LNTH Lantheus Holdings Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
PyL
Prostate cancer
|
NDA Filing
NDA Filing
|
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
|
|
flurpiridaz F 18
Coronary artery disease (CAD)
|
Phase 3
Phase 3
|
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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.
|
|
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
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Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced Mary Anne Heino, President and Chief Executive Officer, will present at the Wells Fargo 2020 Virtual Healthcare Conference at 4:00 p.m. ET on Thursday, September 10.
To access a live webcast of the presentation, please visit the Investors section of the Company's website at www.lantheus.com. A replay of the webcast will be available on the Company's website for 30 days following the live presentation.
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200903005271/en/
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Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for VIALMIX®RFID for DEFINITY®.
VIALMIXRFID is a next generation activation device designed specifically for DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension, an intravenous ultrasound enhancing agent, and our DEFINITY modified formulation product candidate. DEFINITY is supplied as a liquid-filled glass vial and requires activation in order to create the lipid-encapsulated microbubbles. The activation rate and time are controlled by VIALMIXRFID through the use of radio-frequency identification technology to ensure reproducible activation of DEFINITY. The RFID tag, which is affixed to the vial label, enables the DEFINITY vial to be appropriately activated when utilized with VIALMIXRFID activation device.
"The approval of VIALMIXRFID further strengthens and extends our core microbubble franchise," said Mary Anne Heino, President and Chief Executive Officer. "By controlling the activation rate and time, the RFID technology ensures reproducible activation of DEFINITY and reduces risks related to operator or medication errors, potentially increasing patient safety. Importantly, VIALMIXRFID has been designed to work with our currently approved DEFINITY vial and our DEFINITY modified formulation product candidate. I am grateful to the entire Lantheus team that worked tirelessly to bring this next generation activation device to the market."
A U.S. issued patent on the use of the new VIALMIXRFID with an expiration date of 2037 has been listed in the Orange Book, and additional patent applications have been submitted in major markets throughout the world.
About DEFINITY®
DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension (activated) is an ultrasound enhancing agent for use in patients with suboptimal echocardiograms (see Indications and Important Safety Information below and find full Prescribing Information at www.definityimaging.com).1 DEFINITY is engineered to produce small and consistently sized durable microbubbles to fully evaluate the left ventricle.1 DEFINITY has extensive safety experience and a consistent safety profile.2 Since its launch in 2001, more than 13 million echo studies have been performed with DEFINITY and it is the most prescribed ultrasound enhancing agent in the U.S.3
DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
INDICATIONS
Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
CONTRAINDICATIONS
Do not administer DEFINITY® to patients with known or suspected hypersensitivity to perflutren.
IMPORTANT SAFETY INFORMATION
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration.
- Assess all patients for the presence of any condition that precludes DEFINITY® administration [see Contraindications (4)].
- Always have resuscitation equipment and trained personnel readily available.
In post-marketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reported during or shortly following perflutren-containing microsphere administration [see Adverse Reactions (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [see Adverse Reactions (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.
Please see accompanying full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions, on www.definityimaging.com.
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate," "believe," "confident," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) our future operating results; (ii) the impact of the COVID-19 pandemic on our business, financial condition and prospects; (iii) regulatory risks related to our DEFINITY® modified formulation candidate; (iv) risks that the anticipated benefits of the acquisition of Progenics Pharmaceuticals, Inc. or other commercial opportunities may otherwise not be fully realized or may take longer to realize than expected; (v) expectations for future clinical trials, the timing and potential outcomes of clinical studies and filings and other interactions with regulatory authorities; and (vi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).
1 DEFINITY® (Package Insert), North Billerica, MA, Lantheus Medical Imaging, Inc., 2017.
2 Data on file, Lantheus Medical Imaging, Inc.
3 ©2020 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited.
