1. 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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  2. 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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  3. 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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  4. 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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  5. 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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  6. 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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  7. 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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  8. 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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  9. 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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  10. 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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  11. 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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  12. 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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  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 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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  14. 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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  15. 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 VIALMIX®RFIDfor DEFINITY®.

    VIALMIXRFID is a next generation activation device designed specifically for DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension, an intravenous ultrasound enhancing agent, and our DEFINITY modified formulation product candidate. DEFINITY is supplied as a liquid-filled glass vial and requires activation…

    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 VIALMIX®RFID for DEFINITY®.

    VIALMIXRFID is a next generation activation device designed specifically for DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension, an intravenous ultrasound enhancing agent, and our DEFINITY modified formulation product candidate. DEFINITY is supplied as a liquid-filled glass vial and requires activation in order to create the lipid-encapsulated microbubbles. The activation rate and time are controlled by VIALMIXRFID through the use of radio-frequency identification technology to ensure reproducible activation of DEFINITY. The RFID tag, which is affixed to the vial label, enables the DEFINITY vial to be appropriately activated when utilized with VIALMIXRFID activation device.

    "The approval of VIALMIXRFID further strengthens and extends our core microbubble franchise," said Mary Anne Heino, President and Chief Executive Officer. "By controlling the activation rate and time, the RFID technology ensures reproducible activation of DEFINITY and reduces risks related to operator or medication errors, potentially increasing patient safety. Importantly, VIALMIXRFID has been designed to work with our currently approved DEFINITY vial and our DEFINITY modified formulation product candidate. I am grateful to the entire Lantheus team that worked tirelessly to bring this next generation activation device to the market."

    A U.S. issued patent on the use of the new VIALMIXRFID with an expiration date of 2037 has been listed in the Orange Book, and additional patent applications have been submitted in major markets throughout the world.

    About DEFINITY®

    DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension (activated) is an ultrasound enhancing agent for use in patients with suboptimal echocardiograms (see Indications and Important Safety Information below and find full Prescribing Information at www.definityimaging.com).1 DEFINITY is engineered to produce small and consistently sized durable microbubbles to fully evaluate the left ventricle.1 DEFINITY has extensive safety experience and a consistent safety profile.2 Since its launch in 2001, more than 13 million echo studies have been performed with DEFINITY and it is the most prescribed ultrasound enhancing agent in the U.S.3

    DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension

    INDICATIONS

    Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is 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® to patients with known or suspected hypersensitivity to perflutren.

    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® 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) regulatory risks related to our DEFINITY® modified formulation candidate; (iv) risks that the anticipated benefits of the acquisition of Progenics Pharmaceuticals, Inc. or other commercial opportunities may otherwise not be fully realized or may take longer to realize than expected; (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., 2017.

    2 Data on file, Lantheus Medical Imaging, Inc.

    3 ©2020 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited.

    Reprinted with permission.

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    • Completed acquisition of Progenics Pharmaceuticals, Inc., adding robust portfolio of oncology therapeutics and diagnostics to pipeline
    • Worldwide revenue of $66.0 million for the second quarter 2020, representing a decrease of 23.0% from the prior year period
    • Net loss of $7.0 million for the second quarter 2020, compared to net income of $6.4 million in the prior year period
    • GAAP diluted EPS of $(0.16) for the second quarter 2020, compared to GAAP diluted EPS of $0.16 in the prior year period; adjusted diluted EPS of $0.10 for the second quarter 2020, compared to adjusted diluted EPS of $0.27 in the prior year period
    • Net cash used in operating activities was $2.2 million for the second quarter 2020. Free cash flow was a use of $4.4
    • Completed acquisition of Progenics Pharmaceuticals, Inc., adding robust portfolio of oncology therapeutics and diagnostics to pipeline
    • Worldwide revenue of $66.0 million for the second quarter 2020, representing a decrease of 23.0% from the prior year period
    • Net loss of $7.0 million for the second quarter 2020, compared to net income of $6.4 million in the prior year period
    • GAAP diluted EPS of $(0.16) for the second quarter 2020, compared to GAAP diluted EPS of $0.16 in the prior year period; adjusted diluted EPS of $0.10 for the second quarter 2020, compared to adjusted diluted EPS of $0.27 in the prior year period
    • Net cash used in operating activities was $2.2 million for the second quarter 2020. Free cash flow was a use of $4.4 million in the second 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 second quarter ended June 30, 2020.

    On June 19, 2020, the Company completed the acquisition of Progenics Pharmaceuticals, adding three leading FDA approved products and an emerging clinical-stage pipeline of radiopharmaceutical therapeutics and diagnostics for the treatment of cancer.

    The Company's worldwide revenue for the second quarter of 2020 totaled $66.0 million, compared with $85.7 million for the second quarter of 2019, representing a decrease of 23.0% from the prior year period.

    The Company's second quarter 2020 net loss was $7.0 million, or $(0.16) per fully diluted share, as compared to net income of $6.4 million, or $0.16 per fully diluted share for the second quarter of 2019.

    The Company's second quarter 2020 adjusted fully diluted earnings per share were $0.10, as compared to $0.27 for the second quarter of 2019, representing a decrease of 63.0% from the prior year period.

    Lastly, net cash used in operating activities was $2.2 million for the second quarter 2020. Free Cash Flow was a use of $4.4 million in the second quarter of 2020, representing a decrease of approximately $22.0 million from the prior year period.

    "As we continue to navigate through the COVID-19 global pandemic, the health and safety of our employees, patients, and other partners in the healthcare community remain our top priority. We closed our acquisition of Progenics in June and are now integrating our portfolio of innovative products and product candidates to enhance our diagnostic and therapeutic footprint," said Mary Anne Heino, President and CEO. "Procedures utilizing our products for the second quarter were impacted by COVID-related hospital and customer restrictions. However, we demonstrated an impressive month-to-month recovery in our business as healthcare markets across the U.S. began to re-open. As we look to the future, our focus will be on unlocking value across our newly combined company including our exciting portfolio of opportunities."

