Lantheus Holdings, Inc.

Good morning, ladies and gentlemen. Welcome to the Lantius First Quarter 2022 Conditional 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 release 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's call, Mark Anarni, Senior Director of Investor Relations. Mark. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations.

Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior Director of Investor Relations. Mark Anarni, Senior our financial results, and updated guidance. Marion 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 first quarter 2022 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 in the Investors section of our website under the Presentations tab. Before we get started, I would like to remind you that our comments today 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 impact of hospital staffing levels and 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 the 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's my pleasure to now turn the call over to Mary Ann.

Thank you, Mark, and good morning to everyone joining us. I am pleased to say we have very positive news to share today. Lantheus reported a record quarter, led by rapidly increasing Polarify sales and solid DFINITY performance. We continue to execute on our strategy to accelerate growth, position Lantheus as a category leader in the markets in which we compete, and pursue our passion to find, fight, and follow disease to deliver better patient outcomes. As the year continues, we are focused on further establishing Polarify as the PSMA PET imaging agent of choice in the USA prostate cancer community, maintaining market leadership with our microbubble franchise, executing strategic transactions in line with our portfolio objectives, and delivering on our financial objectives, which we believe best enhance shareholder value. I'll now take a few minutes to update you on our progress. It has been an exciting and transformational time for prostate cancer care, with advances in technology and new FDA approvals in both diagnostics and therapeutics. Paul will provide further details on the Polarify launch to date in a few minutes, but I am thrilled that less than one year after we commenced our launch, more than 30,000 men have been imaged with Polarify, including more than 20,000 in the first quarter of 2022 alone. This is a testament to the innovation of our PSMA-targeted PET imaging agent and our efforts to transform patient management for the U.S. prostate cancer community. Now, let me take a few minutes to highlight our recent strategic collaborations with Polarify. First, in March, we announced a collaboration with Novartis to include Polarify in their planned development programs for Pluvicto, their recently approved PSMA-targeted therapeutic for metastatic castation-resistant prostate cancer. This collaboration builds on Polarify's inclusion in their expanded access trial for Poblicto and directly aligns with our strategy to advance precision medicine in the treatment of cancer by enabling partners to use Polarify in ongoing prostate cancer therapeutic trials. As part of the agreement with Novartis, we will supply Polarify for the selection of patients within their trials And Novartis, in turn, will provide Lantheus with all Polarify-related clinical imaging data from these trials. During the quarter, we also entered into two strategic collaborations to advance our artificial intelligence or AI-enabled imaging biomarkers for prostate cancer. In January, we announced a collaboration with the Prostate Cancer Clinical Trials Consortium, or PCCTC. a premier multi-center clinical research organization that specializes in cutting-edge prostate cancer research. The intent of this strategic collaboration is to integrate Lantius' AI platform into early-phase PCCTC studies to advance the discovery, development, and validation of novel AI-enabled biomarkers. And earlier this month, we expanded our collaboration with GE Healthcare to include AI-enabled A-Promise on their latest platform. As a leading supplier of medical technology equipment, GE Healthcare is an ideal partner to provide global access to this unique AI platform for prostate cancer. Turning to DFINITY, our market-leading ultrasound enhancing agent, and our microbubble franchise, sales continue to grow despite widely reported hospital staffing challenges and record high COVID-19 levels early in the quarter. We are pleased to see that DFINITY sales have steadily increased since mid-January. as COVID-19 cases and COVID-related hospitalizations have subsided. With the FDA approval in February of our supplemental new drug application for our Billerica-based manufacturing facility, we are now producing and distributing DFINITY manufactured at our on-campus facility, in addition to continuing to source from our existing long-term contract manufacturer. the investment in our on-campus facility was strategically driven to ensure supply chain redundancy as well as to drive margin expansion over time. I'll speak briefly to Azedra before turning over to Paul. During the first quarter, our team worked with nuclear medicine departments at academic centers of excellence in key markets across the U.S., and we are pleased that two additional centers of excellence have joined the network of centers now offering Azedra treatment. With the COVID-19 pandemic receding, and hospital access improving, we are optimistic both physicians and patients will consider treatment with Azedra for pheochromocytoma and paraganglioma. Now, let me turn the call over to Paul for a commercial update on our key products.