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 third quarter 2021 worldwide revenue of $102.1 million, a 15.3% increase year-over-year. Despite this, the company faced a GAAP net loss of $13.4 million, compared to a loss of $6.4 million in Q3 2020. Adjusted fully diluted EPS rose to $0.08, up 127.4% from $0.04 the previous year. Cash provided by operating activities was $4.3 million, with free cash flow at $1.9 million. The Independent Data Monitoring Committee recommended the continuation of the ARROW Phase 2 study. The company also raised its full-year revenue guidance to $405-$410 million.
Lantheus Holdings (NASDAQ: LNTH) announces upcoming presentations at two investor conferences. Mary Anne Heino, President and CEO, and Bob Marshall, CFO, will present at the Credit Suisse 30th Annual Virtual Healthcare Conference on November 11, 2021, at 8:50 a.m. ET and at the Jefferies London Healthcare Conference on November 18, 2021, with a pre-recorded chat available at 8 a.m. GMT. Webcasts will be accessible on the company's website, and replays will be available for 30 days post-event.
Lantheus Holdings (NASDAQ: LNTH) announced a conference call scheduled for November 4, 2021, at 8:00 a.m. ET to discuss its Q3 2021 financial and operating results. Investors can access the call by dialing 1-866-498-8390 for U.S. callers or 1-678-509-7599 for international callers, using passcode 6775813. A live webcast will also be available on the company's website. The call will provide insights into Lantheus's innovative imaging diagnostics and therapeutic solutions, including products like PYLARIFY® and RELISTOR®.
Lantheus Holdings (NASDAQ: LNTH) announced that its FDA-approved imaging agent, PYLARIFY (piflufolastat F18), has been included in the updated NCCN Guidelines for prostate cancer. This milestone recognizes PYLARIFY’s role in detecting PSMA-positive lesions in men with suspected metastasis or recurrence. Prostate cancer significantly affects the male population, with nearly 250,000 new cases expected in 2021. The inclusion in the NCCN Guidelines is anticipated to enhance awareness and utilization of PYLARIFY in clinical settings.
Lantheus and RefleXion Medical have partnered to develop and commercialize a system for real-time therapeutic guidance in prostate cancer treatment using piflufolastat F 18, a PSMA-targeted PET imaging agent. This collaboration aims to enhance the use of biology-guided radiotherapy (BgRT) via the RefleXion X1 platform, allowing precise radiation delivery to tumor sites. The agreement involves shared responsibilities and potential financial upside from this innovative approach, which could significantly impact treatment outcomes for prostate cancer patients.
Lantheus Holdings (NASDAQ: LNTH) announced promising results from the OSPREY trial regarding piflufolastat F 18, a PSMA-targeted PET imaging agent for high-risk prostate cancer. Data presented at the 2021 AUA Meeting showed that 26.9% of participants had detectable lymph node or distant metastases before definitive therapy. Furthermore, the imaging led to a change in management plans for 43.6% of patients, impacting surgical and radiation therapy recommendations. The trial demonstrated 95-98% specificity but lower sensitivity (28-39%). Overall, piflufolastat F 18 presents significant potential to influence treatment decisions.
Lantheus (NASDAQ: LNTH) has announced that Mary Anne Heino, President and CEO, and Bob Marshall, CFO and Treasurer, will present at upcoming investor conferences. The presentations will take place at the Wells Fargo 2021 Virtual Healthcare Conference on September 9, 2021, and at the Baird 2021 Global Healthcare Conference on September 15, 2021. Investors can access a live webcast of these presentations via Lantheus's website, with replays available for 30 days post-event.
Lantheus Holdings announced that its subsidiary, EXINI Diagnostics AB, received FDA 510(k) clearance for its digital application, aPROMISE™, designed for prostate cancer imaging. This AI-based software enhances efficiency and consistency in PSMA PET/CT assessments, utilizing deep learning algorithms trained on over 3,000 images. The application is intended for healthcare professionals to improve the quantification and reporting of prostate cancer lesions. This follows the recent FDA approval of PYLARIFY®, a PSMA-targeted PET imaging agent, enhancing Lantheus's prostate cancer diagnostic capabilities.
Lantheus Holdings, Inc. (LNTH) reported Q2 2021 revenue of $101.1 million, marking a 53.1% increase from Q2 2020. However, the company posted a GAAP net loss of $26.7 million, compared to $7.0 million in the prior year. Adjusted EPS slightly rose to $0.11 from $0.10. Free Cash Flow jumped to $23.2 million, an increase of approximately $27.6 million year-over-year. The FDA approved PYLARIFY, enhancing their product portfolio. Revised guidance for FY 2021 estimates revenue between $395 million and $402 million.
Lantheus Holdings, Inc. (NASDAQ: LNTH) will host a conference call and webcast on July 28, 2021, at 8:00 a.m. ET to discuss its Q2 2021 financial and operational results. Investors can join the call by dialing U.S. 1-866-498-8390 or international 1-678-509-7599, using passcode 6149638. The live webcast will be accessible on the company's website, with a replay available after the call and archived for 30 days. Lantheus specializes in innovative imaging diagnostics and therapeutics, offering a broad product portfolio, including DEFINITY®, PYLARIFY®, and RELISTOR®.