    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, Lantheus 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 on Thursday, July 30, 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 5565687. A live audio webcast of the call also 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. 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.

    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" as defined under U.S. federal securities laws, including statements about our 2020 outlook. 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 subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. 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) risks that the anticipated benefits of the acquisition of Progenics Pharmaceuticals, Inc. or other commercial opportunities may otherwise not be fully realized or may take longer to realize than expected; (iv) expectations for future clinical trials, the timing and potential outcomes of clinical studies and filings and other interactions with regulatory authorities; 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).

    - Tables Follow -

    Lantheus Holdings, Inc.

    Consolidated Statements of Operations

    (in thousands, except per share data – unaudited)

     

     

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Revenues

     

    $

    66,010

     

     

    $

    85,705

     

     

    $

    156,714

     

     

    $

    172,215

     

    Cost of goods sold

     

    40,162

     

     

    41,132

     

     

    92,864

     

     

    83,558

     

    Gross profit

     

    25,848

     

     

    44,573

     

     

    63,850

     

     

    88,657

     

    Operating expenses

     

     

     

     

     

     

     

     

    Sales and marketing

     

    6,305

     

     

    10,948

     

     

    16,435

     

     

    21,345

     

    General and administrative

     

    20,670

     

     

    13,293

     

     

    37,369

     

     

    25,882

     

    Research and development

     

    4,418

     

     

    5,795

     

     

    8,466

     

     

    10,724

     

    Total operating expenses

     

    31,393

     

     

    30,036

     

     

    62,270

     

     

    57,951

     

    Operating (loss) income

     

    (5,545)

     

     

    14,537

     

     

    1,580

     

     

    30,706

     

    Interest expense

     

    1,914

     

     

    4,543

     

     

    3,860

     

     

    9,135

     

    Loss on extinguishment of debt

     

     

     

    3,196

     

     

     

     

    3,196

     

    Other income

     

    (756)

     

     

    (1,312)

     

     

    (1,106)

     

     

    (2,499)

     

    (Loss) income before income taxes

     

    (6,703)

     

     

    8,110

     

     

    (1,174)

     

     

    20,874

     

    Income tax expense

     

    309

     

     

    1,698

     

     

    2,501

     

     

    4,513

     

    Net (loss) income

     

    $

    (7,012)

     

     

    $

    6,412

     

     

    $

    (3,675)

     

     

    $

    16,361

     

    Net (loss) income per common share:

     

     

     

     

     

     

     

     

    Basic

     

    $

    (0.16)

     

     

    $

    0.16

     

     

    $

    (0.09)

     

     

    $

    0.42

     

    Diluted

     

    $

    (0.16)

     

     

    $

    0.16

     

     

    $

    (0.09)

     

     

    $

    0.41

     

    Weighted-average common shares outstanding:

     

     

     

     

     

     

     

     

    Basic

     

    43,135

     

     

    38,972

     

     

    41,284

     

     

    38,789

     

    Diluted

     

    43,135

    40,239

     

    41,284

     

     

    40,064

    Lantheus Holdings, Inc.

    Consolidated Segment Revenues Analysis

    (in thousands – unaudited)

     

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

    2019

    % Change

     

    2020

    2019

    % Change

    United States

     

     

     

     

     

     

     

     

     

     

     

    DEFINITY

    $

    39,544

     

     

    $

    53,466

     

     

    (26.0)

    %

     

    $

    94,554

     

     

    $

    103,182

     

     

    (8.4)

    %

    TechneLite

    15,591

     

     

    16,865

     

     

    (7.6)

    %

     

    34,947

     

     

    36,923

     

     

    (5.4)

    %

    Other nuclear

    5,804

     

     

    9,127

     

     

    (36.4)

    %

     

    14,866

     

     

    18,651

     

     

    (20.3)

    %

    Rebates and allowances

    (3,540)

     

     

    (4,268)

     

     

    (17.1)

    %

     

    (8,223)

     

     

    (8,132)

     

     

    1.1

    %

    Total United States

    57,399

     

     

    75,190

     

     

    (23.7)

    %

     

    136,144

     

     

    150,624

     

     

    (9.6)

    %

    International

     

     

     

     

     

     

     

     

     

     

     

    DEFINITY

    821

     

     

    1,163

     

     

    (29.4)

    %

     

    2,602

     

     

    2,558

     

     

    1.7

    %

    TechneLite

    3,318

     

     

    3,241

     

     

    2.4

    %

     

    7,060

     

     

    7,328

     

     

    (3.7)

    %

    Other nuclear

    4,473

     

     

    6,119

     

     

    (26.9)

    %

     

    10,911

     

     

    11,715

     

     

    (6.9)

    %

    Rebates and allowances

    (1)

     

     

    (8)

     

     

    (87.5)

    %

     

    (3)

     

     

    (10)

     

     

    (70.0)

    %

    Total International

    8,611

     

     

    10,515

     

     

    (18.1)

    %

     

    20,570

     

     

    21,591

     

     

    (4.7)

    %

    Worldwide

     

     

     

     

     

     

     

     

     

     

     

    DEFINITY

    40,365

     

     

    54,629

     

     

    (26.1)

    %

     

    97,156

     

     

    105,740

     

     

    (8.1)

    %

    TechneLite

    18,909

     

     

    20,106

     

     

    (6.0)

    %

     

    42,007

     

     

    44,251

     

     

    (5.1)

    %

    Other nuclear

    10,277

     

     

    15,246

     

     

    (32.6)

    %

     

    25,777

     

     

    30,366

     

     

    (15.1)

    %

    Rebates and allowances

    (3,541)

     

     

    (4,276)

     

     

    (17.2)

    %

     

    (8,226)

     

     

    (8,142)

     

     

    1.0

    %

    Total Revenues

    $

    66,010

     

     

    $

    85,705

     

     

    (23.0)

    %

     

    $

    156,714

     

     

    $

    172,215

     

     

    (9.0)

    %

    Lantheus Holdings, Inc.

