1. Bela Denes, MD Joins as Vice President of Medical Affairs

    Iryna Teslenko, MD, MBA Joins as Vice President of Clinical Development

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced the hiring of Dr. Bela Denes and Dr. Iryna Teslenko. Both report directly to Lantheus' Chief Medical Officer, Istvan Molnar, MD.

    "At Lantheus, our ultimate goal is to use world-class science to help patients in need, and I am pleased to welcome two top-tier medical professionals to our Lantheus team to advance that mission," said Istvan Molnar, MD…

    Bela Denes, MD Joins as Vice President of Medical Affairs

    Iryna Teslenko, MD, MBA Joins as Vice President of Clinical Development

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced the hiring of Dr. Bela Denes and Dr. Iryna Teslenko. Both report directly to Lantheus' Chief Medical Officer, Istvan Molnar, MD.

    "At Lantheus, our ultimate goal is to use world-class science to help patients in need, and I am pleased to welcome two top-tier medical professionals to our Lantheus team to advance that mission," said Istvan Molnar, MD, Chief Medical Officer of Lantheus. "With the additions of Dr. Denes' expertise in urology and Dr. Teslenko's expertise in radiology, I am confident we are set up for success as we continue to develop our pipeline, particularly our prostate cancer radiopharmaceutical product candidates."

    Bela Denes, MD is a board-certified urologist who practiced for 25 years and subsequently has had a distinguished industry career. Prior to joining Lantheus, Dr. Denes was the Global Medical Affairs Lead at Amgen, responsible for overseeing the medical plans, launch preparation and lifecycle management of three urology pipeline assets in development. Prior to joining Amgen, he served as Vice President of Medical Affairs at Blue Earth Diagnostics until the company's acquisition by Bracco Imaging in August 2019. Prior to Blue Earth he spent time at Genomic Health, Eli Lilly, Pfizer, Spectrum and Abbott across medical affairs and clinical development. Additionally, Dr. Denes has presented and published numerous articles, abstracts, and posters at conferences both in the U.S. and abroad.

    Iryna Teslenko, MD, MBA is a physician, board-certified in radiology diagnostics, with more than 17 years of drug development and clinical research experience in solid tumor and hematological oncology. Before joining Lantheus, Dr. Teslenko worked as a Physician Program Lead at GlaxoSmithKline (GSK), leading the cross-functional team responsible for development of GSK's immuno-oncology assets. Prior to GSK, Dr. Teslenko worked in roles of increasing responsibility at PRA Health Sciences and PSI CRO AG, leading the hematology-oncology medical group and global medical monitoring and consulting group. Due to her strong expertise in medical imaging, she also served as an in-house medical imaging expert for PSI CRO AG and was responsible for the medical imaging aspects of the clinical trials run by the company, as well as for radiological trainings for the company's employees and clinical investigators. Dr. Teslenko is an author of numerous publications in peer reviewed journals and book chapters on Good Clinical Practice and radiology diagnostics. She also has a Master of Business Administration degree.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

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  2. Names Daniel Niedzwiecki as Senior Vice President and General Counsel

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced that Michael P. Duffy, Senior Vice President, Law and Public Policy and General Counsel will retire from Lantheus on June 4, 2021 after more than 13 years with Lantheus. Mr. Duffy will be retained in an advisory capacity. His responsibilities will be assumed by Daniel Niedzwiecki, who has been with the Company since 2013 and will report directly to Mary Anne Heino, President and CEO.

    "On behalf of the entire…

    Names Daniel Niedzwiecki as Senior Vice President and General Counsel

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced that Michael P. Duffy, Senior Vice President, Law and Public Policy and General Counsel will retire from Lantheus on June 4, 2021 after more than 13 years with Lantheus. Mr. Duffy will be retained in an advisory capacity. His responsibilities will be assumed by Daniel Niedzwiecki, who has been with the Company since 2013 and will report directly to Mary Anne Heino, President and CEO.

    "On behalf of the entire Lantheus team and Board of Directors, I thank Mike for his many years of dedicated service to Lantheus and the radiopharmaceutical industry," said Mary Anne Heino, President and Chief Executive Officer. "Mike is the consummate professional, a trusted advisor, a good friend, and it has been my absolute privilege to have worked with him. We wish Mike all the very best as he embarks on new adventures in his retirement."

    "I am honored and privileged to have been part of the team that, starting in 2008, transformed a private equity-backed carve-out from Bristol Myers Squibb into a free-standing public company with a growing product portfolio and pipeline, and a market cap that has expanded by more than seven times since the Company's IPO in 2015," said Mr. Duffy. "With the integration of last year's acquisition of Progenics well advanced, now is an appropriate time for me to step back to pursue other interests. Dan has been an integral member of our strong legal team since 2013, and I believe he is the right leader to continue to help drive the business forward and create additional value for our stakeholders."

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

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  3. Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, announced today it has acquired the exclusive, worldwide rights to develop, manufacture and commercialize NTI-1309, an innovative PET oncology imaging agent from Noria Therapeutics, Inc.

    NTI-1309 targets fibroblast activation protein (FAP), a target with potential broad imaging applicability and targeting implications in oncology. FAP is overexpressed in the tumor microenvironment, specifically in tumor-associated fibroblasts, which are believed to modulate tumor progression and immune response…

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, announced today it has acquired the exclusive, worldwide rights to develop, manufacture and commercialize NTI-1309, an innovative PET oncology imaging agent from Noria Therapeutics, Inc.

    NTI-1309 targets fibroblast activation protein (FAP), a target with potential broad imaging applicability and targeting implications in oncology. FAP is overexpressed in the tumor microenvironment, specifically in tumor-associated fibroblasts, which are believed to modulate tumor progression and immune response. Given its expression in tumors coupled with low expression in normal tissue, FAP has the potential to become an important biomarker for precision medicine in cancer. Already a focus of significant research by academics and the pharmaceutical industry, a FAP biomarker has potential to address unmet medical needs and to impact the clinical management of stroma-dense tumors, such as breast, colon, lung and pancreatic cancer.

    Under terms of the agreement, Noria will drive the early clinical development of NTI-1309, leveraging its experience with early-stage imaging development. Upon completion of the Phase 1 study, NTI-1309 will be integrated into Lantheus' portfolio of imaging biomarkers and included in the offering to academic centers and pharmaceutical companies for use in oncology drug development programs. Simultaneously, Lantheus will assess options for bringing this important biomarker to market through Lantheus-sponsored trials.

    "Lantheus is committed to advancing innovative imaging biomarker solutions to find, fight and follow cancer," said Etienne Montagut, Senior Vice President of Corporate Development at Lantheus. "We believe FAP is a promising target for cancer imaging and has broad potential to inform diagnosis and staging, to guide patient selection for therapy, and to monitor response to treatment across multiple tumor types. This partnership with Noria enables us to progress this development program in a timely fashion, leverage our established leadership in imaging and state of the art artificial intelligence, and position us to monetize this biomarker offering, which has the potential to unlock deep, data-driven insights to inform R&D and clinical decision-making."

    "The Noria team is excited to partner with a proven leader in imaging diagnostics with the experience and resources to advance this development program. Noria is pleased to have been entrusted by Lantheus to continue the development of NTI-1309, leveraging our platform and very experienced team," said Allan M. Green, MD, PhD, JD, Co- Founder and CEO of Noria Therapeutics, Inc.

    Terms of the transaction include an upfront license and development fee to Noria, certain development and regulatory milestones, and royalties if NTI-1309 is commercialized.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

    About Noria Therapeutics, Inc.

    Noria Therapeutics, Inc. is a research and development company managed by experienced radiopharmaceutical development leaders and focused on the development of novel targeted alpha therapeutics and theranostic agents. It has exclusive world-wide rights to technology licensed from Weill Cornell Medical College, Johns Hopkins University and the University of Heidelberg. It is headquartered in New York City.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "believe," "expect," "intend," "potential," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) expectations for future clinical trials, the timing and potential outcomes of clinical studies and filings and other interactions with regulatory authorities; (ii) the safety and efficacy of NTI-1309; (iii) regulatory risks related to NTI-1309; (iv) academic centers and pharmaceutical companies receptivity to NTI-1309 for use in oncology drug development programs; ; (v) the intellectual property protection of NTI-1309; (vi) our dependence upon third parties for the manufacture and supply of NTI-1309; and (vii) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

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  4. - Statistically Significant Correlation Between Biomarker Responses and Objective Tumor Response -

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced today that updated biochemical tumor marker data from its pivotal Phase 2 trial of AZEDRA® (iobenguane I 131) were presented at the Endocrine Society's 2021 Annual Meeting, ENDO 2021.

    Dr. Camilo Jimenez, Professor of Endocrine Neoplasia and Hormonal Disorders at the University of Texas MD Anderson Cancer Center, delivered an oral presentation entitled: "Biochemical Tumor Marker Status…

    - Statistically Significant Correlation Between Biomarker Responses and Objective Tumor Response -

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced today that updated biochemical tumor marker data from its pivotal Phase 2 trial of AZEDRA® (iobenguane I 131) were presented at the Endocrine Society's 2021 Annual Meeting, ENDO 2021.

    Dr. Camilo Jimenez, Professor of Endocrine Neoplasia and Hormonal Disorders at the University of Texas MD Anderson Cancer Center, delivered an oral presentation entitled: "Biochemical Tumor Marker Status and Its Role in Treatment Response in Patients Who Received High-Specific-Activity I-131 MIBG in Advanced Pheochromocytoma and Paraganglioma (PPGL): Results from a Pivotal Phase 2 Clinical Trial" on Saturday, March 20, 2021.

    "AZEDRA yielded reductions in hypersecreted tumor biomarkers in a majority of patients in this pivotal study of advanced pheochromocytoma and paraganglioma," said Dr. Jimenez. "In addition, the overall tumor biomarker response correlated significantly with both the primary and secondary endpoint responses in the study, underscoring the clinical utility and relevance of this important biochemical endpoint to the therapeutic benefit of AZEDRA in patients with these life-threatening tumors."

    Tumor biomarkers were analyzed in patients with hypersecreting tumors (tumor biomarkers 1.5x above the upper limit of normal at baseline). The best biochemical responses (complete response (CR) or partial response (PR) at any time after treatment as evidenced by significant biomarker reductions) were observed in 80% (Chromogranin A), 70% (total metanephrines) and 64% (vanillylmandelic acid) of patients administered at least one therapeutic dose of AZEDRA. The overall tumor biomarker response correlated significantly with the best confirmed objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 (including PR and stable disease; r=0.35, p=0.006). Importantly, none of the responders with an overall biomarker response (CR or PR) had progressive disease as best response per RECIST.

    "AZEDRA is the first and only approved treatment option for patients with advanced or metastatic PPGL," said Istvan Molnar, M.D., Chief Medical Officer of Lantheus. "Elevated neuroendocrine markers are the hallmark of these diseases and are responsible for many of the signs and symptoms of PPGL. We believe these data support the established efficacy of AZEDRA in its approved indication by demonstrating that after treatment with AZEDRA, the majority of patients with elevated baseline neuroendocrine markers had a reduction of these markers."

    Indication

    AZEDRA® (iobenguane I 131) is indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.

    Important Safety Information

    Warnings and Precautions:

    Risk from radiation exposure: AZEDRA contributes to a patient's overall long-term radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. These risks of radiation associated with the use of AZEDRA are greater in pediatric patients than in adults. Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment with AZEDRA consistent with institutional good radiation safety practices and patient management procedures.

    Myelosuppression: Severe and prolonged myelosuppression occurred during treatment with AZEDRA. Among the 88 patients who received a therapeutic dose of AZEDRA, 33% experienced Grade 4 thrombocytopenia, 16% experienced Grade 4 neutropenia, and 7% experienced Grade 4 anemia. Five percent of patients experienced febrile neutropenia. Monitor blood cell counts weekly for up to 12 weeks or until levels return to baseline or the normal range. Withhold and dose reduce AZEDRA as recommended in the prescribing information based on severity of the cytopenia.

    Secondary myelodysplastic syndrome, leukemia, and other malignancies: Myelodysplastic syndrome (MDS) and acute leukemias were reported in 6.8% of the 88 patients who received a therapeutic dose of AZEDRA. The time to development of MDS or acute leukemia ranged from 12 months to 7 years. Two of the 88 patients developed a non-hematological malignancy.

    Hypothyroidism: Hypothyroidism was reported in 3.4% of the 88 patients who received a therapeutic dose of AZEDRA. Initiate thyroid-blocking medications starting at least 1 day before and continuing for 10 days after each AZEDRA dose to reduce the risk of hypothyroidism or thyroid neoplasia. Evaluate for clinical evidence of hypothyroidism and measure thyroid-stimulating hormone (TSH) levels prior to initiating AZEDRA and annually thereafter.

