Full Press Release Details
Lantheus 2022 Investor Day May 17 | New
York City Exhibit 99.1
Welcome & Opening Remarks Mark
Kinarney Senior Director, Investor Relations
Safe Harbor and Non-GAAP Financial
Measures 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) 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; (ii) our ability to continue to grow PYLARIFY as a commercial product, including (A) our ability to obtain
United States Food and Drug Administration ("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, and (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 a competitive environment in which other PSMA PET imaging agents have been approved and additional ones are in development; (iii) the global Molybdenum-99 supply; (iv) our ability to use in-house manufacturing capacity and our ability to
use our in-house manufacturing capacity; (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 of our product candidates and new clinical applications for our products, in each case, that we may develop, including 1095 and LMI 1195, or that our strategic partners may develop, including
flurpiridazfluorine-18 ("F 18"); (viii) our ability to identify and acquire or in-license additional diagnostic and therapeutic product opportunities in oncology and other strategic areas; (ix) the potential reclassification by the FDA
of certain of our products and product candidates from drugs to devices with the expense, complexity and potentially more limited competitive protection such reclassification could cause; 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.
Today's Agenda 9:00 AM Welcome
and Opening Remarks Mark Kinarney, Senior Director, Investor Relations Vision and Strategy for the Next Phase of Growth Mary Anne Heino, President and CEO PYLARIFY - Prostate Cancer Franchise Overview Paul Blanchfield, Chief Commercial Officer
Etienne Montagut, Chief Business Officer Aseem Anand, VP of Digital Solutions PYLARIFY Key Opinion Leader Panel Moderator: Bela Denes, M.D., VP, Medical Affairs E. David Crawford, M.D., Professor of Urology, University of California San Diego
Michael Morris, M.D., Section Head, Prostate Cancer, Memorial Sloan Kettering Cancer Center 10:25 AM Q&A 10:45 AM Break 10:55 AM DEFINITY - Microbubble Franchise Overview Paul Blanchfield, Chief Commercial Officer Etienne Montagut, Chief
Business Officer Uniquely Positioned for Radiopharmaceutical Renaissance Moderator: Bela Denes, M.D., VP, Medical Affairs Jean-Claude Provost, M.D., Interim Chief Medical Officer Executing the Growth Strategy Etienne Montagut, Chief Business Officer
Financial Highlights Bob Marshall, CFO and Treasurer Closing Comments Mary Anne Heino, President and CEO 11:55 AM Q&A
Vision and Strategy for the Next Phase
of Growth Mary Anne Heino President and CEO
Key Messages 65+ Years of Industry
Leadership and Innovation from our diversified portfolio Proven Operational and Commercial Capabilities to capture significant growth opportunities and sustain them over the long-term Seasoned Leadership Team with deep expertise and strong
execution track record of delivering long-term stakeholder value Committed to Optimizing Value by maximizing portfolio opportunities under our stewardship
Proven Management Team with Deep
Industry Expertise Mary Anne Heino President and Chief Executive Officer 2013 Previously: Janssen, Centocor, Inc, Angleini, Labopharm Robert Marshall Chief Financial Officer and Treasurer 2018 Previously: Zimmerbiomet, Brown and Williamson Tobacco
Etienne Montagut Chief Business Office 2018 Previously: GE Healthcare, Ipsen Daniel Niedzwiecki SVP - General Counsel and Corporate Secretary 2013 Previously: Weil, Gotshal & Manges, Palmer & Dodge Paul Blanchfield Chief Commercial
Officer 2020 Previously: Takeda, Shire, McKinsey & Company Vivian Yao Chief Human Resources Officer 2021 Previously: Johnson & Johnson, Jabil, GE Carol Walker SVP - Quality 2015 Previously: Nova Biomedical, Siemens, IMDx, Bayer
Diagnostics Linda Lennox Chief of Staff & VP, Corporate Communications 2020 Previously: AMAG, Critical Therapeutics, Putnam Investments Jean-Claude Provost, M.D. Interim Chief Medical Officer 2022 Previously: Theranostics Consulting, GE
Healthcare, Pfizer, Bayer, Merck-Serono Seasoned and Experienced with a Strong Track Record of Value Creation
Lantheus Holdings Snapshot (NASDAQ:
LNTH) (1) Positron Emission Tomography (2) DRG Echo Monthly Monitor (3) As of 5/10/22 KEY STATISTICS First and best-in-class PSMA PET1 imaging agent for prostate cancer #1 Ultrasound enhancing agent in the U.S. for almost 20 years2 Emerging
therapeutic platform and capabilities with AZEDRA Nearly 50 years of expertise in development and commercialization of radiopharmaceuticals REVENUE DIVERSIFICATION 25% YoY Growth TOP PRODUCTS ~$4.0B 600+ $425.2M $0.49 Market Cap3 Total Employees
2021 Revenue 2021 Adj. EPS 2020 2021 $425M DEFINITY TechneLite Other Precision Diagnostics Other Radiopharmaceutical Oncology Strategic Partnerships & Other PYLARIFY $339M
Where We Were, Where We Are, Where We
Are Going (1) Pheochromocytoma and Paraganglioma A HISTORY OF INDUSTRY FIRSTS 2022 & ONWARD ACCELERATE POSITION DIVERSIFY 1956 Founded as New England Nuclear 1970 First commercially owned cyclotron begins producing radiopharmaceuticals 2021
First to launch a commercially available PSMA PET imaging agent in U.S. with PYLARIFY 1977 First to launch a radiopharmaceutical for non-invasive assessment of coronary artery disease with Thallium-201 1991 First to launch Technetium-99m labeled
myocardial perfusion imaging agent in U.S. with CARDIOLITE 2001 Launched DEFINITY, the leading U.S. echocardiography contrast agent 2015 Lantheus becomes a NASDAQ listed company 2018 First to launch a radiopharmaceutical treatment for PPGL1 in U.S.
