Lantheus Holdings, Inc.

Good morning. Welcome to Lanthea's third quarter 2022 conference call. With me on today's call are Mary Ann Haino, our President and CEO, Bob Marshall, our Chief Financial Officer, and Paul Blanchfield, our Chief Operating Officer. Mary Ann will begin the call with introductory remarks and then turn the call over to Paul for an operational update. Bob will cover our financial results and updated guidance. Then we will open the call for Q&A. And finally, Mary Ann will provide closing remarks. This morning we issued a press release, which was furnished to the Securities and Exchange Commission under Form 8K, reporting our third 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 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 this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is also included in the investor section of our website. With that, it is my pleasure to now turn the call over to Mary Ann.

Thank you, Mark, and good morning to everyone joining us. We delivered an exceptional third quarter as we continue to find, fight, and follow disease to deliver better patient outcomes. Our strategy to accelerate growth and diversify our portfolio and revenue streams, which we outlined at the beginning of this year, is succeeding. I am pleased to note we reported revenue of $239.3 million, up more than 134% year over year. I'll take a few minutes now to highlight some of our recent progress across our portfolio. Almost 18 months into our launch, We are thrilled that Polarify is firmly established as the leading PSMA pet imaging agent. We are particularly proud of the difference it is making for the U.S. prostate cancer community. With commanding market leadership and continued growth of the overall market, our business has continued to grow, even amidst increasing competition. We believe we will see continued growth as more patients and healthcare professionals become aware of the benefits of PSMA PET imaging and Polarify in particular. Since our last call, we further expanded our U.S. footprint with additional sites activated for our PET manufacturing facility or PMF partners, increasing our overall capacity and adding redundancy. Our European partner, Curium, is making progress with their efforts to bring our product to market as the first commercially available F18-based PSMA PET imaging agent in Europe. having filed their marketing authorization application with the European Medicines Agency in June. Last month, Curium presented top-line results from their pivotal Phase III Python clinical trial at the European Society for Nuclear Medicine, or EANM. The trial enrolled prostate cancer patients with biochemical recurrence who underwent definitive radical prostatectomy, external beam radiotherapy, or brachiotherapy. The clinical trial results highlighted that pipoflalostat F18 showed a significantly higher detection rate as compared with 18F fluorocorylene and had a higher impact on intended patient management. We are excited that we are one step closer to our leading U.S. F18-based PSMA PET imaging agent making a difference to the European prostate cancer community. We were also in attendance at EANN with several presentations on APROMIS, which is branded as Polarify AI in the U.S. Of note, in a top-rated oral presentation, we reviewed the results from a retrospective analysis using a promise to evaluate PSMA PET-CT scans pre- and post-androgen deprivation therapy of men with treatment-naive castration-sensitive prostate cancer. The results demonstrated that a change in automated PSMA scores in bone and lymph nodes is strongly associated with PSA response. The analysis also indicated that a quantitative automated PSMA score may assess treatment response in bone, which is not feasible with conventional imaging. We are pleased to share that we signed an agreement with Siemens Healthineers to integrate A-Promise into the latest software for the company's workstations in the US and Europe. Through this collaboration, along with our collaboration with GE Healthcare that we announced earlier this year, our AI technology can be broadly distributed and integrated into the leading workstation systems that facilitate the nuclear medicine clinical workflow across the majority of pet sites in the US and Europe. Switching now to our micro bubble portfolio, In our 22nd year since launch, I am proud to say DFINITY remains the most chosen, most studied, and most trusted diagnostic ultrasound enhancing agent in the U.S. We have continued to grow our franchise and are sustaining our 80-plus percent share of the market. With respect to a key partnership, in September, GE Healthcare, our partner for the product candidates we peer it as, announced that the Aurora Phase III Pribital Trial met its co-primary endpoints for both sensitivity and specificity for detecting coronary