    Reconciliation of GAAP to Non-GAAP Financial Measures

    (in thousands, except per share data – unaudited)

     

     

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

     

     

    2020

     

    2019

     

    2020

     

    2019

     

    Net (loss) income

     

    $

    (7,012)

     

     

    $

    6,412

     

     

    $

    (3,675)

     

     

    $

    16,361

     

     

    Stock and incentive plan compensation

     

    3,385

     

     

    3,376

     

     

    6,460

     

     

    6,157

     

     

    Amortization of acquired intangible assets

     

    927

     

     

    451

     

     

    1,319

     

     

    902

     

     

    Non-recurring refinancing related fees

     

    460

     

     

     

     

    460

     

     

     

     

    Extinguishment of debt

     

     

     

    3,196

     

     

     

     

    3,196

     

     

    Strategic collaboration and license costs

     

     

     

    300

     

     

     

     

    300

     

     

    Integration costs

     

    1,201

     

     

     

     

    3,573

     

     

     

     

    Acquisition-related costs

     

    7,517

     

     

     

     

    8,929

     

     

     

     

    Impairment of long-lived assets

     

     

     

     

     

    7,275

     

     

     

     

    Other

     

     

     

     

     

    (75)

     

     

     

     

    Income tax effect of non-GAAP adjustments(a)

     

    (1,940)

     

     

    (2,852)

     

     

    (5,446)

     

     

    (4,795)

     

     

    Adjusted net income

     

    $

    4,538

     

     

    $

    10,883

     

     

    $

    18,820

     

     

    $

    22,121

     

     

    Adjusted net income, as a percentage of revenues

     

    6.9

    %

     

    12.7

    %

     

    12.0

    %

     

    12.8

    %

     

     

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Net (loss) income per share - diluted

     

    $

    (0.16)

     

     

    $

    0.16

     

     

    $

    (0.09)

     

     

    $

    0.41

     

    Stock and incentive plan compensation

     

    0.08

     

     

    0.08

     

     

    0.14

     

     

    0.15

     

    Amortization of acquired intangible assets

     

    0.02

     

     

    0.01

     

     

    0.03

     

     

    0.02

     

    Non-recurring refinancing related fees

     

    0.01

     

     

     

     

    0.01

     

     

     

    Extinguishment of debt

     

     

     

    0.08

     

     

     

     

    0.08

     

    Strategic collaboration and license costs

     

     

     

    0.01

     

     

     

     

    0.01

     

    Integration costs

     

    0.03

     

     

     

     

    0.09

     

     

     

    Acquisition-related costs

     

    0.18

     

     

     

     

    0.22

     

     

     

    Impairment of long-lived assets

     

     

     

     

     

    0.18

     

     

     

    Income tax effect of non-GAAP adjustments(a)

     

    (0.06)

     

     

    (0.07)

     

     

    (0.13)

     

     

    (0.12)

     

    Adjusted net income per share - diluted

     

    $

    0.10

     

     

    $

    0.27

     

     

    $

    0.45

     

     

    $

    0.55

     

    Weighted-average common shares outstanding - diluted(b)

     

    43,303

     

     

    40,239

     

     

    41,702

     

     

    40,064

     

     
    1. The income tax effect of the adjustments between GAAP net income (loss) 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

    June 30,

     

    Six Months Ended

    June 30,

     

    2020

     

    2019

     

    2020

     

    2019

    Net cash (used in) provided by operating activities

    $

    (2,156)

     

     

    $

    21,053

     

     

    $

    7,252

     

     

    $

    31,521

     

    Capital expenditures

    (2,255)

     

     

    (3,434)

     

     

    (4,953)

     

     

    (13,984)

     

    Free cash flow

    $

    (4,411)

     

     

    $

    17,619

     

     

    $

    2,299

     

     

    $

    17,537

     

    Lantheus Holdings, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands – unaudited)

     

     

    June 30,

    2020

     

    December 31,

    2019

    Assets

     

     

     

    Current assets

     

     

     

    Cash and cash equivalents

    $

    90,309

     

     

    $

    92,919

     

    Accounts receivable, net

    46,883

     

     

    43,529

     

    Inventory

    35,334

     

     

    29,180

     

    Other current assets

    8,630

     

     

    7,283

     

    Total current assets

    181,156

     

     

    172,911

     

    Property, plant and equipment, net

    122,903

     

     

    116,497

     

    Intangibles, net

    389,512

     

     

    7,336

     

    Goodwill

    57,765

     

     

    15,714

     

    Deferred tax assets, net

    67,441

     

     

    71,834

     

    Other long-term assets

    60,918

     

     

    21,627

     

    Total assets

    $

    879,695

     

     

    $

    405,919

     

    Liabilities and stockholders' equity

     

     

     

    Current liabilities

     

     

     

    Current portion of long-term debt and other borrowings

    $

    17,143

     

     

    $

    10,143

     

    Accounts payable

    16,301

     

     

    18,608

     

    Accrued expenses and other liabilities

    42,892

     

     

    37,360

     

    Total current liabilities

    76,336

     

     

    66,111

     

    Asset retirement obligations

    13,602

     

     

    12,883

     

    Long-term debt, net and other borrowings

    210,010

     

     

    183,927

     

    Other long-term liabilities

    64,164

     

     

    28,397

     

    Total liabilities

    364,112

     

     

    291,318

     

    Total stockholders' equity

    515,583

     

     

    114,601

     

    Total liabilities and stockholders' equity

    $

    879,695

    $

    405,919

     

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  16. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH) today announced that it will host a conference call at 8:00 a.m. ET on Thursday, July 30, 2020, to discuss its financial and operating results for the second 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 5565687. A live audio webcast of the call will also 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 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 at 8:00 a.m. ET on Thursday, July 30, 2020, to discuss its financial and operating results for the second 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 5565687. A live audio webcast of the call will also 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 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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  17. 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 that 17 abstracts highlighting PyL™ (18F-DCFPyL) have been selected for presentation at the virtual Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2020 Annual Meeting taking place July 11-14, 2020. PyL is the PSMA-targeted small molecule positron emission tomography (PET) imaging investigational agent designed to visualize prostate cancer, which the Company recently purchased as part of the oncology business of Progenics.

