LNTH Lantheus Holdings Inc.
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
-
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- Worldwide revenue of $94.2 million and $339.4 million for the fourth quarter and full year 2020, representing an increase of 5.4% and a decline of 2.3% over the prior year period, respectively
- Net loss of $3.4 million and $13.5 million for the fourth quarter and full year 2020, compared to net income of $10.5 million and $31.7 million for the fourth quarter and full year 2019
- GAAP fully diluted net loss of $0.05 and $0.25 for the fourth quarter and full year 2020, compared to GAAP fully diluted net income of $0.26 and $0.79 for the fourth quarter and full year 2019; adjusted fully diluted EPS of $0.07 and $0.47 for the fourth quarter and full year 2020, compared to adjusted fully diluted EPS of $0.34 and $1.17 for the fourth quarter and full year 2019
- Net cash provided by operating activities was $0.6 million and $16.4 million for the fourth quarter and full year 2020. Free cash flow of $(3.2) million and $3.9 million for the fourth quarter and full year 2020, compared to free cash flow of $17.7 million and $58.3 million for the fourth quarter and full year 2019
- The Company provides first quarter and full year 2021 revenue and adjusted fully diluted earnings per share guidance
Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today reported financial results for its fourth quarter and full year ended December 31, 2020.
The Company's worldwide revenue for the fourth quarter of 2020 totaled $94.2 million, compared with $89.3 million for the fourth quarter of 2019, representing an increase of 5.4% over the prior year period. Full year 2020 worldwide revenues were $339.4 million, compared with $347.3 million for the full year 2019, representing a decrease of 2.3% over the prior year period.
The Company's fourth quarter 2020 net loss was $3.4 million, or $0.05 per fully diluted share, as compared to net income of $10.5 million, or $0.26 per fully diluted share for the fourth quarter of 2019. Full year 2020 net loss was $13.5 million, or $0.25 per fully diluted share, as compared to net income of $31.7 million, or $0.79 per fully diluted share for the full year 2019.
The Company's fourth quarter 2020 adjusted fully diluted earnings per share were $0.07, as compared to $0.34 for the fourth quarter of 2019, representing a decrease of 79.9% over the prior year period. The Company's full year 2020 adjusted fully diluted earnings per share were $0.47, as compared to $1.17 for the full year 2019, representing a decrease of 59.5% over the prior year period.
Lastly, net cash provided by operating activities was $0.6 million and $16.4 million for the fourth quarter and full year 2020. Free Cash Flow was $(3.2) million for the fourth quarter of 2020, representing a decrease of approximately $20.9 million from the prior year period. Full year 2020 free cash flow was $3.9 million, as compared to $58.3 million for the full year 2019, representing a decrease of approximately $54.4 million from the prior year period.
"While 2020 presented extraordinary challenges, I thank our team for continuing to manufacture and deliver products to our customers throughout the year," said Mary Anne Heino, President and CEO. "Our fourth quarter revenue growth was 5.4% over the prior year period and also represented steady improvement over the prior two quarters of 2020. During 2020, we advanced our strategic mandate by closing the Progenics acquisition in June and receiving FDA approval for DEFINITY RT in November as well as FDA acceptance and Priority Review designation for our PyL NDA in December. In 2021, we will continue to drive sustainable growth, expand product offerings to our customers, improve the lives of the patients we serve, and create value for our shareholders."
Outlook
The Company guidance for the first quarter and full year 2021 is as follows:
Guidance Issued February 25, 2021
Q1 FY 2021 Revenue
$85 million - $89 million
Q1 FY 2021 Adjusted Fully Diluted EPS
$(0.03) - $0.00
Guidance Issued February 25, 2021
FY 2021 Revenue
$385 million - $400 million
FY 2021 Adjusted Fully Diluted EPS
$0.34 - $0.39
On a forward-looking basis, the Company does not provide GAAP income per common share guidance or a reconciliation of adjusted fully diluted EPS to GAAP income per common share because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any one-time, non-recurring charges. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. As a result, it is the Company's view that a quantitative reconciliation of adjusted fully diluted EPS on a forward-looking basis is not available without unreasonable effort.
Internet Posting of Information
The Company routinely posts information that may be important to investors in the "Investors" section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company.
Conference Call and Webcast
As previously announced, the Company will host a conference call and webcast on Thursday, February 25, 2021 at 4:30 p.m. ET. To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1-678-509-7599 (international callers) and provide passcode 5247866. A live webcast will be available in the Investors section of the Company's website at www.lantheus.com.