    Elevations in blood pressure: Eleven percent of the 88 patients who received a therapeutic dose of AZEDRA experienced a worsening of pre-existing hypertension defined as an increase in systolic blood pressure to ≥160 mmHg with an increase of 20 mmHg or an increase in diastolic blood pressure to ≥100 mmHg with an increase of 10 mmHg. All changes in blood pressure occurred within the first 24 hours post infusion. Monitor blood pressure frequently during the first 24 hours after each therapeutic dose of AZEDRA.

    Renal toxicity: Of the 88 patients who received a therapeutic dose of AZEDRA, 7% developed renal failure or acute kidney injury and 22% demonstrated a clinically significant decrease in glomerular filtration rate (GFR) measured at 6 or 12 months. Monitor renal function during and after treatment with AZEDRA. Patients with baseline renal impairment may be at greater risk of toxicity; perform more frequent assessments of renal function in patients with mild or moderate impairment. AZEDRA has not been studied in patients with severe renal impairment.

    Pneumonitis: Fatal pneumonitis occurred 9 weeks after a single dose in one patient in the expanded access program. Monitor patients for signs and symptoms of pneumonitis and treat appropriately.

    Embryo-fetal toxicity: Based on its mechanism of action, AZEDRA can cause fetal harm. Verify pregnancy status in females of reproductive potential prior to initiating AZEDRA. Advise females and males of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with AZEDRA and for 7 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the final dose.

    Risk of infertility: Radiation exposure associated with AZEDRA may cause infertility in males and females. Radiation absorbed by testes and ovaries from the recommended cumulative dose of AZEDRA is within the range where temporary or permanent infertility can be expected following external beam radiotherapy.

    Adverse Reactions: The most common severe (Grade 3–4) adverse reactions observed in AZEDRA clinical trials (≥10%) were lymphopenia (78%), neutropenia (59%), thrombocytopenia (50%), fatigue (26%), anemia (24%), increased international normalized ratio (18%), nausea (16%), dizziness (13%), hypertension (11%), and vomiting (10%). Twelve percent of patients discontinued treatment due to adverse reactions (thrombocytopenia, anemia, lymphopenia, nausea and vomiting, multiple hematologic adverse reactions).

    Drug Interactions: Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells and therefore interfere with dosimetry calculations or the efficacy of AZEDRA. These drugs were not permitted in clinical trials that assessed the safety and efficacy of AZEDRA. Discontinue the drugs listed in the prescribing information for at least 5 half-lives before administration of either the dosimetry dose or a therapeutic dose of AZEDRA. Do not administer these drugs until at least 7 days after each AZEDRA dose.

    For important risk and use information about AZEDRA, please see Full Prescribing Information.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

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  5. OSPREY Phase 2/3 Results Published in the Journal of Urology

    CONDOR Phase 3 Results Published in Clinical Cancer Research

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced the publication of the results of both pivotal studies for PyL™, an investigational PET imaging agent that targets prostate-specific membrane antigen (PSMA). The OSPREY Phase 2/3 trial results have been published online in the Journal of Urology and the CONDOR Phase 3 trial results have been published in the online version of Clinical Cancer Research.

    "The…

    OSPREY Phase 2/3 Results Published in the Journal of Urology

    CONDOR Phase 3 Results Published in Clinical Cancer Research

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced the publication of the results of both pivotal studies for PyL™, an investigational PET imaging agent that targets prostate-specific membrane antigen (PSMA). The OSPREY Phase 2/3 trial results have been published online in the Journal of Urology and the CONDOR Phase 3 trial results have been published in the online version of Clinical Cancer Research.

    "The limitations of conventional imaging modalities for prostate cancer create a need for targeted imaging in the initial assessment of high-risk patients as well as in men with early biochemically relapsed disease," said Michael J. Morris, M.D., Prostate Cancer Section Head, Genitourinary Medical Oncology Service, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, and lead author of the CONDOR manuscript and senior author on the OSPREY manuscript. "The OSPREY trial data highlighted the high positive predictive value, negative predictive value and specificity of PyL in staging high-risk patients. The CONDOR trial demonstrates its high positive predictive value to accurately locate and identify recurrent cancer early and non-invasively. Assuming FDA approval, physicians will be able to use this clinically meaningful information to identify disease, guide treatment plans, and improve disease management."

    Mary Anne Heino, President and Chief Executive Officer of Lantheus added, "We believe these data demonstrate PyL's clinical benefit and are honored to have our studies published in such well-respected peer-reviewed journals. The results of the OSPREY and CONDOR trials are part of our NDA that is currently under priority review at the FDA for marketing authorization in the United States. We believe PyL has the potential to play an important role in transforming the management of men with high-risk, recurrent or metastatic prostate cancer."

    Kenneth J. Pienta, M.D., Director of Research at the James Buchanan Brady Urological Institute and Professor of Urology at Johns Hopkins University School of Medicine, was the lead author of the OSPREY manuscript. The OSPREY publication in the Journal of Urology may be found online here.

    Michael J. Morris, M.D., Prostate Cancer Section Head of the Genitourinary Medical Oncology Service and Division of Solid Tumor Oncology at Memorial Sloan Kettering Cancer Center. Was the lead author of the CONDOR manuscript. The CONDOR publication in Clinical Cancer Research may be found online here.

    OSPREY Phase 2/3 Trial

    The OSPREY trial was designed to assess the diagnostic performance of PyL to detect prostate cancer in pelvic lymph nodes in subjects with high-risk prostate cancer (Cohort A) and confirm distant metastases in subjects with metastatic or recurrent prostate cancer (Cohort B). The primary endpoints for the trial were sensitivity and specificity of PyL PET/CT imaging to detect metastatic prostate cancer within the pelvic lymph nodes relative to histopathology in Cohort A. A key secondary endpoint of the trial was the sensitivity of PyL PET/CT imaging to detect prostate cancer within sites of metastasis or local recurrence relative to histopathology in Cohort B.

    In the trial, the diagnostic performance of PyL in detecting disease in pelvic lymph nodes (Cohort A) was compared with histopathology. PyL showed specificity of 96-99%, sensitivity of 31-42%, and PPV of 78-91% meeting the specificity but not the pre-established sensitivity co-primary endpoint. In the metastatic or recurrent prostate cancer setting (Cohort B), PyL exhibited sensitivity of 93-99% and PPV of 81-88% in detecting metastatic lesions. Overall, PyL demonstrated high diagnostic performance in reliably detecting nodal and distant metastatic prostate cancer.

    Safety results showed PyL was well tolerated. The most frequent adverse events reported were dysgeusia (2.6%), headache (1.8%), and fatigue (1.3%).

    CONDOR Phase 3 Trial

    The CONDOR trial was designed to assess the diagnostic performance and clinical utility of PyL in men with biochemically recurrent prostate cancer and uninformative standard imaging. The primary endpoint in the trial was the Correct Localization Rate (CLR) of PyL. CLR is based on positive predictive value, defined as the percentage of patients with a one-to-one correspondence between localization of at least one lesion identified on PyL PET/CT and a composite truth standard. The composite truth is comprised of, in descending priority, histopathology, subsequent correlative imaging findings, or PSA response following radiation therapy. The key secondary endpoint in the trial was the percent of subjects with a change in intended prostate cancer treatment due to PyL imaging results.

    The CONDOR trial achieved its primary endpoint, with a CLR of 84.8% to 87.0% among the three blinded independent readers (the lower bound of the 95% confidence intervals ranging from 77.8% to 80.4%). In the key secondary endpoint, 63.9% of patients had a change in intended prostate cancer treatment following review of PyL imaging results. The most frequent changes in intended prostate cancer treatment plans included changing salvage local therapy to systemic therapy, observation to initiating therapy, noncurative systemic therapy to salvage curative local therapy and planned treatment to observation.

    Safety results showed PyL was well tolerated. The most frequent adverse event reported was headache, which was reported in four patients (1.9% of the trial population). There was one serious adverse event of hypersensitivity reported as related to the study drug.

    About Prostate Cancer

    Prostate cancer is the second most common form of cancer affecting men in the United States -- an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, 248,530 new cases of prostate cancer will be diagnosed, and 34,130 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.1

    About PyL

    PyL (also known as 18F-DCFPyL) is an investigational fluorinated PSMA-targeted PET imaging agent that enables visualization of localized prostate cancer both localized as well as metastatic to lymph nodes, bone and soft tissue to detect and localize recurrent and/or metastatic prostate cancer. On September 29, 2020, Lantheus submitted a new drug application (NDA) for PyL which was accepted and granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2021.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow™ serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "expect," "intend," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and other regulatory authorities for PyL; (ii) the Company's ability to successfully launch PyL as a commercial product; (iii) the market receptivity to PyL as a new diagnostic agent; (iv) the safety and efficacy of PyL; (v) the intellectual property protection of PyL; and (vi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

    1 American Cancer Society. Facts & Figures 2021. American Cancer Society. Atlanta, GA. 2021.

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    • Worldwide revenue of $94.2 million and $339.4 million for the fourth quarter and full year 2020, representing an increase of 5.4% and a decline of 2.3% over the prior year period, respectively
    • Net loss of $3.4 million and $13.5 million for the fourth quarter and full year 2020, compared to net income of $10.5 million and $31.7 million for the fourth quarter and full year 2019
    • GAAP fully diluted net loss of $0.05 and $0.25 for the fourth quarter and full year 2020, compared to GAAP fully diluted net income of $0.26 and $0.79 for the fourth quarter and full year 2019; adjusted fully diluted EPS of $0.07 and $0.47 for the fourth quarter and full year 2020, compared to adjusted fully diluted EPS of $0.34 and $1.17 for the fourth quarter and
    • Worldwide revenue of $94.2 million and $339.4 million for the fourth quarter and full year 2020, representing an increase of 5.4% and a decline of 2.3% over the prior year period, respectively
    • Net loss of $3.4 million and $13.5 million for the fourth quarter and full year 2020, compared to net income of $10.5 million and $31.7 million for the fourth quarter and full year 2019
    • GAAP fully diluted net loss of $0.05 and $0.25 for the fourth quarter and full year 2020, compared to GAAP fully diluted net income of $0.26 and $0.79 for the fourth quarter and full year 2019; adjusted fully diluted EPS of $0.07 and $0.47 for the fourth quarter and full year 2020, compared to adjusted fully diluted EPS of $0.34 and $1.17 for the fourth quarter and full year 2019
    • Net cash provided by operating activities was $0.6 million and $16.4 million for the fourth quarter and full year 2020. Free cash flow of $(3.2) million and $3.9 million for the fourth quarter and full year 2020, compared to free cash flow of $17.7 million and $58.3 million for the fourth quarter and full year 2019
    • The Company provides first quarter and full year 2021 revenue and adjusted fully diluted earnings per share guidance

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today reported financial results for its fourth quarter and full year ended December 31, 2020.

    The Company's worldwide revenue for the fourth quarter of 2020 totaled $94.2 million, compared with $89.3 million for the fourth quarter of 2019, representing an increase of 5.4% over the prior year period. Full year 2020 worldwide revenues were $339.4 million, compared with $347.3 million for the full year 2019, representing a decrease of 2.3% over the prior year period.

    The Company's fourth quarter 2020 net loss was $3.4 million, or $0.05 per fully diluted share, as compared to net income of $10.5 million, or $0.26 per fully diluted share for the fourth quarter of 2019. Full year 2020 net loss was $13.5 million, or $0.25 per fully diluted share, as compared to net income of $31.7 million, or $0.79 per fully diluted share for the full year 2019.

    The Company's fourth quarter 2020 adjusted fully diluted earnings per share were $0.07, as compared to $0.34 for the fourth quarter of 2019, representing a decrease of 79.9% over the prior year period. The Company's full year 2020 adjusted fully diluted earnings per share were $0.47, as compared to $1.17 for the full year 2019, representing a decrease of 59.5% over the prior year period.

    Lastly, net cash provided by operating activities was $0.6 million and $16.4 million for the fourth quarter and full year 2020. Free Cash Flow was $(3.2) million for the fourth quarter of 2020, representing a decrease of approximately $20.9 million from the prior year period. Full year 2020 free cash flow was $3.9 million, as compared to $58.3 million for the full year 2019, representing a decrease of approximately $54.4 million from the prior year period.

    "While 2020 presented extraordinary challenges, I thank our team for continuing to manufacture and deliver products to our customers throughout the year," said Mary Anne Heino, President and CEO. "Our fourth quarter revenue growth was 5.4% over the prior year period and also represented steady improvement over the prior two quarters of 2020. During 2020, we advanced our strategic mandate by closing the Progenics acquisition in June and receiving FDA approval for DEFINITY RT in November as well as FDA acceptance and Priority Review designation for our PyL NDA in December. In 2021, we will continue to drive sustainable growth, expand product offerings to our customers, improve the lives of the patients we serve, and create value for our shareholders."

