LNTH Lantheus Holdings Inc.

21.01
-0.11  -1%
Previous Close 21.12
Open 20.92
52 Week Low 10.52
52 Week High 24.26
Market Cap $1,417,900,504
Shares 67,486,935
Float 46,318,848
Enterprise Value $1,538,188,067
Volume 339,284
Av. Daily Volume 668,333
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Upcoming Catalysts

Drug Stage Catalyst Date
PyL
Prostate cancer
PDUFA priority review
PDUFA priority review
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Drug Pipeline

Drug Stage Notes
flurpiridaz F 18
Coronary artery disease (CAD)
Phase 3
Phase 3
Phase 3 trial ongoing.
1095
Prostate Cancer
Phase 2
Phase 2
Phase 2 enrolment has paused due to COVID-19.
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

    • Worldwide revenue of $92.5 million for the first quarter 2021, representing an increase of 2.0% from the prior year period
    • Net income of $9.0 million for the first quarter 2021, compared to net income of $3.3 million in the prior year period
    • GAAP fully diluted EPS of $0.13 for the first quarter 2021, compared to GAAP fully diluted EPS of $0.08 in the prior year period; adjusted fully diluted EPS of $0.05 for the first quarter 2021, compared to adjusted fully diluted EPS of $0.36 in the prior year period
    • Net cash provided by operating activities was $9.8 million for the first quarter 2021. Free cash flow was $7.3 million in the first quarter 2021
    • The Company provides second quarter 2021 revenue and adjusted diluted earnings per share
    • Worldwide revenue of $92.5 million for the first quarter 2021, representing an increase of 2.0% from the prior year period
    • Net income of $9.0 million for the first quarter 2021, compared to net income of $3.3 million in the prior year period
    • GAAP fully diluted EPS of $0.13 for the first quarter 2021, compared to GAAP fully diluted EPS of $0.08 in the prior year period; adjusted fully diluted EPS of $0.05 for the first quarter 2021, compared to adjusted fully diluted EPS of $0.36 in the prior year period
    • Net cash provided by operating activities was $9.8 million for the first quarter 2021. Free cash flow was $7.3 million in the first quarter 2021
    • The Company provides second quarter 2021 revenue and adjusted diluted earnings per share guidance; updates full year guidance 

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, today reported financial results for its first quarter ended March 31, 2021.

    The Company's worldwide revenue for the first quarter of 2021 totaled $92.5 million, compared with $90.7 million for the first quarter of 2020, representing an increase of 2.0% from the prior year period.

    The Company's first quarter 2021 net income was $9.0 million, or $0.13 per fully diluted share, as compared to net income of $3.3 million, or $0.08 per fully diluted share for the first quarter of 2020.

    The Company's first quarter 2021 adjusted fully diluted earnings per share were $0.05, as compared to $0.36 for the first quarter of 2020, representing a decrease of 86.3% from the prior year period.

    Lastly, net cash provided by operating activities was $9.8 million for the first quarter 2021. Free Cash Flow was $7.3 million in the first quarter of 2021, representing an increase of approximately $0.6 million from the prior year period.

    "We had a strong start to 2021 with solid first quarter revenue and earnings overperformance driven mainly by DEFINITY volume. While COVID-19 did impact the early part of the quarter, we are encouraged by the continued trend toward in-person delivery of healthcare," said Mary Anne Heino, President and CEO. "Currently, we are focused on preparation for the potential FDA approval and commercial launch of PyL, a best-in-class PSMA prostate cancer imaging agent, to help drive long-term value for patients, healthcare professionals, and shareholders."

    Outlook

    The Company updates its guidance for full year 2021 and offers the following guidance for the second quarter.

     

     

    Q2 Guidance Issued May 4, 2021

     

    Previous Guidance Issued February 25, 2021

    Q2 FY 2021 Revenue

     

    $93 million - $97 million

     

    N/A

    Q2 FY 2021 Adjusted Diluted EPS

     

    $0.03 - $0.06

     

    N/A

     

     

    FY Guidance Updated May 4, 2021

     

    FY Guidance Issued February 25, 2021

    FY 2021 Revenue

     

    $390 million - $400 million

     

    $385 million - $400 million

    FY 2021 Adjusted Diluted EPS

     

    $0.36 - $0.41

     

    $0.34 - $0.39

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

    Internet Posting of Information

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

    Conference Call and Webcast

    As previously announced, the Company will host a conference call and webcast on Tuesday, May 4, 2021 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 9275247. A live webcast will be available in the Investors section of the Company's website at www.lantheus.com.

