UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure |
On January 11, 2023, Lantheus Holdings, Inc. (the “Company”) is delivering a presentation at the 41st Annual J.P. Morgan Healthcare Conference, which also will be webcast live. A copy of the slide presentation that will be used by representatives of the Company in connection with the presentation (the “Corporate Presentation”) is attached to this Current Report on Form 8-K as Exhibit 99.1. The Corporate Presentation is current as of January 11, 2023, and the Company disclaims any obligation to update or revise the Corporate Presentation, including with respect to any forward-looking statements, to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results over time, unless required by law.
The information in this Item 7.01 and Exhibit 99.1 attached hereto are intended to be furnished and shall not be deemed “filed” for any purpose, including for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall they be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit |
Exhibit Description | |
| 99.1* | Corporate Presentation | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
| * | Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| LANTHEUS HOLDINGS, INC. | ||
| By: | /s/ Daniel M. Niedzwiecki | |
| Name: | Daniel M. Niedzwiecki | |
| Title: | Senior Vice President and General Counsel | |
Date: January 11, 2023
41st Annual J.P. Morgan Healthcare Conference © 2023 Lantheus. All rights reserved. January 11, 2023 Exhibit 99.1
Safe Harbor Statements © 2023 Lantheus. All rights reserved. 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 Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “anticipate,” “believe,” “confident,” “continue,” “could,” “estimate,” “expect,” “guidance,” “intend,” “introduce,” “may,” “momentum,” “plan,” “predict,” “progress,” “project,” “promising,” “target,” “will,” “would” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include: (i) our ability to continue to grow PYLARIFY as a commercial product, including (A) our ability to obtain FDA approval for additional positron emission tomography (“PET”) manufacturing facilities (“PMFs”) to manufacture PYLARIFY, (B) the ability of PMFs to manufacture PYLARIFY to meet product demand, (C) our ability to sell PYLARIFY to customers, (D) our ability to obtain and maintain adequate coding, coverage and payment for PYLARIFY, and (E) our ability to establish PYLARIFY as a leading PSMA PET imaging agent in an increasingly competitive environment in which other PSMA PET imaging agents have been approved and additional ones are in development; (ii) continued market expansion and penetration for our established commercial products, particularly DEFINITY, in the face of segment competition and potential generic competition, including as a result of patent and regulatory exclusivity expirations and challenges; (iii) the global Molybdenum-99 (“Mo-99”) supply; (iv) our ability to have third party manufacturers manufacture our products and our ability to manufacture DEFINITY in our in-house manufacturing facility; (v) our ability to successfully launch PYLARIFY AI as a commercial product; (vi) the continuing impact of the global COVID-19 pandemic on our business, supply chain, financial conditions and prospects; (vii) the efforts and timing for clinical development and regulatory approval of our product candidates and new clinical applications and territories for our products, in each case, that we may develop, including 1095 and NM-01, or that our strategic partners may develop, including piflufolastat F 18 in Europe and flurpiridaz fluorine-18 (“F 18”); (viii) our strategies, future prospects, and our projected growth, including revenue related to our collaboration agreements with POINT Biopharma; (ix) our ability to identify and acquire or in-license additional diagnostic and therapeutic product opportunities in oncology and other strategic areas; and (x) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q). All trademarks, logos and service marks on this page are the property of their respective owners. Non-GAAP Financial Measures The Company uses non-GAAP financial measures, such as adjusted net income and its line components; adjusted net income per share - fully diluted; and free cash flow. The Company’s management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the Company’s operations, period over period. However, these measures may exclude items that may be highly variable, difficult to predict and of a size that could have a substantial impact on the Company’s reported results of operations for a particular period. Management uses these and other non-GAAP measures internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.
