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=168&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership of certain beneficial owners, management, and related stockholder matters is incorporated by reference from the company's Definitive Proxy Statement for its 2021 Annual Meeting of Stockholders - The required information for this item will be incorporated by reference from the company's 2021 Proxy Statement[727](index=727&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=168&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the company's Definitive Proxy Statement for its 2021 Annual Meeting of Stockholders - The required information for this item will be incorporated by reference from the company's 2021 Proxy Statement[728](index=728&type=chunk) [Item 14. Principal Accountant Fees and Services](index=168&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information regarding principal accountant fees and services is incorporated by reference from the company's Definitive Proxy Statement for its 2021 Annual Meeting of Stockholders - The required information for this item will be incorporated by reference from the company's 2021 Proxy Statement[729](index=729&type=chunk) [PART IV](index=169&type=section&id=PART%20IV) [Item 15. Exhibits and Financial Statement Schedules](index=169&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements, schedules, and exhibits filed as part of the Form 10-K, with consolidated financial statements included in Item 8 and other schedules omitted as not applicable - This item contains the index of financial statements, schedules, and exhibits filed with the annual report[731](index=731&type=chunk)[733](index=733&type=chunk) [Item 16. Form 10-K Summary](index=171&type=section&id=Item%2016.%20Form%2010-K%20Summary) No Form 10-K summary is provided in this report - This item is not applicable as no summary is provided[737](index=737&type=chunk)