    The abstracts…

    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 that 17 abstracts highlighting PyL™ (18F-DCFPyL) have been selected for presentation at the virtual Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2020 Annual Meeting taking place July 11-14, 2020. PyL is the PSMA-targeted small molecule positron emission tomography (PET) imaging investigational agent designed to visualize prostate cancer, which the Company recently purchased as part of the oncology business of Progenics.

    The abstracts to be presented at the meeting will feature data on PyL from two presentations based on Company-sponsored studies, including the positive results from the Phase 3 CONDOR trial evaluating the diagnostic performance and clinical impact of PyL in patients with biochemical recurrence of prostate cancer. A third abstract focuses on the digital solution the Company is developing in parallel with PyL to potentially support prostate cancer staging using an automated miPSMA Index of the PET/CT PyL-PSMA images.

    "Physicians and patients continue to experience an unmet need for diagnostic imaging that could assist in staging high risk prostate cancer and reliably detect recurrent or metastatic disease. The unmet need is particularly important among patients with low PSA values," said Istvan Molnar, M.D., the Company's Chief Medical Officer. "We believe that the demonstrated strong diagnostic performance of our PSMA-targeted PET imaging investigational agent, PyL, could provide clinicians with actionable information. In addition, the use of the widely available isotope fluorine-18 may result in broad patient accessibility. Data to be presented at SNMMI this year further highlights PyL's clinical potential, including the positive Phase 3 results of the CONDOR study, which achieved its primary endpoint with a correct localization rate of 84.8% to 87.0% among the three blinded independent readers. We remain on track to submit a New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") for PyL in the third quarter of 2020."

    SNMMI presentations will be made available on July 11, 2020 and can be found in the virtual Science Pavilion.

    Details for the SNMMI 2020 presentations based on Company-sponsored studies and Company-led digital solution development are as follows:

    Title: Diagnostic Performance of PSMA-Targeted 18F-DCFPyL PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the Phase 3, Multicenter CONDOR Study

    Lead Author: Steven Rowe, Johns Hopkins University

    Title: miPSMA Index: Comprehensive and Automated Quantification of 18F-DCFPyL (PyL-PSMA) PET/CT for Prostate Cancer Staging

    Lead Author: Kerstin Johnsson, Progenics Pharmaceuticals

    Title: Measuring bias in quantitative PET biomarkers in-vivo

    Lead Author: Martin Lodge, Johns Hopkins University

    About PyL™ for PET Imaging of Prostate Cancer

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

    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 174,650 new cases of prostate cancer will be diagnosed and about 31,620 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.

    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; RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc.; and AZEDRA® for the treatment of certain rare neurological cancers. 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 document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 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. Such statements are based upon current plans, estimates and expectations that are subject to various risks and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "target," "contemplate," "estimate," "predict," "potential," "opportunity," "creates" and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, are forward-looking statements. Important factors that could cause actual results to differ materially from Lantheus' plans, estimates or expectations could include, but are not limited to: (i) the timing of the filing of the Company's PyL NDA with the FDA; (ii) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and other regulatory authorities; (iii) the Company's ability to successfully launch PyL as a commercial product; (iv) the market receptivity to PyL as a new diagnostic agent; (v) the safety and efficacy of PyL; and (vi) the intellectual property protection of PyL. Additional factors that may affect the future results of Lantheus are set forth in Lantheus' filings with the SEC, including Lantheus' most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SEC's website at www.sec.gov. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements. Readers should also carefully review the risk factors described in other documents that Lantheus file from time to time with the SEC. The forward-looking statements in this document speak only as of the date of these materials. Except as required by law, Lantheus assumes no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

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  18. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the 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 that it has completed its previously announced merger with Progenics Pharmaceuticals, Inc. ("Progenics") (NASDAQ:PGNX), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer. The merger agreement was first announced on October 2, 2019.

    "Today marks an important day for Lantheus and Progenics. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio," said Mary Anne Heino, Lantheus President…

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the 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 that it has completed its previously announced merger with Progenics Pharmaceuticals, Inc. ("Progenics") (NASDAQ:PGNX), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer. The merger agreement was first announced on October 2, 2019.

    "Today marks an important day for Lantheus and Progenics. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio," said Mary Anne Heino, Lantheus President and Chief Executive Officer. "The transaction leverages Lantheus' long-standing expertise in complex manufacturing, supply chain and commercial excellence, with Progenics' three leading FDA approved products, clinical pipeline and development capabilities. We're excited to welcome the talented Progenics employees to the Lantheus organization to help build upon our solid foundation."

    Upon completion of the merger, Progenics stockholders received, for each share of Progenics common stock, 0.31 of a share of Lantheus common stock and one non-tradeable contingent value right, which is payable in two contingent payments, subject to a cap, upon the achievement of certain milestones related to the financial performance of PyLTM (18F-DCFPyL), Progenics' prostate-specific membrane antigen targeted imaging agent designed to visualize prostate cancer.

    The Company will continue to trade on Nasdaq under the ticker symbol LNTH. Progenics is being delisted.

    About Lantheus Holdings, Inc. and Lantheus Medical Imaging, Inc.

    Lantheus Holdings, Inc. is the parent company of LMI, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. LMI provides a broad portfolio of products, including the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension and TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures. The Company is headquartered in North Billerica, Massachusetts with offices in Puerto Rico and Canada. For more information, visit www.lantheus.com.

    About Progenics

    Progenics is an oncology company focused on the development and commercialization of innovative targeted medicines and artificial intelligence to find, fight and follow cancer, including: therapeutic agents designed to treat cancer (AZEDRA®, 1095, and PSMA TTC); prostate-specific membrane antigen ("PSMA") targeted imaging agents for prostate cancer (PyL™ and 1404); and imaging analysis technology (aBSI and PSMA AI). Progenics has three commercial products, AZEDRA, for the treatment of patients with unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (rare neuroendocrine tumors of neural crest origin) who require systemic anticancer therapy; and oral and subcutaneous formulations of RELISTOR® (methylnaltrexone bromide) for the treatment of opioid-induced constipation, which are partnered with Bausch Health Companies Inc. Progenics is headquartered in New York, New York with manufacturing facilities in Somerset, New Jersey. Additional information about Progenics is available at www.progenics.com.