Lantheus – A Growth Company Continue to advance our purpose to FIND. FIGHT. FOLLOW. disease to deliver better patient outcomes FOUNDED: 1956 | $800M TTM Revenues1 | 25% 5-Year Revenue CAGR1 | TICKER: LNTH Delivering life-changing science to patients and providers, going further to improve outcomes and lives. #1 Ultrasound Enhancing Agent used in the U.S. for almost 20 years2 65 years of radiopharmaceutical expertise, including development, manufacturing, and commercialization #1 PSMA PET Imaging Agent with Sustainable Competitive Advantages SUSTAIN double-digit growth DIVERSIFY our portfolio POSITION Lantheus as a category leader Executing On Our Strategy to: Leader in radiopharmaceuticals Trailing 12-month revenues ending 3Q 2022. 5-year revenue CAGR ending 3Q 2022. DRG Echo Monthly Monitor. © 2023 Lantheus. All rights reserved.
© 2023 Lantheus. All rights reserved. Precision Diagnostics Our leading diagnostic products assist healthcare professionals (HCPs) in Finding and Following diseases with a current focus in cardiology Radiopharmaceutical Oncology Diagnostics and therapeutics that aid HCPs in Finding, Fighting and Following cancer Strategic Partnerships and Other Strategic Partnerships with a focus on enabling precision medicine with biomarkers, digital solutions and pharma services platforms
Uniquely Positioned to Take Advantage of the Renaissance in Radiopharmaceuticals Source: MEDraysintell 2022 Nuclear Medicine Report 1 Number of assets in preclinical – Phase 3 development, increase vs. 2019. © 2023 Lantheus. All rights reserved. For Internal Use Only. Radiopharmaceuticals (Diagnostic and Therapeutic) Undergoing > 350 Clinical Trials RADIOPHARMACEUTICAL THERAPIES IN DEVELOPMENT1 Isotope Actinium 225 Lutetium 177 Iodine 131 PET RADIOPHARMACEUTICAL DIAGNOSTICS IN DEVELOPMENT1 Global Radiopharmaceutical Market USD Billions 18.6% CAGR 10 YEAR LANTHEUS: Poised to take Advantage of the Renaissance in Radiopharmaceuticals RECOGNIZED LEADER in radiopharmaceuticals CAPABILITIES TO DRIVE INNOVATION right experience & know- how to capture the opportunity UNIQUELY POSITIONED to launch new radiopharmaceutical products 6 # Assets 20 58 16 Isotope Fluorine 18 Gallium 68 Copper 64 Therapeutics Diagnostics D vs. ‘19 +25% +38% +23% # Assets 115 89 41 D vs. ‘19 +12% +45% +28%
Near-Term Growth Drivers
Prostate Specific Membrane Antigen (PSMA) PET Imaging Agent for Prostate Cancer Firmly established as the market leading PSMA PET imaging agent for the U.S. prostate cancer community 90K+ scans $410.2M Net Sales Launched June 2021 Drivers of Success Operational Excellence Innovation Significant unmet need © 2023 Lantheus. All rights reserved. © 2023 Lantheus. All rights reserved. Since Launch through 3Q 2022
Prostate Cancer is the 2nd Most Common Cancer in American Men1 American Cancer Society. Cancer Facts & Figures 2022. American Cancer Society; Atlanta, Ga. 2022. American Cancer Society. Cancer Facts & Figures 2022. American Cancer Society; Atlanta, Ga. 2022, LNTH market research projection for 2023. Farolfi & Ceci. 68Ga-PSMA-11 PET/CT in prostate cancer patients with biochemical recurrence after radical prostatectomy and PSA <0.5 ng/ml. Efficacy and impact on treatment strategy. European Journal of Nuclear Medicine and Molecular Imaging https://doi.org/10.1007/s00259-018-4066-4 (Published online 15 June 2018). © 2023 Lantheus. All rights reserved. 1:8 Diagnosed with prostate cancer during his lifetime1 ~1:41 Will die of prostate cancer1 Up to 50% will experience a recurrence3 3.2M+ Are living with prostate cancer today1 60% 65 or older demographic trends key factor in expected growth1 2023 Prostate Cancer Estimates ~279K new cases2 ~34.5K deaths1