    Outlook

    The Company guidance for the first quarter and full year 2021 is as follows:

     

     

    Guidance Issued February 25, 2021

    Q1 FY 2021 Revenue

     

    $85 million - $89 million

    Q1 FY 2021 Adjusted Fully Diluted EPS

     

    $(0.03) - $0.00

     

     

    Guidance Issued February 25, 2021

    FY 2021 Revenue

     

    $385 million - $400 million

    FY 2021 Adjusted Fully Diluted EPS

     

    $0.34 - $0.39

    On a forward-looking basis, the Company does not provide GAAP income per common share guidance or a reconciliation of adjusted fully diluted EPS to GAAP income per common share because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any one-time, non-recurring charges. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. As a result, it is the Company's view that a quantitative reconciliation of adjusted fully diluted EPS on a forward-looking basis is not available without unreasonable effort.

    Internet Posting of Information

    The Company routinely posts information that may be important to investors in the "Investors" section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company.

    Conference Call and Webcast

    As previously announced, the Company will host a conference call and webcast on Thursday, February 25, 2021 at 4:30 p.m. ET. To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1-678-509-7599 (international callers) and provide passcode 5247866. A live webcast will be available in the Investors section of the Company's website at www.lantheus.com.

    A replay of the audio webcast will be available in the Investors section of our website at www.lantheus.com approximately two hours after completion of the call and will be archived for 30 days.

    The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.

    The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow™ serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

    Non-GAAP Financial Measures

    The Company uses non-GAAP financial measures, such as adjusted net income and its line components; adjusted net income per share - fully diluted; and free cash flow. The Company's management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the Company's operations, period over period. However, these measures may exclude items that may be highly variable, difficult to predict and of a size that could have a substantial impact on the Company's reported results of operations for a particular period. Management uses these and other non-GAAP measures internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.

    This press release includes forward-looking non-GAAP guidance for 2021 adjusted fully diluted EPS. No reconciliation of this forward-looking non-GAAP guidance is included in this press release because, due to the high variability and difficulty in making accurate forecasts and projections of some of the information that would be required to prepare such a reconciliation and the fact that some of the excluded information is not readily ascertainable or accessible, the Company is unable to quantify certain amounts that would be required to be included in the most directly comparable GAAP financial measure without unreasonable efforts.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate," "believe," "confident," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include : (i) the impact of the global COVID-19 pandemic on our business, financial conditions or prospects, or on the timing and enrollment of our clinical trials; (ii) continued market expansion and penetration for our commercial products, particularly DEFINITY, in the face of segment competition and potential generic competition as a result of patent and regulatory exclusivity expirations; (iii) our efforts in new product development, including for PyL, our prostate cancer diagnostic imaging agent, including our ability to obtain U.S. Food and Drug Administration approval of PyL in 2021, and new clinical applications for our products; (iv) our dependence upon third parties for the manufacture and supply of PyL and the timing of that manufacturing capacity becoming available; (v) the global Molybdenum-99 supply; (vi) our products manufactured at Jubilant HollisterStier and our recently-approved modified formulation of DEFINITY ("DEFINITY RT") to be commercially manufactured at Samsung Biologics; (vii) the continued integration of the Progenics product and product candidate portfolio into our business following the June 2020 consummation of the Progenics acquisition; (viii) our ability to use in-house manufacturing capacity; (ix) the expected timing for commercialization of products we or our strategic partners may develop, including flurpiridaz F 18; (x) our ability to develop highly contextualized assessments of disease burden using artificial intelligence; and (xi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

    - Tables Follow -

    Lantheus Holdings, Inc.

    Consolidated Statements of Operations

    (in thousands, except per share data – unaudited)

     

     

     

    Three Months Ended

    December 31,

     

    Year Ended

    December 31,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Revenues

     

    $

    94,152

     

     

     

    $

    89,346

     

     

     

    $

    339,410

     

     

     

    $

    347,337

     

     

    Cost of goods sold

     

    55,501

     

     

     

    44,781

     

     

     

    200,649

     

     

     

    172,526

     

     

    Gross profit

     

    38,651

     

     

     

    44,565

     

     

     

    138,761

     

     

     

    174,811

     

     

    Operating expenses

     

     

     

     

     

     

     

     

    Sales and marketing

     

    12,857

     

     

     

    10,392

     

     

     

    40,901

     

     

     

    41,888

     

     

    General and administrative

     

    13,684

     

     

     

    17,301

     

     

     

    69,270

     

     

     

    61,244

     

     

    Research and development

     

    12,638

     

     

     

    4,434

     

     

     

    32,788

     

     

     

    20,018

     

     

    Total operating expenses

     

    39,179

     

     

     

    32,127

     

     

     

    142,959

     

     

     

    123,150

     

     

    Operating (loss) income

     

    (528

    )

     

     

    12,438

     

     

     

    (4,198

    )

     

     

    51,661

     

     

    Interest expense

     

    2,811

     

     

     

    2,126

     

     

     

    9,479

     

     

     

    13,617

     

     

    Loss on extinguishment of debt

     

     

     

     

     

     

     

     

     

     

    3,196

     

     

    Other (income) loss

     

    (496

    )

     

     

    7,916

     

     

     

    (2,198

    )

     

     

    6,221

     

     

    (Loss) income before income taxes

     

    $

    (2,843

    )

     

     

    $

    2,396

     

     

     

    $

    (11,479

    )

     

     

    $

    28,627

     

     

    Income tax expense (benefit)

     

    569

     

     

     

    (8,054

    )

     

     

    1,994

     

     

     

    (3,040

    )

     

    Net (loss) income

     

    $

    (3,412

    )

     

     

    $

    10,450

     

     

     

    $

    (13,473

    )

     

     

    $

    31,667

     

     

    Net (loss) income per common share:

     

     

     

     

     

     

     

     

    Basic

     

    $

    (0.05

    )

     

     

    $

    0.27

     

     

     

    $

    (0.25

    )

     

     

    $

    0.81

     

     

    Diluted

     

    $

    (0.05

    )

     

     

    $

    0.26

     

     

     

    $

    (0.25

    )

     

     

    $

    0.79

     

     

    Weighted-average common shares outstanding:

     

     

     

     

     

     

     

     

    Basic

     

    66,870

     

     

     

    39,246

     

     

     

    54,134

     

     

     

    38,988

     

     

    Diluted

     

    66,870

     

     

     

    40,133

     

     

     

    54,134

     

     

     

    40,113

     

     

    Lantheus Holdings, Inc.

    Consolidated Segment Revenues Analysis

    (in thousands – unaudited)

     

     

    Three Months Ended

    December 31,

     

    Year Ended

    December 31,

     

    2020

     

    2019

     

    % Change

     

    2020

     

    2019

     

    % Change

    U.S.

     

     

     

     

     

     

     

     

     

     

     

    DEFINITY

    58,924

     

     

     

    57,678

     

     

     

    2.2

     

    %

     

    207,270

     

     

     

    211,777

     

     

     

    (2.1

    )

    %

    TechneLite

    17,130

     

     

     

    17,330

     

     

     

    (1.2

    )

    %

     

    69,729

     

     

     

    72,534

     

     

     

    (3.9

    )

    %

    Other nuclear

    10,427

     

     

     

    8,225

     

     

     

    26.8

     

    %

     

    36,864

     

     

     

    36,231

     

     

     

    1.7

     

    %

    Rebates and allowances

    (5,304

    )

     

     

    (4,518

    )

     

     

    17.4

     

    %

     

    (19,067

    )

     

     

    (16,553

    )

     

     

    15.2

     

    %

    Total U.S. Revenues

    81,177

     

     

     

    78,715

     

     

     

    3.1

     

    %

     

    294,796

     

     

     

    303,989

     

     

     

    (3.0

    )

    %

    International

     

     

     

     

     

     

     

     

     

     

     

    DEFINITY

    1,807

     

     

     

    1,695

     

     

     

    6.6

     

    %

     

    6,046

     

     

     

    5,731

     

     

     

    5.5

     

    %

    TechneLite

    5,615

     

     

     

    3,264

     

     

     

    72.0

     

    %

     

    16,512

     

     

     

    14,058

     

     

     

    17.5

     

    %

    Other nuclear

    5,553

     

     

     

    5,673

     

     

     

    (2.1

    )

    %

     

    22,060

     

     

     

    23,574

     

     

     

    (6.4

    )

    %

    Rebates and allowances

     

     

     

    (1

    )

     

     

    (100.0

    )

    %

     

    (4

    )

     

     

    (15

    )

     

     

    (73.3

    )

    %

    Total International Revenues

    12,975

     

     

     

    10,631

     

     

     

    22.0

     

    %

     

    44,614

     

     

     

    43,348

     

     

     

    2.9

     

    %

    Worldwide

     

     

     

     

     

     

     

     

     

     

     

    DEFINITY

    60,731

     

     

     

    59,373

     

     

     

    2.3

     

    %

     

    213,316

     

     

     

    217,508

     

     

     

    (1.9

    )

    %

    TechneLite

    22,745

     

     

     

    20,594

     

     

     

    10.4

     

    %

     

    86,241

     

     

     

    86,592

     

     

     

    (0.4

    )

    %

    Other nuclear

    15,980

     

     

     

    13,898

     

     

     

    15.0

     

    %

     

    58,924

     

     

     

    59,805

     

     

     

    (1.5

    )

    %

    Rebates and allowances

    (5,304

    )

     

     

    (4,519

    )

     

     

    17.4

     

    %

     

    (19,071

    )

     

     

    (16,568

    )

     

     

    15.1

     

    %

    Total Revenues

    $

    94,152

     

     

     

    $

    89,346

     

     

     

    5.4

     

    %

     

    $

    339,410

     

     

     

    $

    347,337

     

     

     

    (2.3

    )

    %

    Lantheus Holdings, Inc.

    Reconciliation of GAAP to Non-GAAP Financial Measures

    (in thousands, except per share data – unaudited)

     

     

     

    Three Months Ended

    December 31,

     

    Year Ended

    December 31,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Net (loss) income

     

    $

    (3,412

    )

     

     

    $

    10,450

     

     

     

    $

    (13,473

    )

     

     

    $

    31,667

     

     

    Stock and incentive plan compensation

     

    3,623

     

     

     

    2,991

     

     

     

    14,075

     

     

     

    12,571

     

     

    Amortization of acquired intangible assets

     

    4,683

     

     

     

    451

     

     

     

    10,770

     

     

     

    1,804

     

     

    Acquired debt fair value adjustment

     

    (326

    )

     

     

     

     

     

    (711

    )

     

     

     

     

    Contingent consideration fair value adjustments

     

    (2,800

    )

     

     

     

     

     

    (2,000

    )

     

     

     

     

    Non-recurring refinancing related fees

     

     

     

     

     

     

     

    460

     

     

     

     

     

    Non-recurring severance related fees

     

    904

     

     

     

     

     

     

    904

     

     

     

     

     

    Extinguishment of debt

     

     

     

     

     

     

     

     

     

     

    3,196

     

     

    Arbitration award

     

     

     

     

    (3,453

    )

     

     

     

     

     

    (3,453

    )

     

    Strategic collaboration and license costs

     

     

     

     

     

     

     

     

     

     

    300

     

     

    Integration costs

     

    2,772

     

     

     

    1,488

     

     

     

    7,201

     

     

     

    1,488

     

     

    Acquisition-related costs

     

    1,334

     

     

     

    2,834

     

     

     

    11,856

     

     

     

    8,010

     

     

    Impairment of long-lived assets

     

    2,660

     

     

     

     

     

     

    9,935

     

     

     

     

     

    Other

     

    35

     

     

     

     

     

     

    (40

    )

     

     

     

     

    Income tax effect of non-GAAP adjustments(a)

     

    (4,886

    )

     

     

    (1,134

    )

     

     

    (13,152

    )

     

     

    (8,583

    )

     

    Adjusted net income

     

    $

    4,587

     

     

     

    $

    13,627

     

     

     

    $

    25,825

     

     

     

    $

    47,000

     

     

    Adjusted net income, as a percentage of revenues

     

    4.9

     

    %

     

    15.3

     

    %

     

    7.6

     

    %

     

    13.5

     

    %

     

     

    Three Months Ended

    December 31,

     

    Year Ended

    December 31,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Net (loss) income per share - diluted

     

    $

    (0.05

    )

     

     

    $

    0.26

     

     

     

    $

    (0.25

    )

     

     

    $

    0.79

     

     

    Stock and incentive plan compensation

     

    0.05

     

     

     

    0.07

     

     

     

    0.26

     

     

     

    0.31

     

     

    Amortization of acquired intangible assets

     

    0.08

     

     

     

    0.01

     

     

     

    0.20

     

     

     

    0.04

     

     

    Acquired debt fair value adjustment

     

     

     

     

     

     

     

    (0.01

    )

     

     

     

     

    Contingent consideration fair value adjustments

     

    (0.04

    )

     

     

     

     

     

    (0.05

    )

     

     

     

     

    Non-recurring refinancing related fees

     

     

     

     

     

     

     

    0.01

     

     

     

     

     

    Non-recurring severance related fees

     

    0.02

     

     

     

     

     

     

    0.02

     

     

     

     

     

    Extinguishment of debt

     

     

     

     

     

     

     

     

     

     

    0.08

     

     

    Arbitration award

     

     

     

     

    (0.09

    )

     

     

     

     

     

    (0.09

    )

     

    Strategic collaboration and license costs

     

     

     

     

     

     

     

     

     

     

    0.01

     

     

    Integration costs

     

    0.04

     

     

     

    0.04

     

     

     

    0.13

     

     

     

    0.04

     

     

    Acquisition-related costs

     

    0.01

     

     

     

    0.07

     

     

     

    0.22

     

     

     

    0.20

     

     

    Impairment of long-lived assets

     

    0.04

     

     

     

     

     

     

    0.18

     

     

     

     

     

    Income tax effect of non-GAAP adjustments(a)

     

    (0.08

    )

     

     

    (0.02

    )

     

     

    (0.24

    )

     

     

    (0.21

    )

     

    Adjusted net income per share - diluted

     

    $

    0.07

     

     

     

    $

    0.34

     

     

     

    $

    0.47

     

     

     

    $

    1.17

     

     

    Weighted-average common shares outstanding - diluted(b)

     

    67,130

     

     

     

    40,133

     

     

     

    54,471

     

     

     

    40,113

     

     

    (a)

    The income tax effect of the adjustments between GAAP net (loss) income and non-GAAP adjusted net income takes into account the tax treatment and related tax rate that apply to each adjustment in the applicable tax jurisdiction.