    Safe Harbor for Forward-Looking and Cautionary Statements

    This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 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. Such statements are based upon current plans, estimates and expectations that are subject to various risks and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "target," "contemplate," "estimate," "predict," "potential," "opportunity," "creates" and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, including the expected benefits of the merger, such as efficiencies, cost savings, synergies, revenue growth, creating shareholder value, growth potential, market profile, enhanced competitive position, and financial strength and flexibility; the competitive ability and position of the combined company; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Lantheus' plans, estimates or expectations could include, but are not limited to: (i) the merger may involve unexpected costs or liabilities; (ii) the effect of the merger on the ability of Lantheus to maintain relationships with customers, suppliers and others with whom Lantheus does business, or on Lantheus' operating results and business generally; (iii) Lantheus' business may suffer as a result of disruption of management's attention due to the merger; (iv) the outcome of any legal proceedings related to the merger; (v) Lantheus may be adversely affected by other economic, business, and/or competitive factors, including the ongoing COVID-19 pandemic; (vi) risks that the merger disrupts current plans and operations and the potential difficulties in employee retention as a result of the merger; (vii) risks that the anticipated benefits of the merger or other commercial opportunities may otherwise not be fully realized or may take longer to realize than expected; (viii) the impact of legislative, regulatory, competitive and technological changes; and (ix) expectations for future clinical trials, the timing and potential outcomes of clinical studies and interactions with regulatory authorities. Additional factors that may affect the future results of Lantheus are set forth in Lantheus' filings with the SEC, including Lantheus' most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SEC's website at www.sec.gov. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements. Readers should also carefully review the risk factors described in other documents that Lantheus files from time to time with the SEC. The forward-looking statements in this document speak only as of the date of these materials. Except as required by law, Lantheus assumes no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

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  19. NEW YORK, June 17, 2020 /PRNewswire/ -- Independent Bank Group Inc. (NASD: IBTX) will replace Progenics Pharmaceuticals Inc. (NASD: PGNX) in the S&P SmallCap 600 effective prior to the opening of trading on Monday, June 22. S&P Small-Cap 600 constituent Lantheus Holdings Inc. (NASD: LNTH) is acquiring Progenics Pharmaceuticals in a deal expected to be completed on or about June 19 pending final conditions. Post-acquisition, Lantheus Holdings will remain in S&P SmallCap 600.

    Independent Bank Group provides various commercial banking products and services. Headquartered in McKinney, TX the company will be added to the S&P SmallCap 600 GICS (Global Industry Classification Standard) Regional Banks Sub-Industry index.

    Following is a summary of the…

    NEW YORK, June 17, 2020 /PRNewswire/ -- Independent Bank Group Inc. (NASD: IBTX) will replace Progenics Pharmaceuticals Inc. (NASD: PGNX) in the S&P SmallCap 600 effective prior to the opening of trading on Monday, June 22. S&P Small-Cap 600 constituent Lantheus Holdings Inc. (NASD: LNTH) is acquiring Progenics Pharmaceuticals in a deal expected to be completed on or about June 19 pending final conditions. Post-acquisition, Lantheus Holdings will remain in S&P SmallCap 600.

    Independent Bank Group provides various commercial banking products and services. Headquartered in McKinney, TX the company will be added to the S&P SmallCap 600 GICS (Global Industry Classification Standard) Regional Banks Sub-Industry index.

    Following is a summary of the change:

    S&P SMALLCAP 600 INDEX – JUNE 22, 2020



    COMPANY

    GICS ECONOMIC SECTOR

    GICS SUB-INDUSTRY

    ADDED

    Independent Bank Group

    Financials

    Regional Banks

    DELETED

    Progenics Pharmaceuticals

    Health Care

    Biotechnology

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    Cision View original content:http://www.prnewswire.com/news-releases/independent-bank-group-set-to-join-sp-smallcap-600-301079120.html

    SOURCE S&P Dow Jones Indices

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  20. Lantheus Holdings, Inc. (NASDAQ:LNTH) ("Lantheus" or the "Company"), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a leader in the development, manufacture and commercialization of innovative diagnostic imaging agents announced that at a special meeting held earlier today, Lantheus' stockholders voted to approve the issuance of common stock related to the Company's proposed merger with Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) ("Progenics"), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer.

    Lantheus and Progenics previously entered into an Amended and Restated Agreement and Plan of Merger, dated as of February 20, 2020 (the "Merger Agreement"), by and among Progenics…

    Lantheus Holdings, Inc. (NASDAQ:LNTH) ("Lantheus" or the "Company"), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a leader in the development, manufacture and commercialization of innovative diagnostic imaging agents announced that at a special meeting held earlier today, Lantheus' stockholders voted to approve the issuance of common stock related to the Company's proposed merger with Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) ("Progenics"), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer.

    Lantheus and Progenics previously entered into an Amended and Restated Agreement and Plan of Merger, dated as of February 20, 2020 (the "Merger Agreement"), by and among Progenics, Lantheus and Plato Merger Sub, Inc., a wholly-owned subsidiary of Lantheus ("Merger Sub"). Pursuant to the Merger Agreement, Merger Sub will be merged with and into Progenics (the "merger"), with Progenics surviving the merger as a wholly-owned subsidiary of Lantheus.

    Approximately 99% of the total votes cast by holders of Lantheus common stock were voted in favor of the share issuance proposal (excluding abstentions), representing approximately 87% of Lantheus' shares issued and outstanding as of the close of business on May 12, 2020, the record date.