with AZEDRA 2020 Lantheus acquires Progenics Pharmaceuticals
Competitive Advantages to Sustain
Growth and Innovation Well Positioned to Find, Fight And Follow Disease to Deliver Better Patient Outcomes with strong supply chain management DIVERSIFIED PRODUCT PORTFOLIO AND PIPELINE with expertise across the value chain RECOGNIZED LEADER
IN RADIOISOTOPES with proven commercial and operational excellence SEASONED LEADERSHIP TEAM to launch new radiopharmaceutical products UNIQUELY POSITIONED
Our Strategy for Long-term
Profitable Growth Poised to Take Advantage of Renaissance in Radiopharmaceuticals DIVERSIFY our portfolio and optimize value through business development and strategic partnerships POSITION as category leader by enhancing operational and commercial
excellence ACCELERATE growth across our platforms
Experienced and Engaged Board of
Directors SKILLS MATRIX Brian Markison Chairman of the Board CEO & Director of Osmotica Holdings, SCSp 2012 Mary Anne Heino President & CEO Lantheus Holdings 2015 Minnie Baylor-Henry President of B-Henry & Associates 2022 Dr. G rard
Ber Co-Founder & former COO, Advanced Accelerator Applications 2020 Samuel Leno Former EVP & COO, Boston Scientific 2012 Heinz M usli Former CFO, Advanced Accelerator Applications 2020 Julie McHugh Former President of Centocor, Inc.
2017 Gary J. Pruden Former EVP, Worldwide Chairman, Johnson & Johnson 2018 Dr. James H. Thrall Former Chairman of the Department of Radiology at the Massachusetts General Hospital 2018 Strategy Development & Planning M&A and Business
Dev. Human Capital Mgmt. & Development Corporate Governance & ESG Sales & Marketing Supply Chain Mgmt. R&D Experience Technology Finance 89% 44% 33% Independent <5 Yr. Tenure Gender Diversity BOARD ATTRIBUTES
Key Takeaways 65+ Years of Industry
Leadership and Innovation from our diversified portfolio Proven Operational and Commercial Capabilities to capture significant growth opportunities and sustain them over the long-term Seasoned Leadership Team with deep expertise and strong
execution track record of delivering long-term stakeholder value Committed to Optimizing Value by maximizing portfolio opportunities under our stewardship
Prostate Cancer Franchise Paul
Blanchfield Chief Commercial Officer Etienne Montagut Chief Business Officer Aseem Anand VP of Digital Solutions
Key Messages (1) Addressable market
based on current management estimates, internal data and observed market price. Significant Market Opportunity $1.1B+ U.S. PSMA PET TAM1 #1 PSMA PET Imaging Agent with First Mover Advantage strong PYLARIFY adoption-to-date Significant Long-Term
Growth Potential through partnerships and future market expansion
Prostate Cancer (PCa) 2nd Most
Common Cancer in U.S Men (1) American Cancer Society. Cancer Facts & Figures 2022. American Cancer Society; Atlanta, Ga. 2022; (2) Ceci & Fanti. PSMA-PET/CT imaging in prostate cancer: why and when. Clinical and Translational Imaging volume
7, pages 377-379 (2019).; (3); National Cancer Institute - Financial Burden of Care (2020 estimate); (4) Cancer stat facts: prostate cancer. National Cancer Institute Surveillance, Epidemiology, and End Results Program. Accessed February
19, 2021. https://seer.cancer.gov/statfacts/html/prost.html SIGNIFICANT OPPORTUNITY Prostate Cancer is a $20B+ market3 Metastatic PCa particularly challenging with long-term survival <30%4 Significant unmet need for: Safe and effective
diagnostics Additional therapeutic options PYLARIFY creates opportunity to lead in PCa imaging and expand into PCa therapeutics and adjacent areas Find, Fight and Follow Serious Medical Conditions 3+ million are living with prostate cancer