A replay of the audio webcast will be available in the Investors section of our website at www.lantheus.com approximately two hours after completion of the call and will be archived for 30 days.
The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.
The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow™ serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.
Non-GAAP Financial Measures
The Company uses non-GAAP financial measures, such as adjusted net income and its line components; adjusted net income per share - fully diluted; and free cash flow. The Company's management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the Company's operations, period over period. However, these measures may exclude items that may be highly variable, difficult to predict and of a size that could have a substantial impact on the Company's reported results of operations for a particular period. Management uses these and other non-GAAP measures internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.
This press release includes forward-looking non-GAAP guidance for 2021 adjusted fully diluted EPS. No reconciliation of this forward-looking non-GAAP guidance is included in this press release because, due to the high variability and difficulty in making accurate forecasts and projections of some of the information that would be required to prepare such a reconciliation and the fact that some of the excluded information is not readily ascertainable or accessible, the Company is unable to quantify certain amounts that would be required to be included in the most directly comparable GAAP financial measure without unreasonable efforts.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate," "believe," "confident," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include : (i) the impact of the global COVID-19 pandemic on our business, financial conditions or prospects, or on the timing and enrollment of our clinical trials; (ii) continued market expansion and penetration for our commercial products, particularly DEFINITY, in the face of segment competition and potential generic competition as a result of patent and regulatory exclusivity expirations; (iii) our efforts in new product development, including for PyL, our prostate cancer diagnostic imaging agent, including our ability to obtain U.S. Food and Drug Administration approval of PyL in 2021, and new clinical applications for our products; (iv) our dependence upon third parties for the manufacture and supply of PyL and the timing of that manufacturing capacity becoming available; (v) the global Molybdenum-99 supply; (vi) our products manufactured at Jubilant HollisterStier and our recently-approved modified formulation of DEFINITY ("DEFINITY RT") to be commercially manufactured at Samsung Biologics; (vii) the continued integration of the Progenics product and product candidate portfolio into our business following the June 2020 consummation of the Progenics acquisition; (viii) our ability to use in-house manufacturing capacity; (ix) the expected timing for commercialization of products we or our strategic partners may develop, including flurpiridaz F 18; (x) our ability to develop highly contextualized assessments of disease burden using artificial intelligence; and (xi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).
- Tables Follow -
Lantheus Holdings, Inc.
Consolidated Statements of Operations
(in thousands, except per share data – unaudited)
Three Months Ended
December 31,Year Ended
December 31,2020
2019
2020
2019
Revenues
$
94,152
$
89,346
$
339,410
$
347,337
Cost of goods sold
55,501
44,781
200,649
172,526
Gross profit
38,651
44,565
138,761
174,811
Operating expenses
Sales and marketing
12,857
10,392
40,901
41,888
General and administrative
13,684
17,301
69,270
61,244
Research and development
12,638
4,434
32,788
20,018
Total operating expenses
39,179
32,127
142,959
123,150
Operating (loss) income
(528
)
12,438
(4,198
)
51,661
Interest expense
2,811
2,126
9,479
13,617
Loss on extinguishment of debt
—
—
—
3,196
Other (income) loss
(496
)
7,916
(2,198
)
6,221
(Loss) income before income taxes
$
(2,843
)
$
2,396
$
(11,479
)
$
28,627
Income tax expense (benefit)
569
(8,054
)
1,994
(3,040
)
Net (loss) income
$
(3,412
)
$
10,450
$
(13,473
)
$
31,667
Net (loss) income per common share:
Basic
$
(0.05
)
$
0.27
$
(0.25
)
$
0.81
Diluted
$
(0.05
)
$
0.26
$
(0.25
)
$
0.79
Weighted-average common shares outstanding:
Basic
66,870
39,246
54,134
38,988
Diluted
66,870
40,133
54,134
40,113
Lantheus Holdings, Inc.
Consolidated Segment Revenues Analysis
(in thousands – unaudited)
Three Months Ended
December 31,Year Ended
December 31,2020
2019
% Change
2020
2019
% Change
U.S.