    Mary Anne Heino, President and Chief Executive Officer of the Company, said, "We are very excited that our stockholders have approved the share issuance in connection with the Progenics merger and that the Progenics stockholders also approved the transaction earlier today. We believe that the combined company will offer a diversified portfolio of precision diagnostics, radiopharmaceutical therapeutics, digital solutions and pharma service offerings, delivering value across the patient health care continuum."

    The merger remains subject to customary closing conditions. The parties expect to close the merger on or about June 19, 2020.

    About Lantheus Holdings, Inc. and Lantheus Medical Imaging, Inc.

    Lantheus Holdings, Inc. is the parent company of LMI, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. LMI provides a broad portfolio of products, including the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension and TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures. The Company is headquartered in North Billerica, Massachusetts with offices in Puerto Rico and Canada. For more information, visit www.lantheus.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 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. Such statements are based upon current plans, estimates and expectations that are subject to various risks and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "target," "contemplate," "estimate," "predict," "potential," "opportunity," "creates" and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, including the expected timing of the closing of the merger; the ability of the parties to complete the merger considering the various closing conditions; the expected benefits of the merger, such as efficiencies, cost savings, synergies, revenue growth, creating shareholder value, growth potential, market profile, enhanced competitive position, and financial strength and flexibility; the competitive ability and position of the combined company; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Progenics' and Lantheus' plans, estimates or expectations could include, but are not limited to: (i) conditions to the closing of the merger may not be satisfied; (ii) the merger may involve unexpected costs, liabilities or delays; (iii) the effect of the announcement of the merger on the ability of Progenics or Lantheus to retain and hire key personnel and maintain relationships with customers, suppliers and others with whom Progenics or Lantheus does business, or on Progenics' or Lantheus' operating results and business generally; (iv) Progenics' or Lantheus' respective businesses may suffer as a result of uncertainty surrounding the merger and disruption of management's attention due to the merger; (v) the outcome of any legal proceedings related to the merger; (vi) Progenics or Lantheus may be adversely affected by other economic, business, and/or competitive factors, including the ongoing COVID-19 pandemic; (vii) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; (viii) risks that the merger disrupts current plans and operations and the potential difficulties in employee retention as a result of the merger; (ix) risks that the anticipated benefits of the merger or other commercial opportunities may otherwise not be fully realized or may take longer to realize than expected; (x) the impact of legislative, regulatory, competitive and technological changes; (xi) expectations for future clinical trials, the timing and potential outcomes of clinical studies and interactions with regulatory authorities; and (xiii) other risks to the consummation of the merger, including the risk that the merger will not be consummated within the expected time period or at all. Additional factors that may affect the future results of Progenics and Lantheus are set forth in their respective filings with the SEC, including each of Progenics' and Lantheus' most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SEC's website at www.sec.gov. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements. Readers should also carefully review the risk factors described in other documents that Progenics and Lantheus file from time to time with the SEC. The forward-looking statements in this document speak only as of the date of these materials. Except as required by law, Progenics and Lantheus assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

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  21. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the 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 Mary Anne Heino, President and Chief Executive Officer, will present at the BMO 2020 Prescriptions for Success Virtual Healthcare Conference at 3:30 p.m. ET on Tuesday, June 23.

    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. and Lantheus Medical Imaging, Inc.

    Lantheus…

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the 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 Mary Anne Heino, President and Chief Executive Officer, will present at the BMO 2020 Prescriptions for Success Virtual Healthcare Conference at 3:30 p.m. ET on Tuesday, June 23.

    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. and Lantheus Medical Imaging, Inc.

    Lantheus Holdings, Inc. is the parent company of LMI, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. LMI provides a broad portfolio of products, including the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension and TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures. The Company is headquartered in North Billerica, Massachusetts with offices in Puerto Rico and Canada. For more information, visit www.lantheus.com.

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  22. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the 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 Mary Anne Heino, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference at 10:30 a.m. ET on Wednesday, June 3.

    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. and Lantheus Medical Imaging, Inc.

    Lantheus Holdings, Inc. is…

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the 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 Mary Anne Heino, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference at 10:30 a.m. ET on Wednesday, June 3.

    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. and Lantheus Medical Imaging, Inc.

    Lantheus Holdings, Inc. is the parent company of LMI, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. LMI provides a broad portfolio of products, including the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension and TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures. The Company is headquartered in North Billerica, Massachusetts with offices in Puerto Rico and Canada. 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. ("LMI"), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today announced Mary Anne Heino, President and Chief Executive Officer, will present at the UBS Virtual Global Healthcare Conference at 3:00 p.m. ET on Tuesday, May 19.

    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. and Lantheus Medical Imaging, Inc.

    Lantheus Holdings, Inc. is the…

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the 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 Mary Anne Heino, President and Chief Executive Officer, will present at the UBS Virtual Global Healthcare Conference at 3:00 p.m. ET on Tuesday, May 19.

    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. and Lantheus Medical Imaging, Inc.

    Lantheus Holdings, Inc. is the parent company of LMI, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. LMI provides a broad portfolio of products, including the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension and TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures. The Company is headquartered in North Billerica, Massachusetts with offices in Puerto Rico and Canada. For more information, visit www.lantheus.com.

    View Full Article Hide Full Article
    • Worldwide revenue of $90.7 million for the first quarter 2020, representing an increase of 4.8% over the prior year period
    • Net income of $3.3 million for the first quarter 2020, representing a decrease of 66.5% from the prior year period
    • GAAP diluted EPS of $0.08 for the first quarter 2020, representing a decrease of 66.7% from the prior year period; adjusted diluted EPS of $0.36 for the first quarter 2020, representing an increase of 26.1% over the prior year period
    • Net cash provided by operating activities was $9.4 million for the first quarter 2020. Free cash flow of $6.7 million for the first quarter 2020
    • Due to uncertain COVID-19 impact, 2020 guidance withdrawn

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

    • Worldwide revenue of $90.7 million for the first quarter 2020, representing an increase of 4.8% over the prior year period
    • Net income of $3.3 million for the first quarter 2020, representing a decrease of 66.5% from the prior year period
    • GAAP diluted EPS of $0.08 for the first quarter 2020, representing a decrease of 66.7% from the prior year period; adjusted diluted EPS of $0.36 for the first quarter 2020, representing an increase of 26.1% over the prior year period
    • Net cash provided by operating activities was $9.4 million for the first quarter 2020. Free cash flow of $6.7 million for the first quarter 2020
    • Due to uncertain COVID-19 impact, 2020 guidance withdrawn

    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 reported financial results for its first quarter ended March 31, 2020.

