LNTH Lantheus Holdings Inc.

13.49
+0.03  (+0%)
Previous Close 13.46
Open 13.49
52 Week Low 8.67
52 Week High 21.42
Market Cap $902,094,579
Shares 66,871,355
Float 59,988,703
Enterprise Value $1,014,840,031
Volume 360,631
Av. Daily Volume 502,066
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Drug Pipeline

Drug Stage Notes
1095
Prostate Cancer
Phase 2
Phase 2
Phase 2 enrolment has paused due to COVID-19.
flurpiridaz F 18
Coronary artery disease (CAD)
Phase 3
Phase 3
Phase 3 trial ongoing.
PyL
Prostate cancer
NDA Filing
NDA Filing
NDA filing announced September 30, 2020.
Subcutaneous RELISTOR
Chronic pain
Approved
Approved
Approved September 29, 2014.
Oral RELISTOR
Chronic pain
Approved
Approved
Approved July 19 2016.
1404
Help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA)
Phase 3
Phase 3
Phase 3 trial met one of two co-primary endpoints.
Azedra
Pheochromocytoma
Approved
Approved
FDA approval announced July 30, 2018.
DEFINITY (BENEFIT 1)
Left Ventricular Ejection Fraction
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - February 3, 2020.

Latest News

  1. 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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  2. 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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  3. 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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  4. 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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