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

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

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

    About Lantheus Holdings, Inc.

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

    Non-GAAP Financial Measures

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

    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, including statements regarding potential U.S. Food and Drug Administration ("FDA") approval of PyL, 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 and prospects, and on the timing and enrollment of our clinical trials; (ii) continued market expansion and penetration for our commercial products, particularly DEFINITY, in the face of segment competition and potential generic competition as a result of patent and regulatory exclusivity expirations; (iii) our efforts in new product development, including for PyL, our prostate cancer diagnostic imaging agent, including our ability to obtain FDA approval of PyL in 2021, and new clinical applications for our products; (iv) our dependence upon third parties for the manufacture and supply of PyL and the timing of that manufacturing capacity becoming available; (v) the global Molybdenum-99 supply; (vi) our products manufactured at Jubilant HollisterStier and our recently-approved modified formulation of DEFINITY ("DEFINITY RT") to be commercially manufactured at Samsung Biologics; (vii) the continued integration of the Progenics product and product candidate portfolio into our business following the June 2020 consummation of the Progenics Acquisition; (viii) our ability to use in-house manufacturing capacity; (ix) the expected timing for commercialization of products we or our strategic partners may develop, including flurpiridaz F 18; (x) our ability to develop highly contextualized assessments of disease burden using artificial intelligence; and (xi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

     

    Lantheus Holdings, Inc.

    Consolidated Statements of Operations

    (in thousands, except per share data – unaudited)

     

     

     

    Three Months Ended

    March 31,

     

     

    2021

     

    2020

    Revenues

     

    $

    92,509

     

     

    $

    90,704

     

    Cost of goods sold

     

    51,479

     

     

    52,702

     

    Gross profit

     

    41,030

     

     

    38,002

     

    Operating expenses

     

     

     

     

    Sales and marketing

     

    14,173

     

     

    10,130

     

    General and administrative

     

    16,138

     

     

    16,699

     

    Research and development

     

    10,360

     

     

    4,048

     

    Total operating expenses

     

    40,671

     

     

    30,877

     

    Gain on sale of assets

     

    15,263

     

     

     

    Operating income

     

    15,622

     

     

    7,125

     

    Interest expense

     

    2,718

     

     

    1,946

     

    Gain on extinguishment of debt

     

    (889

    )

     

     

    Other income

     

    (549

    )

     

    (350

    )

    Income before income taxes

     

    $

    14,342

     

     

    $

    5,529

     

    Income tax expense

     

    5,334

     

     

    2,192

     

    Net income

     

    $

    9,008

     

     

    $

    3,337

     

    Net income per common share:

     

     

     

     

    Basic

     

    $

    0.13

     

     

    $

    0.08

     

    Diluted

     

    $

    0.13

     

     

    $

    0.08

     

    Weighted-average common shares outstanding:

     

     

     

     

    Basic

     

    67,094

     

     

    39,433

     

    Diluted

     

    67,714

     

     

    40,102

     

     

    Lantheus Holdings, Inc.

    Consolidated Revenues Analysis

    (in thousands – unaudited)

     

     

     

    Three Months Ended

    March 31,

     

     

    2021

    2020 (1)

    % Change

    DEFINITY

     

    $

    55,971

     

    $

    52,505

     

    6.6

    %

    TechneLite

     

    22,800

     

    22,779

     

    0.1

    %

    Other precision diagnostics

     

    6,984

     

    13,057

     

    (46.5)

    %

    Total precision diagnostics

     

    85,755

     

    88,341

     

    (2.9)

    %

    Radiopharmaceutical oncology

     

    1,500

     

    1,968

     

    (23.8)

    %

    Strategic partnerships and other

     

    5,254

     

    395

     

    1,230.1

    %

    Total revenues

     

    $

    92,509

     

    $

    90,704

     

    2.0

    %

    ________________________________

    1. The Company reclassified rebates and allowances of $4.7 million for the three months ended March 31, 2020 within each product category, which included $4.3 million for DEFINITY, $0.3 million for TechneLite and $0.1 million for other precision diagnostics.

       

     

    Lantheus Holdings, Inc.