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- Completed acquisition of Progenics Pharmaceuticals, Inc., adding robust portfolio of oncology therapeutics and diagnostics to pipeline
- Worldwide revenue of $66.0 million for the second quarter 2020, representing a decrease of 23.0% from the prior year period
- Net loss of $7.0 million for the second quarter 2020, compared to net income of $6.4 million in the prior year period
- GAAP diluted EPS of $(0.16) for the second quarter 2020, compared to GAAP diluted EPS of $0.16 in the prior year period; adjusted diluted EPS of $0.10 for the second quarter 2020, compared to adjusted diluted EPS of $0.27 in the prior year period
- Net cash used in operating activities was $2.2 million for the second quarter 2020. Free cash flow was a use of $4.4 million in the second quarter 2020
Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today reported financial results for its second quarter ended June 30, 2020.
On June 19, 2020, the Company completed the acquisition of Progenics Pharmaceuticals, adding three leading FDA approved products and an emerging clinical-stage pipeline of radiopharmaceutical therapeutics and diagnostics for the treatment of cancer.
The Company's worldwide revenue for the second quarter of 2020 totaled $66.0 million, compared with $85.7 million for the second quarter of 2019, representing a decrease of 23.0% from the prior year period.
The Company's second quarter 2020 net loss was $7.0 million, or $(0.16) per fully diluted share, as compared to net income of $6.4 million, or $0.16 per fully diluted share for the second quarter of 2019.
The Company's second quarter 2020 adjusted fully diluted earnings per share were $0.10, as compared to $0.27 for the second quarter of 2019, representing a decrease of 63.0% from the prior year period.
Lastly, net cash used in operating activities was $2.2 million for the second quarter 2020. Free Cash Flow was a use of $4.4 million in the second quarter of 2020, representing a decrease of approximately $22.0 million from the prior year period.
"As we continue to navigate through the COVID-19 global pandemic, the health and safety of our employees, patients, and other partners in the healthcare community remain our top priority. We closed our acquisition of Progenics in June and are now integrating our portfolio of innovative products and product candidates to enhance our diagnostic and therapeutic footprint," said Mary Anne Heino, President and CEO. "Procedures utilizing our products for the second quarter were impacted by COVID-related hospital and customer restrictions. However, we demonstrated an impressive month-to-month recovery in our business as healthcare markets across the U.S. began to re-open. As we look to the future, our focus will be on unlocking value across our newly combined company including our exciting portfolio of opportunities."
Outlook
On April 9, 2020, the Company withdrew full year 2020 revenue, revenue growth, and adjusted fully diluted earnings per share guidance as a result of the continued uncertainties surrounding the scope, duration and impacts of the COVID-19 pandemic. Due to these uncertainties, and uncertain timing of global recovery and economic normalization, Lantheus continues to be unable to provide guidance as to the overall impacts on its operations and financial results during the ongoing pandemic.
Internet Posting of Information
The Company routinely posts information that may be important to investors in the "Investors" section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company.
Conference Call and Webcast
As previously announced, the Company will host a conference call on Thursday, July 30, 2020 at 8:00 a.m. ET. To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1-678-509-7599 (international callers) and provide passcode 5565687. A live audio webcast of the call also will be available in the Investors section of the Company's website at www.lantheus.com.
A replay of the audio webcast will be available in the Investors section of our website at www.lantheus.com approximately two hours after completion of the call and will be archived for 30 days.
The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.
The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.
Non-GAAP Financial Measures
The Company uses non-GAAP financial measures, such as adjusted net income and its line components; adjusted net income per share - fully diluted; and free cash flow. The Company's management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the Company's operations, period over period. However, these measures may exclude items that may be highly variable, difficult to predict and of a size that could have a substantial impact on the Company's reported results of operations for a particular period. Management uses these and other non-GAAP measures internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains "forward-looking statements" as defined under U.S. federal securities laws, including statements about our 2020 outlook. Forward-looking statements may be identified by their use of terms such as anticipate, believe, confident, could, estimate, expect, intend, may, plan, predict, project, target, will and other similar terms. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) our future operating results; (ii) the impact of the COVID-19 pandemic on our business, financial condition and prospects; (iii) risks that the anticipated benefits of the acquisition of Progenics Pharmaceuticals, Inc. or other commercial opportunities may otherwise not be fully realized or may take longer to realize than expected; (iv) expectations for future clinical trials, the timing and potential outcomes of clinical studies and filings and other interactions with regulatory authorities; and (v) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).
