[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)

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, 2020 ☐ 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) Table of Contents Indica ...

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 June 30, 2020 ☐ 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 | | - ...

WASHINGTON, D.C. 20549 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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, 2020 ☐ 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 (State o ...

[Part I](index=7&type=section&id=PART%20I) [Business](index=7&type=section&id=Item%201.%20Business) Lantheus Holdings, Inc. is a global leader in developing, manufacturing, and commercializing diagnostic medical imaging agents, primarily for cardiovascular diseases, operating in U.S. and International segments with key products DEFINITY and TechneLite, pursuing growth through microbubble franchise expansion, strategic acquisitions, and new agent development while managing supply chain instability and generic competition risks - The company operates in **two reportable segments**: the U.S. Segment and the International Segment, selling products to radiopharmacies, hospitals, clinics, and group practices[23](index=23&type=chunk)[25](index=25&type=chunk) - On **February 20, 2020**, Lantheus entered into an Amended Merger Agreement to acquire Progenics Pharmaceuticals, Inc. in an all-stock transaction expected to close in **Q2 2020**[27](index=27&type=chunk)[31](index=31&type=chunk) - Progenics stockholders will receive **0.31 shares** of Lantheus stock and a non-tradeable Contingent Value Right (CVR) for each Progenics share[27](index=27&type=chunk)[31](index=31&type=chunk) - The company's growth strategy includes expanding its microbubble franchise through new patents, developing a modified room-temperature stable formulation of DEFINITY, exploring new clinical applications, and building in-house manufacturing capabilities expected to be operational by **early 2021**[38](index=38&type=chunk)[44](index=44&type=chunk) [Product Portfolio](index=7&type=section&id=Item%201.%20BusinessProduct%20Portfolio) Lantheus's product portfolio is led by DEFINITY, the leading U.S. ultrasound contrast agent with over 80% market share, and TechneLite, a key Technetium-99m generator holding about one-third of the U.S. market, diversified across ultrasound and nuclear imaging modalities - DEFINITY is the leading ultrasound contrast imaging agent in the U.S. by revenue and usage, holding an estimated market share of **over 80%** as of December 2019[34](index=34&type=chunk)[38](index=38&type=chunk) - TechneLite, a Technetium-99m generator, held approximately **one-third** of the U.S. generator market as of December 31, 2019 Its production is highly dependent on the global supply of Molybdenum-99 (Mo-99)[43](index=43&type=chunk)[45](index=45&type=chunk) - The company's portfolio also includes established products such as Xenon (for pulmonary function), Cardiolite (for myocardial perfusion imaging), and Neurolite (for cerebral blood flow imaging)[50](index=50&type=chunk) [Distribution, Marketing and Sales](index=13&type=section&id=Item%201.%20BusinessDistribution,%20Marketing%20and%20Sales) In the U.S. and Canada, Lantheus utilizes a sales team of approximately 80 employees, selling a majority of its U.S. radiopharmaceutical products to five major radiopharmacy groups with agreements expiring at the end of 2020, while relying on third-party distributors for most international markets - The company sells a majority of its U.S. radiopharmaceutical products to five key radiopharmacy groups: GE Healthcare, Cardinal, UPPI, Jubilant Radiopharma, and PharmaLogic[54](index=54&type=chunk) - Supply agreements with major customers like GE Healthcare, Cardinal, UPPI, Jubilant Radiopharma, and PharmaLogic are set to expire on December 31, 2020[55](index=55&type=chunk)[62](index=62&type=chunk) - Outside the U.S., Canada, and Puerto Rico, the company uses third-party distributors for marketing, sales, and distribution[58](index=58&type=chunk) [Raw Materials and Supply Relationships](index=15&type=section&id=Item%201.%20BusinessRaw%20Materials%20and%20Supply%20Relationships) The company is highly dependent on a few key suppliers for critical raw materials, especially Molybdenum-99 (Mo-99) sourced from IRE, NTP, and ANSTO, facing supply chain instability due to recent outages, and is seeking to augment supply through a future agreement with SHINE expected in 2022 - The company purchases finished Mo-99 from three of the world's four main processing sites: IRE (Belgium), NTP (South Africa), and ANSTO (Australia)[68](index=68&type=chunk) - The Mo-99 supply chain has faced significant instability, including periodic outages at NTP's facility in 2017-2019 and production issues at ANSTO's new facility starting in June 2019, which have constrained TechneLite generator supply[71](index=71&type=chunk)[72](index=72&type=chunk) - Lantheus has a strategic agreement with SHINE for a future supply of Mo-99, anticipated to commence in 2022, to help diversify its supply chain[73](index=73&type=chunk) [Clinical Development](index=18&type=section&id=Item%201.