    The Company's worldwide revenue for the first quarter of 2020 totaled $90.7 million, compared with $86.5 million for the first quarter of 2019, representing an increase of 4.8% over the prior year period.

    The Company's first quarter 2020 net income was $3.3 million, or $0.08 per fully diluted share, as compared to $9.9 million, or $0.25 per fully diluted share for the first quarter of 2019, representing a decrease of 66.7% from the prior year period.

    The Company's first quarter 2020 adjusted fully diluted earnings per share were $0.36, as compared to $0.28 for the first quarter of 2019, representing an increase of 26.1% over the prior year period.

    Lastly, net cash provided by operating activities was $9.4 million for the first quarter 2020. Free Cash Flow was $6.7 million for the first quarter of 2020, representing an increase of approximately $6.8 million.

    "First and foremost, Lantheus is proud to serve the life sciences sector and we want to thank healthcare workers everywhere for their extraordinary commitment in these unprecedented times," said Mary Anne Heino, President and CEO of Lantheus. "Although our first quarter started with robust customer demand, by mid-March our business began to experience the effects of the COVID-19 pandemic, including the impact of stay-at-home mandates and related safety measures such as the delay of elective medical procedures. Despite this, we were still able to achieve revenues near the top end of our guidance and exceeded that for adjusted earnings per share. Although we cannot predict the magnitude or duration of the pandemic's impact, with our available liquidity and prudent expense management, including previously announced work week and salary reductions, we maintain a state of preparedness to resume full business activities to support our customers as business conditions allow."

    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 and duration of the COVID-19 pandemic. Due to these uncertainties, and uncertain timing of global recovery and economic normalization, Lantheus is unable to provide guidance as to the overall impacts on its operations and financial results.

    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 on Thursday, April 30, 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 8385228. A live audio webcast of the call also 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. and Lantheus Medical Imaging, Inc.

    Lantheus Holdings, Inc. is the parent company of LMI, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. LMI provides a broad portfolio of products, including the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension and TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures. The Company is headquartered in North Billerica, Massachusetts with offices in Puerto Rico and Canada. 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" as defined under U.S. federal securities laws, including statements about our 2020 outlook. 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 subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. 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 our future operating results, the impact of the COVID-19 pandemic on our business, financial condition and prospects, our ability to complete our acquisition of Progenics Pharmaceuticals and realize the expected benefits on the anticipated timeline or at all, the outcome of our clinical programs, as well as 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).

    Lantheus Holdings, Inc.

    Consolidated Statements of Operations

    (in thousands, except per share data – unaudited)

     

     

     

    Three Months Ended

    March 31,

     

     

    2020

     

    2019

    Revenues

     

    $

    90,704

     

     

    $

    86,510

     

    Cost of goods sold

     

    52,702

     

     

    42,426

     

    Gross profit

     

    38,002

     

     

    44,084

     

    Operating expenses

     

     

     

     

    Sales and marketing

     

    10,130

     

     

    10,397

     

    General and administrative

     

    16,699

     

     

    12,589

     

    Research and development

     

    4,048

     

     

    4,929

     

    Total operating expenses

     

    30,877

     

     

    27,915

     

    Operating income

     

    7,125

     

     

    16,169

     

    Interest expense

     

    1,946

     

     

    4,592

     

    Other income

     

    (350

    )

     

    (1,187

    )

    Income before income taxes

     

    5,529

     

     

    12,764

     

    Income tax expense

     

    2,192

     

     

    2,815

     

    Net income

     

    $

    3,337

     

     

    $

    9,949

     

    Net income per common share:

     

     

     

     

    Basic

     

    $

    0.08

     

     

    $

    0.26

     

    Diluted

     

    $

    0.08

     

     

    $

    0.25

     

    Weighted-average common shares outstanding:

     

     

     

     

    Basic

     

    39,433

     

     

    38,603

     

    Diluted

     

    40,102

     

     

    39,787

    Lantheus Holdings, Inc.

    Consolidated Segment Revenues Analysis

    (in thousands – unaudited)

     

     

    Three Months Ended

    March 31,

     

    2020

    2019

    % Change

    United States

     

     

     

     

     

    DEFINITY

    $

    55,010

     

     

    $

    49,716

     

     

    10.6

    %

    TechneLite

    19,356

     

     

    20,058

     

     

    (3.5

    )%

    Other nuclear

    9,062

     

     

    9,524

     

     

    (4.9

    )%

    Rebates and allowances

    (4,683

    )

     

    (3,864

    )

     

    21.2

    %

    Total United States

    78,745

     

     

    75,434

     

     

    4.4

    %

    International

     

     

     

     

     

    DEFINITY

    1,781

     

     

    1,395

     

     

    27.7

    %

    TechneLite

    3,742

     

     

    4,087

     

     

    (8.4

    )%

    Other nuclear

    6,438

     

     

    5,596

     

     

    15.0

    %

    Rebates and allowances

    (2

    )

     

    (2

    )

     

    %

    Total International

    11,959

     

     

    11,076

     

     

    8.0

    %

    Worldwide

     

     

     

     

     

    DEFINITY

    56,791

     

     

    51,111

     

     

    11.1

    %

    TechneLite

    23,098

     

     

    24,145

     

     

    (4.3

    )%

    Other nuclear

    15,500

     

     

    15,120

     

     

    2.5

    %

    Rebates and allowances

    (4,685

    )

     

    (3,866

    )

     

    21.2

    %

    Total Revenues

    $

    90,704

     

     

    $

    86,510

     

     

    4.8

    %

    Lantheus Holdings, Inc.