    (b)

    Diluted shares may differ for non-GAAP measures as compared to GAAP due to a GAAP net loss position.

    Lantheus Holdings, Inc.

    Reconciliation of Free Cash Flow

    (in thousands – unaudited)

     

     

    Three Months Ended

    December 31,

     

    Year Ended

    December 31,

     

    2020

     

    2019

     

    2020

     

    2019

    Net cash provided by operating activities

    $

    569

     

     

     

    $

    22,421

     

     

     

    $

    16,396

     

     

     

    $

    80,384

     

     

    Capital expenditures

    (3,785

    )

     

     

    (4,741

    )

     

     

    (12,474

    )

     

     

    (22,061

    )

     

    Free cash flow

    $

    (3,216

    )

     

     

    $

    17,680

     

     

     

    $

    3,922

     

     

     

    $

    58,323

     

     

    Lantheus Holdings, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands – unaudited)

     

     

    December 31,

    2020

     

    December 31,

    2019

    Assets

     

     

     

    Current assets

     

     

     

    Cash and cash equivalents

    $

    79,612

     

     

    $

    92,919

     

    Accounts receivable, net

    54,002

     

     

    43,529

     

    Inventory

    35,744

     

     

    29,180

     

    Other current assets

    9,625

     

     

    7,283

     

    Assets held for sale

    5,242

     

     

     

    Total current assets

    184,225

     

     

    172,911

     

    Property, plant and equipment, net

    120,171

     

     

    116,497

     

    Intangibles, net

    376,012

     

     

    7,336

     

    Goodwill

    58,632

     

     

    15,714

     

    Deferred tax assets, net

    70,147

     

     

    71,834

     

    Other long-term assets

    60,634

     

     

    21,627

     

    Total assets

    $

    869,821

     

     

    $

    405,919

     

    Liabilities and stockholders' equity

     

     

     

    Current liabilities

     

     

     

    Current portion of long-term debt and other borrowings

    $

    20,701

     

     

    $

    10,143

     

    Accounts payable

    16,284

     

     

    18,608

     

    Accrued expenses and other liabilities

    41,726

     

     

    37,360

     

    Liabilities held for sale

    1,793

     

     

     

    Total current liabilities

    80,504

     

     

    66,111

     

    Asset retirement obligations

    14,020

     

     

    12,883

     

    Long-term debt, net and other borrowings

    197,699

     

     

    183,927

     

    Other long-term liabilities

    63,393

     

     

    28,397

     

    Total liabilities

    355,616

     

     

    291,318

     

    Total stockholders' equity

    514,205

     

     

    114,601

     

    Total liabilities and stockholders' equity

    $

    869,821

     

     

    $

    405,919

     

     

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  6. Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced Mary Anne Heino, President and Chief Executive Officer, and Bob Marshall, Chief Financial Officer and Treasurer, will present at the 10th Annual SVB Leerink Global Healthcare Conference at 3:00 p.m. ET on Friday, February 26.

    To access a live webcast of the presentation, please visit the Investors section of the Company's website at www.lantheus.com. A replay of the webcast will be available on the Company's website for 30 days following the live presentation.

    About Lantheus Holdings,

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced Mary Anne Heino, President and Chief Executive Officer, and Bob Marshall, Chief Financial Officer and Treasurer, will present at the 10th Annual SVB Leerink Global Healthcare Conference at 3:00 p.m. ET on Friday, February 26.

    To access a live webcast of the presentation, please visit the Investors section of the Company's website at www.lantheus.com. A replay of the webcast will be available on the Company's website for 30 days following the live presentation.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow™ serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

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  7. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH) today announced that it will host a conference call and webcast at 4:30 p.m. ET on Thursday, February 25, 2021, to discuss its financial and operating results for the fourth quarter and full year of 2020.

    To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1‑678-509-7599 (international callers) and provide passcode 5247866. A live webcast will also be available in the Investors section of the Company's website at www.lantheus.com.

    A replay of the webcast will be available in the Investors section of the Company's website approximately two hours after completion of the call and will be archived for 30 days.

    About Lantheus Holdings, Inc.

    Lantheus…

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH) today announced that it will host a conference call and webcast at 4:30 p.m. ET on Thursday, February 25, 2021, to discuss its financial and operating results for the fourth quarter and full year of 2020.

    To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1‑678-509-7599 (international callers) and provide passcode 5247866. A live webcast will also be available in the Investors section of the Company's website at www.lantheus.com.

    A replay of the webcast will be available in the Investors section of the Company's website approximately two hours after completion of the call and will be archived for 30 days.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow™ serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

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  8. Lantheus Holdings, Inc. (NASDAQ:LNTH) (the "Company"), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, announced today three abstracts featuring its PSMA-targeted pipeline of product candidates have been selected for poster presentations at the upcoming 2021 American Society for Clinical Oncology Genitourinary (ASCO GU) Virtual Meeting, which will be held from February 11-13, 2021. Two of the abstracts relate to PyL™, the Company's PET/CT imaging agent for prostate cancer, and the third abstract relates to 1095, the Company's radiopharmaceutical therapeutic for metastatic…

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (the "Company"), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, announced today three abstracts featuring its PSMA-targeted pipeline of product candidates have been selected for poster presentations at the upcoming 2021 American Society for Clinical Oncology Genitourinary (ASCO GU) Virtual Meeting, which will be held from February 11-13, 2021. Two of the abstracts relate to PyL™, the Company's PET/CT imaging agent for prostate cancer, and the third abstract relates to 1095, the Company's radiopharmaceutical therapeutic for metastatic castration resistant prostate cancer.

    The presentations will be made available for the duration of conference.

    Details for the ASCO GU presentations based on Company-sponsored studies are as follows:

    Date & Time: February 11, 2021, 8:00 AM-6:30 PM ET

    Session Title: Poster Session: Prostate Cancer – Advanced Disease

    Title: A prospective phase II/III study of PSMA-targeted 18F-DCFPyL-PET/CT in patients (pts) with prostate cancer (PCa) (OSPREY): A sub analysis of disease staging changes in PCa pts with recurrence or metastases on conventional imaging.

    Presenter: Jeremy C. Durack, M.D., M.S., Memorial Sloan Kettering Cancer Center

    Abstract No: 32

    Date & Time: February 11, 2021, 8:00 AM-6:30 PM ET

    Session Title: Poster Session: Prostate Cancer – Advanced Disease

    Title: PSMA-targeted imaging with 18F-DCFPyL-PET/CT in patients (pts) with biochemically recurrent prostate cancer (PCa): A phase III study (CONDOR) - A sub analysis of correct localization rate (CLR) and positive predictive value (PPV) by standard of truth.

    Presenter: Frederic Pouliot, M.D., Ph.D., F.R.C.S.C., Centre Hospitalier Universitaire (CHU) de Québec-Université Laval

    Abstract No: 33

    Date & Time: February 11, 2021, 8:00 AM-6:30 PM ET

    Session Title: Trials in Progress Poster Session: Advanced Prostate Cancer

    Title: A multicenter, randomized, controlled phase II study: Efficacy and safety of PSMA-targeted radioligand therapy I-131-1095 (1095) plus enzalutamide (enza) in 18F-DCFPyL PSMA scan avid, metastatic castration-resistant prostate cancer (mCRPC) patients post-abiraterone (abi) progression (ARROW).

    Presenter: Oliver Sartor, M.D., Tulane Cancer Center

    Abstract No: TPS187

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada, and Sweden. For more information, visit www.lantheus.com.

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  9. Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for NM-01, a PD-L1 imaging biomarker, and will begin making the biomarker available to academic centers and pharmaceutical companies for use in immuno-oncology (I/O) clinical trials in 2021.

    NM-01 is a proprietary radiopharmaceutical biomarker using a camelid single-domain antibody and a technetium-99 radioisotope that has demonstrated a high affinity for PD-L1 protein…

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for NM-01, a PD-L1 imaging biomarker, and will begin making the biomarker available to academic centers and pharmaceutical companies for use in immuno-oncology (I/O) clinical trials in 2021.

    NM-01 is a proprietary radiopharmaceutical biomarker using a camelid single-domain antibody and a technetium-99 radioisotope that has demonstrated a high affinity for PD-L1 protein. NM-01 could provide a specific, non-invasive approach to patient assessment, including use in whole-body imaging, or virtual biopsy. NM-01 potentially allows detection of PD-L1 expression in tumors and could be used to evaluate patients before, during, or after treatment with I/O agents, including checkpoint inhibitors, in clinical trials. The market for checkpoint inhibitors is expected to grow from $25B in 2019 to $68B in 2026.1 Lantheus licensed NM-01 from NanoMab Technology Limited in 2019 and plans to provide NM-01 as a clinical research tool, together with support and analytics, to pharmaceutical companies and the largest academic centers conducting clinical research in I/O.

    "Evaluation of patients for I/O therapy is a key challenge for companies developing new therapeutics in this high-growth field," said Etienne Montagut, Senior Vice President of Corporate Development at Lantheus. "With the filing of the DMF, Lantheus is pleased to take an important step forward in providing a novel clinical research tool with the potential to provide new information to optimize the use of I/O therapy."

    NanoMab has completed a Phase 1 study using NM-01 in 30 non-small cell lung cancer (NSCLC) patients, and preliminary data of the first 16 patients were published in the February 22, 2019 issue of Journal of Nuclear Medicine (Xing et al.). Separately, an investigator-led clinical trial involving 30 patients with either NSCLC or melanoma is in progress at King's College London and Guy's and St Thomas' NHS Trust (NCT04436406); the study aims to monitor treatment response. A clinical trial authorization (CTA) was also granted by the Medicines Healthcare Products Regulatory Agency (MHRA) in November 2020 for a Phase 2 clinical study on NM-01 in NSCLC patients.

    "We are very encouraged by the results of the Phase I study, which validated our innovative nanobody platform and demonstrated strong correlation with tissue-based biomarker," said Dr. H.H. Ting, Chief Executive Officer of NanoMab. "We are pleased that leading cancer research centers are progressing with the use of NM-01 in I/O clinical trials."

    About a Drug Master File (DMF)

    A Drug Master File (DMF) is a submission to the Food and Drug Administration that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.2

    About NanoMab Technology Limited

    NanoMab Technology Limited is a privately held biopharmaceutical company focusing on cancer precision therapies via the development of radiopharmaceuticals. The company's goal is to develop a pipeline of theranostics with its proprietary camelid antibody platform to address the unmet medical need for cancer patients across the world. An IMPD on NM-01 was filed with UK Medical Healthcare products Regulatory Agency (MHRA) last year. NanoMab is also developing its radio-labelled NM-02 for clinical trials in both imaging and treatment of breast and gastric cancers. NanoMab's third program, NM-03, a single domain antibody targeting a pan-cancer marker, is in preclinical development as a theranostic. NanoMab is registered in Hong Kong with offices in London and Shanghai (www.nano-mab.com).

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate," "believe," "confident," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) pharmaceutical company and academic center receptivity to NM-01 as a clinical research tool; (ii) the safety and efficacy of NM-01; (iii) regulatory risks related to NM-01; (iv) our dependence upon third parties for the manufacture and supply of NM-01; (v) expectations for future clinical trials, the timing and potential outcomes of clinical studies and filings and other interactions with regulatory authorities; (vi) the impact of legislative, regulatory, competitive and technological changes; and (vii) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

    1GlobalData Consensus Forecasts Accessed 01-11-2021 using the criteria immuno-oncology and targets PD-1, PDL-1 and CTLA-4

    2Drug Master File Guidelines. Accessed at https://www.fda.gov/drugs/guidances-drugs/drug-master-files-guidelines

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  10. PDUFA action date of May 28, 2021 assigned by U.S. Food and Drug Administration

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (the Company), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for PyLTM (18F-DCFPyL), a prostate specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent for prostate cancer.