%20BusinessClinical%20Development) Lantheus invested $20.0 million in R&D in 2019, with main clinical programs including flurpiridaz F 18 in Phase 3 collaboration with GE Healthcare, LMI 1195 for neuroendocrine tumors with Orphan Drug designation, and a Phase 3 program for DEFINITY where the first trial did not meet its primary endpoint R&D Investment (in millions) | Year | R&D Expense | | :--- | :--- | | 2019 | $20.0 | | 2018 | $17.1 | | 2017 | $18.1 | - The company has an exclusive collaboration with GE Healthcare for the Phase 3 development and worldwide commercialization of flurpiridaz F 18, a PET MPI agent The second Phase 3 trial is underway with a target completion in the second half of 2020[89](index=89&type=chunk)[90](index=90&type=chunk) - The first of two Phase 3 trials for a new DEFINITY indication (LVEF measurement) did not show a statistically significant improvement in accuracy compared to the truth standard (CMRI)[94](index=94&type=chunk) [Intellectual Property](index=20&type=section&id=Item%201.%20BusinessIntellectual%20Property) Lantheus relies on patents, trademarks, and trade secrets to protect its products, with DEFINITY's U.S. Orange Book-listed composition of matter patent expiring in **June 2019** but a method of use patent extending to **March 2037**, and TechneLite protected by component technology patents expiring in **2029** and manufacturing know-how - As of December 31, 2019, the company's patent portfolio included **43 issued U.S. patents** and **284 issued foreign patents**[101](index=101&type=chunk) - DEFINITY's Orange Book-listed composition of matter patent expired in **June 2019**, but it has a method of use patent listed that expires in **March 2037** The company may face generic challengers but has not received any ANDA notice as of the report filing date[103](index=103&type=chunk)[104](index=104&type=chunk)[105](index=105&type=chunk) - TechneLite has patent protection on certain component technology expiring in **2029**, supplemented by significant trade secrets related to its manufacturing process[106](index=106&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks, including substantial dependence on its top product, DEFINITY, which faces potential generic competition following a patent expiration in **June 2019**, and the fragile global supply of Molybdenum-99 critical for TechneLite, along with reliance on third-party manufacturers, dependence on large customers, complex regulations, product liability, and uncertainties related to the proposed Progenics acquisition - The business is substantially dependent on DEFINITY, which faces potential generic competition as its Orange Book-listed composition of matter patent expired in **June 2019**[164](index=164&type=chunk)[166](index=166&type=chunk) - The global supply of Mo-99 is fragile and unstable Recent outages at supplier facilities (NTP and ANSTO) have resulted in the company being unable to fill all demand for its TechneLite generators[171](index=171&type=chunk)[172](index=172&type=chunk) - The company depends on third parties for manufacturing, relying on JHS as the **sole source** for DEFINITY, Neurolite, and Cardiolite[179](index=179&type=chunk) - The pending acquisition of Progenics is subject to conditions and may not occur If it does, risks include integration challenges, potential dilution to earnings, and failure to realize anticipated benefits[276](index=276&type=chunk)[277](index=277&type=chunk)[291](index=291&type=chunk) [Unresolved Staff Comments](index=59&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - **None**[298](index=298&type=chunk) [Properties](index=60&type=section&id=Item%202.%20Properties) The company's principal property is its owned 431,000 square foot corporate headquarters, manufacturing, and laboratory facility in North Billerica, Massachusetts, complemented by leased smaller facilities in Quebec, Canada, and San Juan, Puerto Rico, for office, distribution, and manufacturing purposes Significant Properties | Location | Purpose | Ownership | Square Footage | | :--- | :--- | :--- | :--- | | North Billerica, MA | Corp. HQ, Manufacturing, Lab | Owned | 431,000 | | San Juan, PR | Manufacturing, Lab, Office | Leased | 9,550 | | Quebec, Canada | Distribution & Office | Leased | ~2,539 (total) | [Legal Proceedings](index=60&type=section&id=Item%203.