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Lantheus Holdings, Inc. reports news on its radiopharmaceutical business, including diagnostic imaging agents, radiotherapeutic assets, regulatory decisions and financial results. The company organizes revenue around Radiopharmaceutical Oncology, Precision Diagnostics and Strategic Partnerships and Other Revenue, with products used by hospitals, independent imaging centers, government facilities and distribution partners in the United States and abroad.
Recurring updates include quarterly earnings, business guidance, FDA activity for products such as PYLARIFY TruVu, PYLARIFY, Lutetium Lu 177 Dotatate (PNT2003) and LNTH-2501, share repurchases, investor presentations and strategic updates involving radiodiagnostics and radiotherapeutic programs.
Lantheus reported strong financial results for Q4 and FY 2021, with worldwide revenue of $129.6 million and $425.2 million, reflecting increases of 37.6% and 25.3% year-over-year, respectively. However, the company faced a GAAP net loss of $40.2 million for Q4 and $71.3 million for the full year. Adjusted fully diluted EPS improved to $0.25 and $0.49 for Q4 and FY 2021, marking increases of 263.5% and 4.0%. The company anticipates Q1 revenue guidance of $160 million - $170 million and FY 2022 guidance of $685 million - $710 million.
Lantheus Holdings has received FDA approval for its on-site drug manufacturing facility in North Billerica, Massachusetts, designed to produce DEFINITY® (Perflutren Lipid Microsphere), a leading ultrasound enhancing agent. This 16,000 sq. ft. facility aims to enhance supply security and support future growth. The facility will aid in margin expansion as DEFINITY supply becomes integrated from this location. The company intends to ship DEFINITY from this facility immediately, marking an important step in ensuring adequate supply for patients with suboptimal echocardiograms.
Lantheus Holdings, Inc. (NASDAQ: LNTH) announced that data from the OSPREY pivotal trial will be presented at the 2022 ASCO GU Meeting on February 17, 2022, in San Francisco, CA. The presentation will cover the performance of Piflufolastat F 18-PET/CT in prostate cancer patients, specifically analyzing standardized uptake value results based on PSA and Gleason scores. PYLARIFY is highlighted as a PSMA-targeted PET imaging agent for identifying recurrent and metastatic prostate cancer. This data presentation is a key opportunity to showcase Lantheus's advancements in oncology diagnostics.
Lantheus Holdings (NASDAQ: LNTH) has scheduled a conference call to announce its financial and operational results for the fourth quarter and full year of 2021. This event will take place on February 24, 2022, at 8:00 a.m. ET. Investors can join via telephone or through a live webcast on the company's website. Following the call, a replay will be accessible for 30 days. Lantheus is known for its diverse portfolio of imaging diagnostics and therapeutics, aimed at addressing serious medical conditions.
Lantheus (NASDAQ: LNTH) announced a collaboration between its subsidiary EXINI Diagnostics and the Prostate Cancer Clinical Trials Consortium (PCCTC) to enhance AI-enabled imaging biomarkers for prostate cancer. The partnership aims to integrate Lantheus' FDA-cleared AI platform into early-phase studies, improving patient selection and therapy response assessments. This initiative involves Lantheus' PSMA PET/CT and bone scintigraphy imaging technologies. Prostate cancer is the second most common cancer among men, with an estimated 268,500 new cases in 2022 in the U.S.
Lantheus Holdings (NASDAQ: LNTH) has appointed Vivian Yao as the new Chief Human Resources Officer, effective immediately. She brings over 25 years of HR experience, having previously served as Vice President of Human Resources at Jabil, overseeing over 100,000 employees. Yao will report to President and CEO Mary Anne Heino and is tasked with enhancing employee experience and talent processes. Heino expressed excitement about Yao’s expertise in fostering a culture of innovation, crucial for the company's continued growth in imaging diagnostics and therapeutics.
Lantheus Holdings announces the commercial availability of PYLARIFY AI, an FDA-cleared AI platform for quantifying PSMA PET/CT scans for prostate cancer. This innovative solution utilizes a deep learning algorithm validated on over 3,000 images to enhance the accuracy and efficiency of assessments. It integrates seamlessly into clinical workflows either via cloud or local server deployment. PYLARIFY AI aims to support the uptake of PYLARIFY in clinical practice, furthering precision oncology. The first distributor in the U.S. is Syntermed.
Lantheus Holdings, Inc. (NASDAQ: LNTH) announced that the Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through Payment Status for PYLARIFY (piflufolastat F 18) effective January 1, 2022. This payment status allows Medicare to provide additional payments for PET-CT scans using PYLARIFY in hospital outpatient settings. PYLARIFY is the first FDA-approved PSMA-targeted PET imaging agent for prostate cancer, enhancing early disease detection. Prostate cancer remains a significant health issue, with nearly 250,000 cases expected in 2021 alone.
Lantheus Holdings (NASDAQ: LNTH) announced that data from the Phase 3 CONDOR study on PYLARIFY® (piflufolastat F 18) will be presented at two significant medical conferences. The first is the RSNA meeting in Chicago from November 28 to December 2, 2021, featuring a poster discussion on diagnostic performance in prostate cancer recurrence. The second is the SUO meeting in Orlando from December 1-3, 2021, also focusing on PYLARIFY’s performance post-treatment. PYLARIFY is crucial for detecting prostate cancer and its PET imaging capabilities have garnered attention for their accuracy and efficacy.
Lantheus Holdings, a leader in imaging diagnostics and therapeutics, will have its CFO, Bob Marshall, present at the 4th Annual Evercore ISI HealthCONx Conference on November 30, 2021, at 1:00 p.m. ET. Interested parties can access a live webcast through the Investors section of their website, with a replay available for 30 days post-event. The company focuses on innovative diagnostic solutions and has a portfolio that includes products like DEFINITY, PYLARIFY, and RELISTOR.