Lantheus Holdings, Inc.

Good morning. Welcome to the LAMPIA's first quarter 2023 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 investors 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 Kinnerney, Vice President of Investor Relations. Mark?

Thank you, and good morning. Welcome to Lantheus' first quarter 2023 Financial Results Conference call. With me on today's call are Marianne Haino, our CEO, Paul Blanchfield, our President, and Bob Marshall, our Chief Financial Officer. Mary Ann 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. Mary Ann 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 2023 results. You can find the release and today's slide presentation 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 those indicated by 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 include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is also included on the Investors 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 joining us. Today, I am pleased to discuss our outstanding first quarter results and update you on the state of our business. During the first quarter of 2023, we generated record results with quarterly revenues of $300 million and adjusted earnings per share of $1.47. I am proud to report we impacted the lives of more than 1.5 million patients, which is a testament to the focus and dedication of our employees as we continue to advance our purpose to find, fight, and follow disease to deliver better patient outcomes. Our impressive first quarter growth was led by the continued strong performance of both Polarify and DFINITY, which continue to have the leading market share in their respective categories. Our market-leading commercial portfolio and superior customer experience have been hallmarks of Lantheus and will continue to fuel our growth. Together, Polarify and DFINITY have already impacted the lives of tens of millions of patients, created significant shareholder value, and enabled us to invest in our business to continue to expand our portfolio of commercial and clinical stage radiopharmaceutical assets, including the recently completed in-licensing of two late-stage radiotherapeutic product candidates from Point Biopharma, and the acquisition of Servo Technologies for MK6240, an Alzheimer's disease PET imaging agent. We are extremely excited about our partnership and the progress we are making with PNT2002 and PNT2003, including in the clinical, regulatory, and manufacturing programs, as well as advancing commercial readiness. Most recently, we were pleased to announce the FDA-granted fast-track designation to PNT2002 for the treatment of metastatic castration-resistant prostate cancer, or MCRPC. Fast-Track is a process designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions that fill an unmet medical need. We are encouraged by the FDA's decision, as every year in the U.S., approximately 70,000 men are eligible for treatment for MCRPC. Importantly, this designation will allow us to work closely with the FDA, along with our partner, Point, to quickly advance the PNT2002 program, which has the potential to make a meaningful difference for patients who require new treatment options. We look forward to sharing our progress, including the anticipated top-line data readout for the PNT2002 flash trial in the second half of 2023. Our most recent acquisition, that of Servo Technologies, which closed in the first quarter of 2023, added MK6240 to our pipeline of assets. MK6240 is a novel, clinical-stage, second-generation PET imaging agent that targets tau tangles in Alzheimer's disease and has the potential to aid in diagnosing and staging Alzheimer's disease, as well as guide treatment choices for modifying therapies. Over the last two months, we continue to advance the utilization of MK6240 in clinical development partnerships. MK6240 is currently being used in more than 60 academic and industry late stage clinical trials for Alzheimer's disease therapeutic candidates under development by more than 16 pharmaceutical companies. With the expanding scope and scale of our business, We recently announced the promotions of Paul Blandfield to President and Dan Nizwicki to Chief Administrative Officer. Paul joined Lantheus in 2020 and has been an exemplary leader throughout his tenure, demonstrating strong strategic and leadership skills, most notably with the very successful launch of Polarify. His commitment to excellence and the patience we serve positioned Paul as the ideal person for the role of President. In this role, he will continue to oversee all aspects of commercial, technical operations and manufacturing, and quality, and will now be responsible for our company's R&D function, which includes our medical team. Dan joined Lantheus in 2013 and has been a critical member of the executive team that has transformed Lantheus. His contribution has been key and will continue to be invaluable as Lantheus continues to grow. In his expanded role, Dan will now oversee several critical functions, including legal, compliance, intellectual property, human resources, and corporate communications. Dan will also continue to serve as our general counsel and corporate secretary. I will now turn the call over to Paul to share an update on the Lantius commercial portfolio, pipeline, and key strategic initiatives.