    The FDA granted Priority Review for the PyL NDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2021. The…

    PDUFA action date of May 28, 2021 assigned by U.S. Food and Drug Administration

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (the Company), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for PyLTM (18F-DCFPyL), a prostate specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent for prostate cancer.

    The FDA granted Priority Review for the PyL NDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2021. The FDA has also indicated in the NDA filing acceptance notification that it is not currently planning to hold an advisory committee meeting to discuss the application.

    "We are pleased that the FDA has accepted our PyL NDA for review and granted our application Priority Review, which is a significant milestone for Lantheus. We believe that there is a significant unmet need for reliable, targeted imaging in prostate cancer, particularly in the high risk and biochemically recurrent populations," said Istvan Molnar, MD, Chief Medical Officer of Lantheus. "We look forward to working with the FDA during the NDA review process with the goal of bringing PyL to patients and physicians who need it."

    The PyL NDA is supported by data from two Company-sponsored pivotal studies (OSPREY and CONDOR) designed to establish the safety and diagnostic performance of PyL imaging across the prostate cancer disease continuum. Results from OSPREY Cohort A demonstrated improvement in specificity and positive predictive value (PPV) of PyL PET imaging over conventional imaging in men with high risk prostate cancer. OSPREY Cohort B and CONDOR studied men with prostate cancer in various disease states, including biochemical recurrent, hormone sensitive, non-metastatic castrate resistant, and metastatic castrate resistant. OSPREY Cohort B demonstrated the sensitivity of PyL PET imaging in detecting metastatic lesions, while CONDOR, in patients with biochemical recurrent prostate cancer and non-informative baseline findings, demonstrated PyL's high correct localization rate and detection rate, including in patients with low PSA values. In the CONDOR study, 63.9% of patients had a change in intended disease management plans due to the PyL PET imaging results. We believe the results from these two studies, taken as a whole, demonstrate the ability of PyL to reliably detect and localize disease and could enable more appropriate patient management.

    PyL has been administered in approximately 3,500 subjects globally, including the two Company-sponsored pivotal studies, multiple investigator sponsored studies, as well as clinical use reported in the literature. Across these studies, PyL has shown an attractive safety profile.

    About PyL™ for PET Imaging of Prostate Cancer

    PyL (also known as 18F-DCFPyL) is an investigational fluorinated PSMA-targeted PET imaging agent that enables visualization of localized prostate cancer as well as bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.

    About OSPREY

    The Phase 2/3 OSPREY trial assessed the diagnostic performance of PyL to detect prostate cancer in pelvic lymph nodes in subjects with high risk, locally advanced prostate cancer (Cohort A) and distant metastases in subjects with metastatic or recurrent prostate cancer (Cohort B). In the trial, the diagnostic performance of PyL in detecting disease in pelvic lymph nodes (Cohort A) showed specificity of 96-99%, sensitivity of 31-42%, and PPV of 78-91% although the trial did not meet one of its the primary endpoints. In the metastatic or recurrent prostate cancer setting (Cohort B), PyL exhibited sensitivity of 93-99% and PPV of 81-88% in detecting metastatic lesions. Overall, PyL demonstrated high diagnostic performance in reliably detecting nodal and distant metastatic prostate cancer.

    About CONDOR

    The Phase 3 CONDOR trial evaluated the diagnostic performance and clinical impact of PyL in men with biochemical recurrence of prostate cancer and uninformative baseline imaging based on conventional modalities. The CONDOR trial achieved its primary endpoint, with a correct localization rate (CLR) of 84.8% to 87.0% among the three blinded independent readers (the lower bound of the 95% confidence intervals ranging from 77.8% to 80.4%). CLR is based on positive predictive value, defined as the percentage of subjects with a one-to-one correspondence between localization of at least one lesion identified on PyL PET/CT and a composite truth standard comprised of histopathology, conventional imaging and/or changes in PSA levels following radiation therapy. 63.9% of subjects in the CONDOR trial had a change in intended disease management plans due to PyL imaging results, a key secondary endpoint of the trial. The changes to treatment management plans due to the PyL results included salvage local therapy to systemic therapy, observation to initiating therapy, noncurative systemic therapy to salvage local therapy, and planned treatment to observation.

    About Prostate Cancer

    Prostate cancer is the second most common form of cancer affecting men in the United States -- an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year 192,000 new cases of prostate cancer will be diagnosed, and 33,000 men will die of the disease. Approximately 3.2 million men in the United States currently count themselves among prostate cancer survivors.1

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate," "believe," "confident," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and other regulatory authorities for PyL; (ii) the Company's ability to successfully launch PyL as a commercial product; (iii) the market receptivity to PyL as a new diagnostic agent; (iv) the safety and efficacy of PyL; (v) the intellectual property protection of PyL; and (vi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

    1National Cancer Institute. SEER Cancer Stat Facts: Prostate Cancer. Accessed at https://seer.cancer.gov/statfacts/html/prost.html on March 15, 2019.

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  11. Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today announced it has entered into a strategic collaboration with POINT Biopharma, Inc. (POINT) to use Lantheus' investigational prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent, PyL, to determine PSMA-avidity during patient selection in POINT's Phase 3 clinical trial to treat metastatic castration resistant prostate cancer (mCRPC). The collaboration directly aligns with an important Lantheus strategy to advance cancer precision medicine…

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today announced it has entered into a strategic collaboration with POINT Biopharma, Inc. (POINT) to use Lantheus' investigational prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent, PyL, to determine PSMA-avidity during patient selection in POINT's Phase 3 clinical trial to treat metastatic castration resistant prostate cancer (mCRPC). The collaboration directly aligns with an important Lantheus strategy to advance cancer precision medicine by enabling partners to use PyL in prostate cancer therapeutic trials.

    As part of the agreement with POINT, Lantheus' subsidiary, Progenics Pharmaceuticals, Inc., will supply PyL at a predetermined supply price.

    "While there have been great advances in the treatment of prostate cancer, there remains an important unmet medical need for therapies that can more specifically target metastatic prostate cancer," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "The inclusion of PyL in POINT's Phase 3 trial reinforces our belief in the potential utility of PyL, not just in assessing metastatic disease, but also in selecting the most appropriate patients for PSMA-targeted therapy."

    POINT will conduct a Phase 3, multicenter, open-label, randomized clinical trial to evaluate the efficacy and safety of their novel PSMA-targeted radioligand, 177Lu-PNT2002, in patients with mCRPC. PyL will be used to select patients with PSMA-avid tumors for treatment with 177Lu-PNT2002, and in a subset of patients also be used to evaluate progression.

    "The combination of diagnostic imaging and radioligand therapy is a validated approach and an important development in cancer treatment," said Joe McCann, Chief Executive Officer of POINT. "POINT is very excited to be enrolling our study using PyL. We believe this promising biomarker will help identify the patients with prostate cancer who will best respond to PNT 2002, our next generation radioligand therapy."

    About PSMA

    PSMA is a protein that has been found to be amplified on the surface of greater than 95% of prostate cancer cells and is a validated target for the detection of primary and metastatic prostate cancer.1

    About PyL for PET Imaging of Prostate Cancer

    PyL (also known as 18F-DCFPyL) is an investigational fluorinated PSMA-targeted PET imaging agent that enables visualization of localized prostate cancer as well as bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. On September 29, 2020, Lantheus filed with the U.S. Food and Drug Administration a New Drug Application for PyL.

    About Prostate Cancer

    Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 192,000 new cases of prostate cancer will be diagnosed, and 33,000 men will die of the disease. Approximately 3.2 million men in the U.S. currently count themselves among prostate cancer survivors.3

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc. and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

    About POINT Biopharma, Inc.

    POINT Biopharma is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT is combining a portfolio of best in class radiopharmaceutical assets, a seasoned management team, strategic partnerships in radio-isotope supply, manufacturing technology and novel direct to patient targeting to revolutionize theragnostic drug development and radioligand commercialization. For more information about radioligands, visit https://www.radioligands.org. For more information about POINT, visit https://www.pointbiopharma.com.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "believe," "can," "estimate," "expect," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) regulatory risks related to PyL; (ii) expectations for POINT's clinical trial and future clinical trials, the timing and potential outcomes of clinical studies and filings and other interactions with regulatory authorities; (iii) the impact of legislative, regulatory, competitive and technological changes; (iv) the safety and efficacy of PyL; (v) the intellectual property protection of PyL; and (vi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

    1Wright, et al. Expression of Prostate-Specific Membrane Antigen in Normal, Benign, and Malignant Prostate Tissue. Urol Oncol 1995;1:18028.

    2S Hammer, et. al. Preclinical Efficacy of PSMA-Targeted Thorium-227 Conjugate (PSMA-TTC), a Targeted Alpha Therapy for Prostate Cancer. Clin Cancer Res 2020; Published Online First December 12, 2019.

    3National Cancer Institute. SEER Cancer Stat Facts: Prostate Cancer. Accessed at https://seer.cancer.gov/statfacts/html/prost.html on March 15, 2019.

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  12. Transaction Extends Relationship with Strategic Partner

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (the Company), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced its entry into a stock purchase agreement to sell its Puerto Rico radiopharmacy and positron emission tomography (PET) manufacturing facility (PMF) to PharmaLogic Holdings Corp. (PharmaLogic). As part of the transaction, Lantheus and PharmaLogic will also enter into a long-term supply agreement under which Lantheus will continue to supply PharmaLogic with Lantheus' products and PharmaLogic will…

    Transaction Extends Relationship with Strategic Partner

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (the Company), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced its entry into a stock purchase agreement to sell its Puerto Rico radiopharmacy and positron emission tomography (PET) manufacturing facility (PMF) to PharmaLogic Holdings Corp. (PharmaLogic). As part of the transaction, Lantheus and PharmaLogic will also enter into a long-term supply agreement under which Lantheus will continue to supply PharmaLogic with Lantheus' products and PharmaLogic will commit to purchase certain products. The transaction is subject to customary closing conditions and is expected to close early in the first quarter of 2021.

    The transaction includes both the Lantheus radiopharmacy and PMF businesses located in San Juan, Puerto Rico. The radiopharmacy prepares individual, patient-ready doses of radiopharmaceuticals, and the PMF manufactures the drug product for individual, patient-ready doses of fluorodeoxygluocose (FDG). The long-term supply agreement provides that Lantheus' nuclear medicine products currently sold through the radiopharmacy will continue to be available in Puerto Rico.

    "This transaction extends our strategic relationship with PharmaLogic, the fundamental business of which is dedicated to nuclear medicine and radiopharmaceutical production, simplifies our distribution model in Puerto Rico, and allows us to use the proceeds from the transaction to invest in our core businesses and product pipeline," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "We look forward to working closely with PharmaLogic to close the transaction and execute a smooth transition for customers, patients, suppliers and employees."

    "This transaction will further expand PharmaLogic's geographical presence in North America," said Steve Chilinski, Chief Executive Officer of PharmaLogic. "We are proud to be a customer-centric company committed to providing leading innovations and solutions to North American practitioners, and we are thrilled to partner with Lantheus to continue to provide their robust nuclear medicine portfolio to customers and patients in Puerto Rico."

    The purchase price for the transaction is $18 million in cash, subject to working capital and other customary adjustments. Proceeds from this transaction are intended to be used in the Company's core businesses and product pipeline.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

    About PharmaLogic

    PharmaLogic Holdings Corp is a leading radiopharmacy group with over 40 facilities across North America. In addition to managing PET cyclotron facilities and SPECT nuclear pharmacies distributing diagnostic agents and therapeutics to hospitals and clinics, PharmaLogic provides mobile PET imaging services, as well as supporting the translation of new radiopharmaceuticals from early stage clinical trials through commercialization. For more information, visit www.radiopharmacy.com.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "expect," "intend," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) conditions to the closing of the sale agreement may not be satisfied; (ii) the transaction may involve unexpected costs, liabilities or delays; (iii) the ability to secure, and the time and process of securing, regulatory approvals and other interactions with regulatory authorities for the transaction; (iv) the anticipated benefits of the transaction and use of proceeds from the transaction may not be fully realized or may take longer to realize than expected; (v) the impact of the COVID-19 pandemic on our business, financial condition and prospects; and (vi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

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  13. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced Bob Marshall, Chief Financial Officer and Treasurer, will present at the 2020 Evercore ISI HealthCONx Conference at 3:30 p.m. ET on Tuesday, December 1.

    To access a live webcast of the presentation, please visit the Investors section of the Company's website at www.lantheus.com. A replay of the webcast will be available on the Company's website for 30 days following the live presentation.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is…

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced Bob Marshall, Chief Financial Officer and Treasurer, will present at the 2020 Evercore ISI HealthCONx Conference at 3:30 p.m. ET on Tuesday, December 1.

