Lantheus Holdings, Inc.

Good morning, ladies and gentlemen, and welcome to Lanthea's fourth quarter full year 2021 financial results conference call. This is your operator for today's call. Please note that all lines have been placed on mute to prevent any background noise. This call is being recorded for replay purposes. A replay of the webcast will be available in the investor section of the company's website approximately two hours after the completion of the call and will be archived for 30 days. I'll now turn the call over to your host for today, Mark Canarni, Senior Director of Investor Relations.

Mark? Thank you, and good morning. Welcome to Lantius' fourth quarter and full year 2021 Financial Results Conference call. With me on today's call are Marianne Haino, our President and CEO, Bob Marshall, our Chief Financial Officer, and Paul Blanchfield, our Chief Commercial Officer. Marianne will begin the call with introductory remarks and then turn the call over to Paul to provide a commercial update. Bob will cover our financial results and provide 2022 financial guidance, and Marianne will provide closing remarks, and then we will open the call for Q&A. This morning, we issued a press release, which was furnished to the Securities and Exchange Commission under Form 8K, reporting our fourth quarter and full year 2021 results. You can find the release in the Investors section of our website at lantheus.com. For those of you not on the webcast, you can find the slide presentation on the Investors section of our website under the Presentations tab. Before we get started, I would like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. In particular, the hospital staffing levels and the impact of COVID-19 on our business results and outlook continues to be a best estimate based on currently available information. Please note that we assume no obligation to update these forward-looking statements, except as required by applicable law, even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Also, discussions during this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is also included on the investor section of our website. With that, it is my pleasure to now turn the call over to Marianne.

Thank you, Mark, and good morning to everyone joining us on today's call. I hope all of you are safe and healthy. 2021 was an incredibly exciting and productive year for Lantheus. As you can see from our fourth quarter and full year results, We've significantly progressed our strategy to accelerate growth, diversify our portfolio, and position Lantheus as a category leader in the markets in which we compete. 2021 was a year of significant achievement across our portfolio, and I'll take a few minutes now to summarize our accomplishments. In our prostate cancer franchise, we launched two products in 2021. First, Polarify. which received priority review designation in December 2020 and was approved by the FDA in May as the first commercially available PSMA-targeted PET imaging agent for prostate cancer. As a reminder, Polarify is an F18-labeled PET imaging agent that enables visualization of lymph nodes, bone, and soft tissue metastasis to determine the presence or absence of recurrent and or metastatic PSMA-avid prostate cancer. We've been thrilled with the progress of Polarify's launch, and I'm excited to announce that fourth quarter sales exceeded $35 million. During the quarter, we made outstanding progress across all our major business drivers, supply, contracting, market access, and customer adoption. We have significant momentum going into 2022, with market access and customer demand continuing to be key drivers. Paul will give you further details on the launch to date in a few minutes. Along with our efforts to launch Polarify, we have also partnered with several companies, including Bayer, Regeneron, and Point Biopharma, to embed pifofolistat F18 imaging, which I will refer to as PYO, into their prostate cancer therapeutic trials to assess PSMA expression. Similarly, we have incorporated PYO into our own PSMA-targeted therapeutic ARO Phase II trial of 1095 to test for PSMA avidity. During 2021, we also announced a development and commercialization collaboration with Reflexion in utilizing PYL. The collaboration is evaluating the use of PYL to enable real-time therapeutic guidance of biology-guided radiotherapy with the goal of improving treatment options for prostate cancer patients. Our second product in our PSMA-targeted portfolio is Polarify AI. which was cleared by the FDA just two months after Polarify's approval. Polarify AI is the first and only FDA-cleared, artificial intelligence-enabled PSMA digital application that demonstrates increased efficacy and reproducibility of clinicians' PSMA PET-CT image assessments, which we believe provides a distinct advantage for our prostate cancer franchise. With FDA clearance, we are working to advance utility of AI-enabled imaging diagnostics in prostate cancer. Just last month, we announced a collaboration with the Prostate Cancer Clinical Trial Consortium, or PCCTC, a premier multicenter clinical research organization that specializes in cutting-edge prostate cancer research. The intent of this strategic collaboration is to integrate Lantheus' AI platform into early phase PCCTC studies to advance the discovery development and validation of novel AI enabled biomarkers. For our micro bubble business in 2021, DFINITY sales continue to grow despite a year challenged by hospital staffing and other COVID related issues, all during which we maintained our market leadership position. In October, 2021, we submitted a Supplemental New Drug Application, or SNDA, for our on-campus manufacturing facility for DFINITY, which we call Genesis, and I'm pleased to announce that we received FDA approval earlier this week. This facility provides us with supply chain redundancy and the opportunity for margin expansion as we progressively include inventory from this manufacturing line into our supply chains. In 2021, we successfully manufactured batches of DFINITY at our Genesis facility so that the product would be ready for commercial sale upon FDA approval. I'm pleased to announce that we've already begun shipping DFINITY from our Genesis manufacturing site to our customers. Additionally, earlier this month, we entered into a new manufacturing and supply agreement with our longstanding DFINITY manufacturer, JHS. Between our Genesis facility and our partner, JHS, We believe we will have sufficient supply of DFINITY to meet our expected demand well into the future. In 2021, we entered into another strategic collaboration for our microbubble franchise. This collaboration is with Allegheny Health Network, or AHN. AHN is investigating our microbubble technology in combination with their ultrasound-assisted gene therapy for the development of a treatment for xerostomia. a chronic and debilitating condition with limited treatment options currently available for patients. Turning to Technolite, sales remained stable during 2021 as compared to the prior year. We successfully navigated the negative impact of both the Delta and Omicron infection rate spikes on supply chain logistics and continuously delivered our just-in-time generators to our customers throughout the year. Azedra, as a hospital-based product, was impacted by staffing and other COVID-related challenges over the course of 2021, and this did negatively impact demand. As such, in 2021, we focused on building out our commercial and medical-based field market model for Exedra and introduced new marketing initiatives to increase awareness of pheochromocytoma and paraganglioma, or PPGL, for referring physicians and Exedra as a treatment option for their patients. We were pleased to see additional centers of excellence join the network of those centers offering Exedra treatment. We believe when hospital conditions permit, our team is well positioned to drive usage of Exedra in PPGL patients. Finally, during 2021, we advanced our pipeline with prudent investment. In March, we announced that we acquired exclusive worldwide rights to develop, manufacture, and commercialize a novel imaging biomarker targeting fibroblast activation protein, or FAP. We believe FAP is a promising target for cancer imaging and has broad potential to inform diagnosis and staging, to guide patient selection for therapy, and to monitor response to treatment across multiple tumor types. We are pleased to partner with a very experienced team led by Dr. Alan Green and Dr. John Babich, both proven experts in the development of radiopharmaceuticals to move this agent into clinical trials. We announced on our third quarter earnings call the completion of an interim analysis of our ongoing Phase II study of 1095, our PSMA-targeted therapeutic. The Independent Data Monitoring Committee recommended the study continue without modification. As a reminder, the ARROWS study is a multicenter, randomized, open-label, controlled Phase II clinical study evaluating the efficacy and safety of 1095 in combination with enzalutamide, compared to enzalutamide alone in patients with metastatic castration-resistant prostate cancer who are PSMA-avid, chemotherapy-naive, and have progressed on abiraterone. As you can see, over the course of 2021, we've made significant progress on our strategy to accelerate growth, diversify our portfolio, and position Lantheus as a category leader in the markets in which we compete. In 2022, we are committed to continuing this same level of progress. Now, I'll turn the call over to Paul for a commercial update on our key products.