~$1.6B U.S. PSMA PET Imaging TAM Estimate +2-3% annual growth due to increasing incidence / prevalence5 Market research interviews, survey, and analysis, Wenzel 2021 Prostate, Nezolosky 2018 J. Clin. Oncol., Agrawal 2020 JAMA. Scher HI, Solo K, Valant J, Todd MB, Mehra M. 2015. Prevalence of Prostate Cancer Clinical States and Mortality in the United States: Estimates Using a Dynamic Progression Model. PloS one 10: e0139440. Based on: CDC.gov, SEER Database, NCCN.org and Axiom Primary and Secondary Market Research and Analysis, validated by Bohm Epidemiology 2020. 3L treatment of adult patients with PSMA-positive mCRPC who have already been treated with other anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy). Addressable market based on: current management estimates, internal data and observed market price. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. 2023 Annual Scan Potential Estimates ~30K Scans ~$1.6B+ MARKET POTENTIAL4 ~350K ANNUAL SCANS SUSPECTED RECURRENCE2 ~110K Patients with Biochemical Recurrence of Prostate Cancer (~195K potential scans) INITIAL STAGING FOR SUSPECTED METASTASES1 ~125K Patients staged with Intermediate Unfavorable, High or Very High Risk Prostate cancer (~125K potential scans) PSMA-TARGETED RADIOLIGAND THERAPY3 ~20k Patients with 3L mCRPC (~30K potential scans) ~125K Scans ~195K Scans © 2023 Lantheus. All rights reserved.
2022 Net Sales through 3Q $181.4M 21M+ echo studies have been performed with DEFINITY Launched 2001 Clinical Differentiation Distribution Model Supporting Data & Publications Market Leading Ultrasound Enhancing Agent © 2023 Lantheus. All rights reserved. Drivers of Success
2022 Heart Disease and Stroke Statistics Update Fact Sheet. Between 2015 and 2018; 2022 Heart Disease and Stroke Statistics Update fact sheet. Heart Disease and Stroke Statistics – 2022: A Report From the American Heart Association. Circulation. 2022;145(8): e153-e 639. Heart Disease is the #1 Cause of Death in the U.S.1 100M+ Impacted in the U.S.2 Every 40 seconds on average, someone in the U.S. will have a myocardial infarction1 20M Adults WITH CAD1,3 ~875K DEATHS3 2022 Heart Disease Estimates (U.S.) 214.6 per 100,000 the age adjusted U.S. death rate attributable to CVD3 2 in 10 deaths from CAD happen in adults less than 65 years old3 © 2023 Lantheus. All rights reserved.
U.S. Ultrasound Enhancing Agent (UEA) TAM is $600M+1 U.S. market; Internal Lantheus estimate. Source: AMR, Echocardiography Monthly Monitor and Real World Data; Kurt M et al. Journal of the American College of Cardiology, March 2009; Senior R et al., The European Society of Cardiology, 2006. ©2020 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission. 20%-30% of echocardiograms result in sub-optimal images. Sources: i. Kurt M et al. Impact of contrast echocardiography on evaluation of ventricular function and clinical management in a large prospective cohort. Journal of the American College of Cardiology, Vol 53, No 9, March 2009, 802-810; ii. Platts DG and Fraser JF. Contrast echocardiography in critical care: echoes of the future? A review of the role of microsphere contrast echocardiography. Critical Care and Resuscitation, Vol 12, No 1, March 2011, 44-55; iii. Senior R et al. Clinical benefits of contrast-enhanced echocardiography during rest and stress examinations. The European Society of Cardiology 6, Suppl. 2, 2005, S6-S13. Internal Lantheus estimate. U.S. Echo Market # of Annual Scans 25M-32M Echoes performed in the U.S. annually2 20%-30% or 5M-10M are considered suboptimal3 U.S. UEA Market ($M) $600M+ U.S. TAM U.S. total addressable market (TAM) Current U.S. UEA Market Size U.S. DEFINITY Sales DEFINITY #1 UEA in the U.S. ~$280M4 Existing Market © 2023 Lantheus. All rights reserved.