    To access a live webcast of the presentation, please visit the Investors section of the Company's website at www.lantheus.com. A replay of the webcast will be available on the Company's website for 30 days following the live presentation.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

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  14. Commercially Available in Early 2021

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for DEFINITY® Room Temperature(DEFINITY RT) (Perflutren Lipid Microsphere) Injectable Suspension.

    "With the approval of DEFINITY RT, we expand our microbubble franchise offering to include a room temperature formulation, in addition to our market leading, refrigerated DEFINITY that our customers and patients have…

    Commercially Available in Early 2021

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for DEFINITY® Room Temperature (DEFINITY RT) (Perflutren Lipid Microsphere) Injectable Suspension.

    "With the approval of DEFINITY RT, we expand our microbubble franchise offering to include a room temperature formulation, in addition to our market leading, refrigerated DEFINITY that our customers and patients have trusted to enhance suboptimal echocardiograms for 19 years. This approval will enable those customers who prefer a non-refrigerated product to be able to continue to benefit from our DEFINITY microbubble products," said Paul Blanchfield, Chief Commercial Officer.

    Mary Anne Heino, President and Chief Executive Officer, added, "We continue to expand the offerings in our microbubble franchise. The addition of DEFINITY RT recognizes the increasing need for portability in delivery of healthcare services, as well as our commitment to partnering with innovators developing complex product formulations which include a microbubble. I am thankful to the entire Lantheus team who worked diligently to bring this new formulation to the market."

    DEFINITY RT is a modified formulation of DEFINITY that allows both storage and shipment at room temperature (DEFINITY's previously approved formulation requires refrigerated storage). The activation of DEFINITY RT will be achieved using the VIALMIX® RFID device, which was approved in August 2020. This modified formulation provides clinicians an additional choice and allows for greater utility of this formulation in broader clinical settings.

    The composition of matter U.S. issued patent for DEFINITY RT has an expiration date of 2035 and will be listed in the Orange Book.

    About DEFINITY® and DEFINITY® RT

    DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension and DEFINITY RT (Perflutren Lipid Microsphere) Injectable Suspension (activated) are ultrasound enhancing agents for use in patients with suboptimal echocardiograms (see Indications and Important Safety Information below and find full Prescribing Information at www.definityimaging.com).1,2 DEFINITY and DEFINITY RT are engineered to produce small and consistently sized durable microbubbles to fully evaluate the left ventricle.1,2 DEFINITY has extensive safety experience and a consistent safety profile.3 Since its launch in 2001, more than 14 million echo studies have been performed with DEFINITY, and it is the most prescribed ultrasound enhancing agent in the U.S.4

    DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension

    DEFINITY® RT (Perflutren Lipid Microsphere) Injectable Suspension

    INDICATIONS

    Activated DEFINITY® and activated DEFINITY® RT (Perflutren Lipid Microsphere) Injectable Suspension are indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

    CONTRAINDICATIONS

    Do not administer DEFINITY® and DEFINITY® RT to patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components.

    IMPORTANT SAFETY INFORMATION

    WARNING: Serious Cardiopulmonary Reactions

     

    Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration.

     

    • Assess all patients for the presence of any condition that precludes DEFINITY® and DEFINITY® RT administration [see Contraindications (4)].
    • Always have resuscitation equipment and trained personnel readily available.

    In post-marketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reported during or shortly following perflutren-containing microsphere administration [see Adverse Reactions (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [see Adverse Reactions (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.

    Please see accompanying full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions, on www.definityimaging.com.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate," "believe," "confident," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) our future operating results; (ii) the impact of the COVID-19 pandemic on our business, financial condition and prospects; (iii) the Company's ability to successfully launch DEFINITY RT as a commercial product and the timing of the launch; (iv) the intellectual property protection of DEFINITY RT; (v) expectations for future clinical trials, the timing and potential outcomes of clinical studies and filings and other interactions with regulatory authorities; and (vi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

    1 DEFINITY® (Package Insert), North Billerica, MA, Lantheus Medical Imaging, Inc.

    2 DEFINITY® RT (Package Insert), North Billerica, MA, Lantheus Medical Imaging, Inc.

    3 Data on file, Lantheus Medical Imaging, Inc.

    4 ©2020 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited.

    Reprinted with permission.

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  15. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the use of Lantheus' artificial intelligence enabled automated bone scan index (aBSI) product on GE Healthcare's Xeleris platform.

    "Lantheus is delighted by the U.S. approval of our digital AI solution for prostate cancer, aBSI, on GE Healthcare's platform. As a leading multinational medical technology company with deep experience in medical imaging and diagnostics…

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the use of Lantheus' artificial intelligence enabled automated bone scan index (aBSI) product on GE Healthcare's Xeleris platform.

    "Lantheus is delighted by the U.S. approval of our digital AI solution for prostate cancer, aBSI, on GE Healthcare's platform. As a leading multinational medical technology company with deep experience in medical imaging and diagnostics, GE Healthcare presents the ideal attributes to provide global access to this unique digital solution," said Etienne Montagut, Sr. Vice President of Corporate Development. "aBSI has demonstrated clinical value in quantifying and managing disease progression in advanced prostate cancer patients with the potential to support critical clinical decisions. Lantheus will continue to develop AI solutions to augment and expand the utility of imaging diagnostics for precision medicine in oncology," Mr. Montagut added.

    In October 2019, the Company entered into a global software licensing agreement with GE Healthcare for the rights to aBSI, a vendor neutral stand-alone platform that is enabled with artificial intelligence, which has been trained to automate the detection of hotspots in bone indicative of metastatic disease and calculate the aBSI. The platform offers a fast and reliable alternative to manual interpretation of bone scan images of metastatic prostate cancer. Recent investigations have demonstrated the clinical utility of aBSI as a prognostic and a response imaging biomarker in patients with metastatic prostate cancer.1,2

    "The pandemic has proven that data, analytics, AI and connectivity will only become more central to delivering care," said Erez Levy, General Manager, Nuclear Medicine, GE Healthcare. "For GE Healthcare, that means continuing to advance intelligent and innovative technologies, like aBSI, and deliver precision health to promote better patient outcomes around the world."

    Under the terms of the non-exclusive agreement, GE Healthcare acquired from Lantheus the software license for aBSI for integration into GE Healthcare's Xeleris platform, excluding the use of aBSI in Japan. Under the agreement with GE Healthcare, Lantheus will receive tiered licensing fees per license sold.

    About aBSI

    The aBSI product is vendor neutral stand-alone software as a medical device which calculates the automated bone scan index in Technetium-99m bone scintigraphy. aBSI received FDA clearance in 2019 (K191262). The product is enabled with a neural network that has been trained to automate the detection of hotspots and calculate the aBSI value.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

    About GE Healthcare

    GE Healthcare is the $16.7 billion healthcare business of GE (NYSE:GE). As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate," "believe," "confident," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the market receptivity to aBSI and to GEHC's XELERIS platform; (ii) the intellectual property protection of aBSI; and (iii) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

    _________________

    1 Armstrong AJ, Anand A, Edenbrandt L,et al. Phase 3 Assessment of the Automated Bone Scan Index as a Prognostic Imaging Biomarker of Overall Survival in Men With Metastatic Castration-Resistant Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):944-951.

    2 Ali A, Hoyle AP, Parker CC, et al. The Automated Bone Scan Index as a Predictor of Response to Prostate Radiotherapy in Men with Newly Diagnosed Metastatic Prostate Cancer: An Exploratory Analysis of STAMPEDE's "M1|RT Comparison". European Urology. 2020 Aug; 3(4): 412-419

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  16. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced that management will present at two investor conferences in November.

    • Credit Suisse 29th Annual Virtual Healthcare Conference
      • Date: Wednesday, November 11, 2020
      • Time: 9:30am Eastern Time
      • Participants: Mary Anne Heino, President and Chief Executive Officer and Bob Marshall, Chief Financial Officer and Treasurer
    • Jefferies Virtual London Healthcare Conference
      • Date: Tuesday, November 17, 2020
      • Time: 7:20am Eastern Time

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced that management will present at two investor conferences in November.

    • Credit Suisse 29th Annual Virtual Healthcare Conference
      • Date: Wednesday, November 11, 2020
      • Time: 9:30am Eastern Time
      • Participants: Mary Anne Heino, President and Chief Executive Officer and Bob Marshall, Chief Financial Officer and Treasurer
    • Jefferies Virtual London Healthcare Conference
      • Date: Tuesday, November 17, 2020
      • Time: 7:20am Eastern Time
      • Participant: Bob Marshall, Chief Financial Officer and Treasurer

    To access a live webcast of the presentation, please visit the Investors section of the Company's website at www.lantheus.com. A replay of the webcast will be available on the Company's website for 30 days following the live presentation.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

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    • Worldwide revenue of $88.5 million for the third quarter 2020, representing an increase of 3.2% from the prior year period
    • Net loss of $6.4 million for the third quarter 2020, compared to net income of $4.9 million in the prior year period
    • GAAP diluted EPS of $(0.10) for the third quarter 2020, compared to GAAP diluted EPS of $0.12 in the prior year period; adjusted diluted EPS of $0.04 for the third quarter 2020, compared to adjusted diluted EPS of $0.28 in the prior year period
    • Net cash provided by operating activities was $8.6 million for the third quarter 2020. Free cash flow was $4.8 million in the third quarter 2020

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and…

    • Worldwide revenue of $88.5 million for the third quarter 2020, representing an increase of 3.2% from the prior year period
    • Net loss of $6.4 million for the third quarter 2020, compared to net income of $4.9 million in the prior year period
    • GAAP diluted EPS of $(0.10) for the third quarter 2020, compared to GAAP diluted EPS of $0.12 in the prior year period; adjusted diluted EPS of $0.04 for the third quarter 2020, compared to adjusted diluted EPS of $0.28 in the prior year period
    • Net cash provided by operating activities was $8.6 million for the third quarter 2020. Free cash flow was $4.8 million in the third quarter 2020

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today reported financial results for its third quarter ended September 30, 2020.

    The Company's worldwide revenue for the third quarter of 2020 totaled $88.5 million, compared with $85.8 million for the third quarter of 2019, representing an increase of 3.2% from the prior year period.

    The Company's third quarter 2020 net loss was $6.4 million, or $(0.10) per fully diluted share, as compared to net income of $4.9 million, or $0.12 per fully diluted share for the third quarter of 2019.

    The Company's third quarter 2020 adjusted fully diluted earnings per share were $0.04, as compared to $0.28 for the third quarter of 2019, representing a decrease of 87.1% from the prior year period.

    Lastly, net cash provided by operating activities was $8.6 million for the third quarter 2020. Free Cash Flow was $4.8 million in the third quarter of 2020, representing a decrease of approximately $18.3 million from the prior year period.

    "We continued to see steady recovery throughout the quarter primarily driven by DEFINITY and complemented by accelerated synergy capture, delivering a strong adjusted EPS performance," said Mary Anne Heino, President and CEO. "Importantly, despite increased investment during the quarter related to our newly-combined business and our on-going integration efforts, we generated positive free cash flow. We remain committed to executing on our corporate initiatives even during these unprecedented times. In our first quarter as an integrated company, we received approval for VIALMIXRFID and submitted the NDA for our PSMA-targeted PET imaging agent, PyL. We believe these accomplishments and our continued financial discipline position us to drive sustainable future growth and enhanced shareholder value."

    Outlook

    On April 9, 2020, the Company withdrew full year 2020 revenue, revenue growth, and adjusted fully diluted earnings per share guidance as a result of the continued uncertainties surrounding the scope, duration and impacts of the COVID-19 pandemic. Due to these uncertainties, and uncertain timing of global recovery and economic normalization, the Company continues to be unable to provide guidance as to the overall impacts on its operations and financial results during the ongoing pandemic.

    Internet Posting of Information

    The Company routinely posts information that may be important to investors in the "Investors" section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company.

    Conference Call and Webcast

    As previously announced, the Company will host a conference call and webcast on Thursday, November 5, 2020 at 8:00 a.m. ET. To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1-678-509-7599 (international callers) and provide passcode 8872902. A live webcast will be available in the Investors section of the Company's website at www.lantheus.com.

    A replay of the audio webcast will be available in the Investors section of our website at www.lantheus.com approximately two hours after completion of the call and will be archived for 30 days.

    The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.