    Reconciliation of GAAP to Non-GAAP Financial Measures

    (in thousands, except per share data – unaudited)

     

     

     

    Three Months Ended

    March 31,

     

     

    2021

     

    2020

    Net income

     

    $

    9,008

     

     

    $

    3,337

     

    Stock and incentive plan compensation

     

    3,317

     

     

    3,075

     

    Amortization of acquired intangible assets

     

    4,685

     

     

    392

     

    Acquired debt fair value adjustment

     

    (307

    )

     

     

    Contingent consideration fair value adjustments

     

    300

     

     

     

    Non-recurring severance related fees

     

    436

     

     

     

    Extinguishment of debt

     

    (889

    )

     

     

    Gain on sale of assets

     

    (15,263

    )

     

     

    Integration costs

     

    19

     

     

    2,372

     

    Acquisition-related costs

     

    (103

    )

     

    1,412

     

    Impairment of long-lived assets

     

     

     

    7,275

     

    Other

     

    10

     

     

    (75

    )

    Income tax effect of non-GAAP adjustments(a)

     

    2,083

     

     

    (3,506

    )

    Adjusted net income

     

    $

    3,296

     

     

    $

    14,282

     

    Adjusted net income, as a percentage of revenues

     

    3.6

    %

     

    15.7

    %

     

     

    Three Months Ended

    March 31,

     

     

    2021

     

     

    2020

     

    Net income per share - diluted

     

    $

    0.13

     

     

    $

    0.08

     

    Stock and incentive plan compensation

     

    0.05

     

     

    0.08

     

    Amortization of acquired intangible assets

     

    0.08

     

     

    0.01

     

    Acquired debt fair value adjustment

     

    (0.01

    )

     

     

    Contingent consideration fair value adjustments

     

    0.01

     

     

     

    Non-recurring severance related fees

     

    0.01

     

     

     

    Extinguishment of debt

     

    (0.01

    )

     

     

    Gain on sale of assets

     

    (0.23

    )

     

     

    Integration costs

     

     

     

    0.06

     

    Acquisition-related costs

     

    (0.01

    )

     

    0.04

     

    Impairment of long-lived assets

     

     

     

    0.18

     

    Other

     

     

     

     

    Income tax effect of non-GAAP adjustments(a)

     

    0.03

     

     

    (0.09

    )

    Adjusted net income per share - diluted

     

    $

    0.05

     

     

    $

    0.36

     

    Weighted-average common shares outstanding - diluted

     

    67,714

     

     

    40,102

     

    (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,

     

    2021

     

     

    2020

     

    Net cash provided by operating activities

    $

    9,818

     

     

    $

    9,408

     

    Capital expenditures

    (2,520

    )

     

    (2,698

    )

    Free cash flow

    $

    7,298

     

     

    $

    6,710

     

     

    Lantheus Holdings, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands – unaudited)

     

     

    March 31,

    2021

     

    December 31,

    2020

    Assets

     

     

     

    Current assets

     

     

     

    Cash and cash equivalents

    $

    68,861

     

    $

    79,612

    Accounts receivable, net

    58,991

     

    54,002

    Inventory

    30,357

     

    35,744

    Other current assets

    10,145

     

    9,625

    Assets held for sale

     

    5,242

    Total current assets

    168,354

     

    184,225

    Property, plant and equipment, net

    118,381

     

    120,171

    Intangibles, net

    371,331

     

    376,012

    Goodwill

    61,189

     

    58,632

    Deferred tax assets, net

    62,832

     

    70,147

    Other long-term assets

    61,361

     

    60,634

    Total assets

    $

    843,448

     

    $

    869,821

    Liabilities and stockholders' equity

     

     

     

    Current liabilities

     

     

     

    Current portion of long-term debt and other borrowings

    $

    10,251

     

    $

    20,701

    Accounts payable

    19,099

     

    16,284

    Accrued expenses and other liabilities

    35,240

     

    41,726

    Liabilities held for sale

     

    1,793

    Total current liabilities

    64,590

     

    80,504

    Asset retirement obligations

    14,408

     

    14,020

    Long-term debt, net and other borrowings

    171,474

     

    197,699

    Other long-term liabilities

    64,857

     

    63,393

    Total liabilities

    315,329

     

    355,616

    Total stockholders' equity

    528,119

     

    514,205

    Total liabilities and stockholders' equity

    $

    843,448

     

    $

    869,821

     