%20Legal%20Proceedings) The company reports no material ongoing litigation as of December 31, 2019, noting a successful arbitration with Pharmalucence concluded in **October 2019**, where Lantheus was awarded approximately **$3.5 million** in damages and fees related to a breached manufacturing and supply agreement for DEFINITY, with proceeds received in **November 2019** - In **October 2019**, the company was awarded approximately **$3.5 million** in an arbitration against Pharmalucence concerning a breach of a manufacturing and supply agreement for DEFINITY The proceeds were received in **November 2019**[301](index=301&type=chunk) - As of December 31, 2019, the company had no other material ongoing litigation, regulatory proceedings, or known governmental investigations[302](index=302&type=chunk) [Mine Safety Disclosures](index=60&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - **Not applicable**[303](index=303&type=chunk) [Part II](index=61&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=61&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the NASDAQ Global Market under the symbol "**LNTH**", with 8 stockholders of record as of February 19, 2020, and does not anticipate paying cash dividends, intending to retain earnings for business growth and debt repayment, having withheld **2,127 shares** in **Q4 2019** to satisfy employee tax obligations related to equity awards - The company's common stock trades on the NASDAQ Global Market under the symbol "**LNTH**"[305](index=305&type=chunk) - The company does not currently intend to pay dividends and expects to retain future earnings to finance growth and repay debt[313](index=313&type=chunk) - During **Q4 2019**, the company purchased **2,127 shares** by withholding them to satisfy minimum statutory tax withholding obligations for employees related to equity awards[315](index=315&type=chunk)[316](index=316&type=chunk)[317](index=317&type=chunk) [Selected Financial Data](index=64&type=section&id=Item%206.%20Selected%20Financial%20Data) This section provides a five-year summary of the company's consolidated financial data, reporting total revenues of **$347.3 million** and net income of **$31.7 million**, or **$0.79** per diluted share, with total assets of **$405.9 million** and total long-term debt, net of **$183.9 million** at year-end 2019 Selected Financial Data (Year Ended Dec 31, in thousands, except per share data) | Metric | 2019 | 2018 | 2017 | | :--- | :--- | :--- | :--- | | **Revenues** | $347,337 | $343,374 | $331,378 | | **Operating Income** | $51,661 | $64,488 | $51,853 | | **Net Income (Loss)** | $31,667 | $40,518 | $123,385 | | **Diluted EPS** | $0.79 | $1.03 | $3.17 | | **Total Assets** | $405,919 | $439,831 | $383,858 | | **Long-term debt, net** | $183,927 | $263,709 | $265,393 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=66&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In 2019, total revenues increased by 1.2% to **$347.3 million**, driven by an 18.8% growth in DEFINITY sales to **$217.5 million**, offsetting declines in TechneLite and other nuclear products due to Mo-99 supplier disruptions, resulting in flat gross profit at **$174.8 million**, decreased operating income to **$51.7 million** due to higher G&A expenses including Progenics acquisition costs, net income of **$31.7 million**, and strong operating cash flow of **$80.4 million** after debt refinancing [Results of Operations (2019 vs. 2018)](index=72&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20OperationsResults%20of%20Operations) For 2019 compared to 2018, total revenues grew 1.2% to **$347.3 million**, driven by a **$34.4 million** (18.8%) increase in worldwide DEFINITY revenue, offset by declines in TechneLite and other nuclear products, resulting in nearly flat gross profit at **$174.8 million**, increased operating expenses due to Progenics transaction costs, and a decrease in operating income to **$51.7 million** and net income to **$31.7 million** Worldwide Revenue by Product (2019 vs 2018, in thousands) | Product | 2019 | 2018 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | DEFINITY | $217,508 | $183,073 | $34,435 | 18.8% | | TechneLite | $86,592 | $98,858 | ($12,266) | (12.4)% | | Other nuclear | $59,805 | $74,284 | ($14,479) | (19.5)% | | **Total Revenues** | **$347,337** | **$343,374** | **$3,963** | **1.2%** | - U.S. segment G&A expenses increased by **$11.6 million (23.6%)** in 2019, primarily due to acquisition-related costs for the pending Progenics acquisition and higher employee-related