Sustaining Double Digit Growth
Candidate Target Isotope Indication / Disease Area Pre-Clinical Phase I Phase II Phase III Reg. Filling MICROBUBBLE DEFINITY N/A N/A Pediatric Echocardiography RADIOPHARMACEUTICALS Prostate Cancer PYLARIFY (1) PSMA 18F Prostate Cancer (Europe) PNT-2002 PSMA 177Lu Metastatic Prostate Cancer LNTH-1095 PSMA 131I Metastatic Prostate Cancer LNTH-1404 (2) PSMA 99mTc Prostate Cancer PSMA-TAC (3) PSMA 225Ac Prostate Cancer LNTH-1558 PSMA TBD Prostate Cancer Neuro-Endocrine Tumors AZEDRA NE Transp. 131I Neuroblastoma PNT-2003 SSTR2 177Lu GEP-NETs Tumor micro-environment NM-01 PD-L1 99mTc PD-L1 expression (biomarker) NTI-1309 FAP 64Cu Tumor / Fibrosis assessment (biomarker) Cardiology Flurpiridaz (4) MC-1 18F Myocardial Perfusion Lantheus Product Pipeline Out-Licensed to Curium for Europe. Out-Licensed to Rotop Pharmaka GmbH. Out-Licensed to Bayer Pharmaceuticals. Out-Licensed to GE Healthcare. Diagnostic Therapeutic © 2023 Lantheus. All rights reserved. PSMA: Prostate specific membrane antigen NE Transp.: Norepinephrine transporter SSTR2: Somatostatin receptor 2 GEP-NETs: Gastroenteropancreatic neuroendocrine tumors PD-L1: Programmed death-ligand 1 FAP: Fibroblast activation protein MC-1: Mitochondrial complex 1
Radiopharmaceutical Portfolio Expands with Late-stage Therapeutic Candidates (1/2) Projected TAM in 2029 based on management estimates and internal data. Data from 27 patients enrolled in Lead-In cohort presented at ESMO 2022: 84.8% of individuals imaged with PSMA-PET met PSMA eligibility criteria Median rPFS was 11.5 months, longer than statistical assumptions of the protocol Reduction of ≥ 50% of PSA baseline PSA (PSA50 response) was achieved in 42% of patients Well tolerated with no treatment-related deaths and few treatment-related AEs of grade 3 or higher 70K+ men eligible for mCRPC treatment every year in the U.S. Phase 3 SPLASH Trial for mCRPC Ongoing TAM1 (U.S.) ~$3.5B (Licensed from POINT, December 2022) PNT2002 177Lu-based PSMA-targeted radiopharmaceutical therapy in development to treat metastatic castration-resistant prostate cancer (mCRPC) Combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope lutetium-177 (177Lu) © 2023 Lantheus. All rights reserved.
© 2023 Lantheus. All rights reserved. Radiopharmaceutical Portfolio Expands with Late-stage Therapeutic Candidates (2/2) Projected TAM in 2027 based on management estimates and GlobalData Neuroendocrine Tumors Global Drug Forecast and Market Analysis to 2030, published Sept 2021. 18K GEP-NET patients in the U.S. Uses the SSTR-targeted DOTA-TATE ligand, also utilized in currently approved radiopharmaceutical product for the GEP-NETs indication SSTRs seen as ideal targets for GEP-NET and certain other NETs therapy Somatostatin analogs have been developed with anti-secretory and anti-proliferative effects for NET therapy Randomized clinical trials with somatostatin analogs have demonstrated efficacy TAM1 (U.S.) ~$800M (Licensed from POINT, December 2022) PNT2003 Somatostatin receptor (SSTR) targeted radioligand therapy with non-carrier added 177Lu in development to treat SSTR-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) © 2023 Lantheus. All rights reserved.