artery disease, or CAD, the most common form of heart disease and the leading cause of death globally. The trial also met its key secondary endpoint, demonstrating higher diagnostic efficacy for Plupirida's PET as compared with SPECT myocardial perfusing imaging, or MPI, the predominant procedure used in nuclear cardiology today. In the U.S., there are approximately 6 million MPI procedures performed each year. The Phase III open-label study, which enrolled over 600 patients across sites in the U.S., Europe, and Canada, assessed the diagnostic efficacy of Flupiridaz in detecting CAD with invasive coronary angiography as the standard of truth. If Flupiridaz is approved, given the advantages of the F18 isotope, this product would have broad available distribution and also be suitable for exercise stress testing, which is challenging with the currently available cardiac PET radio tracer. Under the terms of our agreement with GE Healthcare, we are eligible to receive up to $60 million in regulatory and sales milestone payments, tiered double-digit royalties on U.S. sales, and mid-single-digit royalties on sales outside the U.S. 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, specifically for Polarify and DFINITY, which I'll highlight now. I'm pleased to announce that Polarify, the U.S. market leader in PSMA-targeted PET imaging, generated net sales of $143.8 million and was used in over 30,000 patient scans during the quarter. Our success derives from significant unmet need, innovation, and execution. Prostate cancer is one of the leading causes of death for men, and conventional imaging does not offer sufficient sensitivity or specificity to adequately identify metastatic disease. Polarify's innovation is its ability as a PSMA PET imaging agent to selectively bind to prostate cancer cells. In fact, PSMA binds to over 90% of prostate cancer cells, which in turn allows physicians to identify the location and extent of disease. In our clinical trial, two-thirds of men had a change in their intended treatment plan based on their Polarify image, demonstrating that these new insights are actionable by HCPs. And finally, execution since we acquired Progenix. The team successfully gained FDA priority review, which accelerated our time to approval and secured widespread reimbursement, established manufacturing and distribution capabilities at scale, built a commercial infrastructure to support a best-in-class launch that has already impacted the lives of over 90,000 men to date. Since the beginning of the third quarter, We further expanded Polarify's US footprint with new PMFs, including the first academic PMF to self-supply Polarify, increased capacity at existing sites, added redundancy in key geographic areas, broadened our customer base, and made progress with Polarify AI. Our new PMFs include Somerset, New Jersey, Nashville, Denver, Birmingham, and most recently, Davenport, Iowa, and Salt Lake City. These new PMFs enhance our capacity in the New York City metro area and Tennessee markets and expand our footprint into Colorado, Alabama, and now Iowa and Utah. We have now successfully served patients in 46 of the 48 contiguous states and the District of Columbia. As I mentioned last quarter, we modified our existing agreement with a key PMF partner, to double the number of their pmf locations manufacturing polarify and extend the agreement to 2027. by the end of 2023 we expect our existing pmf network to increase by over 50 percent further enhancing capacity and redundancy in turn our customer base continues to grow we have been pleased with the rate of adoption and note that more than 1 000 customers have now ordered polarify with 97% of them being repeat customers. Our promotional efforts are increasingly focused on ensuring that referring ACPs, namely urologists, medical oncologists, and radiation oncologists, are aware of the benefits that Polarify can offer the U.S. prostate cancer community. In market access, we continue to make progress and are pleased that now five of seven Medicare administrative contractors, or MACs, have confirmed an agnostic approach to patient selection for PSMA-targeted radioligand therapy, such as Plovicto, meaning any approved PSMA PET agent, including Polarifi, can be used. Finally, we established a European collaboration with Curium for the commercialization of A-Promise, as they anticipate approval for piflufolistat F18 in Europe in mid-2023. Turning now to DFINITY, the market-leading ultrasound enhancing agent, sales for the third quarter were $60.7 million, up 5.4% from the prior year period. We continue to grow the franchise and maintain market leadership, even amidst staffing challenges and a decrease in referring physician-patient visits that continues to impact the broader healthcare market, including echocardiography. I'll now turn it over to Bob.