costs[375](index=375&type=chunk)[376](index=376&type=chunk) - The company recorded a **$3.2 million loss** on extinguishment of debt in 2019 related to the refinancing of its credit facility[383](index=383&type=chunk) [Liquidity and Capital Resources](index=79&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20OperationsLiquidity%20and%20Capital%20Resources) As of December 31, 2019, the company had **$92.9 million** in cash and cash equivalents, with net cash from operating activities of **$80.4 million** for the year, having refinanced its debt in **June 2019** with a new **$200 million term loan facility** and a **$200 million revolving credit facility** maturing in **June 2024**, and believes existing cash, cash flow, and available credit will be sufficient for future liquidity needs Cash Flow Summary (Year ended Dec 31, in thousands) | Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net cash provided by operating activities | $80,384 | $61,193 | | Net cash used in investing activities | ($22,061) | ($19,132) | | Net cash used in financing activities | ($78,881) | ($4,668) | - In **June 2019**, the company entered into a new credit agreement consisting of a **$200 million term loan facility** and a **$200 million revolving credit facility**, both maturing in **June 2024**[399](index=399&type=chunk)[569](index=569&type=chunk) - As of December 31, 2019, total contractual obligations for the next five years amount to **$234.1 million**, primarily consisting of debt principal and interest[411](index=411&type=chunk) [Critical Accounting Policies and Estimates](index=85&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20OperationsCritical%20Accounting%20Policies%20and%20Estimates) The company's critical accounting policies involve significant estimates and judgments in revenue recognition, requiring estimation of variable consideration like rebates, and income taxes, which involves assessing deferred tax asset realizability and uncertain tax positions, with a tax indemnification agreement with BMS resulting in **no net impact on net income** - Revenue recognition requires estimating variable consideration for discounts, returns, and rebates, based on historical experience, contractual requirements, and market trends[424](index=424&type=chunk) - Accounting for income taxes involves significant judgment in assessing the realizability of deferred tax assets and determining uncertain tax positions[426](index=426&type=chunk)[428](index=428&type=chunk) - A tax indemnification agreement with former parent BMS covers certain uncertain tax positions Changes in these liabilities are recorded in the tax provision, with an offsetting adjustment in other income/expense, resulting in **no net impact on net income**[432](index=432&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=88&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risk from changes in interest rates and foreign currency exchange rates, with its primary interest rate risk stemming from **$195.0 million** in variable-rate debt, where a hypothetical **100 basis point** adverse change would impact interest expense by approximately **$2.4 million**, and began using foreign currency forward contracts in **2019** to hedge Canadian dollar exposure - The company has substantial variable rate debt (**$195.0 million** as of Dec 31, 2019) A hypothetical **100 basis point** increase in interest rates would increase annual interest expense by approximately **$2.4 million**[436](index=436&type=chunk)[437](index=437&type=chunk) - The primary foreign currency risk exposure is the Canadian dollar The company began using foreign currency forward contracts in **2019** to mitigate this risk[440](index=440&type=chunk)[441](index=441&type=chunk) [Financial Statements and Supplementary Data](index=89&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains the company's audited consolidated financial statements for the fiscal year ended December 31, 2019, and the **unqualified opinion** report from the independent registered public accounting firm, Deloitte & Touche LLP, on both the financial statements and the **effectiveness** of internal control over financial reporting, including detailed notes [Report of Independent Registered Public Accounting Firm](index=90&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20DataReport%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Deloitte & Touche LLP issued an **unqualified opinion**, stating that the consolidated financial statements present fairly the financial position, results of operations, and cash flows of Lantheus Holdings, Inc. as of December 31, 2019 and 2018, and for the three years then ended, in conformity with U.S. GAAP, and also issued