- Tables Follow -
Lantheus Holdings, Inc.
Consolidated Statements of Operations
(in thousands, except per share data – unaudited)
Three Months Ended
June 30,Six Months Ended
June 30,2020
2019
2020
2019
Revenues
$
66,010
$
85,705
$
156,714
$
172,215
Cost of goods sold
40,162
41,132
92,864
83,558
Gross profit
25,848
44,573
63,850
88,657
Operating expenses
Sales and marketing
6,305
10,948
16,435
21,345
General and administrative
20,670
13,293
37,369
25,882
Research and development
4,418
5,795
8,466
10,724
Total operating expenses
31,393
30,036
62,270
57,951
Operating (loss) income
(5,545)
14,537
1,580
30,706
Interest expense
1,914
4,543
3,860
9,135
Loss on extinguishment of debt
—
3,196
—
3,196
Other income
(756)
(1,312)
(1,106)
(2,499)
(Loss) income before income taxes
(6,703)
8,110
(1,174)
20,874
Income tax expense
309
1,698
2,501
4,513
Net (loss) income
$
(7,012)
$
6,412
$
(3,675)
$
16,361
Net (loss) income per common share:
Basic
$
(0.16)
$
0.16
$
(0.09)
$
0.42
Diluted
$
(0.16)
$
0.16
$
(0.09)
$
0.41
Weighted-average common shares outstanding:
Basic
43,135
38,972
41,284
38,789
Diluted
43,135
40,239
41,284
40,064
Lantheus Holdings, Inc.
Consolidated Segment Revenues Analysis
(in thousands – unaudited)
Three Months Ended
June 30,Six Months Ended
June 30,2020
2019
% Change
2020
2019
% Change
United States
DEFINITY
$
39,544
$
53,466
(26.0)
%
$
94,554
$
103,182
(8.4)
%
TechneLite
15,591
16,865
(7.6)
%
34,947
36,923
(5.4)
%
Other nuclear
5,804
9,127
(36.4)
%
14,866
18,651
(20.3)
%
Rebates and allowances
(3,540)
(4,268)
(17.1)
%
(8,223)
(8,132)
1.1
%
Total United States
57,399
75,190
(23.7)
%
136,144
150,624
(9.6)
%
International
DEFINITY
821
1,163
(29.4)
%
2,602
2,558
1.7
%
TechneLite
3,318
3,241
2.4
%
7,060
7,328
(3.7)
%
Other nuclear
4,473
6,119
(26.9)
%
10,911
11,715
(6.9)
%
Rebates and allowances
(1)
(8)
(87.5)
%
(3)
(10)
(70.0)
%
Total International
8,611
10,515
(18.1)
%
20,570
21,591
(4.7)
%
Worldwide
DEFINITY
40,365
54,629
(26.1)
%
97,156
105,740
(8.1)
%
TechneLite
18,909
20,106
(6.0)
%
42,007
44,251
(5.1)
%
Other nuclear
10,277
15,246
(32.6)
%
25,777
30,366
(15.1)
%
Rebates and allowances
(3,541)
(4,276)
(17.2)
%
(8,226)
(8,142)
1.0
%
Total Revenues
$
66,010
$
85,705
(23.0)
%
$
156,714
$
172,215
(9.0)
%
Lantheus Holdings, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(in thousands, except per share data – unaudited)
Three Months Ended
June 30,Six Months Ended
June 30,2020
2019
2020
2019
Net (loss) income
$
(7,012)
$
6,412
$
(3,675)
$
16,361
Stock and incentive plan compensation
3,385
3,376
6,460
6,157
Amortization of acquired intangible assets
927
451
1,319
902
Non-recurring refinancing related fees
460
—
460
—
Extinguishment of debt
—
3,196
—
3,196
Strategic collaboration and license costs
—
300
—
300
Integration costs
1,201
—
3,573
—
Acquisition-related costs
7,517
—
8,929
—
Impairment of long-lived assets
—
—
7,275
—
Other
—
—
(75)
—
Income tax effect of non-GAAP adjustments(a)
(1,940)
(2,852)
(5,446)
(4,795)
Adjusted net income
$
4,538
$
10,883
$
18,820
$
22,121
Adjusted net income, as a percentage of revenues
