Lantheus Holdings, Inc.

Good morning. Welcome to the Lanthea's fourth quarter 2023 and full year 2023 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 investors section of the company's web site approximately two hours after the completion of the call. and will be archived for at least 30 days. I'd now like to turn the call over to your host for today, Mark Canarni, Vice President of Investor Relations. Mark?

Mark Canarni Thank you. Good morning and welcome to today's call. With me today are Mary Ann Hano, our CEO, Brian Markeson, current Executive Chair of the Board and incoming CEO, Paul Blanchfield, our President, and Bob Marshall, our Chief Financial Officer. We'll begin the call with Marianne's introductory remarks, followed by operational and strategic updates from Paul and Brian. Bob will cover our 2023 financial results and financial guidance for 2024. 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 2023 results. The release and today's slide presentation are in the investor section of our website at Lantheus.com. Any comments made during our call 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, everyone. Before we get started, I want to welcome Brian Markison as the company's new chief executive officer, effective March 1st. It was so important to the Lantheus board and me that our new CEO be able to drive forward the great work we have done. And in Brian, we have an experienced executive who intimately understands Lantheus, our strategy, and our industry. He brings decade of leadership experience in life science and deep expertise in oncology and neurology that will be essential to delivering on our strategic priorities. Welcome, Brian. 2023 was another stellar year at Lanthea, delivering record revenues, earning in cash flows, bolstering our position as a leading radiopharmaceutical-focused company. I'm particularly proud that our products were used to impact the lives of more than 6 million patients and their families in 2023. a testament to our purpose to find, fight, and follow disease to deliver better patient outcomes. For full year 2023, we reported revenue of approximately $1.3 billion, representing year-over-year growth of 39%, in line with what the company pre-announced in early January. This growth was primarily driven by Polarify and DFINITY, both of which delivered strong performance of over 61% and 14% growth year-over-year, respectively, continuing solid momentum for 2024. Polarify continues to grow with the potential to reach a billion dollars in sales this year and remains the clear market leader. offering a differentiated value proposition that, together with our operational excellence, give us confidence that Polarify will remain the number one PSMA PET imaging agent for prostate cancer patients, even amidst increasing competition and potential transitional paths to expiry. Definity, as well, delivered solid growth and remains the ultrasound-enhancing agent of choice. Beyond our existing commercial diagnostics portfolio, we also made significant advancements across our radiopharmaceutical pipeline for both late and earlier stage oncology therapeutics, as well as oncologic and non-oncologic diagnostics. In mid-December, we reported positive top-line Phase III splash results for PNT2002. are investigational PSMA-targeted radiotherapeutic in development for the treatment of patients with metastatic castration-resistant prostate cancer, or MCRPC. The SPLASH trial met its primary endpoint, demonstrating a statistically significant 29% reduction in the risk of radiographic progression or death. We continue to review the SPLASH study results and are specifically awaiting more mature overall survival data, which we currently expect later this year. For PNT2003, our product candidate for the treatment of neuroendocrine tumors, we filed, and the FDA accepted, our abbreviated new drug application, or ANDA. As expected, Novartis filed a patent infringement lawsuit, which triggered a potential 30-month stay under the Hatch-Waxman Act. We are very excited about the process of commercializing this important radio equivalent to Lutaterra and look forward to a potential launch in 2026. As the leading radiopharmaceutical-focused company, we continually explore opportunities to grow and expand our pipeline. We are particularly focused on identifying the targets and complementary isotopes that are best suited to treat certain diseases. As an example, we recently announced a strategic partnership with Prospective Therapeutics that provides us with options to add radioligand therapy, or RLT, assets to our pipeline and expand into alpha therapeutics. These options will allow us to diversify our RLT pipeline with Perspectives-led 212-labeled product candidates and Alpha RLT for the treatment of neuroendocrine tumors, currently in Phase I-IIa development. In addition, we have an opportunity to co-develop Perspectives-led 212 isotope-based alpha-generating therapy candidates for prostate cancer. We are also investing in our innovative diagnostic pipeline. We continue to progress MK6240, an F18-based tau PET tracer under development for the detection of tau tangles in patients with Alzheimer's disease. To date, it is being used in more than 90 clinical trials, either as a staging tool or as a biomarker to identify patients to be enrolled in trials of Alzheimer's disease therapeutic candidates. We are finalizing the regulatory path to bring this exciting product candidate to market as a commercially approved agent. Similar to how PSMA PET imaging has transformed staging and patient selection for prostate cancer, we believe that cow-based PET imaging agents like MK6240 can play a similar role in staging and patient selection for Alzheimer's disease treatment. With that, I'll now turn the call over to Paul.