an **unqualified opinion** on the **effectiveness** of the company's internal control over financial reporting, identifying Asset Retirement Obligations as a critical audit matter - The independent auditor, Deloitte & Touche LLP, issued an **unqualified opinion** on the company's financial statements and its internal control over financial reporting[446](index=446&type=chunk)[447](index=447&type=chunk) - The audit identified Asset Retirement Obligations as a critical audit matter due to the significant management estimation involved in determining the expected decommissioning costs for certain facilities[451](index=451&type=chunk)[452](index=452&type=chunk) [Consolidated Financial Statements](index=92&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20DataConsolidated%20Financial%20Statements) The consolidated financial statements detail the company's financial position and performance, with total assets of **$405.9 million** and total liabilities of **$291.3 million** as of December 31, 2019, and for the year, **$347.3 million** in revenue and **$31.7 million** in net income, with cash and cash equivalents decreasing from **$113.4 million** to **$92.9 million** largely due to debt refinancing Consolidated Balance Sheet Highlights (As of Dec 31, 2019, in thousands) | Account | Amount | | :--- | :--- | | Cash and cash equivalents | $92,919 | | Total current assets | $172,911 | | Total assets | $405,919 | | Total current liabilities | $66,111 | | Long-term debt, net | $183,927 | | Total liabilities | $291,318 | | Total stockholders' equity | $114,601 | Consolidated Statement of Operations Highlights (Year ended Dec 31, 2019, in thousands) | Account | Amount | | :--- | :--- | | Revenues | $347,337 | | Gross profit | $174,811 | | Operating income | $51,661 | | Net income | $31,667 | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=131&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) This item is not applicable to the company - **Not applicable**[628](index=628&type=chunk) [Controls and Procedures](index=131&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2019, and assessed its internal control over financial reporting using the COSO framework, concluding it was **effective**, with the independent auditor, Deloitte & Touche LLP, issuing an **unqualified attestation report** on its **effectiveness**, and no material changes to internal controls reported for Q4 2019 - Management concluded that the company's disclosure controls and procedures were **effective** as of the end of the period covered by the report[629](index=629&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2019, based on the COSO (2013) framework[631](index=631&type=chunk) - The independent registered public accounting firm, Deloitte & Touche LLP, issued an **unqualified attestation report** on the **effectiveness** of the company's internal control over financial reporting[632](index=632&type=chunk)[633](index=633&type=chunk) [Other Information](index=134&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - **None**[640](index=640&type=chunk) [Part III](index=135&type=section&id=PART%20III) [Directors, Executive Officers and Corporate Governance](index=135&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) Information required for this item, including details on directors, executive officers, and corporate governance matters such as the Code of Conduct, will be incorporated by reference from the company's **2020 Proxy Statement** - The required information for this item is incorporated by reference from the company's **2020 Proxy Statement**[644](index=644&type=chunk) [Executive Compensation](index=135&type=section&id=Item%2011.%20Executive%20Compensation) Information required for this item regarding executive compensation will be incorporated by reference from the company's **2020 Proxy Statement** - The required information for this item is incorporated by reference from the company's **2020 Proxy Statement**[645](index=645&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=135&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information required for this item, including security ownership of certain beneficial owners and management, will be incorporated by reference from the company's **2020 Proxy Statement** - The required information for this item is incorporated by reference from the company's **2020 Proxy Statement**[646](index=646&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=135&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) Information required for this item concerning related party transactions and director independence will be incorporated by reference from the company's **2020 Proxy Statement** - The