6.9
%
12.7
%
12.0
%
12.8
%
Three Months Ended
June 30,Six Months Ended
June 30,2020
2019
2020
2019
Net (loss) income per share - diluted
$
(0.16)
$
0.16
$
(0.09)
$
0.41
Stock and incentive plan compensation
0.08
0.08
0.14
0.15
Amortization of acquired intangible assets
0.02
0.01
0.03
0.02
Non-recurring refinancing related fees
0.01
—
0.01
—
Extinguishment of debt
—
0.08
—
0.08
Strategic collaboration and license costs
—
0.01
—
0.01
Integration costs
0.03
—
0.09
—
Acquisition-related costs
0.18
—
0.22
—
Impairment of long-lived assets
—
—
0.18
—
Income tax effect of non-GAAP adjustments(a)
(0.06)
(0.07)
(0.13)
(0.12)
Adjusted net income per share - diluted
$
0.10
$
0.27
$
0.45
$
0.55
Weighted-average common shares outstanding - diluted(b)
43,303
40,239
41,702
40,064
- The income tax effect of the adjustments between GAAP net income (loss) and non-GAAP adjusted net income takes into account the tax treatment and related tax rate that apply to each adjustment in the applicable tax jurisdiction.
-
Diluted shares may differ for non-GAAP measures as compared to GAAP due to a GAAP net loss position.
Lantheus Holdings, Inc.
Reconciliation of Free Cash Flow
(in thousands – unaudited)
Three Months Ended
June 30,Six Months Ended
June 30,2020
2019
2020
2019
Net cash (used in) provided by operating activities
$
(2,156)
$
21,053
$
7,252
$
31,521
Capital expenditures
(2,255)
(3,434)
(4,953)
(13,984)
Free cash flow
$
(4,411)
$
17,619
$
2,299
$
17,537
Lantheus Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands – unaudited)
June 30,
2020December 31,
2019Assets
Current assets
Cash and cash equivalents
$
90,309
$
92,919
Accounts receivable, net
46,883
43,529
Inventory
35,334
29,180
Other current assets
8,630
7,283
Total current assets
181,156
172,911
Property, plant and equipment, net
122,903
116,497
Intangibles, net
389,512
7,336
Goodwill
57,765
15,714
Deferred tax assets, net
67,441
71,834
Other long-term assets
60,918
21,627
Total assets
$
879,695
$
405,919
Liabilities and stockholders' equity
Current liabilities
Current portion of long-term debt and other borrowings
$
17,143
$
10,143
Accounts payable
16,301
18,608
Accrued expenses and other liabilities
42,892
37,360
Total current liabilities
76,336
66,111
Asset retirement obligations
13,602
12,883
Long-term debt, net and other borrowings
210,010
183,927
Other long-term liabilities
64,164
28,397
Total liabilities
364,112
291,318
Total stockholders' equity
515,583
114,601
Total liabilities and stockholders' equity
$
879,695
$
405,919
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Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH) today announced that it will host a conference call at 8:00 a.m. ET on Thursday, July 30, 2020, to discuss its financial and operating results for the second quarter of 2020.
To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1‑678-509-7599 (international callers) and provide passcode 5565687. A live audio webcast of the call will also be available in the Investors section of the Company's website at www.lantheus.com.
