Lantheus Holdings, Inc.

Good morning. Welcome to Delente's second quarter 2023 financial results conference call. This is your operator for today's call. Please note that all lines have been placed in 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's section of the company's website approximately two hours after the completion of the call and will be archived for at least 30 days. I'll now turn the call over to your host for today, Mark Kinarni, Vice President of the Investor Relations. Mark.

Thank you. Good morning and welcome to today's call. With me are Marianne Haino, our CEO, Paul Blanchfield, our President, and Bob Marshall, our Chief Financial Officer. Marianne will begin the call with introductory remarks and then turn the call over to Paul to provide a strategic and operational update. Bob will cover our financial results and provide updated guidance 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 second quarter 2023 results. The release and today's slide presentation are in the investor section of our website at Lantheus.com. I would like to remind you that any comments made during our call today could include forward-looking statements. Actual results may differ materially from these statements due to a variety of risks and uncertainties. Please note that we assume no obligation to update our commentary or any 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. Discussions during this call will also 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. It is my pleasure to now turn the call over to our CEO, Marianne.

Thank you, Mark, and good morning to everyone. I am so pleased to share that Lansi has delivered yet another solid quarter with reported revenue of $321.7 million, up 44% year over year. We continue to focus on our commitment to innovation and operational excellence, and ultimately to making a meaningful difference in patients' lives. In fact, in the first half of 2023, we impacted the lives of more than 3 million patients. Outside the U.S., we are pleased to note that our PSMA PET imaging agent will soon be available to prostate cancer patients in Europe. Curium, our European partner, announced last week that they have received marketing authorization for Pilcari from the European Commission. Lantheus has been a recognized leader in nuclear medicine for more than 65 years, and we believe our differentiated capabilities uniquely support our position as the leading radiopharmaceutical-focused company. Our expertise and commitment to bringing unique products of differentiated clinical value are why we are the clear market leader with both PSMA PET with Polarify and with our ultrasound-enhancing agent, DFINITY. It's an inspiring time for our industry as the renaissance underway in radiopharmaceuticals was clearly evident at the recent Society of Nuclear Medicine and Molecular Imaging, or SNMMI, annual meeting. The breadth of attendees from across medical specialties and the increased focus on radiopharmaceuticals, including diagnostics, biomarkers, and therapeutics, speaks to the increased adoption and importance of these innovative products to the healthcare community. Our deep expertise in radiopharmaceuticals and our proven ability to successfully commercialize products have made us the partner of choice in this space and enabled us to expand our pipeline with late stage radiotherapeutic candidates. This includes PNT2002 for prostate cancer and PNT2003 for neuroendocrine tumors. We also have earlier stage assets such as MK6240, our F18-labeled PET diagnostic imaging agent targeting tau tangles for Alzheimer's disease, and our novel fibroblast activation protein alpha or FAP imaging agent, which recently entered the clinic. It's an exciting time to be in radiopharmaceuticals, and as the leading radiopharmaceutical-focused company, we are committed to advancing our portfolio of leading products and late-stage product candidates to deliver better patient outcomes for those we serve. Before I turn the call over to Paul, I would like to take a minute to note recent developments in the PSMA PET imaging class, including the recent approval of an additional F18-based agent. We believe the healthcare community is well served to have a broad set of choices available. We're also confident that PSMA PET with Polarify offers clear clinical and commercial differentiation. Clinically, Polarify offers the best combination of both isotope and F18 and our unique and very PSMA targeting ligand. It's important to note that each of the approved F18 PSMA agents are new chemical entities with unique pharmacokinetics as well as corresponding pharmacodynamic profiles. We believe the clinical value of Polarify was well demonstrated in our pivotal trials. These trials for Polarify, Condor, and Osprey Both demonstrated a high predictive value, positive predictive value, which by definition correlates to a low rate of false positives. Additionally, it is worth noting that the newly approved F18 PSMA agent in the U.S. includes an explicit warning and precaution in its label that recommends, because of the associated risk of false positive interpretation, that healthcare professionals should consider multidisciplinary consultation and histopathological confirmation or biopsy when clinical decision-making hinges on uptake only in the prostate and or prostate bed region, or only on uptake interpreted as borderline in patients with suspected recurrence. We believe the advantages of PSMA PET with Polarify are clear, robust, and well-documented in scientific literature and our package insert. With that, I'll now turn the call over to Paul to provide a strategic and operational update.