    Reconciliation of GAAP to Non-GAAP Financial Measures

    (in thousands, except per share data – unaudited)

     

     

     

    Three Months Ended

    March 31,

     

     

    2020

     

    2019

    Net income

     

    $

    3,337

     

     

    $

    9,949

     

    Stock and incentive plan compensation

     

    3,075

     

     

    2,781

     

    Amortization of acquired intangible assets

     

    392

     

     

    451

     

    Integration costs

     

    2,372

     

     

     

    Acquisition-related costs

     

    1,412

     

     

     

    Impairment of long-lived assets

     

    7,275

     

     

     

    Other

     

    (75

    )

     

     

    Income tax effect of non-GAAP adjustments(a)

     

    (3,506

    )

     

    (1,943

    )

    Adjusted net income

     

    $

    14,282

     

     

    $

    11,238

     

    Adjusted net income, as a percentage of revenues

     

    15.7

    %

     

    13.0

    %

     

     

    Three Months Ended

    March 31,

     

     

    2020

     

    2019

    Net income per share - diluted

     

    $

    0.08

     

     

    $

    0.25

     

    Stock and incentive plan compensation

     

    0.08

     

     

    0.07

     

    Amortization of acquired intangible assets

     

    0.01

     

     

    0.01

     

    Integration costs

     

    0.06

     

     

     

    Acquisition-related costs

     

    0.04

     

     

     

    Impairment of long-lived assets

     

    0.18

     

     

     

    Other

     

     

     

     

    Income tax effect of non-GAAP adjustments(a)

     

    (0.09

    )

     

    (0.05

    )

    Adjusted net income per share - diluted

     

    $

    0.36

     

     

    $

    0.28

     

    Weighted-average common shares outstanding - diluted

     

    40,102

     

     

    39,787

     

    (a) The income tax effect of the adjustments between GAAP net 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.

    Lantheus Holdings, Inc.

    Reconciliation of Free Cash Flow

    (in thousands – unaudited)

     

     

    Three Months Ended

    March 31,

     

    2020

     

    2019

    Net cash provided by operating activities

    $

    9,408

     

     

    $

    10,468

     

    Capital expenditures

    (2,698

    )

     

    (10,550

    )

    Free cash flow

    $

    6,710

     

     

    $

    (82

    )

    Lantheus Holdings, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands – unaudited)

     

     

    March 31,

    2020

     

    December 31,

    2019

    Assets

     

     

     

    Current assets

     

     

     

    Cash and cash equivalents

    $

    95,713

     

     

    $

    92,919

     

    Accounts receivable, net

    44,883

     

     

    43,529

     

    Inventory

    30,814

     

     

    29,180

     

    Other current assets

    8,967

     

     

    7,283

     

    Total current assets

    180,377

     

     

    172,911

     

    Property, plant and equipment, net

    108,613

     

     

    116,497

     

    Intangibles, net

    6,930

     

     

    7,336

     

    Goodwill

    15,714

     

     

    15,714

     

    Deferred tax assets, net

    70,454

     

     

    71,834

     

    Other long-term assets

    22,037

     

     

    21,627

     

    Total assets

    $

    404,125

     

     

    $

    405,919

     

    Liabilities and stockholders' equity

     

     

     

    Current liabilities

     

     

     

    Current portion of long-term debt and other borrowings

    $

    10,143

     

     

    $

    10,143

     

    Accounts payable

    18,980

     

     

    18,608

     

    Accrued expenses and other liabilities

    32,836

     

     

    37,360

     

    Total current liabilities

    61,959

     

     

    66,111

     

    Asset retirement obligations

    13,243

     

     

    12,883

     

    Long-term debt, net and other borrowings

    181,488

     

     

    183,927

     

    Other long-term liabilities

    29,037

     

     

    28,397

     

    Total liabilities

    285,727

     

     

    291,318

     

    Total stockholders' equity

    118,398

     

     

    114,601

     

    Total liabilities and stockholders' equity

    $

    404,125

     

     

    $

    405,919

     

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  24. Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH) today announced that it will host a conference call at 8:00 a.m. ET on Thursday, April 30, 2020, to discuss its financial and operating results for the first 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 8385228. A live audio webcast of the call will also 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 the Company's website approximately two hours after completion of the call and will be archived for 30 days.

    About Lantheus Holdings, Inc. and Lantheus

    Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH) today announced that it will host a conference call at 8:00 a.m. ET on Thursday, April 30, 2020, to discuss its financial and operating results for the first 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 8385228. A live audio webcast of the call will also 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 the Company's website approximately two hours after completion of the call and will be archived for 30 days.

    About Lantheus Holdings, Inc. and Lantheus Medical Imaging, Inc.

    Lantheus Holdings, Inc. is the parent company of LMI, a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. LMI provides a broad portfolio of products, including the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension and TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures. The Company is headquartered in North Billerica, Massachusetts with offices in Puerto Rico and Canada. For more information, visit www.lantheus.com.

    View Full Article Hide Full Article
  25. Lantheus Holdings, Inc. (NASDAQ:LNTH) ("Lantheus" or the "Company"), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a leader in the development, manufacture and commercialization of innovative diagnostic imaging agents announced today that its preliminary unaudited revenue for the fiscal first quarter ended March 31, 2020 will be near the top end of previously disclosed guidance range issued on February 25, 2020.

    "For the first quarter of 2020, business results through the first two months were ahead of Company expectations," said Mary Anne Heino, President and CEO. "However, as COVID-19 reached a global pandemic level in March, procedural volumes declined. Although we do not currently have visibility as to the scope and duration…

    Lantheus Holdings, Inc. (NASDAQ:LNTH) ("Lantheus" or the "Company"), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a leader in the development, manufacture and commercialization of innovative diagnostic imaging agents announced today that its preliminary unaudited revenue for the fiscal first quarter ended March 31, 2020 will be near the top end of previously disclosed guidance range issued on February 25, 2020.

    "For the first quarter of 2020, business results through the first two months were ahead of Company expectations," said Mary Anne Heino, President and CEO. "H