    The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

    Non-GAAP Financial Measures

    The Company uses non-GAAP financial measures, such as adjusted net income and its line components; adjusted net income per share - fully diluted; and free cash flow. The Company's management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the Company's operations, period over period. However, these measures may exclude items that may be highly variable, difficult to predict and of a size that could have a substantial impact on the Company's reported results of operations for a particular period. Management uses these and other non-GAAP measures internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate," "believe," "confident," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include : (i) the impact of the global COVID-19 pandemic on our business, financial conditions or prospects, or on the timing and enrollment of our clinical trials; (ii) continued market expansion and penetration for our commercial products, particularly DEFINITY®, in the face of segment competition and potential generic competition as a result of patent and regulatory exclusivity expirations; (iii) the global Molybdenum-99 supply; (iv) our products manufactured at Jubilant HollisterStier and our plans to develop a modified formulation of DEFINITY with Samsung Biologics; (v) our efforts in new product development, including for PyL, the Progenics prostate cancer diagnostic imaging agent, including our ability to obtain FDA approval of PyL in 2021, and new clinical applications for our products; (vi) our dependence upon third parties for the manufacture and supply of PyL and the timing of that manufacturing capacity becoming available; (vii) the continued integration of the Progenics product and product candidate portfolio following the consummation of the Progenics transaction; (viii) our capacity to use in-house manufacturing; and (ix) our ability to commercialize our products in new ex-U.S. markets; (x) the expected timing for commercialization of products we or our strategic partners may develop, including flurpiridaz F 18; (xi) our ability to develop highly contextualized assessments of disease burden using PSMA AI and (xii) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

    - Tables Follow -

     

    Lantheus Holdings, Inc.

    Consolidated Statements of Operations

    (in thousands, except per share data – unaudited)

     

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Revenues

     

    $

    88,544

     

     

    $

    85,776

     

     

    $

    245,258

     

     

    $

    257,991

     

    Cost of goods sold

     

    52,284

     

     

    44,187

     

     

    145,148

     

     

    127,745

     

    Gross profit

     

    36,260

     

     

    41,589

     

     

    100,110

     

     

    130,246

     

    Operating expenses

     

     

     

     

     

     

     

     

    Sales and marketing

     

    11,609

     

     

    10,151

     

     

    28,044

     

     

    31,496

     

    General and administrative

     

    18,217

     

     

    18,061

     

     

    55,586

     

     

    43,943

     

    Research and development

     

    11,684

     

     

    4,860

     

     

    20,150

     

     

    15,584

     

    Total operating expenses

     

    41,510

     

     

    33,072

     

     

    103,780

     

     

    91,023

     

    Operating (loss) income

     

    (5,250)

     

     

    8,517

     

     

    (3,670)

     

     

    39,223

     

    Interest expense

     

    2,808

     

     

    2,356

     

     

    6,668

     

     

    11,491

     

    Loss on extinguishment of debt

     

     

     

     

     

     

     

    3,196

     

    Other (income) loss

     

    (596)

     

     

    804

     

     

    (1,702)

     

     

    (1,695)

     

    (Loss) income before income taxes

     

    $

    (7,462)

     

     

    $

    5,357

     

     

    $

    (8,636)

     

     

    $

    26,231

     

    Income tax (benefit) expense

     

    (1,076)

     

     

    501

     

     

    1,425

     

     

    5,014

     

    Net (loss) income

     

    $

    (6,386)

     

     

    $

    4,856

     

     

    $

    (10,061)

     

     

    $

    21,217

     

    Net (loss) income per common share:

     

     

     

     

     

     

     

     

    Basic

     

    $

    (0.10)

     

     

    $

    0.12

     

     

    $

    (0.20)

     

     

    $

    0.55

     

    Diluted

     

    $

    (0.10)

     

     

    $

    0.12

     

     

    $

    (0.20)

     

     

    $

    0.53

     

    Weighted-average common shares outstanding:

     

     

     

     

     

     

     

     

    Basic

     

    66,820

     

     

    39,123

     

     

    49,858

     

     

    38,901

     

    Diluted

     

    66,820

     

     

    40,286

     

     

    49,858

     

     

    40,123

     

     

    Lantheus Holdings, Inc.

    Consolidated Segment Revenues Analysis

    (in thousands – unaudited)

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

    2020

     

    2019

     

    % Change

     

    2020

     

    2019

     

    % Change

    United States

     

     

     

     

     

     

     

     

     

     

     

    DEFINITY

    $

    53,792

     

     

    $

    50,917

     

     

    5.6

    %

     

    $

    148,346

     

     

    $

    154,099

     

     

    (3.7)

    %

    TechneLite

    17,652

     

     

    18,281

     

     

    (3.4)

    %

     

    52,599

     

     

    55,204

     

     

    (4.7)

    %

    Other nuclear

    11,571

     

     

    9,355

     

     

    23.7

    %

     

    26,437

     

     

    28,006

     

     

    (5.6)

    %

    Rebates and allowances

    (5,540)

     

     

    (3,903)

     

     

    41.9

    %

     

    (13,763)

     

     

    (12,035)

     

     

    14.4

    %

    Total United States

    77,475

     

     

    74,650

     

     

    3.8

    %

     

    213,619

     

     

    225,274

     

     

    (5.2)

    %

    International

     

     

     

     

     

     

     

     

     

     

     

    DEFINITY

    1,637

     

     

    1,478

     

     

    10.8

    %

     

    4,239

     

     

    4,036

     

     

    5.0

    %

    TechneLite

    3,837

     

     

    3,466

     

     

    10.7

    %

     

    10,897

     

     

    10,794

     

     

    1.0

    %

    Other nuclear

    5,596

     

     

    6,186

     

     

    (9.5)

    %

     

    16,507

     

     

    17,901

     

     

    (7.8)

    %

    Rebates and allowances

    (1)

     

     

    (4)

     

     

    (75.0)

    %

     

    (4)

     

     

    (14)

     

     

    (71.4)

    %

    Total International

    11,069

     

     

    11,126

     

     

    (0.5)

    %

     

    31,639

     

     

    32,717

     

     

    (3.3)

    %

    Worldwide

     

     

     

     

     

     

     

     

     

     

     

    DEFINITY

    55,429

     

     

    52,395

     

     

    5.8

    %

     

    152,585

     

     

    158,135

     

     

    (3.5)

    %

    TechneLite

    21,489

     

     

    21,747

     

     

    (1.2)

    %

     

    63,496

     

     

    65,998

     

     

    (3.8)

    %

    Other nuclear

    17,167

     

     

    15,541

     

     

    10.5

    %

     

    42,944

     

     

    45,907

     

     

    (6.5)

    %

    Rebates and allowances

    (5,541)

     

     

    (3,907)

     

     

    41.8

    %

     

    (13,767)

     

     

    (12,049)

     

     

    14.3

    %

    Total Revenues

    $

    88,544

     

     

    $

    85,776

     

     

    3.2

    %

     

    $

    245,258

     

     

    $

    257,991

     

     

    (4.9)

    %

     

    Lantheus Holdings, Inc.

    Reconciliation of GAAP to Non-GAAP Financial Measures

    (in thousands, except per share data – unaudited)

     

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Net (loss) income

     

    $

    (6,386)

     

     

    $

    4,856

     

     

    $

    (10,061)

     

     

    $

    21,217

     

    Stock and incentive plan compensation

     

    3,992

     

     

    3,423

     

     

    10,452

     

     

    9,580

     

    Amortization of acquired intangible assets

     

    4,768

     

     

    451

     

     

    6,087

     

     

    1,353

     

    Acquired debt fair value adjustment

     

    (385)

     

     

     

     

    (385)

     

     

     

    Contingent consideration fair value adjustments

     

    800

     

     

     

     

    800

     

     

     

    Non-recurring refinancing related fees

     

     

     

     

     

    460

     

     

     

    Extinguishment of debt

     

     

     

     

     

     

     

    3,196

     

    Strategic collaboration and license costs

     

     

     

     

     

     

     

    300

     

    Integration costs

     

    855

     

     

     

     

    4,428

     

     

     

    Acquisition-related costs

     

    1,593

     

     

    5,176

     

     

    10,522

     

     

    5,176

     

    Impairment of long-lived assets

     

     

     

     

     

    7,275

     

     

     

    Other

     

     

     

     

     

    (75)

     

     

     

    Income tax effect of non-GAAP adjustments(a)

     

    (2,819)

     

     

    (2,653)

     

     

    (8,265)

     

     

    (7,449)

     

    Adjusted net income

     

    $

    2,418

     

     

    $

    11,253

     

     

    $

    21,238

     

     

    $

    33,373

     

    Adjusted net income, as a percentage of revenues

     

    2.7

    %

     

    13.1

    %

     

    8.7

    %

     

    12.9

    %

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Net (loss) income per share - diluted

     

    $

    (0.10)

     

     

    $

    0.12

     

     

    $

    (0.20)

     

     

    $

    0.53

     

    Stock and incentive plan compensation

     

    0.06

     

     

    0.08

     

     

    0.21

     

     

    0.24

     

    Amortization of acquired intangible assets

     

    0.08

     

     

    0.01

     

     

    0.12

     

     

    0.03

     

    Acquired debt fair value adjustment

     

    (0.01)

     

     

     

     

    (0.01)

     

     

     

    Contingent consideration fair value adjustments

     

    0.01

     

     

     

     

    0.01

     

     

     

    Non-recurring refinancing related fees

     

     

     

     

     

    0.01

     

     

     

    Extinguishment of debt

     

     

     

     

     

     

     

    0.08

     

    Strategic collaboration and license costs

     

     

     

     

     

     

     

    0.01

     

    Integration costs

     

    0.01

     

     

     

     

    0.09

     

     

     

    Acquisition-related costs

     

    0.02

     

     

    0.13

     

     

    0.21

     

     

    0.12

     

    Impairment of long-lived assets

     

     

     

     

     

    0.14

     

     

     

    Income tax effect of non-GAAP adjustments(a)

     

    (0.03)

     

     

    (0.06)

     

     

    (0.16)

     

     

    (0.18)

     

    Adjusted net income per share - diluted

     

    $

    0.04

     

     

    $

    0.28

     

     

    $

    0.42

     

     

    $

    0.83

     

    Weighted-average common shares outstanding - diluted(b)

     

    67,006

     

     

    40,286

     

     

    50,210

     

     

    40,123

     

    1. The income tax effect of the adjustments between GAAP net (loss) income and non-GAAP adjusted net income takes into account the tax treatment and related tax rate that apply to each adjustment in the applicable tax jurisdiction.
    2. Diluted shares may differ for non-GAAP measures as compared to GAAP due to a GAAP net loss position.
     

    Lantheus Holdings, Inc.

    Reconciliation of Free Cash Flow

    (in thousands – unaudited)

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

    2020

     

    2019

     

    2020

     

    2019

    Net cash provided by operating activities

    $

    8,575

     

     

    $

    26,442

     

     

    $

    15,827

     

     

    $

    57,963

     

    Capital expenditures

    (3,736)

     

     

    (3,336)

     

     

    (8,689)

     

     

    (17,320)

     

    Free cash flow

    $

    4,839

     

     

    $

    23,106

     

     

    $

    7,138

     

     

    $

    40,643

     

     

    Lantheus Holdings, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands – unaudited)

     

     

    September 30,

    2020

     

    December 31,

    2019

    Assets

     

     

     

    Current assets

     

     

     

    Cash and cash equivalents

    $

    87,994

     

     

    $

    92,919

     

    Accounts receivable, net

    49,206

     

     

    43,529

     

    Inventory

    37,623

     

     

    29,180

     

    Other current assets

    9,709

     

     

    7,283

     

    Total current assets

    184,532

     

     

    172,911

     

    Property, plant and equipment, net

    122,381

     

     

    116,497

     

    Intangibles, net

    384,747

     

     

    7,336

     

    Goodwill

    57,765

     

     

    15,714

     

    Deferred tax assets, net

    69,345

     

     

    71,834

     

    Other long-term assets

    60,824

     

     

    21,627

     

    Total assets

    $

    879,594

     

     

    $

    405,919

     

    Liabilities and stockholders' equity

     

     

     

    Current liabilities

     

     

     

    Current portion of long-term debt and other borrowings

    $

    18,138

     

     

    $

    10,143

     

    Accounts payable

    24,070

     

     

    18,608

     

    Accrued expenses and other liabilities

    39,792

     

     

    37,360

     

    Total current liabilities

    82,000

     

     

    66,111

     

    Asset retirement obligations

    13,962

     

     

    12,883

     

    Long-term debt, net and other borrowings

    204,669

     

     

    183,927

     

    Other long-term liabilities

    65,384

     

     

    28,397

     

    Total liabilities

    366,015

     

     

    291,318

     

    Total stockholders' equity

    513,579

     

     

    114,601

     

    Total liabilities and stockholders' equity

    $

    879,594

     

     

    $

    405,919

     

     

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  17. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced that management will present at two investor conferences in November.

    • Credit Suisse 29th Annual Virtual Healthcare Conference
      • Date: Wednesday, November 11, 2020
      • Time: 9:30am Eastern Time
      • Participants: Mary Anne Heino, President and Chief Executive Officer and Bob Marshall, Chief Financial Officer and Treasurer
    • Jefferies Virtual London Healthcare Conference
      • Date: Tuesday, November 17, 2020
      • Time: 8:20am Eastern Time

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced that management will present at two investor conferences in November.