required information for this item is incorporated by reference from the company's **2020 Proxy Statement**[647](index=647&type=chunk) [Principal Accountant Fees and Services](index=135&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information required for this item regarding principal accountant fees and services will be incorporated by reference from the company's **2020 Proxy Statement** - The required information for this item is incorporated by reference from the company's **2020 Proxy Statement**[648](index=648&type=chunk) [Part IV](index=136&type=section&id=PART%20IV) [Exhibits and Financial Statement Schedules](index=136&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements, schedules, and exhibits filed as part of the Annual Report on Form 10-K, with consolidated financial statements included in **Part II, Item 8**, and all financial statement schedules omitted as they are not applicable or the required information is included elsewhere, providing a detailed index of exhibits - The consolidated financial statements of Lantheus Holdings, Inc. are filed under **Part II, Item 8**[650](index=650&type=chunk) - All financial statement schedules are omitted because they are not applicable, not required, or the information is included in the financial statements or notes[651](index=651&type=chunk) [Form 10-K Summary](index=140&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has not provided a summary for this item - **None**[658](index=658&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 WASHINGTON, D.C. 20549 For the quarterly period ended September 30, 2019 ☐ 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 (Sta ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 ☐ 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 (State or ...

[Financial Information](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited financial statements, management's discussion and analysis of financial condition, and internal controls [Unaudited Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) For the three months ended March 31, 2019, the company reported total revenues of **$86.5 million**, a **4.7%** increase year-over-year, and net income of **$9.9 million**, a **21.2%** increase; total assets grew slightly to **$443.9 million** from **$439.8 million** at year-end 2018, while total liabilities decreased, resulting in a stronger stockholders' equity position of **$83.2 million**; cash flow from operations was positive at **$10.5 million**, a significant improvement from a negative **$0.7 million** in the prior-year period [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet highlights show slight asset growth, a decrease in total liabilities, and an increase in stockholders' equity as of March 31, 2019 Balance Sheet Highlights (in thousands) | | March 31, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Total current assets** | $195,498 | $195,415 | | **Total assets** | $443,908 | $439,831 | | **Total current liabilities** | $42,768 | $52,755 | | **Total liabilities** | $360,695 | $368,829 | | **Total stockholders' equity** | $83,213 | $71,002 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statement of operations indicates increased revenues, gross profit, operating income, and net income for the three months ended March 31, 2019 Statement of Operations (in thousands, except per share data) | | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--- | :--- | :--- | | **Revenues** | $86,510 | $82,630 | | **Gross profit** | $44,084 | $42,309 | | **Operating income** | $16,169 | $15,137 | | **Net income** | $9,949 | $8,211 | | **Diluted EPS** | $0.25 | $0.21 | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The cash flow statement shows positive net cash from operating activities, increased cash used in investing, and a net decrease in cash and cash equivalents Cash Flow Summary (in thousands) | | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--- | :--- | :--- | | **Net cash provided by (used in) operating activities** | $10,468 | $(666) | | **Net cash used in investing activities** | $(10,550) | $(1,135) | | **Net cash used in financing activities** | $(1,231) | $(704) | | **Net decrease in cash and cash equivalents** | $(1,340) | $(2,551) | | **Cash and cash equivalents, end of period** | $112,061 | $73,739 | [Notes to Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes include the adoption of the new lease accounting standard (ASC 842), which resulted in recording a **$1.1 million** lease asset and liability; revenue is primarily driven by product sales in the U.S. segment, which accounts for the majority of revenue and operating income; the company also details its asset retirement