Lantheus Holdings, Inc.

results and 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 2022 results. You can find the release in the investor section of our website at lantheus.com. For those of you not on the webcast, you can find the slide presentation in the investor section of our website under the presentations tab. Before I 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. 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 Investors 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. We had another outstanding quarter as we continued to execute on our strategy to accelerate growth, diversify our portfolio, and position Lantheus as a category leader in the markets in which we compete. I'm particularly pleased to share that for the second quarter in a row, we reported record revenue of 121% year over year, led by Polarify growth in our radiopharmaceutical oncology category. Having launched Polarify just over one year ago, we are delighted with the impact PSMA-targeted PET imaging is making on the U.S. prostate cancer community. In fact, at our inaugural Investor Day in May, Dr. E. David Crawford, an internationally renowned urologist at the University of California, San Diego, highlighted that he believes PET PSMA imaging is one of the most important steps forward he has seen in prostate cancer in the last few decades. We believe that endorsements from experts in the field, such as Dr. Crawford, along with inclusion in the guidelines for both the National Comprehensive Cancer Network, or NCCN, and the Society of Nuclear Medicine and Medical Imaging, or SNMMI, speak to the importance of PSMA-targeted PET imaging for the U.S. prostate cancer community. In the EU, we are pleased to note that Curium completed its Phase III Python clinical trial for Pitfufolistat F18 in May and submitted its marketing authorization application to the European Medicines Agency, or EMA, on June 27th. We also worked with Curium to add Polarify to its U.S. ECLIPSE trial, a multicenter, open-label, randomized Phase III trial comparing the safety and efficacy of Curium's PSMA-targeted therapeutic versus hormone therapy in patients with metastatic, cascation-resistant prostate cancer. Polarify will be used to determine PSMA avidity as part of patient selection. Polarify will now be included in the vast majority of late-stage U.S. trials for the study of PSMA-targeted therapies. We also noted progress with our AI offering, having received an additional FDA clearance for Polarify AI during the second quarter. The updated deep learning algorithm of Polarify AI has been trained and validated on one of the largest and rapidly growing databases of contextualized Polarify PSMA PET-CT images in the world. The enhanced performance of Polarify AI was presented by Dr. Jeremy Kalai at the SNMMI annual meeting, along with the results from our prospectively planned and independently validated study of Polarify AI in our Phase 3 Condor study. These results independently validated and confirmed the efficiency, consistency, and diagnostic accuracy of AI-assisted image interpretation in detecting and quantifying disease in patients with prostate cancer. Polarify AI provides a standardized approach to identifying and quantifying prostate cancer and further enhances the clinical utility of Polarify as an imaging agent. Earlier this year, in the American Neurological Association's annual meeting, Dr. Nicholas Nichols presented data on the AI-enabled quantification of disease by PSMA PET and how Polarify AI could serve as an imaging biomarker to predict response to androgen deprivation therapy. Polarify AI continues to add real-world evidence and enhance the utility of Polarify in the effective care and management of prostate cancer patients. We are pleased to continue to support the U.S. prostate cancer community with Polarify and Polarify AI to find and follow disease. Our market-leading ultrasound enhancing agent, Affinity, grew, despite headwinds associated with a decrease in referring physician visits and staffing-related challenges consistent with trends noted by other companies in the healthcare sector. While in-person U.S. cardiology visits were down during the quarter year over year, and reported staffing challenges for nurses persisted at US healthcare institutions, DFINITY grew quarter sales year over year. While DFINITY growth during the second quarter was lower than expected, we believe that contrast-enhanced echocardiography continues to play an important role in cardiac imaging, and we are confident growth levels will normalize as these challenges abate. Moving now to our clinical development programs, We have recently progressed two of our pipeline products, 1095, our PSMA-targeted I131 prostate cancer therapeutic, and NM01, our novel imaging agent currently under development for the assessment of PD-L1 expression in non-small cell lung cancer. For 1095, I'm pleased to announce that we have enrolled the last patient in our ARROW trial. In total, 120 patients have been randomized. 80 in the 1095 plus enzalutamide combination group, and 40 in the enzalutamide group alone. As a reminder, the primary endpoint in ARROW is prostate-specific antigen or PSA response rate. Key secondary endpoints include time to radiographic-free progression, progression-free survival, and overall survival. Patients in the ARROW trial will be followed for one year after their first treatment for all efficacy endpoints. Survival and safety data will be collected for an additional year. That is an important milestone, and I look forward to sharing more information in the future. Moving to NM01, the preliminary study results of the Phase I PCAM study evaluating PD-L1 express in cancer were presented at SNMMI. These results indicate that NM01 has the potential to identify non-small cell lung cancer patients. who will respond to checkpoint inhibitor therapies and monitor the early response of these patients to these therapies, pending further and ongoing investigation. In addition to the Phase I PCAN study being run by King's College, we continue to progress this asset with the initiation of a single-arm Phase IIa pelican trial and enroll the first patients in May. The primary endpoint of the pelican study is the measurement of PD-L1 expression in non-small cell lung cancer, both primary tumor and metastatic lesions, as assessed using NMO1 compared to immunohistochemistry PD-L1 expression results. We continue to seek ways to further expand our portfolio, evaluating several opportunities to collaborate, in-license, or acquire additional assets which match our strategic priorities. We are particularly pleased and focused on late-stage diagnostic and therapeutic product opportunities in oncology that complement our existing portfolio. In addition, certain early-stage opportunities also align with the strategy that drives our pharma services business. For example, we recently entered into a collaboration agreement with RadioPharm Theranostics. RadioPharm is an Australian-based developer of platforms of radiopharmaceutical products for both diagnostic and therapeutic uses. RadioPharm plans to initiate a phase one therapeutic trial for patients with PD-L1 positive non-small cell lung cancer in Australia. Lantheus will supply our diagnostic product candidate NMO1 to RadioPharm for their clinical trials to be used as a clinical research tool to assess PD-L1 expression in patient selection. We have also retain the option to expand our partnership to additional assets in Radioform's pipeline. Finally, I would like to share an important change I recently made in the executive team. In June, I promoted Paul Blanchfield to the role of Chief Operating Officer. I've had the pleasure of working with Paul since he joined Lantheus in January 2020 as Chief Commercial Officer. Paul has been an exemplary leader throughout his tenure and combines a strong command of the data that drives the business with attention to longer-term strategy. In his new role, Paul has taken responsibility for commercial, manufacturing, and technical operations, quality, and corporate communications. Now, let me turn the call over to Paul for an operational update on our business.