    • Credit Suisse 29th Annual Virtual Healthcare Conference
      • Date: Wednesday, November 11, 2020
      • Time: 9:30am Eastern Time
      • Participants: Mary Anne Heino, President and Chief Executive Officer and Bob Marshall, Chief Financial Officer and Treasurer
    • Jefferies Virtual London Healthcare Conference
      • Date: Tuesday, November 17, 2020
      • Time: 8:20am Eastern Time
      • Participant: Bob Marshall, Chief Financial Officer and Treasurer

    To access a live webcast of the presentation, please visit the Investors section of the Company's website at www.lantheus.com. A replay of the webcast will be available on the Company's website for 30 days following the live presentation.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

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  18. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today announced a strategic collaboration with Insightec Ltd., a global healthcare company focused on the therapeutic power of acoustic energy. Under the agreement, Lantheus' microbubbles will be used in combination with Insightec's investigational MR-guided Focused Ultrasound (MRgFUS) platform to evaluate treatment of glioblastoma and neurodegenerative conditions. The collaboration directly aligns with key Lantheus growth strategies of pursuing new applications for its microbubble franchise and expansion into…

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today announced a strategic collaboration with Insightec Ltd., a global healthcare company focused on the therapeutic power of acoustic energy. Under the agreement, Lantheus' microbubbles will be used in combination with Insightec's investigational MR-guided Focused Ultrasound (MRgFUS) platform to evaluate treatment of glioblastoma and neurodegenerative conditions. The collaboration directly aligns with key Lantheus growth strategies of pursuing new applications for its microbubble franchise and expansion into oncology.

    Under the terms of the agreement, Lantheus' microbubbles will be used together with Insightec's MRgFUS platform designed to deliver ultrasound energy deep in the brain with no incisions. The microbubbles, combined with the application of focused ultrasound, are being investigated in the temporary disruption of the blood brain barrier to potentially allow for more effective delivery of chemotherapeutic agents in the treatment of glioblastoma patients. Glioblastoma is the most aggressive malignant primary brain tumor affecting 3.19 Americans per one hundred thousand and has a less than 5% five-year survival rate.1

    Lantheus will supply its microbubbles and activation devices while Insightec will be responsible for future regulatory submissions and commercialization. The deal terms include a transfer price and royalties.

    "We are thrilled to partner with Insightec to further expand our microbubble franchise within oncology and potentially neurodegenerative conditions," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "Our collaboration with Insightec could help change the paradigm in glioblastoma, an aggressive cancer for which patients and clinicians unfortunately have few options, and where the unmet medical need is truly significant."

    "Focused ultrasound has strong potential to transform the treatment of diseases that currently have poor outcomes and few options. Partnerships, like this one with Lantheus, will help Insightec's future customers push the boundaries of what is possible in providing care to patients with neurooncologic as well as neurodegenerative diseases," said Maurice R. Ferré MD, Chairman and CEO of Insightec.

    About Glioblastoma

    There are approximately 12,500 new cases of glioblastoma in the United States each year. Glioblastoma is the most commonly occurring primary malignant brain tumor, accounting for over 48% of all malignant tumors.2 Overall, median survival for glioblastoma patients is 12-15 months. Glioblastoma has a poor prognosis due to its high rate of tumor recurrence, which has been described clinically as inevitable.3 Worldwide, there are more than 240,000 estimated deaths from brain and central nervous system cancers each year, and glioblastoma represents one of the most common and lethal forms of these cancers.4

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate," "believe," "confident," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) regulatory risks related to our DEFINITY® modified formulation candidate; (ii) expectations for future clinical trials, the timing and potential outcomes of clinical studies and filings and other interactions with regulatory authorities; (iii) the impact of legislative, regulatory, competitive and technological changes; (iv) Insightec's ability to successfully launch its MRgFUS platform with our microbubble as a commercial product; and (v) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

    1Tamimi AF, Juweid M. Epidemiology and Outcome of Glioblastoma. In: De Vleeschouwer S, editor. Glioblastoma [Internet]. Brisbane (AU): Codon Publications; 2017 Sep 27. Chapter 8.

    2National Brain Tumor Society Statistics accessed at: https://braintumor.org/brain-tumor-information/brain-tumor-facts/ on October 16, 2020.

    3van Linde ME, Brahm CG, de Witt Hamer PC, et al. Treatment outcome of patients with recurrent glioblastoma multiforme: a retrospective multicenter analysis. J Neuro oncol. 2017;135(1):183-192.

    4Bray, F. et al. Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA. Cancer, J Clin: 2018: 68: 394-424.

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  19. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH) today announced that it will host a conference call and webcast at 8:00 a.m. ET on Thursday, November 5, 2020, to discuss its financial and operating results for the third quarter of 2020.

    To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1‑678-509-7599 (international callers) and provide passcode 8872902. A live webcast will also be available in the Investors section of the Company's website at www.lantheus.com.

    A replay of the webcast will be available in the Investors section of the Company's website approximately two hours after completion of the call and will be archived for 30 days.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc…

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH) today announced that it will host a conference call and webcast at 8:00 a.m. ET on Thursday, November 5, 2020, to discuss its financial and operating results for the third quarter of 2020.

    To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1‑678-509-7599 (international callers) and provide passcode 8872902. A live webcast will also be available in the Investors section of the Company's website at www.lantheus.com.

    A replay of the webcast will be available in the Investors section of the Company's website approximately two hours after completion of the call and will be archived for 30 days.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

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  20. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced that two abstracts featuring data from the Company's prostate specific membrane antigen artificial intelligence (PSMA AI) tool will be presented at the upcoming European Association of Nuclear Medicine (EAMN) Virtual Congress, which will be held from October 22-30, 2020. Details on the presentations are included below.

    Oral Presentation
    Title:
    Deep Learning-Enabled Comprehensive Detection and Quantification of 18FDCFPyL (PyL-PSMA…

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB, and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced that two abstracts featuring data from the Company's prostate specific membrane antigen artificial intelligence (PSMA AI) tool will be presented at the upcoming European Association of Nuclear Medicine (EAMN) Virtual Congress, which will be held from October 22-30, 2020. Details on the presentations are included below.

    Oral Presentation

    Title:
    Deep Learning-Enabled Comprehensive Detection and Quantification of 18FDCFPyL (PyL-PSMA) PET/CT

    Presenter: Johan Brynolfsson; Data Scientist; EXINI Diagnostics AB, Lund, SWEDEN

    Abstract ID: OP-548

    Session Title: 1006: Cutting Edge Science Track - TROP Session: AI -Radiomics and Modelling

    Date and Time: Saturday, October 24, 2020, 10:40 - 12:10 CEST on an "on demand" basis

    e-Poster Presentation

    Title:
    Deep-learning based urinary bladder segmentation using 18FDCFPyL (PyL-PSMA) PET/CT images

    Presenter: Johan Brynolfsson; Data Scientist; EXINI Diagnostics AB, Lund, SWEDEN

    Abstract ID: EPS-145

    Session Title: 1411: e-Poster Presentation Session 9: Physics -Software and Image Processing

    Date and Time: Friday, October 30, 2020, 09:00 - 10:30 CEST on an "on demand" basis

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc., and EXINI Diagnostics AB and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

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  21. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PyL™ (18F-DCFPyL), a prostate specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent for prostate cancer. The NDA includes a request for Priority Review, which if granted, could shorten the FDA's review of the NDA to six months from the time of acceptance, versus the standard review timeline of 10 months from acceptance…

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PyL™ (18F-DCFPyL), a prostate specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent for prostate cancer. The NDA includes a request for Priority Review, which if granted, could shorten the FDA's review of the NDA to six months from the time of acceptance, versus the standard review timeline of 10 months from acceptance. The Company expects to receive notification from the FDA confirming acceptance of the filing for substantive review in early December 2020.

    "The completion of our NDA submission marks a significant milestone for Lantheus and our PyL clinical development program," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "Prostate cancer is the second leading cause of cancer death in men. Fortunately, men can live for a long time with their disease if managed appropriately. There are approximately 3.2 million men in the United States annually living with this disease.1 We believe that PyL, if approved, will play an ongoing role in the diagnosis and management of prostate cancer."

    The NDA is supported by data from two pivotal studies (OSPREY and CONDOR), designed to establish the safety and diagnostic performance of PyL imaging across the disease continuum of prostate cancer. Results from OSPREY Cohort A demonstrated improvement in specificity and positive predictive value (PPV) of PyL PET imaging over conventional imaging in men with high risk prostate cancer. OSPREY Cohort B and CONDOR studied men with prostate cancer in various disease states, including biochemical recurrent prostate cancer, hormone sensitive prostate cancer, non-metastatic castrate resistant prostate cancer, and metastatic castrate resistant prostate cancer. OSPREY Cohort B demonstrated a sensitivity in detecting metastatic lesions, while CONDOR, in patients with biochemical recurrent prostate cancer and non-informative baseline findings, demonstrated a high correct localization rate and high detection rate, including patients with low PSA values. In the CONDOR study, 63.9% of patients had a change in intended disease management plans due to the PyL imaging results. We believe the results from these two studies, taken as a whole, demonstrate the ability of PyL to reliably detect and localize disease and could enable more appropriate patient management.

    PyL has been administered in approximately 3,500 subjects globally, including the two Company sponsored studies, multiple investigator sponsored studies, as well as clinical use reported in the literature. Across all of these studies PyL has shown an attractive safety profile.

    "We are extremely grateful to the prostate cancer patients and investigators who participated in PyL's clinical development program," said Istvan Molnar, MD, Chief Medical Officer of Lantheus. "We believe that the demonstrated strong diagnostic performance of PyL, will assist in treatment decisions and, ultimately, may improve patient outcomes. We look forward to working with the FDA during the regulatory process in pursuit of our goal of bringing PyL to patients."

    About PyL™ for PET Imaging of Prostate Cancer

    PyL (also known as 18F-DCFPyL) is a fluorinated PSMA-targeted PET imaging agent that enables visualization of localized prostate cancer as well as bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.

    About OSPREY

    The Phase 2/3 OSPREY trial assessed the diagnostic performance of PyL to detect prostate cancer in pelvic lymph nodes in subjects with high risk locally advanced prostate cancer (Cohort A) and distant metastases in subjects with metastatic or recurrent prostate cancer (Cohort B). In the trial, the diagnostic performance of PyL in detecting disease in pelvic lymph nodes (Cohort A) showed specificity of 96-99%, sensitivity of 31-42%, and PPV of 78-91% although the trial did not meet one of its the primary endpoints. In the metastatic or recurrent prostate cancer setting (Cohort B), PyL exhibited sensitivity of 93-99% and PPV of 81-88% in detecting metastatic lesions. Overall, PyL demonstrated high diagnostic performance in reliably detecting nodal and distant metastatic prostate cancer.

    About CONDOR

    The Phase 3 CONDOR trial evaluated the diagnostic performance and clinical impact of PyL in men with biochemical recurrence of prostate cancer and uninformative baseline imaging based on conventional modalities. The CONDOR trial achieved its primary endpoint, with a correct localization rate (CLR) of 84.8% to 87.0% among the three blinded independent readers (the lower bound of the 95% confidence intervals ranging from 77.8% to 80.4%). CLR is based on positive predictive value, defined as the percentage of subjects with a one-to-one correspondence between localization of at least one lesion identified on PyL PET/CT and a composite truth standard comprised of histopathology, conventional imaging and/or changes in PSA levels following radiation therapy. 63.9% of subjects in the CONDOR trial had a change in intended disease management plans due to PyL imaging results, a key secondary endpoint of the trial. The changes to treatment management plans due to the PyL results included salvage local therapy to systemic therapy, observation to initiating therapy, noncurative systemic therapy to salvage local therapy, and planned treatment to observation.

    About Prostate Cancer

    Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 192,000 new cases of prostate cancer will be diagnosed, and 33,000 men will die of the disease. Approximately 3.2 million men in the U.S. currently count themselves among prostate cancer survivors.1

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate," "believe," "confident," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and other regulatory authorities for PyL; (ii) the Company's ability to successfully launch PyL as a commercial product; (iii) the market receptivity to PyL as a new diagnostic agent; (iv) the safety and efficacy of PyL; (v) the intellectual property protection of PyL; and (vi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

    1National Cancer Institute. SEER Cancer Stat Facts: Prostate Cancer. Accessed at https://seer.cancer.gov/statfacts/html/prost.html on March 15, 2019.

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  22. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced Mary Anne Heino, President and Chief Executive Officer, will present at the Wells Fargo 2020 Virtual Healthcare Conference at 4:00 p.m. ET on Thursday, September 10.

    To access a live webcast of the presentation, please visit the Investors section of the Company's website at www.lantheus.com. A replay of the webcast will be available on the Company's website for 30 days following the live presentation.

    About Lantheus Holdings, Inc.

    Lantheus Holdings…

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced Mary Anne Heino, President and Chief Executive Officer, will present at the Wells Fargo 2020 Virtual Healthcare Conference at 4:00 p.m. ET on Thursday, September 10.

    To access a live webcast of the presentation, please visit the Investors section of the Company's website at www.lantheus.com. A replay of the webcast will be available on the Company's website for 30 days following the live presentation.

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

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  23. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the develo