obligations, primarily for its radioactive material facilities, which are secured by a **$28.2 million** surety bond - The company adopted the new lease standard ASC 842 on January 1, 2019, resulting in the recording of an additional lease asset and lease liability of approximately **$1.1 million**[22](index=22&type=chunk)[41](index=41&type=chunk) Revenue by Segment (in thousands) | Segment | Q1 2019 Revenue | Q1 2018 Revenue | | :--- | :--- | :--- | | U.S. | $75,434 | $71,488 | | International | $11,076 | $11,142 | | **Total** | **$86,510** | **$82,630** | Operating Income by Segment (in thousands) | Segment | Q1 2019 Operating Income | Q1 2018 Operating Income | | :--- | :--- | :--- | | U.S. | $14,584 | $14,156 | | International | $1,585 | $981 | | **Total** | **$16,169** | **$15,137** | - The company has asset retirement obligations related to its radioactive material facilities, with a liability of **$11.9 million** as of March 31, 2019, and has provided financial assurance via a **$28.2 million** surety bond[34](index=34&type=chunk)[35](index=35&type=chunk)[37](index=37&type=chunk) [Management's Discussion and Analysis (MD&A)](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the **4.7%** year-over-year revenue growth primarily to increased sales of DEFINITY and TechneLite in the U.S. market; key strategic focuses include expanding the DEFINITY franchise through new indications and formulations, managing the fragile global Molybdenum-99 (Moly) supply chain, and diversifying manufacturing capabilities; R&D expenses increased by **23.6%** due to investments in clinical studies; the company believes its current liquidity, including a **$75 million** revolving credit facility, is sufficient to fund operations for the foreseeable future [Business Overview and Product Portfolio](index=22&type=section&id=Overview) The company is a global leader in diagnostic medical imaging agents, with principal products including DEFINITY and TechneLite - Lantheus is a global leader in diagnostic medical imaging agents, operating in two segments: U.S. and International; its principal products are DEFINITY (ultrasound contrast agent) and TechneLite (Technetium generator)[62](index=62&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk) Revenue by Principal Product (in thousands) | Product | Q1 2019 Revenue | % of Total | Q1 2018 Revenue | % of Total | | :--- | :--- | :--- | :--- | :--- | | DEFINITY | $51,111 | 59.1% | $44,655 | 54.0% | | TechneLite | $24,145 | 27.9% | $21,395 | 25.9% | | Other nuclear | $15,120 | 17.5% | $19,486 | 23.6% | [Key Factors Affecting Results](index=23&type=section&id=Key%20Factors%20Affecting%20Our%20Results) Key factors influencing results include the company's reliance on DEFINITY, strategic expansion initiatives, and challenges in the global Molybdenum-99 supply chain - The company's growth is significantly dependent on its highest margin product, DEFINITY, which held over **80%** of the U.S. market share as of December 31, 2018[67](index=67&type=chunk) - Strategic initiatives for the DEFINITY franchise include pursuing a new LVEF indication, developing a room-temperature stable formulation, and building in-house manufacturing capabilities expected to be operational by early 2021[69](index=69&type=chunk)[75](index=75&type=chunk) - The global Molybdenum-99 (Moly) supply remains a challenge due to periodic outages at the NTP facility in South Africa; the company is mitigating this risk through supply from IRE and ANSTO, and expects ANSTO's new facility to provide incremental supply[74](index=74&type=chunk)[75](index=75&type=chunk) - The company is investing in several R&D programs, including Phase 3 studies for a DEFINITY LVEF indication and development of LMI 1195 for neuroendocrine tumors[80](index=80&type=chunk) [Results of Operations Analysis](index=27&type=section&id=Results%20of%20Operations) Analysis of operations reveals revenue growth driven by U.S. DEFINITY and TechneLite sales, alongside increased R&D expenses and a lower effective tax rate Revenue Change by Segment and Product (in thousands) | Category | Q1 2019 | Q1 2018 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | **$86,510** | **$82,630** | **$3,880** | **4.7%** | | U.S. DEFINITY | $49,716 | $43,506 | $6,210 | 14.3% | | U.S. TechneLite | $20,058 | $18,063 | $1,995 | 11.0% | | U.S. Other nuclear | $9,524 | $12,817 | ($3,293) | (25.7)% | - Gross profit increased by **4.2%** to **$44.1 million**, primarily due to higher DEFINITY and TechneLite unit volumes in the U.S., offset by lower Xenon volumes[87](index=87&type=chunk)[88](index=88&type=chunk) - Research and development expenses increased **23.6%** to **$4.9 million**, driven by clinical research