Good morning, everyone. As Marianne noted, we continue to execute on our strategy during the quarter. including for Polarify and DFINITY. Beginning with Polarify, the market leader in PSMA-targeted pet imaging, I am pleased to announce Polarify net sales were $130.2 million compared to $92.8 million in the first quarter. We continued to make progress during the quarter in our geographic footprint, including capacity and redundancy, new customers, market access, and our Polarify AI software, while monitoring medical practice and guidelines as it relates to our Total Addressable Market, or TAM. We expanded our U.S. geographic footprint with the activation of four additional pet manufacturing facilities, or PMS, since our last quarterly earnings call. These new PMS are located in New York and West Virginia, which add redundancy and enhanced capacity, and in Colorado and Florida, which are new geographies where we had previously been flying doses. I am also pleased to announce that we have reached an agreement with one of our key PMF partners to nearly double the number of their PMFs that are manufacturing Polarify and extend our partnership through 2027. This agreement will expand our geographic footprint and provide redundancy and enhanced capacity in existing geographies to ensure we can continue to meet the needs of the U.S. prostate cancer community for many years to come. We also continue to focus on adding new customers, whether they be hospitals, freestanding imaging centers, or government facilities. We now have almost 900 customers across 45 states and the District of Columbia actively ordering Polarify. This is up from the approximately 700 customers at the end of the first quarter, even with the availability of competing PSMA PET imaging agents. With respect to market access, both NCCN and SNMMI updated their guidelines earlier this year to endorse all PSMA PET imaging agents, including Polarify, for the use of patient selection for PSMA-targeted radioligand therapy, including Plavicto. We are pleased to note that several commercial payers, including Humana, Aetna, and Anthem BCBS, or Blue Cross Blue Shield, have updated their policies to reflect an agnostic approach to the choice of imaging agent used to identify patients with PSMA-avid lesions who may be eligible for radioligand therapy. Humana's policy, in particular, highlights piflufolistat F18 by name as an alternative to other tracers. We believe these advancements, combined with more than $130 million in sales for this quarter, speak to the clinical benefits of Polarify, its scalable manufacturing network, and our operational capabilities. I also want to note the progress we have made with Polarify AI. As Marianne mentioned, the FDA cleared an updated version of Polarify AI. In addition, we continue to install Polarify AI at leading institutions and incorporate it into PSMA-targeted therapeutic trials. We believe this continued progress will have a positive impact on patient care and help sustain Polarify's market leadership going forward. During Investor Day in May, I told you there were three key takeaways for Polarify. First, PSMA PET imaging has significant opportunity with a total addressable market of approximately $1.1 billion that continues to grow. Second, we have a significant first mover advantage that has translated into what we believe is sustainable market leadership. And third, there's significant long-term potential with the likelihood of labels and guidelines expanding in the future. On the TAM specifically, I would note that we continue to see guidelines and medical practice evolve, as it frequently does in oncology based on real-world experience, and we expect the same for PSMA PET more broadly and Polarify specifically. We believe the TAM could increase by an additional 100,000 scans from its existing 250,000 scans that we highlighted in April from two primary areas. First, We believe there could be additional PSMA PET scans for patient selection for metastatic castrate-resistant prostate cancer in the first and second line, in which PSMA-targeted therapeutics are currently being studied. Second, we believe that medical usage of PSMA PET imaging may expand over time to additional patient populations, including but not limited to the intermediate favorable patient population. These additional 100,000 scans would increase the TAM to approximately 1.5 billion up from 1.1 billion. We will continue to monitor guidelines for both PSMA PET and radiotherapeutics as well as medical practice and continue to update the total addressable market as it evolves. I am thrilled with our results for the first half of 2022 as well as the opportunity to continue to expand the market and believe our continued efforts to solidify Polarify as the PSMA pet imaging agent of choice will continue to positively impact the prostate cancer community for the foreseeable future. Turning now to DFINITY, the market leading ultrasound enhancing agent, sales for the second quarter were $62.3 million compared to $59.8 million in the prior year quarter. While we saw increasing momentum in DFINITY during the first quarter as COVID-19 levels receded, staffing and customer capacity-related challenges impacted growth in the second quarter, particularly at our largest customers. We note a year-over-year decrease in in-person cardiology visits, and many customers noted a backlog of patients needing an echo ultrasound. We continue to have over 80% share of the U.S. ultrasound enhancing agent market, but believe near-term growth will remain constrained until hospitals have adequate staff to support the current demand for echocardiography and ultrasound enhancing agents. Bob will show more about our 2022 expectations when he reviews guidance as part of his financial update. Bob?