DEFINITY
58,924
57,678
2.2
%
207,270
211,777
(2.1
)
%
TechneLite
17,130
17,330
(1.2
)
%
69,729
72,534
(3.9
)
%
Other nuclear
10,427
8,225
26.8
%
36,864
36,231
1.7
%
Rebates and allowances
(5,304
)
(4,518
)
17.4
%
(19,067
)
(16,553
)
15.2
%
Total U.S. Revenues
81,177
78,715
3.1
%
294,796
303,989
(3.0
)
%
International
DEFINITY
1,807
1,695
6.6
%
6,046
5,731
5.5
%
TechneLite
5,615
3,264
72.0
%
16,512
14,058
17.5
%
Other nuclear
5,553
5,673
(2.1
)
%
22,060
23,574
(6.4
)
%
Rebates and allowances
—
(1
)
(100.0
)
%
(4
)
(15
)
(73.3
)
%
Total International Revenues
12,975
10,631
22.0
%
44,614
43,348
2.9
%
Worldwide
DEFINITY
60,731
59,373
2.3
%
213,316
217,508
(1.9
)
%
TechneLite
22,745
20,594
10.4
%
86,241
86,592
(0.4
)
%
Other nuclear
15,980
13,898
15.0
%
58,924
59,805
(1.5
)
%
Rebates and allowances
(5,304
)
(4,519
)
17.4
%
(19,071
)
(16,568
)
15.1
%
Total Revenues
$
94,152
$
89,346
5.4
%
$
339,410
$
347,337
(2.3
)
%
Lantheus Holdings, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(in thousands, except per share data – unaudited)
Three Months Ended
December 31,Year Ended
December 31,2020
2019
2020
2019
Net (loss) income
$
(3,412
)
$
10,450
$
(13,473
)
$
31,667
Stock and incentive plan compensation
3,623
2,991
14,075
12,571
Amortization of acquired intangible assets
4,683
451
10,770
1,804
Acquired debt fair value adjustment
(326
)
—
(711
)
—
Contingent consideration fair value adjustments
(2,800
)
—
(2,000
)
—
Non-recurring refinancing related fees
—
—
460
—
Non-recurring severance related fees
904
—
904
—
Extinguishment of debt
—
—
—
3,196
Arbitration award
—
(3,453
)
—
(3,453
)
Strategic collaboration and license costs
—
—
—
300
Integration costs
2,772
1,488
7,201
1,488
Acquisition-related costs
1,334
2,834
11,856
8,010
Impairment of long-lived assets
2,660
—
9,935
—
Other
35
—
(40
)
—
Income tax effect of non-GAAP adjustments(a)
(4,886
)
(1,134
)
(13,152
)
(8,583
)
Adjusted net income
$
4,587
$
13,627
$
25,825
$
47,000
Adjusted net income, as a percentage of revenues
4.9
%
15.3
%
7.6
%
13.5
%
Three Months Ended
December 31,Year Ended
December 31,2020
2019
2020
2019
Net (loss) income per share - diluted
$
(0.05
)
$
0.26
$
(0.25
)
$
0.79
Stock and incentive plan compensation
0.05
0.07
0.26
0.31
Amortization of acquired intangible assets
0.08
0.01
0.20
0.04
Acquired debt fair value adjustment
—
—
(0.01
)
—
Contingent consideration fair value adjustments
(0.04
)
—
(0.05
)
—
Non-recurring refinancing related fees
—
—
0.01
—
Non-recurring severance related fees
0.02
—
0.02
—
Extinguishment of debt
—
—
—
0.08
Arbitration award
—
(0.09
)
—
(0.09
)
Strategic collaboration and license costs
—
—
—
0.01
Integration costs
0.04
0.04
0.13
0.04
Acquisition-related costs
0.01
0.07
0.22
0.20
Impairment of long-lived assets
0.04
—
0.18
—
Income tax effect of non-GAAP adjustments(a)
(0.08
)
(0.02
)
(0.24
)
(0.21
)
Adjusted net income per share - diluted
$
0.07
$
0.34
$
0.47
$
1.17
Weighted-average common shares outstanding - diluted(b)
67,130
40,133
54,471
40,113
(a) The income tax effect of the adjustments between GAAP net (loss) income and non-GAAP adjusted net income takes into account the tax treatment and related tax rate that apply to each adjustment in the applicable tax jurisdiction.
(b) Diluted shares may differ for non-GAAP measures as compared to GAAP due to a GAAP net loss position.
Lantheus Holdings, Inc.