A replay of the audio webcast will be available in the Investors section of the Company's website approximately two hours after completion of the call and will be archived for 30 days.
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20200723005082/en/
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Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced that 17 abstracts highlighting PyL™ (18F-DCFPyL) have been selected for presentation at the virtual Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2020 Annual Meeting taking place July 11-14, 2020. PyL is the PSMA-targeted small molecule positron emission tomography (PET) imaging investigational agent designed to visualize prostate cancer, which the Company recently purchased as part of the oncology business of Progenics.
The abstracts to be presented at the meeting will feature data on PyL from two presentations based on Company-sponsored studies, including the positive results from the Phase 3 CONDOR trial evaluating the diagnostic performance and clinical impact of PyL in patients with biochemical recurrence of prostate cancer. A third abstract focuses on the digital solution the Company is developing in parallel with PyL to potentially support prostate cancer staging using an automated miPSMA Index of the PET/CT PyL-PSMA images.
"Physicians and patients continue to experience an unmet need for diagnostic imaging that could assist in staging high risk prostate cancer and reliably detect recurrent or metastatic disease. The unmet need is particularly important among patients with low PSA values," said Istvan Molnar, M.D., the Company's Chief Medical Officer. "We believe that the demonstrated strong diagnostic performance of our PSMA-targeted PET imaging investigational agent, PyL, could provide clinicians with actionable information. In addition, the use of the widely available isotope fluorine-18 may result in broad patient accessibility. Data to be presented at SNMMI this year further highlights PyL's clinical potential, including the positive Phase 3 results of the CONDOR study, which achieved its primary endpoint with a correct localization rate of 84.8% to 87.0% among the three blinded independent readers. We remain on track to submit a New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") for PyL in the third quarter of 2020."
SNMMI presentations will be made available on July 11, 2020 and can be found in the virtual Science Pavilion.
Details for the SNMMI 2020 presentations based on Company-sponsored studies and Company-led digital solution development are as follows:
Title: Diagnostic Performance of PSMA-Targeted 18F-DCFPyL PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the Phase 3, Multicenter CONDOR Study
Lead Author: Steven Rowe, Johns Hopkins UniversityTitle: miPSMA Index: Comprehensive and Automated Quantification of 18F-DCFPyL (PyL-PSMA) PET/CT for Prostate Cancer Staging
Lead Author: Kerstin Johnsson, Progenics PharmaceuticalsTitle: Measuring bias in quantitative PET biomarkers in-vivo
Lead Author: Martin Lodge, Johns Hopkins UniversityAbout PyL™ for PET Imaging of Prostate Cancer
PyL (also known as 18F-DCFPyL) is a fluorinated PSMA-targeted positron emission tomography (PET) imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.
About Prostate Cancer
Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 174,650 new cases of prostate cancer will be diagnosed and about 31,620 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc.; and AZEDRA® for the treatment of certain rare neurological cancers. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.
Safe Harbor for Forward-Looking and Cautionary Statements
This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements are based upon current plans, estimates and expectations that are subject to various risks and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "target," "contemplate," "estimate," "predict," "potential," "opportunity," "creates" and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, are forward-looking statements. Important factors that could cause actual results to differ materially from Lantheus' plans, estimates or expectations could include, but are not limited to: (i) the timing of the filing of the Company's PyL NDA with the FDA; (ii) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and other regulatory authorities; (iii) the Company's ability to successfully launch PyL as a commercial product; (iv) the market receptivity to PyL as a new diagnostic agent; (v) the safety and efficacy of PyL; and (vi) the intellectual property protection of PyL. Additional factors that may affect the future results of Lantheus are set forth in Lantheus' filings with the SEC, including Lantheus' most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SEC's website at www.sec.gov. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements. Readers should also carefully review the risk factors described in other documents that Lantheus file from time to time with the SEC. The forward-looking statements in this document speak only as of the date of these materials. Except as required by law, Lantheus assumes no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
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