Strong Financial Profile Enables Investment Strategy
Disciplined Strategic and Financial Approach to Growth Enabling an Attractive & Sustainable Financial Profile Revenue growth Margin expansion FCF generation Flexible balance sheet Delivering on Our Strategy Sustain double-digit growth Diversify our portfolio Position Lantheus as a category leader Continuing to Execute Invest in strategically aligned organic and inorganic assets Integrate and deliver on value creation drivers Create shareholder value
5-year Financial Targets FCF = Free Cash Flow = Operating Cash Flow less Capital Expenditures; 2022-2027 cumulative estimate. Delivering Profitable Growth Delivering levered P&L Disciplined investment to support growth and efficiencies 45%+ EBITDA MARGIN Strong cash and earnings growth Prioritized capital expenditures CUMULATIVE FCF $1.5B+1 Favorable volume and product mix Managing for profitability 70%+ GROSS MARGIN © 2023 Lantheus. All rights reserved.
Summary
Lantheus – A Growth Company © 2023 Lantheus. All rights reserved. Continue to advance our purpose to FIND. FIGHT. FOLLOW. disease to deliver better patient outcomes Proven Track Record of Success 65 years of radiopharmaceutical expertise #1 PSMA PET Imaging Agent with Sustainable Competitive Advantages #1 Ultrasound Enhancing Agent used in the U.S. for almost 20 years1 Clear Strategy to Create Shareholder Value SUSTAIN double-digit growth DIVERSIFY our portfolio POSITION Lantheus as a category leader Disciplined capital allocation strategy Enabling an Attractive & Sustainable Financial Profile Managing and Investing for Long-term Growth, Profitability & Cash Flow Generation Rigorous Business Development Process and Focus on Value Creation
Appendix
Proven Management Team with Deep Industry Expertise Seasoned and Experienced with a Strong Track Record of Value Creation Mary Anne Heino President and Chief Executive Officer 2013 Previously: Janssen, Centocor, Inc, Angleini, Labopharm Daniel Niedzwiecki SVP – General Counsel and Corporate Secretary 2013 Previously: Weil, Gotshal & Manges, Palmer & Dodge Jean-Claude Provost, M.D. Chief Medical Officer 2022 Previously: Theranostics Consulting, GE Healthcare, Pfizer, Bayer, Merck-Serono Etienne Montagut Chief Business Officer 2018 Previously: GE Healthcare, Ipsen Paul Blanchfield Chief Operating Officer 2020 Previously: Takeda, Shire, McKinsey & Company Robert Marshall Chief Financial Officer and Treasurer 2018 Previously: Zimmerbiomet, Brown and Williamson Tobacco
© 2023 Lantheus. All rights reserved. Market research interviews, survey, and analysis, Wenzel 2021 Prostate, Nezolosky 2018 J. Clin. Oncol., Agrawal 2020 JAMA. Scher HI, Solo K, Valant J, Todd MB, Mehra M. 2015. Prevalence of Prostate Cancer Clinical States and Mortality in the United States: Estimates Using a Dynamic Progression Model. PloS one 10: e0139440. Based on: CDC.gov, SEER Database, NCCN.org and Axiom Primary and Secondary Market Research and Analysis, validated by Bohm Epidemiology 2020. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. Prostate Cancer Patients May Undergo Imaging Several Times During Their Disease Journey Recurrent Disease (RD) 3-5 YEARS 1-10 YEARS 1-3 MONTHS Illustrative Pt. with Local OR Locoregional Disease PCa Negative PCa Positive Initial Evaluation for Prostate Biopsy Intermediate Unfavorable, High or Very High Risk Active Surveillance (low risk) Active Treatment (medium/high risk) Screening (PSA +/- DRE) Establish presence of metastatic disease Monitoring for disease progression Treatment for oligo- metastatic disease Treatment for metastatic disease Response evaluation without imaging Response evaluation with imaging Treatment for non- metastatic disease Definitive Treatment +/- ADT ~110K Patients2 ~125K Patients1 Treatment for oligo- metastatic disease Treatment for metastatic disease Response evaluation without imaging Response evaluation with imaging Treatment for non- metastatic disease Monitoring for disease progression Establish presence of metastatic disease ~30K Patients2 ~20K Patients3 3L mCRPC BCR Recurrence Estimated 2-3% annual growth due to increasing incidence / prevalence4 Initial Staging Radioligand Therapy # Annual Incidence