expenses for DEFINITY studies[94](index=94&type=chunk) - The effective tax rate decreased to **22.1%** for Q1 2019 from **31.6%** in Q1 2018, primarily due to increased tax benefits from stock compensation deductions[100](index=100&type=chunk)[101](index=101&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is supported by positive operating cash flow, a revolving credit facility, and sufficient cash to fund future operations - Net cash from operating activities was **$10.5 million**, a significant improvement from a **$0.7 million** use of cash in the prior year, driven by higher net income and non-cash charges[102](index=102&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk) - Net cash used in investing activities increased to **$10.6 million** from **$1.1 million** YoY, due to higher capital expenditures[102](index=102&type=chunk)[105](index=105&type=chunk) - The company has a **$275 million** term loan facility and a **$75 million** revolving credit facility as external sources of liquidity; as of March 31, 2019, cash and cash equivalents were **$112.1 million**[108](index=108&type=chunk)[116](index=116&type=chunk) - Management believes existing cash, operating results, and availability under the revolving facility are sufficient to fund liquidity requirements for the foreseeable future[117](index=117&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of the end of the period; no material changes were made to internal controls over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2019[123](index=123&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[124](index=124&type=chunk) [Other Information](index=36&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section details ongoing legal proceedings, significant risk factors, and the company's policies regarding equity and dividends [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is currently in arbitration with Pharmalucence concerning a Manufacturing and Supply Agreement for DEFINITY; the company is seeking monetary damages but cannot predict the outcome; no other material ongoing litigation was reported - The company is in an ongoing arbitration with Pharmalucence over a manufacturing and supply agreement for DEFINITY, seeking monetary damages[127](index=127&type=chunk)[51](index=51&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) The company highlights two key risk areas: first, the global supply of Molybdenum-99 (Moly), a critical ingredient for TechneLite, is fragile and unstable, with recent outages at a key supplier (NTP) impacting production; second, the process of developing new drugs and obtaining regulatory approval for its pipeline candidates (DEFINITY for LVEF, flurpiridaz F 18, LMI 1195) is complex, costly, and uncertain, with potential for significant delays and failure - The global supply of Moly is fragile, with periodic outages at the NTP processing facility in South Africa impacting the company's ability to meet full demand for its TechneLite generators[130](index=130&type=chunk)[131](index=131&type=chunk) - Mitigation efforts for Moly supply risk include relying on other suppliers (IRE, ANSTO) and the recent FDA approval of ANSTO's new, higher-capacity facility[132](index=132&type=chunk) - The company faces significant risk related to the complex, time-consuming, and costly process of obtaining regulatory approval for its three active clinical development programs[137](index=137&type=chunk) - The regulatory approval process for DEFINITY in China is experiencing further delays related to packaging components and clinical data assessment[141](index=141&type=chunk) [Share Repurchases and Dividend Policy](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company does not have a share repurchase program in effect but withheld **50,475** shares during the quarter to satisfy employee tax obligations on vested equity awards; the company did not pay dividends and does not intend to in the foreseeable future, retaining earnings to repay debt and fund growth - During Q1 2019, the company withheld **50,475** shares of common stock to satisfy minimum statutory tax withholding obligations for employees related to equity awards[146](index=146&type=chunk)[147](index=147&type=chunk) - The company does not currently intend to pay dividends and expects to retain future earnings to repay debt and finance business growth[148](index=148&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _______________________________________________________________ FORM 10-K _______________________________________________________________ (Mark One) þ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 ☐ 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 ...