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  1. EXINI Diagnostics AB, a subsidiary of Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence (AI) solutions to Find, Fight and Follow serious medical conditions, announced today that it has received CE Mark clearance for aPROMISE in Europe.

    aPROMISE is artificial intelligence-based, deep learning-enabled, medical device software that allows healthcare professionals and researchers to perform quantitative assessment of prostate-specific membrane antigen (PSMA) PET/CT in oncology. aPROMISE includes a solution for automated body segmentation and marking, quantifying and reporting suspicious lesions in their anatomical…

    EXINI Diagnostics AB, a subsidiary of Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence (AI) solutions to Find, Fight and Follow serious medical conditions, announced today that it has received CE Mark clearance for aPROMISE in Europe.

    aPROMISE is artificial intelligence-based, deep learning-enabled, medical device software that allows healthcare professionals and researchers to perform quantitative assessment of prostate-specific membrane antigen (PSMA) PET/CT in oncology. aPROMISE includes a solution for automated body segmentation and marking, quantifying and reporting suspicious lesions in their anatomical context.1,2 The AI tool provides enhanced consistency in quantitative analysis and is intended to increase efficiency, accuracy and reproducibility of PSMA PET/CT image assessments.

    In a prospectively planned independent analysis of the PyL OSPREY trial, aPROMISE demonstrated a high reproducibility with an intraclass correlation coefficient (ICC) of 0.99 (95%CI 0.99 - 0.99). In metastatic prostate cancer patients, the sensitivity of aPROMISE in a pre-selection of lesions was 92% for regional lymph nodes, 91% for distant lymph nodes, and 87% for bone.

    "The Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) criteria has proposed a uniform language for objective reporting to assist physicians in assessing a patient's tumor burden and also provides clinically meaningful information to physicians for developing therapeutic plans," said Matthias Eiber, Department of Nuclear Medicine, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany. "With the introduction of automation to the PROMISE criteria, the software is able to facilitate adherence to standardized reporting in clinical practice by reducing reporting time and limitations of manual assessment."

    "The aPROMISE CE Mark clearance is an exciting milestone for Lantheus on the path to possible U.S. approval later this year," said Etienne Montagut, Sr. Vice President, Corporate Development. "We believe aPROMISE is a unique offering that could complement and strengthen our PSMA assets portfolio by improving their value and ease of use while assisting treating clinicians in their patient management decisions."

    About Prostate Cancer

    Prostate cancer is the second most common form of cancer affecting men in the United States - an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, 248,530 new cases of prostate cancer will be diagnosed, and 34,130 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.3

    About PyL

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

    OSPREY Phase 2/3 Trial

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

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

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

    About Lantheus Holdings, Inc.

    Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find Fight and Follow® serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, please 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 "believe," "could," "expect," "intend," "possible," "propose," "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 or aPROMISE; (ii) the Company's ability to successfully launch aPROMISE as a commercial product; (iii) the market receptivity to using artificial intelligence-based, deep learning-enabled, medical device software; (iv) the intellectual property protection of aPROMISE; 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).

    1 Deep Learning-Enabled Comprehensive Detection and Quantification of 18FDCFPyL (PyL-PSMA) PET/CT. Brynolfsson J, Johnsson K, Sahlstedt H, Richter J, et al, OP-548, 1006: Cutting Edge Science Track – TROP Session: AI -Radiomics and Modelling, EANM 2020.

    2 miPSMA Index: Comprehensive and Automated Quantification of 18F-DCFPyL (PyL-PSMA) PET/CT for Prostate Cancer Staging. Johnsson K, Sahlstedt H, Brynolfsson J, et al. J Nucl Med. 2020;61(1):1435

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

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  2. Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced a strategic collaboration with Allegheny Health Network (AHN), a western Pennsylvania healthcare delivery system headquartered in Pittsburgh, PA. Under the agreement, Lantheus' microbubbles will be used in combination with AHN's ultrasound-assisted non-viral gene transfer (UAGT) technology for the development of a proposed treatment for xerostomia.

    Xerostomia, a lack of saliva production leading to dry mouth, has a variety of causes, including radiotherapy and chemotherapy, the…

    Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced a strategic collaboration with Allegheny Health Network (AHN), a western Pennsylvania healthcare delivery system headquartered in Pittsburgh, PA. Under the agreement, Lantheus' microbubbles will be used in combination with AHN's ultrasound-assisted non-viral gene transfer (UAGT) technology for the development of a proposed treatment for xerostomia.

