Lantheus Holdings, Inc.

Good morning, ladies and gentlemen. Welcome to the Land Use Holdings Third 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 Investors section of the company's website approximately two hours after the completion of of the call and will be archived for 30 days. I'll now turn the call over to your host for today, Mark Kinnerney, Senior Director of Investor Relations. Mark?

Thank you, and good morning. Welcome to Lantheus Holdings' third quarter 2021 Financial Results 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 Commercial Officer. Mary Ann will begin the call with introductory remarks and then turn the call over to Paul to provide a commercial update. Mary Ann will return to provide 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 third 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 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. 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 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's my pleasure to now turn the call over to Marianne.

Thank you, Mark, and good morning to everyone joining us on today's call. I hope all of you are safe and healthy. We delivered a strong quarter despite a resurgence of COVID-19 infections that impacted elective procedures and hospital access. We did see an impact to certain aspects of our business, which Bob and Paul will discuss, and we did note, in our monitoring across our sites of care, the more recent and increasing reference by analysts covering healthcare of concern about staffing levels in hospitals. The past few months have been a period of intense activity and significant progress for Lanthea's across our portfolio. DFINITY again delivered solid growth. We are thrilled with the launch and reception to Polarify in its first full quarter since approval and believe there is significant momentum heading into the fourth quarter and 2022. Before I turn the call over to Paul to give an update on our commercial portfolio, let me update you on select strategic developments since our last call. We reached an important milestone towards our goal of supplementing DFINITY Supply with our own on-campus manufacturing facility by filing our Supplemental New Drug Application, or SNDA, with the FDA. The SNDA review process is expected to take approximately four months and will require a pre-approval inspection before anticipated approval in the first quarter of 2022. Earlier this year, we successfully manufactured batches of DFINITY on this manufacturing line that will be commercially saleable upon FDA approval. For Polarify, which remains the first and only commercially available PSMA-targeted PET imaging agent for prostate cancer, We continue to make significant progress on our commercial launch, including ongoing investment in our customer-facing teams, where we have, we believe, the largest fully dedicated PSMA pet sales force and market access teams. We are delighted by the reception to and adoption of Polarify to date, including interest from institutions, physicians, patients, and patient advocacy groups to this game-changing prostate cancer diagnostic, even against the backdrop of COVID resurgence and other challenges facing our customers during this period. We have continued to actively work with our pet manufacturing facilities, or PMS, channel partners to build out our polarified manufacturing and distribution network access across the U.S. As a reminder, for over 20 years, PMS have been reliably delivering FDG, another F18 isotope-based test diagnostic, nationwide to imaging centers on a daily basis. At almost 2 million patient procedures per year, FDG is the most widely used diagnostic cancer cut imaging agent in the U.S. We are tapping into the same proven wide scale cut manufacturing and distribution network for Polarify. PMS work with the imaging centers they serve to meet the needs of physicians ordering imaging studies for their patients. The high batch yields of F18 from cyclotron production is particularly well suited to the demographic and needs of the prostate cancer community, as has already been proven with its use in other cancer types with significant patient populations. Cyclotron-based manufacturing offers the scale needed to meet customer demand, and this can be offered at whatever time of day suits that imaging center's needs. This is in direct comparison to generator-produced products, which are limited by both the quantity and frequency of doses that can be produced at any one time, and the limited time frame during which the produced dose must be delivered and utilized. With Polarify, the availability and scale offered through the PMS geographic network we are building with our partners, combined with F18's 110-minute half-life, allows for broad availability across the U.S. and the flexibility needed for physicians and the prostate cancer patients they treat. During the quarter, we continued to expand our network in line with our year-end goals of broad availability across the U.S. At the start of the third quarter, our network covered approximately 6% of the U.S. population. Throughout the quarter, we continually expanded coverage, and I am pleased to report that we are now able to serve approximately 70% of the U.S. population across 20 PNFs. Paul will give you further details on that and other aspects of the Polarify launch shortly. The advantages of PET imaging and PSMA targeting with Polarify are further complemented by Polarify AI, the branded name for APromise, the first and only FDA-cleared, AI-enabled PSMA digital application. Polarify AI employs a deep learning algorithm trained and validated by employing more than 3,000 PSMA images. Polarify AI offers a standardized platform for physicians and researchers to efficiently, consistently, and accurately quantify PSMA uptake at the lesion level for men with prostate cancer. We were honored to have been selected to present Polarify AI at the preeminent Prostate Cancer Conference, the annual Prostate Cancer Foundation scientific retreat, which took place last week. At the conference, we introduced Polarify AI to prominent researchers and key opinion leaders in the field of prostate cancer. Since 1993, the Prostate Cancer Foundation has hosted this annual scientific retreat that brings together diverse researchers in a collaborative forum to present and discuss new findings for prostate cancer diagnosis, prognosis, and treatment. We will be launching Polarify AI at the Radiological Society of North America, or RSNA, meeting later this month, and are pleased to report that, to date, five leading cancer centers are already in the process of adding Polarify AI into their prostate cancer diagnostic workflows. Now I'll turn the call over to Paul for a commercial update.