today ~269K new cases ~35K deaths 2022 Prostate Cancer Estimates1,2 1:8 diagnosed with the disease during his lifetime 60% 65+ demographic trends key factor in expected growth 1:41 will suffer a terminal fate from prostate cancer Up to 50% of
patients will experience a recurrence
PSMA PET Imaging Can Enhance
Therapeutic Decision Making PET imaging has the potential to improve disease localization, thus enhancing therapeutic decision-making1,2,6 PSMA PET can detect lesions between 4-8 mm, and therefore has a higher detection rate3,5 PSMA PET is also
effective at lower PSAs3 In the biochemical recurrent (BCR) setting, conventional imaging offers limited utility, potentially compromising therapeutic decision making1,2 Bone scans and CT scans can detect bone, nodal and soft tissue metastasis,
but lack sensitivity for early lesion detection3 Conventional imaging offers limited utility in detecting BCR lesions at PSA levels <1.0 ng/mL4 CT scans and MRIs are less likely to detect metastatic tumors between 4-8 mm3,5 PYLARIFY Can Address
Significant Unmet Medical Need Conventional Imaging Challenges in PCa Advantages of PSMA PET Imaging (1) Hofman MS, Lawrentschuk N, Francis RJ, et al; proPSMA Study Group Collaborators. Prostate-specific membrane antigen PET-CT in patients with
high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. Lancet. 2020;395(10231):1208-1216. doi:10.1016/S0140-6736(20)30314-7;; (2) ousseau E, Wilson D, Lacroix-Poisson F, et
al. A prospective study on 18F-DCFPYL PSMA PET/CT imaging in biochemical recurrence of prostate cancer. J Nucl Med. 2019;60(11):1587-1593. doi:10.2967/jnumed.119.226381; (3) Mena E, Lindenberg ML, Turkbey IB, et al. 18F-DCFPYL PET/CT imaging in
patients with biochemically recurrent prostate cancer after primary local therapy. J Nucl Med. 2020;61(6):881-889. doi:10.2967/jnumed.119.234799; (4) Taneja SS. Imaging in the diagnosis and management of prostate cancer. Rev Urol.
2004;6(3):101-113.; (5) Pienta KJ, Gorin MA, Rowe SP, et al. A phase 2/3 prospective multicenter study of the diagnostic accuracy of prostate specific membrane antigen PET/CT with 18F-DCFPYL in prostate cancer patients (OSPREY) [published online
ahead of print, February 26, 2021]. J Urol. doi:10.1097/JU.0000000000001698; (6) Li R, Ravizzini GC, Gorin MA, et al. The use of PET/CT in prostate cancer. Prostate Cancer Prostatic Dis. 2018;21(1):4-21. doi:10.1038/s41391-017-0007-8
$1.1B+ U.S. PSMA PET TAM $92.8M in
PYLARIFY Sales for 1Q'22 = ~34% Annualized Penetration Potential to Expand TAM with Expanding Therapeutic Utilization $1.1B+ U.S. TAM PYLARIFY #1 PSMA PET Imaging Agent U.S. PSMA PET Market U.S. PSMA PET Market Potential # of Annual Scans
~130K 52% ~90K 36% ~30K 12% ~250K Annual Scan Potential U.S. TAM Annualized U.S. PYLARIFY 1Q Sales Recurrent: pre-mCRPC1 Metastatic: High / Very High, Intermediate Unfavorable2 Recurrent: mCRPC 3L3 (1) 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. (2) Market research interviews, survey, and analysis, Wenzel 2021 Prostate, Nezolosky 2018 J. Clin. Oncol., Agrawal 2020 JAMA. (3) For the treatment of adult patients with PSMA-positive
metastatic castration-resistant prostate cancer ("mCRPC") who have already been treated with other anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy).
PYLARIFY | First Commercially
Available PSMA PET Imaging Agent Game Changer to Find, Fight and Follow This Important Disease PYLARIFY Indication: Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with
prostate cancer: with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level PSMA PET Imaging Approvals MAR 2022 Locametz Ga-68 Approved DEC 2021
Illuccix Ga-68 Approved MAY 2021 PYLARIFY Approved as 1st Commercially Available Agent DEC 2020 Ga-68-PSMA-11 Approved at UCLA / UCSF
PYLARIFY | #1 PSMA PET Imaging Agent