Reconciliation of Free Cash Flow
(in thousands – unaudited)
Three Months Ended
December 31,Year Ended
December 31,2020
2019
2020
2019
Net cash provided by operating activities
$
569
$
22,421
$
16,396
$
80,384
Capital expenditures
(3,785
)
(4,741
)
(12,474
)
(22,061
)
Free cash flow
$
(3,216
)
$
17,680
$
3,922
$
58,323
Lantheus Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands – unaudited)
December 31,
2020December 31,
2019Assets
Current assets
Cash and cash equivalents
$
79,612
$
92,919
Accounts receivable, net
54,002
43,529
Inventory
35,744
29,180
Other current assets
9,625
7,283
Assets held for sale
5,242
—
Total current assets
184,225
172,911
Property, plant and equipment, net
120,171
116,497
Intangibles, net
376,012
7,336
Goodwill
58,632
15,714
Deferred tax assets, net
70,147
71,834
Other long-term assets
60,634
21,627
Total assets
$
869,821
$
405,919
Liabilities and stockholders' equity
Current liabilities
Current portion of long-term debt and other borrowings
$
20,701
$
10,143
Accounts payable
16,284
18,608
Accrued expenses and other liabilities
41,726
37,360
Liabilities held for sale
1,793
—
Total current liabilities
80,504
66,111
Asset retirement obligations
14,020
12,883
Long-term debt, net and other borrowings
197,699
183,927
Other long-term liabilities
63,393
28,397
Total liabilities
355,616
291,318
Total stockholders' equity
514,205
114,601
Total liabilities and stockholders' equity
$
869,821
$
405,919
View source version on businesswire.com: https://www.businesswire.com/news/home/20210225005882/en/
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Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced Mary Anne Heino, President and Chief Executive Officer, and Bob Marshall, Chief Financial Officer and Treasurer, will present at the 10th Annual SVB Leerink Global Healthcare Conference at 3:00 p.m. ET on Friday, February 26.
To access a live webcast of the presentation, please visit the Investors section of the Company's website at www.lantheus.com. A replay of the webcast will be available on the Company's website for 30 days following the live presentation.
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow™ serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210212005068/en/
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Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH) today announced that it will host a conference call and webcast at 4:30 p.m. ET on Thursday, February 25, 2021, to discuss its financial and operating results for the fourth quarter and full year of 2020.
To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1‑678-509-7599 (international callers) and provide passcode 5247866. A live webcast will also be available in the Investors section of the Company's website at www.lantheus.com.
A replay of the webcast will be available in the Investors section of the Company's website approximately two hours after completion of the call and will be archived for 30 days.
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow™ serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210211005736/en/
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Lantheus Holdings, Inc. (NASDAQ:LNTH) (the "Company"), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, announced today three abstracts featuring its PSMA-targeted pipeline of product candidates have been selected for poster presentations at the upcoming 2021 American Society for Clinical Oncology Genitourinary (ASCO GU) Virtual Meeting, which will be held from February 11-13, 2021. Two of the abstracts relate to PyL™, the Company's PET/CT imaging agent for prostate cancer, and the third abstract relates to 1095, the Company's radiopharmaceutical therapeutic for metastatic castration resistant prostate cancer.
The presentations will be made available for the duration of conference.
Details for the ASCO GU presentations based on Company-sponsored studies are as follows:
Date & Time: February 11, 2021, 8:00 AM-6:30 PM ET
Session Title: Poster Session: Prostate Cancer – Advanced Disease
Title: A prospective phase II/III study of PSMA-targeted 18F-DCFPyL-PET/CT in patients (pts) with prostate cancer (PCa) (OSPREY): A sub analysis of disease staging changes in PCa pts with recurrence or metastases on conventional imaging.
Presenter: Jeremy C. Durack, M.D., M.S., Memorial Sloan Kettering Cancer Center
Abstract No: 32Date & Time: February 11, 2021, 8:00 AM-6:30 PM ET
Session Title: Poster Session: Prostate Cancer – Advanced Disease
Title: PSMA-targeted imaging with 18F-DCFPyL-PET/CT in patients (pts) with biochemically recurrent prostate cancer (PCa): A phase III study (CONDOR) - A sub analysis of correct localization rate (CLR) and positive predictive value (PPV) by standard of truth.
Presenter: Frederic Pouliot, M.D., Ph.D., F.R.C.S.C., Centre Hospitalier Universitaire (CHU) de Québec-Université Laval
Abstract No: 33Date & Time: February 11, 2021, 8:00 AM-6:30 PM ET
Session Title: Trials in Progress Poster Session: Advanced Prostate Cancer
Title: A multicenter, randomized, controlled phase II study: Efficacy and safety of PSMA-targeted radioligand therapy I-131-1095 (1095) plus enzalutamide (enza) in 18F-DCFPyL PSMA scan avid, metastatic castration-resistant prostate cancer (mCRPC) patients post-abiraterone (abi) progression (ARROW).
