Lantheus Holdings, Inc.

Good morning, ladies and gentlemen. Welcome to the Atlantis Holdings second quarter 2021 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 investor section of the company's website approximately two hours after the completion of the call and will be archived for 30 days. I'll now turn it over to your host for today, Mark Kinnarney, Senior Director of Investor Relations. Mark?

Thank you, and good morning. Welcome to the Lanthius Holdings Second Quarter 2021 Financial Results Conference Call. With me on today's call are Marianne Haino, our President and CEO, Bob Marshall, our Chief Financial Officer, and Paul Blanchfield, our Chief Commercial Officer. Mary Ann will begin the call with introductory remarks and then turn the call over to Paul to give an update on the Polarify commercial launch. Mary Ann will return to give a business update and then Bob will cover our financial results and updated guidance. Mary Ann will conclude the call with 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 2021 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 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. In particular, the impact of COVID-19 on our business results and outlook continues to be a best estimate based on currently available information. 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 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 on today's call. I'm pleased to report that the second quarter was a successful and productive one. During the quarter, we announced the FDA approval and commenced the commercial launch of Polarify, the first and only commercially available PSMA PET imaging agent for prostate cancer. DFINITY performed well and has maintained its market leadership with more than 80% share of the U.S. ultrasound-enhancing agent market. Azedra sales significantly increased, and Technolite delivered stable revenue sequentially. We are committed to building on this positive momentum and delivering value for shareholders. Before I turn the call over to Paul for an update on our Polarify launch, I would like to provide background on why we believe Polarify is an important addition to the treatment of prostate cancer. On May 26th, the FDA approved Polarify, a fluorine-18 labeled prostate-specific membrane antigen, or PSMA, targeted positive emission tomography, or PET, imaging agent. Polarify identifies PSMA, the protein expressed on the surface of prostate cancer cells in men with suspected metastasis who are candidates for initial definitive therapy and or with suspected recurrence of prostate cancer. Slide 7 highlights the time points where Polarify received approval by the FDA. Starting with the purple box, initial staging describes patients who are candidates for initial definitive therapy and are suspected to have metastasis. While approximately 248,000 men are diagnosed annually with prostate cancer, currently we believe there are approximately 40,000 men in this category who may be eligible for Polarify scans based on suspected metastasis. Second, as shown in the two blue boxes, there are approximately 105,000 and 25,000 men respectively who may have a suspected recurrence of prostate cancer as indicated by rising prostate-specific antigens or PSA. These patients are also candidates for a Polarify scan based on our awarded indication. As you can see overall, a prostate cancer patient's journey can last 15 years or more and is marked by frequent interactions with the physician to determine treatment course. We believe Polarify offers a number of advantages as a diagnostic agent. First, it is a PET modality, which offers several advantages versus current conventional imaging modalities. Polarify demonstrated a high detection rate of metastatic disease, even in patients with low PSA levels, and was not limited by the size of lymph nodes with respect to detection of nodal disease and visualized metastasis where CT or bone scan could not, as was demonstrated in our Phase III condor study. Another advantage of Polarify is that it works by binding to PSMA. a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. This enables the reader of a Polarify PET scan to detect the presence and location of prostate cancer cells with greater sensitivity versus imaging modalities that are not specific to PSMA. The third advantage is that Polarify is radio labeled with F18. The attributes of F18 contribute to high quality, clear, detailed and reproducible images for prostate cancer disease monitoring. Production of the F18 isotope at TET manufacturing facilities, or PMS, offers high batch capacity, and F18's 110-minute half-life allows broad geographic distribution and clinical flexibility in administration. Finally, a distinct advantage of Polarify is that the proprietary patent-protected artificial intelligent medical device software we have developed to assist physicians with the reading of Polarify scans. APROMIS employs deep learning to quantify and automate the reading of Polarify images. APROMIS is designed to provide enhanced consistency in quantitative analysis and precise anatomical context and can enable quantitative reporting. Collectively, these benefits potentially contribute to increased rear efficiency and reproducibility of PSMA PET-CT image assessments. Importantly, for the manage of prostate cancer, the data from our studies demonstrated Polarify is more likely than conventional imaging to detect the spread of disease, providing more accurate and potentially earlier detection of disease, which we believe will empower doctors, along with patients and their families, to make more informed decisions about how to treat their prostate cancer. Based on the data from our clinical trials, we believe Polarify may also have an important role in the clinical development of product candidates for prostate cancer treatment as an important biomarker. For these clinical applications, I will refer to Polarify by its compound name, Pseudobulostat F18, or PYL. Along with our current Phase II trial for our 1095 product candidates, PYL is also included in several ongoing clinical trials for other prostate cancer therapeutics to assess PSMA expression with leading companies such as Bayer, Regeneron, and Point Biopharma. Before I turn the call over to Paul to provide details on the Polarify launch to date, I would like to share with you an image from our Condor trial. This image shows a 71-year-old patient with a Gleason score of 4 plus 3. a history of radical prostatectomy and external beam radiation therapy, and equivocal results on an axon and PET CT scan, which is the image shown on the right side of this slide. This same patient was then imaged with Polarify. The Polarify image identified less common iliac lesions and multiple retroperitoneal paraperiaortic lymph node lesions, which were later confirmed to be prostate cancer by biopsies. Similar to the results found here, Polarify similarly demonstrated higher clarity results versus other forms of conventional imaging in our phase 3 condor study, as well as in other studies. We are extremely excited about the potential of Polarify. Now, I'll turn the call over to Paul.