    Xerostomia, a lack of saliva production leading to dry mouth, has a variety of causes, including radiotherapy and chemotherapy, the chronic use of drugs and rheumatic and dysmetabolic diseases. It is also a common side effect of ionizing radiation used to treat head and neck cancer.1

    A proof of concept Phase 1 clinical trial sponsored by a third party showed that Aquaporin-1 (AQP1), a trans-membrane protein that facilitates water movement across lipid layers, restored saliva flow in a human population using an adenovirus-based vector encoding AQP1 to a single previously irradiated parotid gland.2 The results from this study led AHN to research using UAGT technology targeting the salivary gland, which combines the use of nonviral DNA vector and lipid microbubbles with a low-frequency acoustic field to create a ‘sonoporation' effect allowing gene transfer to the cells of the salivary gland without the introduction of viral antigens.3

    According to Mark Trombetta, MD, Director of Clinical Program Development for the AHN Cancer Institute, a radiation oncologist and co-investigator in the network's study of UAGT, thousands of cancer patients suffer from radiation-induced xerostomia, which can cause severe tooth decay, chronic oral pain, loss of taste, inability to eat properly and increased oral infections. Once xerostomia begins, it is a permanent condition.

    "We believe that UAGT may provide long-term relief of radiation-induced xerostomia, with adjustable dosing and potential for booster doses over time," said Warren Swegal, MD, an AHN head and neck surgeon and clinical lead of the network's UAGT program. "No other existing treatment offers a long-lasting solution for this life-altering condition, and we are thrilled to be able to further develop and improve the therapy by leveraging Lantheus' proven microbubble technology."

    "We are excited to support AHN in its efforts to progress this innovative development program. Xerostomia is a chronic and debilitating condition with limited treatment options for patients," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "We believe our microbubble combined with AHN's UAGT technology have the potential to make a difference in the lives of these patients."

    Lantheus will supply its microbubbles and activation devices to AHN. AHN will be solely responsible for all development work, future regulatory submissions and commercialization. The deal terms include a transfer price and royalties.

    About Lantheus Holdings, Inc.

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

    About Allegheny Health Network

    Allegheny Health Network (AHN.org) is an integrated healthcare delivery system serving the greater Western Pennsylvania region. The Network is composed of 13 hospitals, ambulatory surgery centers, Health + Wellness Pavilions, an employed physician organization, home and community-based health services, a research institute and a group purchasing organization. The Network provides patients with access to a complete spectrum of advanced medical services, including nationally recognized programs for primary and emergency care, cardiovascular disease, cancer care, orthopedic surgery, neurology and neurosurgery, women's health, autoimmune diseases, diabetes and more. AHN employs approximately 21,000 people, has more than 2,600 physicians on its medical staff and serves as a clinical campus for Drexel University College of Medicine and the Lake Erie College of Osteopathic Medicine.

    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," "potential," "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) expectations for future clinical trials, the timing and potential outcomes of clinical studies and filings and other interactions with regulatory authorities; (ii) the impact of legislative, regulatory, competitive and technological changes; (iii) AHN's ability to successfully launch its UAGT technology with our microbubble as a commercial product; and (iv) 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).

    1Pinna R, Campus G, Cumbo E, Mura I, Milia E. Xerostomia induced by radiotherapy: an overview of the physiopathology, clinical evidence, and management of the oral damage. Ther Clin Risk Manag. 2015; 11:171-188.

    2https://clinicaltrials.gov/ct2/show/NCT02446249

    3Wang Z, Zourelias L, Wu C, Edwards PC, Trombetta M, Passineau MJ. Ultrasound-assisted nonviral gene transfer of AQP1 to the irradiated minipig parotid gland restores fluid secretion. Gene Therapy. 2015; 22:739-749.

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  3. 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 Tuesday, May 4, 2021, to discuss its financial and operating results for the first quarter of 2021.

    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 9275247. 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…

    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 Tuesday, May 4, 2021, to discuss its financial and operating results for the first quarter of 2021.

    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 9275247. A live webcast will also be available in the Investors section of the Company's website at www.lantheus.com.

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

    About Lantheus Holdings, Inc.

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

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

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

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

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

    Bela Denes, MD Joins as Vice President of Medical Affairs

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

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

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

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

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

    About Lantheus Holdings, Inc.

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

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