Presenter: Oliver Sartor, M.D., Tulane Cancer Center
Abstract No: TPS187About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada, and Sweden. For more information, visit www.lantheus.com.View source version on businesswire.com: https://www.businesswire.com/news/home/20210204005162/en/
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Lantheus Holdings, Inc. (NASDAQ:LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for NM-01, a PD-L1 imaging biomarker, and will begin making the biomarker available to academic centers and pharmaceutical companies for use in immuno-oncology (I/O) clinical trials in 2021.
NM-01 is a proprietary radiopharmaceutical biomarker using a camelid single-domain antibody and a technetium-99 radioisotope that has demonstrated a high affinity for PD-L1 protein. NM-01 could provide a specific, non-invasive approach to patient assessment, including use in whole-body imaging, or virtual biopsy. NM-01 potentially allows detection of PD-L1 expression in tumors and could be used to evaluate patients before, during, or after treatment with I/O agents, including checkpoint inhibitors, in clinical trials. The market for checkpoint inhibitors is expected to grow from $25B in 2019 to $68B in 2026.1 Lantheus licensed NM-01 from NanoMab Technology Limited in 2019 and plans to provide NM-01 as a clinical research tool, together with support and analytics, to pharmaceutical companies and the largest academic centers conducting clinical research in I/O.
"Evaluation of patients for I/O therapy is a key challenge for companies developing new therapeutics in this high-growth field," said Etienne Montagut, Senior Vice President of Corporate Development at Lantheus. "With the filing of the DMF, Lantheus is pleased to take an important step forward in providing a novel clinical research tool with the potential to provide new information to optimize the use of I/O therapy."
NanoMab has completed a Phase 1 study using NM-01 in 30 non-small cell lung cancer (NSCLC) patients, and preliminary data of the first 16 patients were published in the February 22, 2019 issue of Journal of Nuclear Medicine (Xing et al.). Separately, an investigator-led clinical trial involving 30 patients with either NSCLC or melanoma is in progress at King's College London and Guy's and St Thomas' NHS Trust (NCT04436406); the study aims to monitor treatment response. A clinical trial authorization (CTA) was also granted by the Medicines Healthcare Products Regulatory Agency (MHRA) in November 2020 for a Phase 2 clinical study on NM-01 in NSCLC patients.
"We are very encouraged by the results of the Phase I study, which validated our innovative nanobody platform and demonstrated strong correlation with tissue-based biomarker," said Dr. H.H. Ting, Chief Executive Officer of NanoMab. "We are pleased that leading cancer research centers are progressing with the use of NM-01 in I/O clinical trials."
About a Drug Master File (DMF)
A Drug Master File (DMF) is a submission to the Food and Drug Administration that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.2
About NanoMab Technology Limited
NanoMab Technology Limited is a privately held biopharmaceutical company focusing on cancer precision therapies via the development of radiopharmaceuticals. The company's goal is to develop a pipeline of theranostics with its proprietary camelid antibody platform to address the unmet medical need for cancer patients across the world. An IMPD on NM-01 was filed with UK Medical Healthcare products Regulatory Agency (MHRA) last year. NanoMab is also developing its radio-labelled NM-02 for clinical trials in both imaging and treatment of breast and gastric cancers. NanoMab's third program, NM-03, a single domain antibody targeting a pan-cancer marker, is in preclinical development as a theranostic. NanoMab is registered in Hong Kong with offices in London and Shanghai (www.nano-mab.com).
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate," "believe," "confident," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will" and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) pharmaceutical company and academic center receptivity to NM-01 as a clinical research tool; (ii) the safety and efficacy of NM-01; (iii) regulatory risks related to NM-01; (iv) our dependence upon third parties for the manufacture and supply of NM-01; (v) expectations for future clinical trials, the timing and potential outcomes of clinical studies and filings and other interactions with regulatory authorities; (vi) the impact of legislative, regulatory, competitive and technological changes; and (vii) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).
1GlobalData Consensus Forecasts Accessed 01-11-2021 using the criteria immuno-oncology and targets PD-1, PDL-1 and CTLA-4
2Drug Master File Guidelines. Accessed at https://www.fda.gov/drugs/guidances-drugs/drug-master-files-guidelinesView source version on businesswire.com: https://www.businesswire.com/news/home/20210112005260/en/